Conditions: Efficacy and Safety
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 733
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) as a treatment for outpatients COVID-19 subjects.

Detailed description:
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of Proxalutamide (GT0918) in adult outpatients diagnosed with mild to moderate COVID-19. The study will be 2-arm comparison against matched placebo. The study will be conducted in around 100 sites in the USA and other countries. This study utilizes an adaptive design that maximizes our efficiency in identifying a safe and efficacious therapeutic agent for COVID-19 during the current outbreak. There will be an interim analysis after 334 subjects complete Day 28 after the first dose to allow early stopping for futility, efficacy, or safety. The study population will be subjects with mild to moderate COVID-19 illness chosen to evaluate if early intervention with anti-androgen therapy prior to respiratory compromise can effectively prevent progression to the severe form of COVID-19 illness. Randomization is essential for establishing efficacy of these new therapeutic agents.

The blood samples for PK analysis need to be collected for at least 200 subjects, whom will also be randomized into the interventional treatment or placebo group with 1:1 ratio.

Arms:
arm 1: Proxalutamide 200mg, oral, QD, for continuous 14 days, plus standard of care(n=334) arm 2: Placebo 200mg, oral, QD, for continuous 14 days, plus standard of care(n=334)

Interventions: intervention 1: Proxalutamide (GT0918) intervention 2: Placebo
Intervention descriptions: intervention 1: Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory intervention 2: Placebo+Standard of care determined by PI and local regulatory

Protocol document:
ICF_002.pdf: 
Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
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MODEL INFORMED CONSENT FORM 
VERSION LOG 
Version 
Date 
Reason for Change 
1.0 
13 April 2021 
Not applicable 
2.0 
09July 2021 
Protocol Amendment 1 – 08Jul2021 
 
 
 
 
 
 
 
 
 
 
 
 


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Model Informed Consent Form 
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CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
 
Title of Study 
A Randomized, Double-blind, Placebo-
Controlled, Phase 3 Study to Evaluate the 
Efficacy and Safety of Proxalutamide (GT0918) 
in Outpatients with Mild to Moderate COVID-
19 Illness 
Protocol Number 
GT0918-US-3001 
Aligned with protocol version and 
date 
Version 2.0, 08Jul2021 
Sponsor 
Suzhou Kintor Pharmaceuticals, Inc. 
Investigator 
(to be filled in at each site) 
Title of Investigator 
(to be filled in at each site [delete, if study subjects 
are located outside Japan]) 
Subject 
(to be filled in at each site) 
 
CONCISE SUMMARY 
Being a participant in this research study is voluntary; it is your choice. If you join this 
study, you can still stop at any time. Do not join this study unless all your questions are 
answered. 
You are being asked to take part in this study because you recently tested positive for 
SARS-CoV-2, which is the virus that causes the COVID-19 illness. This study is being 
done to find out if a new investigational drug, GT0918 (proxalutamide), helps your 
COVID-19 better than other drugs or types of treatments that are currently available and 
approved to be sold in the market. 
By participating in this study, you may reduce the chance of progressing to severe illness 
and needing to go to the hospital. 
There are treatments, referred to as “standard of care,” that are available to treat your 
COVID-19 that your doctor will use if you do not want to join this research study. 


Suzhou Kintor Pharmaceuticals, Inc. 
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GT0918-US-3001, Version 2.0, 09 July 2021 
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Researchers believe that this new drug GT0918 might work better because it has been 
shown to be effective in inhibiting the entry and spread of the SARS-CoV-2. 
You will undergo a 1-day screening that includes a physical examination, measurement 
of vital signs, blood draw, and nasopharyngeal swab. Once screening is complete, you 
will be assigned to one of two groups to receive GT0918 plus standard of care or placebo 
plus standard of care. You will take the study medication daily for 14 consecutive days 
and will complete a daily diary and questionnaire. You will have 3 study visits during 
which you will have measurement of vital signs, a blood draw, and a nasopharyngeal 
swab. You will have a follow-up visit, with a measurement of vital signs, a blood draw, 
and a nasopharyngeal swab, 14 days following your last dose of study medication. You 
will have a safety follow-up phone call 14 days after that. The total duration of the study 
is about 6 weeks. 
There are risks that may affect you due to GT0918. You may experience fatigue, 
decreased appetite, diarrhea, stomach pain, and confusion or dizziness. A comprehensive 
list of risks and discomforts is described later in this document. 
It is not known whether GT0918 will have any benefit for you different from the 
treatment that your doctor would normally choose. By participating in this research 
study, you may help doctors answer this question.  
Being in the study will not cost anything, although you or your insurance will be billed 
for standard medical care. 
 
This form is for use in a research study that may involve subjects who may or may not have the 
capacity to consent to take part in the study. When the subject cannot legally consent to take part, 
the pronouns “you” and “your” should be read as referring to the subject rather than the person 
(legally authorized representative) who is signing this form for the subject. In cases where the 
subject’s representative gives consent, the subject should be informed about the study to the extent 
possible given his/her understanding. During the course of the study, if the subject regains the 
capacity to consent, informed consent will be obtained from the subject and the subject offered the 
ability to leave the study if desired. 
1 WHY HAVE I BEEN GIVEN THIS FORM? 
You are invited to review this consent form because you recently tested positive for SARS-CoV-
2 which is the virus that causes the COVID-19 illness. 
Coronavirus disease 2019 (COVID-19) emerged in late 2019 and spread rapidly, resulting in a 
global pandemic. COVID-19 is caused by a novel coronavirus (SARS-CoV-2), and infected 
persons can have a wide range of disease severity, with many patients showing mild or moderate 
disease. Although many therapies have been and are being explored in various stages of 


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COVID- 19, for the large population with mild and moderate COVID-19, limited treatments are 
available. 
The study drug, GT0918 (proxalutamide), is a new androgen receptor (AR) antagonist that has 
been shown to be effective in inhibiting virus entry and replication. GT0918 is an investigational 
drug, which means that it is still being studied and has not been approved by the United States 
Food and Drug Administration (FDA), European Medicines Agency (EMA) in Europe, the 
National Medical Products Administration (NMPA) in China, or any other regulatory authorities 
to be prescribed by doctors. Throughout this information consent form, GT0918 will be referred 
to as the “study drug.” 
This clinical research study is being sponsored by Suzhou Kintor Pharmaceuticals, Inc. (hereafter 
referred to as the Sponsor). 
Before you decide if you want to take part in this study, it is important for you to understand why 
the research is being is done and what the study will involve. 
2 DO I HAVE TO TAKE PART? 
You are invited to take part in a clinical research study. To help you decide, you should understand 
the study and what it will involve for you. To make an informed decision to take part, you should 
know the purpose of the study, the procedures, the benefits and risks of the study, the discomforts 
and the precautions taken. This process is called “informed consent.” 
If there is anything you do not understand or if you would like more information, please ask the 
study doctor or study staff. You may also discuss the study with family members, friends, and your 
own doctor if you wish. Once you have decided that you want to take part, you will be asked to 
sign and date this informed consent form. You will be given a copy of this signed and dated form 
to keep, and the original will stay at the study center. 
It cannot be promised that the study will help you, but in the future the information we get from 
this study may help improve the future treatment of people with the same condition.  
A clinical research study is an experimental investigation designed to answer specific questions 
about potential new drugs or existing drugs. These questions may include how safe and effective 
a particular study drug is, or what is the best dose of the study drug. All new drugs must undergo 
thorough testing in clinical research studies before they may be prescribed by doctors. Without 
clinical research studies, no new drugs could be developed, and few medical advances would be 
made.  
Taking part in a clinical research study is completely voluntary and your participation will be kept 
private. You can choose not to take part in the study if you wish, and you can decide to stop taking 
part at any time, without giving a reason. The decision you make will not change the legal rights 
or the treatment options you have.  


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The study doctor can withdraw you from the study at any time if he or she feels it is in your best 
interest or if you cannot comply with study requirements.  
Your participation in the study may also be stopped at any time by the Sponsor (for medical or 
business reasons), the regulatory authorities, or independent ethics committees such as the 
Institutional Review Board or Institutional Ethics Committee. These committees ensure that your 
rights are not violated. The reason(s) for stopping the study will be explained to you, and you will 
be given advice about continued care for your condition, if this is appropriate. 
If you leave (or withdraw from) the study, you will be asked to go through study withdrawal 
procedures detailed in Section 4 and information about you will be handled as detailed in 
Section 12. 
3 WHAT IS THE STUDY ABOUT? 
There are no FDA approved treatments available for patients with confirmed SARS-CoV-2 with 
mild or moderate COVID-19 illness. Mild to moderate COVID-19 symptoms can include fever, 
cough, headache, shortness of breath, and other symptoms your study doctor considers mild to 
moderate. Because there are no approved treatments available for mild to moderate COVID-19 
illness, this study is to evaluate the study drug effects for a larger population. 
The study drug has completed the Phase I, first-in-human study, to confirm the recommended 
study drug dose is safe. The study drug has also completed the Phase II to evaluate whether or not 
the study drug works well for some subjects. The study drug has also completed a Phase III study 
to evaluate whether or not the study drug works well for many subjects. 
The Phase I and Phase II studies were not evaluated on COVID-19 subjects; they were conducted 
using both healthy volunteers and cancer subjects. A Phase III study in Brazil enrolled 262 male 
COVID-19 positive subjects. Of the subjects given study treatment with the study drug plus 
standard of care, none were hospitalized. Among the group of subjects who received placebo 
(inactive substance) plus standard of care, 27.3% required hospitalization over the course of the 
full 30-day participation. The subjects in Brazil were given 200 mg tablets of the study drug every 
day for 15 consecutive days by mouth. The same study dose (200 mg/day) is being tested in this 
study. The study drug dose is fixed, regardless of body mass or weight. 
This is a Phase III study which the Sponsor plans to implement in the USA and other countries. 
There will be approximately 100 study sites participating globally, and it is expected that about 
668 subjects will be enrolled. 
Because we do not know if GT0918 is better than the current standard of care for treating 
COVID- 19 we need to compare them. For this reason, we will put people into 2 groups: a group 
receiving the study drug plus standard of care and a group receiving placebo plus standard of care. 
To make the comparison as fair as possible, this study is “double-blinded.” This means that neither 
you nor the study doctor will know whether you are taking GT0918. 


Suzhou Kintor Pharmaceuticals, Inc. 
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GT0918-US-3001, Version 2.0, 09 July 2021 
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The purpose of this study is to test the study drug against placebo for:  
• 
How effective the study drug works with your disease, which includes reducing virus in 
your body, relieving your COVID-19 symptoms, and reducing the chance of your 
COVID-19 illness getting worse. 
• 
How safe the study drug is and how long it may work for you. 
4 WHAT WILL HAPPEN TO ME DURING THE STUDY?  
4.1 Screening 
If the study is right for you and you agree to take part, you will be asked to sign and date this 
information consent form. After you have signed and dated the consent form, you will be asked to 
complete a series of screening assessments. Screening assessments will include procedures such 
as: 
• Review of inclusion and exclusion criteria 
• Demographics, medical history, tobacco use and pre-existing conditions 
• Review of any prior treatments within the last 30 days, including over-the-counter and 
prescribed treatments 
• Physical examination 
• Vital signs, including body temperature, pulse rate, blood pressure and respiratory rate 
• Nasopharyngeal swab 
• Laboratory blood tests  
Screening procedures may also include: 
• Chest X-ray, Computed Tomography (CT) Scan or Electrocardiogram (ECG), if your 
study doctor deems any of these clinically necessary. 
• Also, if you are female regardless of child bearing potential, you must do a pregnancy 
test with your blood samples.  
 
If the study doctor decides that you are not eligible to take part in this study, then he/she will 
discuss with you other treatments for your condition. 
4.2 Randomization 
Once you have signed and dated this consent, and your study doctor confirms you are eligible to 
take part, and you want to continue, you will be assigned, by computer, to 1 of 2 groups. This is 
called “Randomization.” Randomization means group assignment is completely random and 
unknown to your study team. There is a 1 in 2 chance of being assigned to either group, like 
flipping a coin. 
The first group is a study treatment group. This group will receive the study drug plus standard of 
care. The second group is the placebo group. This group will receive the placebo plus standard of 


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care. The term ‘placebo’ means the tablets you receive will look the same as the study drug but 
will not have active ingredient. 
Neither you nor your study team will know to which group you have been assigned. Your study 
doctor will not tell you to which group you have been assigned. If for reasons associated to any 
medical emergencies during or after the study treatment period, the study doctor will be able to 
request the information regarding your group assignment. 
• Group 1: Standard of care with oral administration in tablet form, 200 mg of study drug 
(two 100 mg tablets), taken once a day, every day for 14 consecutive days. 
• Group 2: Standard of care with oral administration in tablet form, placebo (identical to 
study drug), taken once a day, every day for 14 consecutive days. 
4.3 Study Treatment Period 
4.3.1 
Study Medication 
The study treatment period of this study is 14 consecutive days, or earlier if you decide to stop 
your participation to this clinical study. If your disease worsens and you are hospitalized, you may 
continue per your study doctor’s discretion. Signs of disease progression can include increased 
severity of COVID-19 symptoms or developments of unacceptable side effects. 
Your study doctor will provide you with enough study drug/placebo for accurate dosing throughout 
the 14 consecutive days study treatment period. You will need to take the doses around the same 
time each day (+/- 2 hours) around 30 mins after a meal for 14 consecutive days. For example, if 
you take the first dose (two 100 mg tablets) on Day 1 at 1 PM after your lunch (you finish your 
lunch around 12:30 PM), you should take your remaining daily doses between 11 AM- 3 PM, 30 
mins after your meal on the subsequent days (Day 2, Day 3, etc.)  through Day 14. Swallow the 
tablets whole and do not chew or crush them. 
Your doses will not be increased and your schedule (how often you receive the study drug) will 
not be changed.  
4.3.2 
Daily Diary and Daily Questionnaire 
During your participation you will need to keep a daily diary. This diary captures:  
• When you take your tablets (14 consecutive days) 
• How many tablets/doses you take 
• Any missed doses you have 
The study doctor will show you how to use this daily diary. You will either be provided information 
to access an electronic or a paper version of the diary. The electronic version can be accessed either 
through a computer/Web-based portal, or by smart phone application. If you are unable or 
unwilling to complete the daily diary electronically, your study doctor will provide you with a 
printed, paper diary that you can complete in writing and bring back to your study site staff or 
home visit staff. Each time you visit the clinic or meet your home visit staff, you must bring the 


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
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daily diary, study drug containers, and any remaining tablets. You will need to complete the daily 
diary from first day you take the study drugs until the last day you complete your study treatment.  
In addition to answering questions about the study medication, you will be asked to fill out a form 
with questions/ questionnaire about your physical and emotional well-being, mostly focused on 
the COVID-19 related symptoms (such as, fever, diarrhea, cough, etc.). The questionnaire helps 
you and your study doctor keep track of any changes to your symptoms. This questionnaire form 
can either be completed on paper or electronically for you to self-evaluate every day from the day 
you start the study to 14 days after your last dose of your study medication (Day 28 per schedule 
of activities). The form will take about 5-10 minutes to complete each day. You don’t have to 
answer any question that makes you feel uncomfortable. If you are completing the daily paper 
questionnaire, please let your study doctor know of any important changes to your symptoms like 
going to the hospital or a need for home oxygen.  
4.3.3 
Study Visits 
Before you begin the study, your study doctor will review the results of your screening exams, 
tests, and procedures. This helps your study doctor decide if it is safe for you to take part in the 
study. If you join the study, you will have more exams, tests, and procedures to closely monitor 
your safety and health. Most of these are included in the usual care you would get even if you were 
not in a study.  
Listed below are exams, tests, and procedures that need to be done as part of this study to monitor 
your safety and health. We will use them to carefully follow the effects of the study drug, including 
preventing and managing side effects. 
These exams, tests, and procedures to monitor your safety and health include: 
• Blood tests and physical exams done before you begin the study. 
• Blood tests done on Day 7, the last day of study drug taken (Day 14) and 14 days after 
last dose (Day 28). 
• Nasopharyngeal swabs taken for virus tests before you start the study, Days 3, 7, 14, and 
28. The study doctor may be required by law to report the result of these tests to the local 
health authority. 
• Chest X-ray or CT Scan, physical exams or 12 ECG tests may need to be done per your 
study doctor’s decision. 
• Daily diary completed from first day you take the study drug to the last day you finish 
your study treatment (Day 14). 
• COVID-19 related symptoms questionnaire (subject self-evaluation) daily since you start 
the study to 14 days after last dose (Day 28). 
• Pregnancy test with blood sample for all female subjects regardless of childbearing 
potential before you begin the study and urine sample on Day 28 will be done if you are 
the childbearing-potential female subjects  


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During your participation in the study, you will be asked not to take certain medications (called 
“prohibited medications”). These will be prohibited during all periods of the study. You will also 
be asked to use caution with some medications including some over-the-counter medications or 
other anti-COVID-19 drugs and/or treatment procedures. The study doctor will review this with 
you. If you choose to take part in this study, you will be asked to fill out a form with questions/  
questionnaire about your physical and emotional well-being, mostly focused on the COVID-19  
related symptoms (such as, fever, diarrhea, cough, etc.).  Researchers will use this information to 
learn more about how the COVID-19 illness progresses and the study drug treatment affects 
people. This questionnaire form can either be completed on paper or electronically for you to 
self-evaluate every day from the day you start the study to 14 days after your last dose of your 
study drugs.  The form will take about 5-10 minutes to complete each day. You don’t have to 
answer any question that makes you feel uncomfortable. 
 
If you have any serious health issues or other concerns, please talk with your study doctor or study 
nurse right away. 
A subject study calendar/schedule of activities is included as an Appendix at the end of this 
document for your quick reference. It shows how often these exams, tests, and/or procedures will 
be done. 
4.4 Follow-up Period/ Post-study Treatment 
After you finish the 14-day study treatment period, your study doctor will continue to follow your 
condition for another consecutive 14 days and watch you for side effects. That is called post-study 
treatment. You will continue to fill out the questionnaire about your physical and emotional well-
being, mostly focused on the COVID-19 related symptoms, until Day 28. The post-study treatment 
visit will occur on Day 28 or last dose +14 days. This visit can be either in home health visit or in-
office visit with study doctor. This is determined at your study doctor’s discretion. 
4.5 Safety Follow-up Period 
After you finish the 14-day post-study treatment period, your study doctor will continue to follow 
your condition for another 14 days or last dose +28 days (whichever occurs first) and to watch you 
for side effects. This is called the safety follow-up. The safety follow-up visit will occur by phone. 
This means you will be seen or contacted by your study doctor for approximately 6 weeks.  
You also should understand the continued scientific importance of your data. In order to prevent 
missing data even if you are taken off of the study early, you and/or your close contacts may be 
contacted via telehealth visits or other approaches (for example, telephone calls, texts, and emails). 


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4.6 Early Withdrawal 
You can decide to stop taking part in the study at any time, without any penalty. If you decide to 
stop, you should notify your study doctor know as soon as possible. It is important that you 
discontinue your participation safely. If you stop, you can decide if you want to keep letting the 
study doctor know how you are doing. Your study doctor will tell you about new information or 
changes in the study that may affect your health or your willingness to continue in the study. 
The study doctor may decide to withdraw you from the study if: 
• Your health changes and the study is no longer in your best interest. 
• New information becomes available and the study is no longer in your best interest. 
• You do not follow the study rules. 
• You become pregnant 
• The study is stopped by the Sponsor, IRB/IEC, or regulatory agency.  
If you withdraw early from this study for any reason, you will complete the Early Withdrawal visit 
within 2 days of the day you withdraw. You will go to the safety follow-up period for 28 days after 
your last dose. 
4.7 Drug Access after Study Completion 
You will only be given GT0918 while the study is going on but not after it has ended.  
4.8 Blood Tests 
The total amount of blood that will be taken over the entire study is about 120 mL, which is 
much less than what you would give as a blood donor (500mL). 
5 WHAT WILL I HAVE TO DO DURING THE STUDY? 
If you choose to take part in this study, you will need to: 
• Keep your study appointments 
• Tell your study doctor about: 
o All medications and supplements you are taking 
o Any side effects you may experience  
o Any doctors’ visits or hospital stays outside of this study  
o If you have been or are currently in another research study 
• Complete the daily diary each time you take the study drug 
• Complete the daily questionnaire 
• Follow recommendations for reducing reproductive risks 
o Remain abstinent or have birth control for the duration of the study and until 90 
days after the last dose of study drug.  


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o Advise all of your female partners of the need for them to use contraception 
during your participation in this study and until 90 days after your last study dose. 
6 WHAT ARE THE POSSIBLE RISKS? 
If you choose to take part in this study, there is a risk that the study drug with standard care may 
not be as good as the usual approach for relieving or reducing COVID-19 illness. You also may 
have the discomfort of spending more time in the laboratory or study doctor’s office. 
As with all research studies, the study medication and study procedures may involve unknown 
risks. Any medication can have temporary and permanent side effects and can cause unforeseen 
adverse reactions. The study drug may affect how different parts of your body work such as your 
liver, kidneys, heart, and blood. The study doctor will test your blood and let you know if changes 
occur that may affect your health. 
Here are important things to know about side effects: 
• The study doctor does not know who will or will not have side effects. 
• Some side effects may go away soon, some may last a long time, and some may never go 
away. 
• Some side effects may make it hard for you to have children. 
• Some side effects may be mild. Other side effects may be very serious and even result in 
death. 
You can ask your study doctor questions about side effects at any time. Here are important ways 
to make side effects less of a problem: 
• If you notice or feel anything different, tell your study doctor immediately. He or she can 
check to see if it is a side effect. 
• Your study doctor will work with you to treat your side effects. 
• Your study doctor may take you off the study drug to try to reduce side effects. 
6.1 Study Drug Risks 
Risks are possible side effects from the study treatment and from tests done during the study. You 
should tell the study doctor if you have any unusual complaints, behaviors, or side effects, or had 
other doctor visits or hospitalizations outside of the study. 
The tables below show the most common and most serious side effects of the study drug that 
doctors currently know about. Keep in mind that there might be other side effects doctors do not 
yet know. If important new side effects are found, the study doctor will discuss these with you. 


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6.1.1 
The study drug risks experience based on previous studies in subjects 
with breast or prostate cancers. 
VERY COMMON, SOME MAY BE SERIOUS 
In 100 subjects receiving the study drug GT0918 (proxalutamide), more than 10 may have 
(greater than or equal to 10%): 
• Feeling tiredness 
• Decreased appetite 
• Gastrointestinal disorders including diarrhea, abdominal (stomach) discomfort, pain, 
distension 
• Nervous system disorders including confusion, dizziness, heart beats faster than normal 
while at rest, shortness of breath, changes in taste, loss of the sense of smell 
• Weight decrease, weakness 
• Liver damage that may cause yellowing of eyes and skin 
• Infection, especially when white blood cell count is low 
• Anemia (low red blood cell count) which may require blood transfusion 
• Blockage of internal organs which may cause vomiting or inability to pass stool, or 
straining to have bowel movements 
• Hot flush 
• Kidney damage may cause protein in your urine 
• Breast enlargement or pain 
 
COMMON, SOME MAY BE SERIOUS 
In 100 subjects receiving the study drug GT0918 (proxalutamide), more than one but less than 
10 people may have (greater than or equal to 1% and less than 10%): 
• Increased creatine phosphokinase which may cause heart damage 
• Low potassium level (hypokalemia) which can cause heart rhythm problems, weakness, 
muscle cramps 
• Low calcium level (hypocalcemia) which may cause bone or other problems 
• Low blood sugar (hypoglycemia) which may cause dizziness  
• Lipoproteins increased which may cause heart, liver or other problems 
6.1.2 
The study drug risks experience based on a previous study in subjects 
with COVID-19 illness. 
VERY COMMON, SOME MAY BE SERIOUS 
In 100 subjects receiving the study drug GT0918 (proxalutamide), more than 10 may have 
(greater than or equal to 10%): 
• Diarrhea, nausea, abdomen pain 


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VERY COMMON, SOME MAY BE SERIOUS 
In 100 subjects receiving the study drug GT0918 (proxalutamide), more than 10 may have 
(greater than or equal to 10%): 
• Dyspepsia may cause burning or discomfort in the stomach or upper abdomen, full 
feeling 
COMMON, SOME MAY BE SERIOUS 
In 100 subjects receiving the study drug GT0918 (proxalutamide), more than one but less than 
10 people may have (greater than or equal to 1% and less than 10%): 
• Abdominal discomfort 
• Heartburn 
• Vomiting  
• Skin Lesions 
6.1.3 
Additional Study Drug Risks 
The study drug could interact with other drugs such as moderate/strong inhibitors or inducers of 
CYP3A4/2D6 an important enzyme in the body, mainly found in the liver and in the intestine that 
helps small organic molecules, such as toxins or drugs, so they can be removed from the body. 
Nutritional supplements such as St. John’s Wort, grapefruit or extracts of grapefruit, and 
immunosuppression medicine should be used with caution. Your study doctor will give you 
information that lists these possible interactions. Share this information with your family members, 
caregivers, other health care providers, and pharmacists. 
6.2 Reproductive Risks 
The study drug could be very harmful to an unborn or newborn baby. There may be some risks 
that doctors do not yet know about. It is very important that you check with your study doctor 
about what types of birth control or pregnancy prevention you must use during the study and for 
90 days after you have completed the study. 
If you are male, regardless of your fertility status, you must agree to either remain abstinent (if this 
is your preferred and usual lifestyle), or use condoms for the duration of the study and until 90 
days after the last dose of study drug. As a condom alone is not considered adequate contraception 
for this study, you are also strongly recommended to advise all of your female partners of the need 
for them to use at least one of the methods of contraception listed below. Female partners should 
be advised of the need for them to use contraception during your participation in this study and 
until 90 days after your last study dose.  
Women of child-bearing potential who are completely abstinent or in a same sex relationship, as 
part of their preferred and usual lifestyle, must agree to either remain abstinent or stay in a same 
sex relationship without sexual relationships with males. 


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
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All other women of child-bearing potential must agree to use two forms of effective 
contraception, where at least one form is highly effective (less than 1% failure rate), for the 
entirety of the study. 
Recommended methods of method of contraception for females, use of one of the following 
combinations (a+b or a+c or b+c): 
a) Use of oral, injected or implanted hormonal methods of contraception or other forms of 
hormonal contraception that have comparable efficacy, for example hormone vaginal ring or 
transdermal hormone contraception. 
b) Placement of an intrauterine device (IUD) or intrauterine system (IUS)  
c) Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault 
caps) with spermicidal foam/gel/film/cream/vaginal suppository 
Do not father a baby or become pregnant while taking part in this study. Your study doctor will 
discuss with you what qualifies as acceptable contraception during this study. Also, you should 
not donate eggs, semen/sperm during the study or within 90 days after your last dose. 
Tell the study doctor right away you get pregnant (for female participants) or you get you partner 
pregnant (for male participants) or thinks she may be pregnant during the study or within 90 days 
after your last dose of study drug. The study doctor or study staff will advise you of the possible 
risks to the fetus and baby. The study doctor must follow-up and keep a record of the course and 
the outcome of all pregnancies, even if you withdraw from the study or if the study has finished. 
If your partner becomes pregnant during the study, the study doctor or his/her staff will ask to 
contact you/your partner and your/your partner’s doctor for information about the pregnancy and 
the child until 3 months after the birth. Your partner will be asked to sign a consent to report 
information regarding pregnancy outcomes.  
6.3 Procedure Risks 
There is also a risk that you could have other side effects from the study procedures, such as blood 
draws, nasopharyngeal swabs, etc. 
Blood Tests 
For most people, needle punctures for blood draws do not cause any bad problems. However, 
sometimes they may cause bleeding, bruising, discomfort, infections and/or pain where you had 
the blood drawn. You may also feel dizzy. 
Nasopharyngeal Swabs 
There may be some pain and discomfort when receiving a nasopharyngeal swab (a swab that goes 
into your nostril). There is a small risk of bleeding. 


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
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Electrocardiogram 
Electrocardiogram (ECG, a recording of the heart’s rhythm). An ECG (electrocardiogram) will be 
done. An ECG traces the electrical activity of the heart. You may have mild irritation, slight 
redness, or itching at the sites on your skin where the recording patches are placed. 
Computed Tomography (CT) Scan  
A CT scan is a computerized x-ray picture of your internal organs. You may feel some discomfort 
or anxiety when lying inside of the CT scanner. 
Chest X-Ray 
X-rays involve exposure to radiation.  The amount of radiation exposure you may receive from 
these standard diagnostic tests is considered small and will not adversely affect the treatment of 
your disease. 
Discomfort with Questionnaires 
Some people feel uncomfortable when answering questions about the quality of their life. Though 
it is always better to have fully completed questionnaires, you do not need to answer any questions 
that make you feel uncomfortable.  
Risks with Electronic Transmission of Personal Information 
As part of this research study, you will have the option to use an electronic daily diary and/or a 
daily diary app downloaded onto your personal smartphone. Transmission of information via the 
internet is not completely secure, so there is a small risk of unintentional release of your 
information and safeguards are in place to protect your personal information.  
7 WHAT ARE THE POSSIBLE BENEFITS? 
The study drug is an experimental treatment and there is no proven benefit to taking the study 
drug. There is preliminary evidence that this study drug plus usual care may be effective in 
reducing the chance of progressing to severe illness requiring hospitalization. It is not possible to 
know now if the study drug GT0918 with standard care will reduce your COVID-19 illness 
compared to the usual approach. This study will help the study doctors learn things that will help 
people in the future. 
8 ARE THERE ALTERNATIVE TREATMENTS? 
You do not have to be in this study to get treatment for your COVID-19. We are doing this study 
because we want to find out if the approach used with this study drug is better or worse than the 
usual approach for your COVID-19 illness. The usual approach to treating COVID-19 illness 
with mild or moderate symptoms is also called standard of care. 
The current standard of care for people with COVID-19 is rapidly changing and includes a 
number of medicines and experimental treatments, which may vary from site to site. It may also 


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
Parexel 261488_Kintor GT0918-US-3001_Global Model ICF _Version 2.0_09Jul2021  
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include infection prevention and control measures and supportive care, including oxygen and 
ventilatory support when indicated. Your doctor can discuss your treatment options with you. 
9 WILL I INCUR ANY EXPENSES OR RECEIVE ANY PAYMENTS? 
9.1 Expenses 
The study drug or placebo will be provided to you at no cost. You and/or your insurance provider 
will not have to pay for exams, tests, and procedures done for research purposes only, or that are 
covered by the study. These include the extra samples taken of blood or nasopharyngeal swabs.  
You and/or your insurance plan will need to pay for the costs of usual medical care you get during 
this study, just as you would if you were getting the usual care for your COVID-19 illness. This 
includes the costs of tests, exams, procedures, and drugs that you get in addition to the study drug 
during the study to monitor your safety and prevent and treat side effects. 
Talk to your insurance provider and make sure that you understand what your insurance pays for 
and what it doesn’t pay for if you take part in this clinical study. Also, you should find out if you 
need approval from your insurance before you can take part in this study.  
Ask your study doctor or study nurse for help finding the right person to talk to if you are unsure 
which costs will be billed to you or your insurance provider.  
9.2 Compensation for Participation 
Taking part in this study may mean that you need to make more visits to the clinic or hospital than 
if you were getting the usual approach to treat your COVID-19. You may need to take more time 
off work and have other additional personal costs. 
You may get compensation for every visit up to $XXX _and/or reimbursement for the travel and 
parking costs.  
If you do not complete the study, for any reason, you will be paid for each study visit you do 
complete.  
You will be paid ___________ [“following each completed visit”, “monthly”, “quarterly”, “at the 
end of your participation in the research study”, “following each completed visit or at the end of 
your participation in the research study, whichever you prefer”]. 
If you have any questions regarding your compensation for participation, please contact the study 
staff.  
The research may lead to new tests, drugs, or other products for sale. You will not be entitled to 
compensation related to these during or after your participation in this research study. 
10 WHAT IF I AM INJURED DURING THE STUDY? 
If you experience any unexpected symptoms or injury, and if emergency medical treatment is 
required, please report it immediately to: 


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
Parexel 261488_Kintor GT0918-US-3001_Global Model ICF _Version 2.0_09Jul2021  
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_______________________________ (Site to insert contact name and number). 
Any compensation payable for any injury caused to you by taking part in this study will be in line 
with local guidelines. The Sponsor will pay for the cost of medical treatment for any injury that is 
directly due to study treatment with the study drug or study procedure (that has been used as 
described in the study plan). The Sponsor will not compensate you where the injury has happened 
because a procedure has been carried out that is not in line with the study plan or where the study 
doctor has acted negligently. 
The Sponsor has taken out an insurance policy to cover compensation for any personal injury 
resulting from you taking the study drug, provided such personal injury is not due to fault or 
negligence of the study doctor or his team. To pay medical expenses, the Sponsor will need to 
know some information about you like your name and date of birth. 
If you have medical insurance, please check with your insurance company that taking part in this 
study will not affect your policy. By signing and dating this document, you will not lose any of 
your legal rights or release anyone involved in the research from responsibility for mistakes. 
11 WHAT WILL HAPPEN IF THERE IS ANY NEW INFORMATION? 
The study doctor or his/her staff will tell you in a timely manner if any new information becomes 
available which may influence your decision to stay in this research study. 
12 WILL INFORMATION ABOUT ME BE KEPT CONFIDENTIAL? 
By signing this form, you consent to the study doctor and his or her staff collecting and using your 
personal and study data for the study.  
• Personal data include: your gender, your ethnic origin, your date of birth (day, month and 
year), information on your physical or mental health or condition.  
• Study data are information collected from you including results from the tests and 
examinations performed during this study. 
The data shared with the Sponsor is protected using a code specifically assigned to you. The study 
doctor is in control of the code needed to connect your personal data to you. 
All data that identify you by name will be held confidential and will not be made publicly available. 
This means that such data will be kept in locked electronic files with appropriate levels of security. 
Only staff with proper approvals will be able see or refer to these files. However, the study doctor, 
the authorized personnel from the Sponsor and its representatives, the study monitor (who checks 
how the study is going and makes sure that the information is being collected and used properly) 
and, under certain circumstances, the regulatory authorities and members of the ethics committees 
will be able to inspect confidential data that identify you by name. This will be done without 
violating your confidentiality to the extent permitted by the applicable laws and regulations. 
By signing this consent form, you grant permission for personal data and medical information 
about you obtained during this study (your study data) to be made available to authorized or 


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
Parexel 261488_Kintor GT0918-US-3001_Global Model ICF _Version 2.0_09Jul2021  
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approved representatives of the regulatory authorities and other government agencies. You also 
grant permission for your personal data to be made available to the Sponsor auditors, the study 
monitor, other study personnel, and ethics committees.  
Your coded data and study data may be sent to other countries) since some of the recipients are 
based outside of your country. When your personal data is sent to another country, it is either 
controlled by a contract approved by government agencies supervising protection of your data 
(data privacy authorities) or by the Sponsor’s rules which have been approved by data privacy 
authorities (called Binding Corporate Rules). Your personal information will still be kept 
completely confidential, no matter which country it goes to, even if that country does not have the 
same level of protection for personal information as <Country>. 
The data collected during this study, including your personal data, may be further used in analyses 
by the Sponsor or other researchers to answer additional scientific questions related to GT0918 
and COVID-19. The Sponsor will take appropriate measures to protect your information and will 
only use and share coded data for such additional research. 
Your data may be used by the Sponsor or contract research organization on a coded basis for 
administrative purposes. For example, such coded data may be used to track the overall progress 
of this study and to improve the manner in which future clinical trials are conducted. Your data 
may also be stripped of any information that could be used to identify you or combined with other 
data by the Sponsor or contract research organization as part of their efforts to protect personal 
information. 
If you withdraw your consent for participating in this study, your personal and study data that were 
collected before you withdrew your consent may still be used as described above. Once you have 
withdrawn your consent for participating in the study, no further data will be collected about you 
for the purposes of this study unless you agree otherwise, for example, you agree to have further 
tests and examinations. If you do agree to have further data collected after you have withdrawn 
your consent, these study data may also be used as described above. By signing this consent, you 
explicitly agree that if you decide to withdraw from the study, your medical data (and samples) 
collected prior to withdrawal may still be processed along with other data collected as part of the 
study. If you prefer any previously retained samples destroyed, you must notify your study doctor 
in writing. 
Please note that you have the right to view and access your personal data and to ask for correction 
as allowed by <European Union regulation /national law. > [delete “national law” if subjects are 
located in European Economic Area (EEA) member state; otherwise delete “European Union 
regulation”]. If you wish to make a request, then please contact the study doctor, who can help you 
contact the Sponsor, if needed. 
You can also request that the Sponsor completely delete any personal data that was collected from 
you. However, it may not always be possible to meet such requests. If deleting your personal data 
makes the results from this study undependable or if the Sponsor is required to keep such personal 


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
Parexel 261488_Kintor GT0918-US-3001_Global Model ICF _Version 2.0_09Jul2021  
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data for legal reasons, then they will not be deleted. In this regard your coded personal data will 
be retained for a period of <xx> years after the end of the study [delete this paragraph, if study 
subjects are located outside the EEA]. 
If you wish to exercise these rights, <or file a complaint> [delete, if study subjects are located 
outside the European Economic Area], please contact your study doctor <or the data protection 
officer (staff who makes sure that personal data is kept confidential) of your study site> [delete, if 
study subjects are located outside the EEA]. You can find out more about how <Sponsor> keeps 
personal information at <insert url>. 
<You have the right to lodge a complaint to your data protection authority. In case you decide to 
do so, the Sponsor is very interested to understand your perspective and, therefore kindly asks you 
to inform them via your study doctor when you lodge a complaint.> [delete, if study subjects are 
located outside the EEA]. 
The results of this study may be published in a medical journal and shown at medical meetings. 
You will not be identified (by name or any other means, e.g., photo) in any of these publications. 
Researchers from for example the Sponsor, other companies, and universities might ask to use 
information from this study, including your coded data and samples for other medical, healthcare 
or scientific related research. The researchers may combine the results from this study with results 
from other studies. If the Sponsor lets them have your personal data, the Sponsor will make sure 
that they cannot find out who you are and that such research is in line with this document. You 
may have a right to object to the use of your personal data for this additional research for reasons 
specific to you. If you wish to object to such use, please contact your study doctor. 
The blood samples that you donate will be used in this research study and will not be used for 
medical diagnosis or treatment decision-making. Unless required by law, you will not get copies 
of the results. If you decide to stop taking part in this study, your samples that we have already 
collected will still be used in the ways that you agreed to when you started in the study. Once you 
have withdrawn your consent for participating in the study, no further data will be collected about 
you for the purposes of this study. If you withdraw consent to take part in the study, you can request 
for your samples to be destroyed. We will try to destroy samples, but if the samples are no longer 
linked to you or if the samples were sent to a third party, this might not be possible. 
In future, identifiers associated with your data and/or specimens could be removed from the data 
and specimens. The de-identified data and specimens could then be used for future research by our 
research team or other researchers without notifying you or asking your permission for this use. 
Your samples may be analyzed or safely stored in another country but will always be coded. 
<Some> samples will be destroyed when they have been used for the purpose of the study <or be 
kept longer, up to <xx> years, if you agree>. The Sponsor will be the owner of the study results. 
 
[If applicable, explain whether the subject will be informed about clinically relevant research 
results, and if so, under what conditions.] 


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
Parexel 261488_Kintor GT0918-US-3001_Global Model ICF _Version 2.0_09Jul2021  
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“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time.  
For applicable clinical trials that are conducted in the EU and the European Economic Area 
(EEA) or Clinical trials conducted outside the EU / EEA that are part of an EU Paediatric 
Investigation Plan (PIP), include:  
“A description of this clinical trial will be available through the public website 
https://www.clinicaltrialsregister.eu. This Web site will include information on the trial and 
summary of the results but will not include any information that can identify you. You can search 
this Web site at any time.” 
For trials in China, include: 
A description of this clinical trial will be available on www.chinadrugtrials.org.cn. This Web site 
will not include information that can identify you. At most, the Web site will include a summary 
of the results. You can search this Web site at any time. 
For trials in Japan, include: 
A description of this clinical trial will be available on Medical Information Database of Japan 
Pharmaceutical 
Information 
Center 
(JAPIC) 
according 
to 
the 
Sponsor’s 
request: 
http://www.clinicaltrials.jp/user/cteSearch.jsp. You can search this Web site at any time. 
[Include any Sponsor-specific websites where information may be available, if applicable.] 
13 WHAT IF I HAVE QUESTIONS? 
If you have questions about the study, or have a problem related to the study, you may contact the 
study doctor or his/her staff at the telephone number below. 
 
Name:_______________________________Telephone: (_____)  ________________ 
Title of Investigator: ______________________________ 
 
If you are calling after hours or on a weekend, you may contact the individual below. 
 
Name:_______________________________Telephone: (_____)  ________________ 
 
If you have questions about your rights as a research participant, you should contact the individual 
below. 


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
Parexel 261488_Kintor GT0918-US-3001_Global Model ICF _Version 2.0_09Jul2021  
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(Note:  Insert name of IRB/IEC chairperson and/or name of IRB/IEC, [For Japan, type of IRB/IEC 
(eg. specialized IRB)], address, and telephone number.) 
 
Name:_______________________________Telephone: (_____)  ________________ 
Address: ______________________________________________________________ 
 
(Note:  Insert name of data protection officer of the site, address, and telephone number.) 
Name:_______________________________Telephone: (_____)  ________________ 
Address: ______________________________________________________________


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
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14 CONSENT STATEMENT OF SUBJECT 
I have received verbal information on the above study and have read the attached written 
information. I have been given the chance to discuss the study and ask questions. 
I voluntarily consent to participate in this study, including all assessments, lifestyle restrictions, 
contraception requirements, and taking of blood samples.  
I understand that I am free to withdraw at any time. I understand that if I choose to not participate 
or to withdraw, my current medical care will not be affected by this decision. 
I agree that my primary doctor may be told of my participation in this study.  
I agree that my primary doctor may be asked to give information about my medical history. 
I agree that my personal data, including data relating to my physical or mental health or condition, 
and ethnic origin, may be used as described in this consent form. 
I agree and authorize that my coded personal data may be transferred within and outside [Country] 
to countries, where personal data may not have the same level of statutory protection as in 
[Country]. 
I agree and authorize that samples collected from me for the purposes described in this consent 
form will be processed in coded form within and outside [Country], where personal data may not 
have the same level of statutory protection as in [Country], by the Sponsor, its affiliates, 
representatives and collaborators for scientific and regulatory purposes and that these samples may 
be stored up to [insert number] years after the conclusion of the study for further research. 
I understand that I will get and may keep a copy of this signed and dated consent form. 
By signing and dating this consent form, I have not given up any of the legal rights that I would 
have if I were not a participant in a medical research study. 
 


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
Parexel 261488_Kintor GT0918-US-3001_Global Model ICF _Version 2.0_09Jul2021  
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Signature of Patient 
Date 
(mm/dd/yyyy) 
Printed Name of Patient 
 
 
 
 
Signature of Legal Representative Date 
(mm/dd/yyyy) 
Printed Name of Legal 
Representative 
 
Relationship of Legal 
Representative to Patient 
 
 
 
 
 
 
Signature of Witness 
Date 
(mm/dd/yyyy) 
Printed Name of Witness 
 
15 STATEMENT OF PERSON CONDUCTING INFORMED CONSENT 
DISCUSSION 
I, the undersigned, certify that to the best of my knowledge, the patient signing this consent form 
had the study fully and carefully explained and clearly understands the nature, risks, and benefits 
of participation in this research study. 
 
 
 
 
 
 
Signature of 
Investigator (or other 
Person Obtaining 
Consent) 
 
Date 
(mm/dd/yyyy) 
 
Printed Name of Person Obtaining 
Consent 


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
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16 Appendix: Subject Calendar/ Schedule of Activities (SoA) 
Assessments obtained previously as part of routine clinical care may be used as the screening assessment if they were done no more 
than 1 day before randomization. Visits may be conducted as a telephone call, outpatient clinic visit, or home visit if the study plan 
SoA is followed and in compliance with local regulatory requirements. 
 
 
 
 
Screen Study Treatment Period 
Early 
Withdrawal16 
Post-study 
Treatment 
Safety 
Follow 
Up17 
Study Day (Visit Window ± days) 
Day -1 Day 
1 
Day 
3 
Day 
7 (±1) 
Day 
14 
(+1) 
 (+2) 
Day 15 
Day 
28 
(±2) 
Day 
42 
Phone 
Call 
(±2) 
Informed Consent 
X 
  
  
  
  
  
  
  
  
Inclusion/Exclusion Review1 
X 
  
  
  
  
  
  
  
  
Demographics2 
X 
  
  
  
  
  
  
  
  
Pre-existing Conditions and Medical 
History3 
X 
  
  
  
  
  
  
  
  


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
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NIAID Ordinal Scale4 
 X 
Daily 
  
Prior Treatment 5 
X 
  
  
  
  
  
  
  
  
Tobacco Use 
X 
  
  
  
  
  
  
  
  
Physical Examination 6 
X 
Symptom Directed PE only if Clinically Indicated 
  
Vital Signs 7 
X 
  
X 
X 
X 
X 
  
X 
  
Nasopharyngeal swabs 8 
X 
  
X 
X 
X 
X 
  
X 
  
Randomization 9 
X 
X 
  
  
  
  
  
  
  
Hematology 10 
X 
  
  
X 
X 
X 
  
X 
  
Chemistry 10 
X 
  
  
 X 
X 
X 
  
X 
  
Biomarkers 10  
X 
  
X 
  
X 
X 
  
X 
  
Coagulation 10 
X 
  
  
  
X 
X 
  
X 
  
Drugs and Diary Dispense 11 
X 
X 
  
  
  
  
  
  
  


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
Parexel 261488_Kintor GT0918-US-3001_Global Model ICF _Version 2.0_09Jul2021  
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GT0918 or Placebo Administration 11 
  
Daily from Day 1 to Day 14 
  
  
  
  
Subject Diary 11 
 
Daily from Day 1 to Day 14 
  
  
  
  
Questionnaire (Symptoms; Overall Clinical 
Status; ) 11 
Daily 
  
Chest X-ray or CT Scan 12 
Clinically Indicated 
  
12-ECG 12 
Clinically Indicated 
  
Hospitalization events 13 
  
Daily  
Clinical status and concomitant procedures if 
subject is hospitalized 14 
  
Daily if hospitalized 
Adverse Events 15 
X 
Concomitant Medications 16 
X 
Pharmacokinetics 17 
 
X 
X 
X 
X 
X 
 
 
 
Pregnancy test 18  
X 
 
 
 
 
 
 
X 
 
COVID-19 vaccination status 
X 
 
 
 
 
 
 
 
 
 


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
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Annotation: 
1. Inclusion/Exclusion review: every subject needs to meet all inclusion and exclusion criteria. The eligibility checklist needs to be signed by the investigator or 
sub-investigator.  
2. Demographics: includes age, gender, race, and ethnicity. 
3. Pre-existing conditions and medical history: obtained from interview or available information and including timing of exposure and onset of symptoms 
suggestive of SARS-CoV-2 infection. 
4. NIAID ordinal scale to be completed daily through Day 28 or 14 days after last dose. This information can be collected from questionnaire; reported events; 
or directly from the patient. 
5. Prior treatments within last 30 days. 
6. Physical exam (PE): Full physical exam should be done at screening visit. For the subsequent visits, symptom directed PE can be done per investigator’s 
discretion. If the result is clinically significant, the PE result should be recorded in eCRF.  
7. Vital sign: documentation of hospital-based exam is acceptable. Vital signs include body temperature, pulse rate, systolic and diastolic blood pressure, 
respiratory rate. For screening visit, SpO2, and supplemental oxygen flow rate, FiO2 if known and method of delivery if applicable, also need to be recorded.  
Record blood pressure and SpO2 while subject is at rest.  
8. Nasopharyngeal (NP) swabs: Only NP swab sample is acceptable. The method of taking samples should be consistent for each subject during the whole 
period of this study. This does not need to be the same before screening visit, when the subject is first time confirmed SARS-CoV-2 positive at local 
laboratory and/or Point of Care testing. Sample for first positive test must be collected within 3 days prior to start of dosing. Local laboratory and/or Point of 
Care testing are acceptable. 
9. Randomization: randomization should be via the Interactive Voice/Web (IxRS) Response System. Randomization should be done after confirmation the 
subject meets all inclusion/exclusion criteria. Drugs and Diary Dispense should occur after randomization. It is allowed for the subject to take the drug on the 
same day of the screening visit after confirmation of eligibility and randomization (the screening visit is counted as D1 too). The Subject Diary should start to 
be completed.   
10. Laboratory tests: Hematology, Chemistry (including Creatinine Kinase), Biomarkers (including Procalcitonin, C-reactive protein, D-dimer, Ferritin, 
Troponin, Testosterone), Coagulation. For details refer to Section 7.2.2 and 7.2.4.  
11. GT0918 or placebo administration: GT0918 or placebo will be given orally once daily on Days 1-14 during the study period after a meal (±2 hours for 
medication scheduling). The drug taken time should be recorded with subject diary. If the screening day is also D1, the subject does not need to follow the 
drug taken window on screening day/D1. For details refer to Section 6.1. 
Subject Diary should be completed every day since first dose until the last dose.  
Questionnaire should be completed every day since screening visit to the end of post-treatment by Day 28. For details refer to Section 7.2.6.  
12. Chest X-ray or CT-Scan or 12-ECG can be done per investigator’s discretion. If investigator deems the result is clinically significant, the result should be 
recorded with eCRF. 
13. Hospitalization events: if the subject is hospitalized, the treatment may be continued to the 14 days per PI. Hospitalization is defined as ≥24 hours in hospital 
of care. For details refer to Section 7.1.2. 
Record if the following events occur: 
• 
Emergency room visits 


Suzhou Kintor Pharmaceuticals, Inc. 
Model Informed Consent Form 
GT0918-US-3001, Version 2.0, 09 July 2021 
CONFIDENTIAL 
Parexel 261488_Kintor GT0918-US-3001_Global Model ICF _Version 2.0_09Jul2021  
28 of 28 
• 
Hospitalized  
• 
ICU admittance 
• 
Discharge 
• 
Extended care facility admittance(refers to long term care for chronic diseases or prolonged rehabilitation, which is not defined as hospitalization) 
14. Documentation from hospital records is acceptable. 
Includes: 
• 
Limitation on activities due to COVID- 19 
• 
Ongoing hospital medical care 
• 
Supplemental oxygen 
• 
Non-invasive ventilation or high flow oxygen device 
• 
Mechanical ventilation 
• 
ECMO, or 
15. Adverse events: any events that occur after signing the informed consent are considered AEs as defined in Section 10.3. 
16. Concomitant medications: all medications administered within 30 days prior to the first dose of study treatment through 30 days after the last dose of study 
treatment will be recorded in the concomitant medications, for details refer to Section 6.4.  
17. Pharmacokinetics (PK) samples only need to be taken for at least 100 subjects, who will be assigned according. For details refer to Section 7.2.3. 
18. All women regardless of childbearing potential must complete a serum pregnancy test at screening visit, urinary pregnancy test on day 28 as per the schedule 
of assessment for women of childbearing potential. Local laboratories will be used for the analysis of serum and urinary pregnancy tests. 
19. Early withdrawal (EW): if the subject is early withdrawn from this study for any reason (Section 7.1.4), the subject should complete the EW visit, and the 
visit should occur within 2 days of the EW day. The subject will go to the safety follow-up period for additional 28 days after his last dose.   
20. D42 (or 28 days ±2 post last dose if subject is withdrawn early) safety follow-up visit is phone call visit.  
 

Prot_000.pdf: 
Suzhou Kintor Pharmaceuticals, Inc.                           Protocol # GT0918-US-3001                       
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TITLE PAGE 
 
 
Protocol Title: 
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to 
Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in 
Outpatients with Mild to Moderate COVID-19 Illness 
 
 
Protocol Number: GT0918-US-3001 
Protocol Version: 2.0  
Amendment Number: 1 
Compound: Proxalutamide (GT0918) 
Study Phase: 3 
Document Status: Final  
Release date: 08Jul2021 
Regulatory Agency Identifier Number(s) 
IND:  154032 
EudraCT Number: 2021-002153-29 
 
 
Confidential Information 
The information provided herein contains Company trade secrets, commercial or financial 
information that the Company customarily holds close and treats as confidential. The 
information is being provided under the assurance that the recipient will maintain the 
confidentiality of the information under applicable statutes, regulations, rules, protective orders 
or otherwise. 




Suzhou Kintor Pharmaceuticals, Inc.                           Protocol # GT0918-US-3001                       
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INVESTIGATOR STATEMENT  
 
Protocol title: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to 
Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in 
Outpatients with Mild to Moderate COVID-19 Illness 
 
Protocol No.: 
GT0918-US-3001 
Version: 
2.0 
The trial will be conducted in accordance with the ICH E6. The Principal Investigator 
will assure that no deviation from, or changes to the protocol will take place without 
prior agreement from the Sponsor and documented approval from the Institutional 
Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to 
the trial subjects. All personnel involved in the conduct of this study have completed 
Human Subjects Protection Training. 
• I confirm agreement to conduct this study in compliance with the protocol. 
• I acknowledge that I am responsible for overall study conduct. I agree to 
personally conduct or supervise the described study.  
• I agree to ensure that all staff members involved in the conduct of this study 
are informed about their obligations in meeting the above commitments. 
 
Principal Investigator:    
  
Print/Type Name 
 
Signed:    
           
 
Signature Date: 
 
 
 
 
           (DD-MMM-YYYY) 


Suzhou Kintor Pharmaceuticals, Inc.                           Protocol # GT0918-US-3001                       
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ABBREVIATIONS  
Term  
Definition 
AACR 
American Association for Cancer Research 
ACE2 
Angiotensin Converting Enzyme 2  
ACVPU 
Alert, Consciousness, Verbal, Pain, Unresponsive Scale 
AE 
Adverse Event 
ALT 
Alanine Transaminase 
ANC 
Absolute Neutrophil Count  
APTT 
Activated Partial Thromboplastin Time 
AR 
Androgen Receptor 
ARDS 
Acute Respiratory Distress Syndrome 
AST 
Aspartate Transaminase 
ATC 
Anatomical Therapeutic Chemical  
AUC  
Area under the Curve 
BID 
Twice a Day 
BP 
Blood Pressure 
BMI 
Body Mass Index 
CDC 
Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
CHO 
Chinese Hamster Ovary 
CI 
Confidence Interval 
CIOMS 
Council for International Organizations of Medical Sciences 
CK 
Creatinine kinase 
CLIA 
Clinical Laboratory Improvement Amendments 
CMH 
Cochran–Mantel–Haenszel 
CMP 
Clinical Monitoring Plan 
CMS 
Clinical Material Services 
CNS 
Central Nervous System 
Cr 
Creatinine 
CR 
Complete Response 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CROMS 
Clinical Research Operations and Management Support 
CRP 
C-reactive Protein 
CRPC 
Castrate Resistant Prostate Cancer  
COVID-19 
Coronavirus Disease 2019  
CQMP 
Clinical Quality Management Plan 
CSR 
Clinical Study Report 
CTCAE 
Common Terminology Criteria for Adverse Events 
DAIDS 
Division of Allergy and Infectious Diseases   
DCR 
Disease Control Rate 


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DHHS 
Department of Health and Human Services 
 
DMC 
Data Monitoring Committee 
DMID 
Division of Microbiology and Infectious Diseases 
DLT 
Dose Limiting Toxicity 
DMP 
Data Management Plan 
EC 
Ethics Committee 
ECOM 
Extracorporeal Membrane Oxygenation 
EOS 
End of Study 
EUA 
Emergency Use Authorization  
FDA 
Food and Drug Administration 
FiO2 
Fraction of Inspired Oxygen in the Air 
FWA 
Federal Wide Assurance 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
hEGR 
Human Ether-a-go-go-related Gene 
Hgb 
Hemoglobin 
HR 
Heart Rate 
IB 
Investigator’s Brochure 
IC50 
A quantitative measure that indicates how much of a particular inhibitory 
substance (e.g., drug) is needed to inhibit, in vitro, a given biological 
process or biological component by 50% 
ICD 
International Classification of Diseases 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonization 
ICU 
Intensive Care Unit 
IIT 
Institute Initiated Trial 
IND 
Investigational New Drug Application 
INR 
International Normalized Ratio 
iNOS 
Inducible Nitric Oxide Synthase  
IRB 
Institutional Review Board 
IV 
Intravenous 
IWRS 
Interactive Web Response System 
IxRS 
Interactive Web/Voice Response System 
LLOQ 
Lower Limit of Quantitation 
LNCaP 
Lymph Node Carcinoma of the Prostate 
MCG 
Microgram 
MedDRA 
Medical Dictionary for Regulatory Activities 
MERS 
Middle East Respiratory Syndrome 
MG 
Milligram 
MOP 
Manual of Procedures 
MTD 
Maximum Tolerated Dose  
N 
Number (typically refers to subjects) 


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NDA 
New Drug Application 
NIAID 
National Institute of Allergy and Infectious Diseases 
NIH 
National Institutes of Health 
NP 
Nasopharyngeal 
NOAEL 
No Observed Adverse Effect Level  
NSAID 
nonsteroidal anti-inflammatory drug 
OHRP 
Office for Human Research Protections 
OP 
Oropharyngeal 
OTC 
Over-the Counter  
PCR 
Polymerase Chain Reaction 
PD 
Protocol Deviation 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PLT 
Platelet 
PP 
Per Protocol 
PR 
Partial Response 
PSA 
 
Prostate-Specific Antigen 
PT 
Prothrombin Time 
QD 
Once A Day 
QT Interval 
Measured from the Beginning of the QRS Complex to the End of the T 
wave 
QTc 
Corrected Q-T Interval 
RNA 
Ribonucleic Acid 
RBC 
Red Blood Cell 
RECIST 
Response Evaluation Criteria in Solid Tumors 
RT-PCR 
Reverse Transcription-Polymerase Chain Reaction 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SARS 
Severe Acute Respiratory Syndrome 
SARS-CoV-2 
Severe Acute Respiratory Syndrome Coronavirus 2  
SC 
Steering Committee 
SD 
Stable Disease 
SDCC 
Statistical and Data Coordinating Center 
SDSP 
Study Data Standardization Plan 
SMC 
Safety Monitoring Committee 
SNP 
Single Nucleotide Polymorphisms 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
SpO2 
Saturation of Peripheral Oxygen 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
T.Bili 
Total Bilirubin 


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TEAE 
Treatment Emergent Adverse Events  
TMPRSS2 
Transmembrane Protease Serine 2  
TNF 
Tumor Necrosis Factor 
ULN 
Upper Limited Number 
UP 
Unanticipated Problem 
US 
United States 
WBC 
White Blood Cell 
WHO 
World Health Organization 
 
 
 


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Sponsor Signature Page .......................................................................................... - 2 - 
Investigator Statement............................................................................................ - 3 - 
Abbreviations .......................................................................................................... - 4 - 
Protocol Summary ....................................................................................................... 1 
Synopsis ..................................................................................................................... 1 
Schedule of Activities (SoA) ................................................................................... 11 
Amendment 1(11-JUN-2021) ........................................................................................ 
1 .............................................................................................................  BACKGROUND
...................................................................................................................................... 15 
Overview of Disease Pathogenesis, Epidemiology, and Current Treatment ........... 15 
Epidemiology........................................................................................................ 15 
Pathogenesis ......................................................................................................... 15 
Available Therapeutic Options in COVID-19 ...................................................... 15 
Role of Androgen Receptor Antagonist in COVID-19 ........................................ 15 
Introduction to Investigational Treatment(s)............................................................ 16 
1.2.1 Overview of Proxalutamide (GT0918) ........................................................ 16 
1.2.2 Nonclinical Studies ...................................................................................... 17 
1.2.3 Clinical Studies ............................................................................................ 20 
Risks and Benefits .................................................................................................... 23 
1.3.1 Overall Benefit-Risk .................................................................................... 23 
1.3.2 Potential Benefits to Clinical Study Subjects .............................................. 23 
1.3.3 Potential Risks to Clinical Trial Subjects .................................................... 23 
2 .................................................................................................................... RATIONALE
...................................................................................................................................... 24 
2.1 
 Study Rationale and Purpose........................................................................ 24 
2.2 Rationale for Study Design ................................................................................ 24 
2.3 Rationale for GT0918 Dose and Regimen Selection ......................................... 25 
2.4 Rationale for Choice of Comparator Drugs ....................................................... 25 


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3     OBJECTIVES AND ENDPOINTS ................................................................... 26 
4  ............................................................................................................. STUDY DESIGN
...................................................................................................................................... 29 
4.1 Description of Study Design .............................................................................. 29 
4.1.1 Screening and Randomization ..................................................................... 30 
4.1.2 Treatment Duration ...................................................................................... 31 
4.2 Timing of Interim Analyses and Design Adaptations ........................................ 31 
4.3 End of the study.................................................................................................. 31 
4.4 Early Study Termination .................................................................................... 31 
5 ................................................................................................................. POPULATION
...................................................................................................................................... 32 
5.1 Patient Population .............................................................................................. 32 
5.2 Inclusion Criteria ................................................................................................ 32 
5.3 Exclusion Criteria ............................................................................................... 33 
6 .................................................................................................................. TREATMENT
...................................................................................................................................... 34 
6.1 Study Treatment ................................................................................................. 34 
6.1.1 Dosing Regimen .......................................................................................... 34 
6.1.2 Guidelines for Continuation of Treatment ................................................... 35 
6.1.3 Ancillary Treatments ................................................................................... 36 
6.1.4 Rescue Medication ...................................................................................... 36 
6.1.5 Treatment Duration ...................................................................................... 36 
6.2 Dose Escalation .................................................................................................. 36 
6.3 Dose Modifications ............................................................................................ 36 
6.3.1 Dose Discontinuation .................................................................................. 36 
6.3.2 Follow-Up for Toxicities ............................................................................. 36 
6.3.3 Anticipated Risks and Safety Concerns of the Study Treatment ................. 36 
6.4 Concomitant Medications .................................................................................. 37 
6.4.1 Permitted Concomitant Therapy .................................................................. 37 
6.4.2 Prohibited Concomitant Therapy................................................................. 38 
6.4.3 Concomitant Therapy to Be Used with Caution .......................................... 38 


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6.5 Patient numbering, Treatment Assignment or Randomization .......................... 38 
6.5.1 Patient numbering ........................................................................................ 38 
6.5.2 Treatment Assignment or Randomization ................................................... 39 
6.5.3 Treatment Blinding ...................................................................................... 39 
6.6 Study Treatment Supply ..................................................................................... 39 
6.6.1 Study Treatment Preparation and Dispensation .......................................... 40 
6.6.2 Study Treatment Packaging and Labeling ................................................... 40 
6.6.3 Drug Supply and Storage ............................................................................. 41 
6.6.4 Study Treatment Compliance and Accountability ....................................... 41 
6.6.5 Disposal and Destruction ............................................................................. 41 
7 .................................................................VISIT SCHEDULE AND ASSESSMENTS
...................................................................................................................................... 42 
7.1 Study Flow and Visit Schedule .......................................................................... 42 
7.1.1 Screening ..................................................................................................... 42 
7.1.2 Treatment Period ......................................................................................... 43 
7.1.3 End of Treatment  ........................................................................................ 44 
7.1.4 Withdrawal of Consent ................................................................................ 45 
7.1.5 Follow-Up for Safety Evaluations ............................................................... 46 
7.1.6 Lost to Follow-Up ....................................................................................... 46 
7.1.7 End of Safety Follow-Up ............................................................................. 47 
7.2 Assessment ......................................................................................................... 47 
7.2.1 Efficacy Assessments .................................................................................. 47 
7.2.2 Safety and Tolerability Assessments ........................................................... 49 
7.2.3 Pharmacokinetics ......................................................................................... 52 
7.2.4 Biomarkers................................................................................................... 52 
7.2.5 Polymerase Chain Reaction (PCR) .............................................................. 52 
7.2.6 Patient Reported Outcomes ......................................................................... 53 
7.2.7 Virology ....................................................................................................... 53 
7.2.8 Development of resistance........................................................................... 53 
8. SAFETY MONITORING AND REPORTING ................................................... 55 
8.1 Adverse Events ................................................................................................... 55 


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8.1.1 Definitions and Reporting ........................................................................... 55 
8.1.2 Events NOT Meeting the AE Definition: .................................................... 56 
8.1.3 Laboratory Test Abnormalities .................................................................... 57 
8.2 Adverse Events of Special Interest (AESI) ........................................................ 58 
8.3 Serious Adverse Events ...................................................................................... 58 
8.3.1 Definitions ................................................................................................... 58 
8.3.2 SAE Reporting ............................................................................................. 58 
8.4 Suspected Unexpected Serious Adverse Reactions (SUSARs) ......................... 59 
8.5 Emergency Unblinding of Treatment Assignment............................................. 60 
8.6 Pregnancies......................................................................................................... 60 
8.7 Warnings and Precaution ................................................................................... 61 
8.8 Independent Data Monitoring Committee (IDMC) ........................................... 61 
8.9 Steering Committee ............................................................................................ 62 
9. DATA COLLECTION AND MANAGEMENT ................................................. 63 
9.1 Data Confidentiality ........................................................................................... 63 
9.2 Site Monitoring .................................................................................................. 63 
9.3 Data Collections ................................................................................................. 63 
9.4 Database Management ....................................................................................... 64 
9.5 Quality Control ................................................................................................... 64 
10. STATISTICAL METHODS AND DATA ANALYSIS .................................... 65 
10.1 General Considerations .................................................................................... 65 
10.2 Analysis Sets .................................................................................................... 65 
10.2.1 Intent-to-Treat Analysis Set (ITT) ............................................................. 65 
10.2.2 Modified Intent-to-Treat Analysis Set (mITT) .......................................... 65 
10.2.3 Safety Analysis Set (SS) ............................................................................ 65 
10.2.4 Per-Protocol Analysis Set (PPS)................................................................ 65 
10.2.5 Pharmacokinetic Analyses ......................................................................... 65 
10.3 Subject Demographics/Other Baseline Characteristics .................................... 66 
10.4 Treatments (Study Treatment, Concomitant Therapies, Compliance) ............. 66 
10.5 Efficacy Analysis ............................................................................................. 66 


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10.5.1 Primary Efficacy Objective ....................................................................... 66 
10.5.2 Secondary Objectives Variables ................................................................ 68 
10.6 Exploratory Objectives ..................................................................................... 71 
10.6.1 Pharmacokinetics of GT0918 .................................................................... 71 
10.6.2 Viral resistance to GT0918 ........................................................................ 71 
10.7 Safety Analysis ................................................................................................. 72 
10.7.1 Analysis set and grouping for the analyses ............................................... 72 
10.7.2. Adverse events .......................................................................................... 72 
10.7.3 Laboratory abnormalities ........................................................................... 72 
10.7.4 Other safety data ........................................................................................ 73 
10.8 Interim Analysis ............................................................................................... 73 
10.9 Sample Size Calculation................................................................................... 74 
11. . ETHICAL CONSIDERATIONS AND ADMINISTRATIVE PROCEDURES
...................................................................................................................................... 75 
11.1 Regulatory and Ethical Compliance ................................................................. 75 
11.2 Responsibilities of the Investigator and IRB/IEC/REB ................................... 75 
11.3 Informed Consent Procedures .......................................................................... 76 
11.4 Discontinuation of the Study ............................................................................ 76 
11.5 Publication of Study Protocol and Results ....................................................... 76 
11.6 Study Documentation, Record Keeping and Retention of Documents ............ 77 
11.7 Source Documents............................................................................................ 77 
11.8 Confidentiality of Study Documents and Subject Records .............................. 77 
11.9 Audits and Inspections ..................................................................................... 78 
11.10 Financial Disclosures ..................................................................................... 78 
12. PROTOCOL ADHERENCE .............................................................................. 79 
13. REFERENCES ..................................................................................................... 80 
14.APPENDICES ....................................................................................................... 81 
Appendix 1. Drugs that Should Be Used Cautiously with GT0918......................... 81 
Appendix 2. Common COVID-19-Related Symptoms............................................ 83 
Appendix 3 COVID-19:  .......................................................................................... 85 


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BASELINE SEVERITY CATEGORIZATION (Developing Drugs and Biological 
Products for Treatment or Prevention Guidance for Industry ) ............................... 85 
Appendix 4 Clinical Laboratory Parameters Collection Plan .................................. 87 
Appendix 5. Subject Questionnaire .......................................................................... 89 


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1 
 
PROTOCOL SUMMARY  
Synopsis 
Protocol Title:  
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to 
Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in 
Outpatients with Mild to Moderate COVID-19 Illness. 
Short Title: A Phase 3 Study to Evaluate the Efficacy and Safety of GT0918 in 
Outpatients with Mild to Moderate COVID-19 Illness 
Protocol Number: GT0918-US-3001 
Study Phase: 3 
Sponsor: Suzhou Kintor Pharmaceuticals, Inc. 
Rationale:  
Coronavirus disease 2019 (COVID-19) emerged in late 2019 and spread rapidly, 
resulting in a global pandemic. New COVID-19 cases and deaths have been 
constantly rising. COVID-19 is caused by a novel coronavirus (SARS-CoV-2), and 
infected persons can have a wide range of disease severity, with many patients 
showing mild or moderate disease. Although many therapies have been and are being 
explored in various stages of COVID-19, for the large population with mild and 
moderate COVID-19, limited treatments are available. There is a huge unmet medical 
need for home-use, oral intake, treatments for mild to moderate COVID-19 patients to 
ameliorate symptoms and prevent hospitalization. 
Much research has proven that SARS-CoV-2 cell entry and fusion depends on 
angiotensin converting enzyme 2 (ACE2) and transmembrane protease serine 2 
(TMPRSS2). In humans, androgens are the only known transcription promoters for 
the TMPRSS2 gene. Further, the ACE2 receptor, also critical for SARS-CoV-2 viral 
infectivity, is affected by male sex hormones with higher activity found in males. So, 
androgen receptor antagonists have the potential to reduce virus entry and viral 
infectivity.  
Proxalutamide (GT0918), a new investigational androgen receptor (AR) antagonist 
with more specificity and activity in inhibiting androgen receptors, has shown to 
inhibit the expression of ACE2 and TMPRSS2 in lung epithelial cells. GT0918 can 
also down-regulate the protein expression level of inflammation-related factor 
inducible nitric oxide synthase (iNOS) and the mRNA expression level of iNOS and 
tumor necrosis factor (TNF). Recent research showed that GT0918 inhibited SARS-
CoV-2 infection more effectively than Enzalutamide in LNCaP cells in a dose-
dependent manner, with concentration that inhibits response by 50% (IC50) values of 


  Suzhou Kintor Pharmaceuticals, Inc.                           Protocol # GT0918-US-3001                      Confidential   
 
2 
 
97 nM. Furthermore,  the preclinical results suggest that GT0918 should more 
effectively inhibit AR-dependent expression of ACE-2 and TMPRSS2 than 
Enzalutamide in a variety of SARS-Cov2 infected organs, including lung, 
Gastrointestinal (GI), heart, and kidney. 
The clinical study of GT0918 treatment in Brazil for COVID-19 outpatients 
(NCT04446429) showed the hospitalization rate was significantly decreased in the 
GT0918 group compared with placebo group (0 vs. 27% in the male cohort and 3 
vs.19% in the female cohort). No serious adverse event (SAE) occurred in the 
GT0918 group compared with 27% in the placebo group in the male cohort. In the 
female cohort, the percentage of subjects reported to have SAEs was 3%  in the 
GT0918 group and 19% in the placebo group. 
GT0918 will be administered to evaluate its effect in accelerating recovery following 
SARS-CoV-2 infection, limiting spread into lung cells, improving the clinical 
outcome and reducing hospitalization in COVID-19 infected outpatients with mild or 
moderate symptoms. 
Objectives and Endpoints: 
 
Objectives 
Endpoints 
Primary 
  Primary  
To evaluate the efficacy in terms of 
clinical status following treatment 
with GT0918 compared to placebo 
Percentage of subjects who do not experience any of the 
following events due to all causes by Day 28: 
• 
Hospitalization for ≥ 24 hours or 
• 
Supplemental oxygen for ≥24 hours in response to 
SpO2 ≤93% or 
• 
Death 
Secondary  
 Secondary 
 
• 
 


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To evaluate the clinical efficacy of 
GT0918 compared to placebo 
using the NIAID 8- point scoring 
scale 
Percentage of subjects achieving each clinical 
status by Days 7, 14 and 28 as defined below based 
on The National Institute of Allergy and Infectious 
Diseases (NIAID) 8- point scoring scale: 
1 Death 
2 Hospitalized, on invasive mechanical ventilation 
or extracorporeal membrane oxygenation 
(ECMO) 
3 Hospitalized, on non-invasive ventilation or 
high flow oxygen devices 
4 Hospitalized, requiring supplemental oxygen 
5 Hospitalized, not requiring supplemental oxygen 
- requiring ongoing medical care (COVID-19-
related or otherwise) 
6 Hospitalized, not requiring supplemental oxygen 
- no longer requires ongoing medical care 
7 Not hospitalized, limitation on activities and/or 
requiring home oxygen 
8 Not hospitalized, no limitations on activities  
To evaluate the clinical efficacy of 
GT0918 compared to placebo 
based on clinical status 
• 
Proportion of subjects with all-cause hospitalization 
(defined as ≥24 hours) by Day 28 
• 
Proportion of subjects hospitalized (defined as ≥24 
hours) due to COVID-19 related events by Day 28 
• 
Days of hospitalization due to all causes or COVID-
19 
• 
Proportion of subjects with all-cause mortality by 
Day 28 
• 
Proportion of subjects with COVID-19 related 
mortality by Day 28 
• 
Proportion of subjects admitted to an ICU due to 
COVID-19 by Day 28 
• 
Days in intensive care unit (ICU)  
• 
Proportion of subjects requiring supplemental 
oxygen, high-flow oxygen, any ventilation or 
ECMO due to COVID-19 by Day 28 
• 
Proportion of subjects requiring mechanical 
ventilation or ECMO due to COVID-19 by Day 28 
• 
Days on supplemental oxygen/high flow oxygen 
devices/mechanical ventilation  
• 
 
Characterize the effect of GT0918 
compared to placebo on symptom 
improvement or resolution 
Symptom Improvement: 
• 
Change in symptom score (total of ratings) from 
baseline to Days 3, 7, 14 and 28 
• 
Time to symptom improvement 
• 
Proportion of subjects demonstrating symptom 
improvement via the symptom questionnaire (total 
of ratings) on Days 3, 7, 14 and 28 
Symptom resolution: 


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• 
Proportion of subjects demonstrating symptom 
resolution via the symptom questionnaire on Days 
3, 7, 14 and 28 
• 
Time to symptom resolution 
Characterize the effect of GT0918 
compared to placebo on 
SARS-CoV-2 viral load clearance 
• Change from baseline to Days 3, 7, 14 and 28 in SARS-
CoV-2 viral load  
• Proportion of subjects that achieve SARS-CoV-2 
clearance (Days 3, 7, 14 and 28) 
• Time to SARS-CoV-2 clearance 
• SARS-CoV-2 viral load area under the 
concentration-time curve (AUC) assessed to days 3, 7, 
14 and 28 
Characterize the effect of GT0918 
compared to placebo on safety 
Safety assessments such as AEs, SAEs and laboratory data 
Exploratory 
Exploratory  
Characterize the pharmacokinetics 
of GT0918 
• Mean trough concentration of GT0918 and GT0955 on 
Days 1, 3, 7 and 14  
• To explore relationships between GT0918 and/or 
GT0955 exposure and selected efficacy and safety 
endpoints and/or biomarkers 
Characterize emergence of viral 
resistance to GT0918 
Screening for novel mutants in subjects who do not 
respond to GT0918 
• Genotype of SARS-CoV-2 viral isolates 
To explore biomarkers predictive of 
GT0918 safety, efficacy, and/or 
disease progression and COVID-19 
clinical outcomes 
  
• The association between changes in disease related 
biomarkers with clinical endpoints  
Study Design  
Overall Design: 
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to 
evaluate the safety and efficacy of Proxalutamide (GT0918) in adult outpatients 
diagnosed with mild to moderate COVID-19. 
The population of subjects with mild to moderate COVID-19 illness will be chosen to 
evaluate if anti-androgen therapy may effectively prevent progression to the severe 
form of COVID-19 illness by treating this population early in their disease course and 
prior to respiratory compromise and failure.  
This study utilizes an adaptive design that maximizes efficiency in identifying a safe 
and efficacious therapeutic agent for COVID-19 during the current outbreak. The 
study is a multicenter trial that will be conducted in the United States (US) and other 
countries. Approximately 668 subjects will be randomized in a 1:1 ratio to either 
GT0918 or placebo. There will be one interim analysis. The interim analysis will be 
conducted when 334 subjects complete Day 28 after first dose. The blood samples for 


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population (pop) PK analysis need to be collected for at least 100 subjects, whom will 
also be randomized into the interventional treatment or placebo group with 1:1 ratio. 
Randomization: 
Subjects will be randomized into 1 of 2 arms with 1:1 ratio, each will receive an 
interventional treatment or placebo with standard of care. 
Randomization will be stratified by: 
• Sex: Male or Female  
• Race and ethnicity (non-Hispanic White or other /Hispanic or Latino /non-
Hispanic Black) 
• Number of risk factors 0, 1-2, ≥3 (based on CDC defined conditions) 
  
Study Duration 
The subject will remain on study treatment up to 14 days. 14-day post treatment period 
with a post treatment visit on Day 28. The safety follow-up will be up to 28 days after 
last dose making the overall duration of monitoring 42 days for each subject. 
End of Study 
A subject is considered to have completed the study if he has completed all required 
phases of the study including the last scheduled procedure shown in the Schedule of 
Activities (SoA). 
The end of the study is defined as the date of last scheduled procedure shown in the 
SoA for the last enrolled subject or last ongoing subject in the study, whichever comes 
later. 
Inclusion Criteria 
Subjects are eligible to be included in the study only if all the following criteria apply: 
1. The subject or legally authorized representative give signed informed consent 
which includes compliance with the requirements and restrictions listed in the 
ICF and in this protocol. 
2. Understand and agree to comply with planned study procedures. 
3. Male and non-pregnant female subjects with age ≥18 years of age at the time of 
randomization. 
4. Are currently not hospitalized. 
5. Have one or more COVID-19-related symptoms within 5 days of onset of 
symptoms onset (FDA COVID-19-Related symptom guidance, See Appendix 
2, available at: https://www.fda.gov/media/142143/download) 


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6. Must have first positive SARS-CoV-2 viral infection determination (has 
laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other 
commercial or public health assay in any specimen) ≤3 days prior to start of the 
first dose.  
7. Women of child-bearing potential, defined as all women physiologically 
capable of becoming pregnant, unless they are using highly effective 
contraception, as shown below, throughout the study and for 3 months after 
stopping GT0918 treatment. Highly effective contraception methods include:  
• Total Abstinence (when this is in line with the preferred and usual 
lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, 
symptothermal, post-ovulation methods) and withdrawal are not 
acceptable methods of contraception, or  
• Use of one of the following combinations (a+b or a+c or b+c):  
a: Use of oral, injected or implanted hormonal methods of 
contraception or other forms of hormonal contraception that have 
comparable efficacy (failure rate < 1%), for example hormone vaginal 
ring or transdermal hormone contraception.  
b: Placement of an intrauterine device (IUD) or intrauterine system 
(IUS); 
c: Barrier methods of contraception: Condom or Occlusive cap 
(diaphragm or cervical/vault caps) with spermicidal 
foam/gel/film/cream/vaginal suppository; 
• Female sterilization (have had prior surgical bilateral oophorectomy with 
or without hysterectomy) or tubal ligation at least six weeks before taking 
study treatment. In case of oophorectomy alone, only when the 
reproductive status of the woman has been confirmed by follow-up 
hormone level assessment; 
• Male sterilization (at least 6 months prior to screening). For female 
subjects on the study, the vasectomized male partner should be the sole 
partner for that subject; 
In case of use of oral contraception women should have been stable for a 
minimum of 3 months before taking study treatment. Women are considered 
post-menopausal and not of childbearing potential if they have had 12 months 
of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. 
age appropriate, history of vasomotor symptoms) or have had surgical 
bilateral oophorectomy (with or without hysterectomy) or tubal ligation at 
least six weeks ago. In the case of oophorectomy alone, only when the 
reproductive status of the woman has been confirmed by follow up hormone 
level assessment, is she considered not of childbearing potential; 


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8. Regardless of their fertility status, male subjects must agree to either remain 
abstinent (if this is their preferred and usual lifestyle) or use condoms as well 
as one additional highly effective method of contraception (less than 1% failure 
rate) or effective method of contraception with nonpregnant women of 
childbearing potential partners for the duration of the study and until 90 days 
after the last dose. 
9. Agree to the collection of nasopharyngeal swabs and venous blood. 
Exclusion Criteria  
Subjects are excluded from the study if any of the following criteria apply: 
1. Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate 
≥30 per minute, heart rate ≥125 per minute (FDA resource page, COVID-19: 
Developing Drugs and Biological Products for Treatment or Prevention 
Guidance for Industry (fda.gov)). 
2. Estimated glomerular filtration rate (eGFR) < 30 ml/min 
3. Serum total bilirubin > 1.5 x ULN (upper limit of normal) and AST and ALT >3 
x ULN 
4. Subjects with significant cardiovascular disease as following: 
i. heart failure NYHA class ≥3 
ii. left ventricular ejection fraction <50% 
iii. those with a history of cardiac arrhythmias, including long QT syndrome. 
5. Has been admitted to a hospital prior to randomization, or is hospitalized 
(inpatient) at randomization, due to COVID-19 or requires treatment with 
supplemental oxygen. 
6. Have known allergies to any of the components used in the formulation of the 
interventions. 
7. Have hemodynamic instability requiring use of vasopressors within 24 hours 
of randomization. 
8. Suspected or proven serious, active bacterial, fungal, viral, or other infection 
(except COVID-19) that in the opinion of the investigator could constitute a 
risk when taking intervention (i.e. known history of human immunodeficiency 
virus [HIV]). 
9. Have any co-morbidity requiring surgery within <7 days, or that is considered 
life-threatening within 30 days. 
10. Have any serious concomitant systemic disease, condition, or disorder that, in 
the opinion of the investigator, should preclude participation in this study.  
11. Subjects with myopathy. 


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12. Prior, current, or planned future use of any of the following treatments: COVID-
19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), 
where prior use is defined as the past 30 days or less than 5 half-lives of the 
investigational product (which is longer) from screening. 
13. Have participated, within the last 30 days, in a clinical study involving an 
investigational intervention. If the previous investigational intervention has a 
long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. 
14. Are concurrently enrolled in any other type of medical research judged not to 
be scientifically or medically compatible with this study. 
15. Subject taking an anti-androgen of any type including androgen depravation 
therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing. 
16. Are investigator site personnel directly affiliated with this study. 
Investigational and Reference therapy 
For this study, investigational drug (study drug) refers to Kintor study drug 
Proxalutamide (GT0918). GT0918 will be supplied by Kintor or its designee as 
100 mg tablets as individual patient supply packaged in blister. 
• Arm 1: Subjects administered GT0918, 200 mg q.d. after regular conventional 
meal plus standard of care for 14 consecutive days  
• Arm 2: Subjects administered GT0918, matched placebo q.d. after regular 
conventional meal plus standard of care for 14 consecutive days  
The dose should be given the same time each day (+/- 2 hours for medication 
scheduling). 
Any dose that is delayed may be given later that calendar day. Any dose that is missed 
(not given that calendar day) is not made up. The treatment course should continue as 
described above even if the subject becomes SARS-Cov-2 test negative or 
experiences complete resolution of symptoms.  
All subjects may be treated according to standard of care simultaneously, and 
medications may be part of the treatment paradigm. The study treatment refers to the 
study drug/placebo plus standard of care. Dose escalation is not applicable in this 
study.  
For the subjects who develop Grade 3 or 4 adverse events (AEs), suspected to be 
drug-related by the investigator, the study drug administration should be discontinued. 
This subject will enter post-treatment period with the safety follow-up up to 28 days 
after last lose. There is no dose interruption or reduction in this study.  
Safety Assessment 


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• Safety assessments will include the incidence, and severity of AEs and laboratory 
abnormalities graded per Division of Allergy and Infectious Diseases (DAIDS) 
Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 
(July 2017). 
• Safety evaluations will be performed per SoA during the study.  
• The assessments, as described in Section 7.2.2, will occur at baseline, Days 3, 7, 
14 and 28 or early withdrawal visit following randomizations (+/-2 days). The 
information will be recorded in the appropriate eCRF. 
• Subjects will receive safety evaluation at regular visits as specified in the 
procedures, including physical examination, vital signs, laboratory tests. In 
addition, ECGs, chest X-ray, and CT-scan could be done per the investigator’s 
discretion.  
• In addition to scheduled visits in the protocol, unscheduled visits may be 
conducted as appropriate based on the subject`s AEs or clinical status.  


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Statistical considerations: 
Sample size calculation 
The primary endpoint event rate for the treatment arm is assumed at 97% and for the 
placebo arm is assumed at 91%.  
The sample size was calculated using EAST v6.5 software for a group sequential test 
for 2 proportions. With a total of 668 subjects the study will have 90% power at a 
one-sided 0.025 significance level of the hospitalization or death rate using a Chi-
square test with one interim analysis at 50% of the information (when 334 subjects 
have been observed for 28 days). 
Statistical analysis: 
The primary endpoint event rate will be compared between treatment and placebo arm 
using Cochran–Mantel–Haenszel (CMH) chi-square test using the stratification 
factors at time of randomization at the one-sided 0.025 level based on modified 
Intent-to-Treat (mITT).  
An interim analysis will be conducted when 334 subjects complete Day 28 after first 
dose. An independent data monitoring committee (IDMC) will review the interim 
analysis report to conclude early efficacy, make recommendations about early study 
closure, change study population, or change to study sample size. 
If the one-sided p-value is less than 0.0015, the stopping boundary for efficacy is met 
and the study could be stopped for efficacy. 
Analysis Sets 
The intent-to-treat analysis set (ITT) includes all randomized subjects. 
The mITT set will include all randomized subjects who have received at least one 
dose of study medication.  
The safety analysis set (SS) includes all subjects with at least one dose of study 
medication and will be analyzed as treated.  
The Per-Protocol Analysis Set (PP) includes all mITT subjects without major protocol 
violations which will be defined under classification specification prior to unblinding 
of the study treatment code. 
The Pharmacokinetic Analyses (PK) will be conducted on data from at least 100 
subjects who receive intervention and have evaluable PK. 


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Schedule of Activities (SoA) 
Assessments obtained previously as part of routine clinical care may be used as the screen assessment if they were done no more 
than one day before randomization. Visits may be conducted as a telephone call, outpatient clinic or home visit, if the protocol SoA 
is followed and in compliance with local regulatory.  
Table 1 Schedule of Activities 
  
Screen 
Treatment Period 
Early 
Withdrawal 
19 
Post-treatment 
Safety 
Follow 
Up 20 
Study Day (Visit Window ± 
days) 
D-1 
D1 
D3 
D7 (±1)  
D14 
(+1) 
 (+2) 
D15 
D28 
(±2)  
D42 
Phone 
Call 
(±2)  
Informed Consent 
X 
  
  
  
  
  
  
  
  
Inclusion/Exclusion Review 1 
X 
  
  
  
  
  
  
  
  
Demographics 2 
X 
  
  
  
  
  
  
  
  
Preexisting Conditions and 
Medical History 3 
X 
  
  
  
  
  
  
  
  
NIAID Ordinal Scale4 
 X 
Daily 
  
Prior Treatment 5 
X 
  
  
  
  
  
  
  
  
Tobacco Use 
X 
  
  
  
  
  
  
  
  
Physical Examination 6 
X 
Symptom Directed PE only if Clinical Indicated 
  


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Vital Signs 7 
X 
  
X 
X 
X 
X 
  
X 
  
Nasopharyngeal swabs 8 
X 
  
X 
X 
X 
X 
  
X 
  
Randomization 9 
X 
X 
  
  
  
  
  
  
  
Hematology 10 
X 
  
  
X 
X 
X 
  
X 
  
Chemistry 10 
X 
  
  
X  
X 
X 
  
X 
  
Biomarkers 10  
X 
  
X 
  
X 
X 
  
X 
  
Coagulation 10 
X 
  
  
  
X 
X 
  
X 
  
Drugs and Diary Dispense 11 
X 
X 
  
  
  
  
  
  
  
GT0918 or Placebo 
Administration 11 
  
Daily from D1 to D14 
  
  
  
  
Subject Diary 11 
 
Daily from D1 to D14 
  
  
  
  
Questionnaire (Symptoms; 
Overall Clinical Status; ) 11 
Daily 
  
Chest X-ray or CT Scan 12 
Clinically Indicated 
  
12-ECG 12 
Clinically Indicated 
  
Hospitalization events 13 
  
Daily  


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Clinical status and 
concomitant procedures if 
subject is hospitalized 14 
  
Daily if hospitalized 
Adverse Events 15 
X 
Concomitant Medications 16 
X 
Pharmacokinetics  17 
  
X 
X 
X 
X 
  
  
  
  
Pregnancy test18 
X 
 
 
 
 
 
 
X 
 
COVID-19 vaccination status 
X 
 
 
 
 
 
 
 
 
 
 
Annotation: 
1. Inclusion/Exclusion review: every subject needs to meet all inclusion and exclusion criteria. The eligibility checklist needs to be signed by the investigator or 
sub-investigator.  
2. Demographics: includes age, gender, race, and ethnicity. 
3. Pre-existing conditions and medical history: obtained from interview or available information and including timing of exposure and onset of symptoms 
suggestive of SARS-CoV-2 infection. 
4. NIAID ordinal scale to be completed daily through Day 28 or 14 days after last dose. This information can be collected from questionnaire; reported events; 
or directly from the patient. 
5. Prior treatments within last 30 days. 
6. Physical exam (PE): Full physical exam should be done at screening visit. For the subsequent visits, symptom directed PE can be done per investigator’s 
discretion. If the result is clinically significant, the PE result should be recorded in eCRF.  
7. Vital sign: documentation of hospital-based exam is acceptable. Vital signs include body temperature, pulse rate, systolic and diastolic blood pressure, 
respiratory rate. For screening visit, SpO2, and supplemental oxygen flow rate, FiO2 if known and method of delivery if applicable, also need to be recorded.  
Record blood pressure and SpO2 while subject is at rest.  
8. Nasopharyngeal (NP) swabs: Only NP swab sample is acceptable. The method of taking samples should be consistent for each subject during the whole 
period of this study. This does not need to be the same before screening visit, when the subject is first time confirmed SARS-CoV-2 positive at local 
laboratory and/or Point of Care testing. Sample for first positive test must be collected within 3 days prior to start of dosing. Local laboratory and/or Point of 
Care testing are acceptable. 
9. Randomization: randomization should be via the Interactive Voice/Web (IxRS) Response System. Randomization should be done after confirmation the 
subject meets all inclusion/exclusion criteria. Drugs and Diary Dispense should occur after randomization. It is allowed for the subject to take the drug on the 


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same day of the screening visit after confirmation of eligibility and randomization (the screening visit is counted as D1 too). The Subject Diary should start 
to be completed.   
10. Laboratory tests: Hematology, Chemistry (including Creatinine Kinase), Biomarkers (including Procalcitonin, C-reactive protein, D-dimer, Ferritin, 
Troponin, Testosterone), Coagulation. For details refer to Section 7.2.2 and 7.2.4.  
11. GT0918 or placebo administration: GT0918 or placebo will be given orally once daily on Days 1-14 during the study period after a meal (±2 hours for 
medication scheduling). The drug taken time should be recorded with subject diary. If the screening day is also D1, the subject does not need to follow the 
drug taken window on screening day/D1. For details refer to Section 6.1. 
Subject Diary should be completed every day since first dose until the last dose.  
Questionnaire should be completed every day since screening visit to the end of post-treatment by Day 28. For details refer to Section 7.2.6.  
12. Chest X-ray or CT-Scan or 12-ECG can be done per investigator’s discretion. If investigator deems the result is clinically significant, the result should be 
recorded with eCRF. 
13. Hospitalization events: if the subject is hospitalized, the treatment may be continued to the 14 days per PI. Hospitalization is defined as ≥24 hours in hospital 
of care. For details refer to Section 7.1.2. 
Record if the following events occur: 
• 
Emergency room visits 
• 
Hospitalized  
• 
ICU admittance 
• 
Discharge 
• 
Extended care facility admittance(refers to long term care for chronic diseases or prolonged rehabilitation, which is not defined as hospitalization) 
14. Documentation from hospital records is acceptable. 
Includes: 
• 
Limitation on activities due to COVID- 19 
• 
Ongoing hospital medical care 
• 
Supplemental oxygen 
• 
Non-invasive ventilation or high flow oxygen device 
• 
Mechanical ventilation 
• 
ECMO, or 
15. Adverse events: any events that occur after signing the informed consent are considered AEs as defined in Section 10.3. 
16. Concomitant medications: all medications administered within 30 days prior to the first dose of study treatment through 30 days after the last dose of study 
treatment will be recorded in the concomitant medications, for details refer to Section 6.4.  
17. Pharmacokinetics (PK) samples only need to be taken for at least 100 subjects, who will be assigned according. For details refer to Section 7.2.3. 
18. All women regardless of childbearing potential must complete a serum pregnancy test at screening visit, urinary pregnancy test on day 28 as per the schedule 
of assessment for women of childbearing potential. Local laboratories will be used for the analysis of serum and urinary pregnancy tests. 
19. Early withdrawal (EW): if the subject is early withdrawn from this study for any reason (Section 7.1.4), the subject should complete the EW visit, and the 
visit should occur within 2 days of the EW day. The subject will go to the safety follow-up period for additional 28 days after his last dose.   
20. D42 (or 28 days ±2 post last dose if subject is withdrawn early) safety follow-up visit is phone call visit.  


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1  BACKGROUND 
Overview of Disease Pathogenesis, Epidemiology, and Current Treatment 
Epidemiology  
Coronavirus disease 2019 (Covid-19) emerged in late 2019 and spread rapidly, resulting in a 
global pandemic. New COVID-19 cases and deaths have been constantly rising. As of 
20 December 2020, there have been over 75 million cases and over 1.6 million deaths since the 
start of the pandemic. In the US, the overall cumulative COVID-19-associated hospitalization 
rate through the week ending 05 December 2020, was 278.7 hospitalizations per 100,000 
population. (CDC weekly summary).  
Pathogenesis 
COVID-19 is caused by a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-
2), and infected persons can have a wide range of disease severity, with many subjects showing 
asymptomatic, mild or moderate disease. In severe and critical cases, it results in progressive 
pulmonary infection, complicated by respiratory failure, with a high prevalence of acute 
respiratory distress syndrome. According to data from China, 81% of people with COVID-19 
had mild or moderate disease, 14% had severe disease, and 5% had critical illness（3）. 
Two main processes are thought to drive the pathogenesis of COVID-19. Early in the course of 
the infection, the disease is primarily driven by replication of SARS-CoV-2. Later in the course 
of infection, the disease is driven by an exaggerated immune/inflammatory response to the virus 
that leads to tissue damage (NIH Therapeutic Management of Patients with COVID-19). 
Available Therapeutic Options in COVID-19  
Although many therapies have been and are being explored in various stages of COVID-19, for 
the large population with mild and moderate COVID-19, limited treatments are available. By 
December 2020, the FDA had issued an emergency use authorization (EUA) to only 2 
treatments: Bamlanivimab given alone, as well as Casirivimab and Imedevimab given together 
for the treatment of mild to moderate COVID-19, which could work against the SARS-CoV-2 
spike protein to reduce viral replication. However, both EUA-issued treatments are monoclonal 
antibodies and require IV injection. Therefore, there is a huge unmet medical need for home-use, 
oral intake, treatments for mild to moderate COVID-19 patients to ameliorate symptoms and 
prevent hospitalization.  
Role of Androgen Receptor Antagonist in COVID-19 
SARS-CoV-2 encodes nonstructural and structural proteins required for its viral life cycle. 
Among them, the spike glycoprotein plays a pivotal role in SARS-CoV-2 infection by 
recognizing and attaching to ACE2 transmembrane protein on host cells. The spike protein is 
also cleaved and activated by cell surface TMPRSS2 to facilitate membrane fusion and entry. It 
has been confirmed that targeting the expression or activity of ACE2 or TMPRSS2 plays a 
critical role in the pathogenicity of coronavirus infection. In mice models, inhibition of 
TMPRSS2 function can decrease the SARS-CoV-2 entry into lung cells and similar observation 
was shown in the inhibition of ACE2 function (5).   


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Furthermore, it has become clear that there is a gender disparity in severity of COVID-19 with 
males having higher hospitalization and mortality rates than females.  
However, elevated testosterone level has also been observed in most female COVID-19 subjects 
(Maria Schroeder 2020), and there was a positive correlation between testosterone levels and 
pro-inflammatory cytokines in female COVID-19 subjects. 
The data have shown that treatment with an antiandrogen reduces TMPRSS2 in human lung cells 
dramatically decreased TMPRSS2 levels in the lungs of mice (1). To determine therapeutic 
potential, the authors assessed uptake of live SARS-CoV-2 into human lung cells and saw a 
significant reduction in viral entry and infection upon treatment with an antiandrogen. Together 
with striking co-expression of AR and TMPRSS2 in specific lung cell types that are targeted by 
SARS-CoV-2., these data provide strong evidence to support clinical trials to assess the efficacy 
of antiandrogens as a treatment option for COVID-19. 
 
Introduction to Investigational Treatment(s) 
1.2.1 Overview of Proxalutamide (GT0918) 
Compound Name: Proxalutamide Tablet (GT0918) 
Chemical Name: 
4-[4,4-dimethyl-3-[6-[3-(2-oxazolyl) propyl]-3-pyridinyl]-5-oxo-2-thioxo-1-imidazolidinyl]-3-
fluoro-2-(trifluoromethyl)-benzonitrile 
 
Chemical Structure  
 
 
 
Molecular Formula: C24H19F4N5O2S 
Molecular Mass: 517.50 g/mol 
Dosage Form: Tablet (100 mg) 
GT0918 is a new investigational second-generation AR antagonist with more specificity and 
activity in inhibiting androgen receptors. GT0918 demonstrates a dual mechanism of action in 
cell assays: inhibiting the binding of androgen to AR as well as exhibiting pharmacological 
effects of inducing the downregulation of AR expression（2）. 


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1.2.2 Nonclinical Studies 
1.2.2.1 Nonclinical Pharmacology  
In vitro studies, GT0918 demonstrates a dual mechanism of action, i.e., highly effective in 
inhibiting the binding of androgen to AR as well as exhibiting pharmacological effects of 
inducing the downregulation of AR expression, while bicalutamide and enzalutamide did not 
affect AR level in the same study, GT0918 also down-regulated AR protein level in tumors in a 
dose-dependent manner (4). 
1.2.2.2 Anti-tumor Activity in Xenograft Models 
GT0918 is also effective in blocking AR signaling in breast cancer cells expressing AR. In an 
anti-proliferation assay, it selectively inhibited the growth of AR+ breast cancer cells such as 
MCF-7 and MDA-MB-453 while demonstrated no effects toward AR- breast cancer cells such as 
MDA-MB-231 and MDA-MB-468. Furthermore, GT0918 demonstrated excellent anti-tumor 
effectiveness in nude mice AR+ breast cancer xenograft tumor models including MCF-7 model 
and BT474 model. GT0918 did not significantly affect the body weight of animals. The optimal 
effective dose in nude mice was 10- 20 mg/kg (QD). The in vivo anti-tumor efficacy was better 
than that of enzalutamide at lower or equal dose. 
GT0918 demonstrated the dose-dependent anti-tumor effectiveness in nude mice xenograft 
tumor models. GT0918 did not significantly affect the body weight of animals and effectively 
suppressed the elevation of PSA. The optimal effective dose in nude mice was 20 mg/kg (BID). 
The in vivo efficacy was similar to that of enzalutamide but required much lower drug exposure 
than enzalutamide.  
GT0918 is also effective in blocking AR signaling in breast cancer cells expressing AR. In an 
anti-proliferation assay, it selectively inhibited the growth of AR+ breast cancer cells such as 
MCF-7 and MDA-MB-453 while demonstrated no effects toward AR- breast cancer cells such as 
MDA-MB-231 and MDA-MB-468. Furthermore, GT0918 demonstrated excellent anti-tumor 
effectiveness in nude mice AR+ breast cancer xenograft tumor models including MCF-7 model 
and BT474 model. GT0918 did not significantly affect the body weight of animals. The optimal 
effective dose in nude mice was 10- 20 mg/kg (QD). The in vivo anti-tumor efficacy was better 
than that of enzalutamide at lower or equal dose. 
1.2.2.3 Safety Pharmacology and Toxicology  
An in vitro cardiovascular safety pharmacology study for human ether-a-go-go-related gene 
(hERG) channel inhibition in CHO cells showed that GT0918 was a very weak hERG-mediated 
potassium channel blocker, with an IC50 much higher than 10 μM. This strongly suggests that 
the potential for QT prolongation at clinically relevant concentrations by GT0918 is low. In 
addition, no evidence of QTc prolongation was observed in the cardiovascular and respiratory 
safety pharmacology study in conscious Beagle dogs after oral administration at doses up to 
50 mg/kg.  
The maximum tolerated dose (MTD) was 500 mg/kg in the acute animal study, and the no 
observed adverse effect level (NOAEL) was 60 mg/kg after GT0918 orally administered to 
Sprague Dawley rats for 28 days. In Beagle dogs, the MTD and NOAEL were 2000 mg/kg and 


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50 mg/kg, respectively, in the acute and the 28-day study. The adverse effect noted in rat and dog 
studies were reversible during the 4-week recovery period. No seizure or convulsion was 
observed in animals throughout the general toxicology studies including high doses in acute 
studies as well as repeat dosing studies. 
No significant changes in CNS function were observed with GT0918 in rats at doses up to 
180 mg/kg. GT0918 did not produce adverse effects on cardiovascular functions, respiratory 
functions, and the body temperature in conscious beagle dogs after oral administration at doses 
up to 50 mg/kg.  
Altogether, these findings with high doses of GT0918 in animal were benign. When choosing a 
dose for start of clinical studies in humans, algorithms were used to choose a lower dose at which 
these findings would be absent or minimized.  
1.2.2.4 Drug Metabolism and Pharmacokinetic 
In vitro studies to establish the metabolite profiles of GT0918 were performed in multiple animal 
species including mouse, rat, dog, monkey, and human. Drug metabolism and pharmacokinetic 
studies were also performed in vivo in rats and dogs. 
Chemical inhibitor in human live microsomal incubation indicate CYP3A4 was the major 
cytochrome P450 enzyme responsible for the formation of major metabolites of GT0918 in 
human liver microsomes. LC-MS/MS results showed that GT0918 showed no significant 
inhibition on CYP1A2 and CYP2E1, weak inhibition on CYP2D6, CYP2C9, CYP2C19 and 
CYP3A (midazolam), but marked inhibition on CYP3A4 (testosterone). Therefore, the inhibitory 
effect of GT0918 on CYP3A4 in vitro and the corresponding in vivo drug interaction potential 
needs to be further investigated. 
1.2.2.5 GT0918 Effect on TMPRSS2 and ACE2 Expression 
The spike glycoprotein plays a pivotal role in SARS-CoV-2 infection by recognizing and 
attaching to ACE2 transmembrane protein on host cells. The spike protein is also cleaved and 
activated by cell surface TMPRSS2 to facilitate membrane fusion and entry. GT0918 has shown 
to inhibit protein expression of ACE2 and TMPRSS2 induced by androgen-AR activation in 
prostate and lung epithelial cells. 
 
 


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Figure 2. The protein levels of AR, ACE2 and TMPRSS2 in LNCaP (left) and A549 (right) 
cells with the indicated treatment were determined by western blotting. 
GT0918 was also showed to inhibit macrophage activation markers iNOS and TNF-α expression 
induced by Lipopolysaccharide in macrophage cells. These results suggested that GT0918 could 
inhibit the pathogen-induced macrophage activation. 
 
 
 
Figure 3 Relative expression of iNOS in RLE-6TN cells with the indicated treatment was 
determined by Quantitative PCR. 
Recently, using this SARS-CoV-2 bioassay platform, we demonstrated that Proxalutamide more 
effectively inhibited SARS-CoV-2 infection than Enzalutamide in LNCaP cells in a dose-
dependent manner, with concentration that inhibits response by 50% (IC50) values of 97 nM. 
We have also compared the effect of Proxalutamide with Enzalutamide on the expression of 
androgen receptor (AR), ACE2 and TMPRSS2 in an AR overexpressing/androgen independent 
prostate cancer cell line C4-2B at the concentration of 12.5µM  (data on file). The results showed 
that proxalutamide more effectively inhibited the expression of AR, ACE-2 and TMPRSS2 than 


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Enzalutamide in C4-2B cells. These results suggest that GT0918 should more effectively inhibit 
AR-dependent expression of ACE-2 and TMPRSS2 than Enzalutamide in a variety of SARS-Cov2 
infected organs, including lung, GI, heart, and kidney. 
 
1.2.3 Clinical Studies 
1.2.3.1 Clinical Studies in Solid Tumors 
Four clinical studies are ongoing in both China and the US and 3 studies conducted both in 
China and in US have been completed in prostate cancer and breast cancer.  
1.2.3.1.1 Completed Clinical Studies in Solid Tumors 
GT0918-US-1001 
The US study is a Phase I/II open-label, non-randomized, dose escalation, 2-part, study in 
subjects with metastatic castrate resistant prostate cancer (mCRPC) who progressed after both 
hormonal therapy (abiraterone or enzalutamide) and chemotherapy (docetaxel), or who could not 
tolerate either or both therapies. The finished Phase 1 part (GT0918-US-1001) was a multiple 
dose-escalation evaluation to establish safety and tolerability of GT0918. Total of 40 subjects 
were enrolled into this study at 7 dose levels: 50 mg (n=3), 100 mg (n=6), 200 mg (n=6), 300 mg 
(n=7), 400 mg (n=7), 500 mg (n=6) and 600 mg (n=5). Of the 40 subjects in the GT0918-US-
1001 study, 39 (98%) experienced at least 1 treatment-emergent adverse events (TEAE) during 
the study, with the most frequent AEs being fatigue, nausea, decreased appetite, anemia, weight 
decrease, diarrhea, constipation, back pain, and dizziness. Most of subjects reported TEAEs that 
were considered related to the study drug, with the most common drug-related AEs being fatigue 
(42.5%), decreased appetite (20%), nausea (15%), dizziness (12.5%), constipation (12.5%), 
anemia (10%), weight decrease (10%), dysgeusia (10%), and diarrhea (7.5%). Most TEAEs were 
Grade 1 or 2. Twenty subjects across all dose cohorts reported TEAEs of Grade 3 or higher. 
Each individual TEAE of Grade 3 or higher occurred sporadically in 1 or 2 subjects, except for 
the following: anemia (7/40), fatigue (5/40) and sepsis (3/40). The majority of Grade 3 or higher 
TEAEs were considered not related to the study drug. All serious adverse events (SAEs) and 
Grade 3 or higher AEs were reported across all dose cohorts. The majority of SAEs and Grade 3 
or higher AEs, as well as 2 deaths, were due to disease progression and were not related to the 
study drug, except for one event of Grade 4 increased creatine phosphokinase (CK). 
Overall, GT0918 was generally well tolerated in mCRPC subjects who had progressed after 
multi-lines of hormone therapies and chemotherapies. No DLT was reported and MTD was not 
established. No partial response (PR) or complete response (CR) was observed in the study. 
Clinical responses of stable disease (SD) were observed and used for decision on-treatment 
continuation. Dose levels of 400 and 500 mg/day were chosen for the Phase 2 study to further 
establish the safety and tolerability of GT0918. 
GT0918-CN-1001 
The GT0918-CN-1001 study was a Phase 1 study, conducted in China, to investigate safety, 
tolerability, and pharmacokinetics of GT0918 in subjects with advanced CRPC. Nineteen 
subjects were enrolled, and 16 subjects were treated with GT0918 at f5 dose levels: 50 mg (n 


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= 2), 100 mg (n = 4), 200 mg (n = 3), 300 mg (n = 3) and 400 mg (n = 4). GT0918 showed some 
preliminary anti-tumor activity. No DLT was observed. The MTD was not reached. All the 
GT0918-related adverse events (AEs) were Grade 1, including hypercholesterolemia, 
hyperglyceridemia, anemia, hot flush, fatigue, constipation, and loss of appetite. All subjects 
who received GT0918 showed some preliminary anti-tumor activity with SD (bone scans 
showed no change in target and non-target lesions comparing with baseline). 
GT0918-CN-1003 
The GT0918-CN-1003 was an open-label, randomized, Phase 2, multicenter study to evaluate 
the safety and efficacy in subjects with mCRPC. Total of 108 subjects were enrolled in the study 
and randomized in 1:1:1 ratio in to 100 mg, 200 mg and 300 mg cohorts: 100 mg (n=37), 200 mg 
(n=35) and 300 mg (n=36). Eighty-one subjects (75.0%) experienced ≥grade 1 drug-related 
AEs. Fourteen subjects (13.0%) experienced ≥ Grade 3 AEs based on CTCAE v4.03. Most 
common drug-related AEs experienced ≥10% of subjects included aspartate aminotransferase 
increased (AST) (14.8%), alanine aminotransferase increased (ALT) (13.0%), white blood cell 
count decreased (12.0%), appetite decreased (13.0%), asthenia (17.6%), anemia (14.8%) and 
proteinuria (12.0%). Grade 3 asthenia, Grade 2 vomiting, Grade 2 hypokalemia, Grade 2 lung 
infection, Grade 3 anemia were the reported SAEs among all subjects. There were about 41.9% 
subjects who experienced Prostate-Specific Antigen (PSA) 50 reduction. Based on Response 
Evaluation Criteria in Solid Tumors (RECIST) 1.1 evaluation, the Overall Response Rate (ORR) 
was 15.8% and Disease Control Rate (DCR) was 78.9%. 
1.2.3.1.2 Ongoing Clinical Studies in Solid Tumors 
GT0918-US-1002 
The ongoing GT0918-US-1002 study was an open-label randomized, expanded/phase 2 study in 
subjects with metastatic hormone sensitive prostate cancer (mHSPC) or mCRPC who progressed 
after either Abiraterone or Enzalutamide treatment to further evaluate the safety, tolerability, and 
anti-tumor activity of once daily orally administered GT0918.  
GT0918-CN-1004 
A Phase 3, multicenter, randomized, double-blind, placebo-controlled study is being conducted to 
evaluate the efficacy and safety of GT0918 in subjects mCRPC who progressed after both 
Abiraterone and Docetaxel in China. Subjects in the GT0918 cohort or control cohort received 
GT0918/placebo tablets 200 mg QD until radiographic progression, unacceptable toxicity, or 
withdrawal from the study.  
GT0918-CN-1005 
A Phase 3, multicenter, randomized double-blind study to evaluate the efficacy and safety of 
GT0918 in combination with Abiraterone vs Placebo plus Abiraterone as first-line treatment in 
subjects with mCRPC in China. This two-stage study consisted of a dose-finding stage followed 
by a dose-expansion stage.  
GT0918-CN-2001 


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A Phase 1/1b study is being conducted to assess the safety, tolerability, and pharmacokinetics of 
GT0918 in subjects with advanced breast cancer. This two-stage study consisted of a dose-
escalation stage followed by a dose-expansion stage. All subjects received oral GT0918 once daily 
until disease progression, unacceptable toxicity, or withdrawal from the study.  
1.2.3.2 Clinical Study in COVID-19 
A randomized, double-blinded, clinical study of GT0918 was done in Brazil for both male and 
female subjects with mild or moderate COVID-19 illness (NCT04446429). Two hundred and 
sixty-two (262) men were included in the study. 134 men were assigned to the GT0918 group and 
128 men were assigned to the control group. The mean age was 44.5±7.7 years old. Thirty-five 
subjects (27%) were hospitalized in the control group compared to 0 patients in the GT0918 group 
by Day 30. The proportion of COVID-19 subjects hospitalized was significantly different between 
the GT0918 and control arms; p<0.0001. No subject receiving GT0918 died compared to 2% in 
the control group. Additionally, it also showed a clinical meaningful SARS-Cov-2 viral load 
reduction and clearance in the GT0918 group compared to the placebo group (RT-PCR positive 
rate: 42.5% vs 93.8% on Day 7, 15.0% vs 56.2% on Day 14 and 10.0% vs 43.8% on Day 28, 
respectively).   
Treatment-emergent adverse events were reported for 34% of subjects in the GT0918 group and 
for 61% of subjects in the placebo group. SAEs were only reported in the placebo group. There 
was no AE leading to discontinuation.  
The most frequently reported TEAEs (occurring in ≥10% of subjects) were diarrhea (21%), 
dehydration (15%), nausea (14%), abdominal pain (12%), dyspepsia (11%) and back pain (10%) 
in the GT0918 group. The most frequently reported TEAE were disease progression (54%), fatigue 
(45%), shortness of breath (36%), fever (20%), dehydration (14%), anosmia (13%), ageusia (12%), 
back pain (12%), and ear pain (10%) in the placebo group. Gastrointestinal TEAE were more 
frequent in the GT0918 group. General, respiratory, and nerve system TEAEs are more frequent 
in the placebo group. The TEAEs suspected to be related with study treatment (≥10%) were 
diarrhea, nausea, abdominal pain and dyspepsia in the GT0918 group. No SAE was reported in the 
GT0918 group. Acute respiratory distress syndrome was reported as SAE in 27% of the subjects 
in the placebo group. 
178 female subjects were randomized to the study with 76 in the GT0918 group and 102 in the 
control group. All subjects were also treated with the standard of care. 
The mean age was 44.2 years old. Nineteen subjects (19%) were hospitalized in the control group 
compared to 2 patients (3%) in the GT0918 group by Day 30 . (p<0.0001). No subject receiving 
GT0918 died compared to one (1%) in the control group. 
Treatment-emergent adverse events were reported with 36% of subjects in the GT0918 group and 
with 55% of subjects in the placebo group. TESAEs were reported with 3% and 19% of subjects 
in the GT0918 and placebo groups respectively.  
Gastrointestinal TEAE were more frequent in the GT0918 group  compared with the control group: 
Diarrhea (17% vs. 10%), Nausea (12% vs. 6%), Abdominal pain (12% vs 5%), Dyspepsia (12% 


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vs. 4%).Therefore, GT0918 may be an excellent treatment option to improve the clinical outcomes 
and reduce the hospitalization for COVID-19 infected patients.  
Risks and Benefits 
1.3.1 Overall Benefit-Risk 
GT0918 dosed at 200 mg once daily has shown remarkable activity for accelerating SARS-Cov-
2 clearance and decreasing the hospitalization rate significantly in subjects with mild to moderate 
COVID-19 illness. The clinically meaningful benefit combined with the clinically manageable 
safety profile of GT0918 strongly support a positive benefit-risk balance for treatment of 
COVID-19 subjects. 
1.3.2 Potential Benefits to Clinical Study Subjects 
All subjects with COVID-19 mild/moderate illness enrolled in this study will be randomized to 
receive GT0918 or placebo plus standard of care. The efficacy of GT0918 seen in the IIT study 
(NCT04446429) is highly encouraging in patients with mild or moderate COVID-19 illness. 
Based on preclinical and preliminary clinical data (Section 1.2.2 and 1.2.3), treatment with 
GT0918 is expected to be well tolerated and it is hypothesized that it will result in preventing 
disease progression by decreasing the expression of ACE2 and TMPRSS2 and preventing SARS-
CoV-2 entry into lung cells. 
1.3.3 Potential Risks to Clinical Trial Subjects 
The safety profile of GT0918 is manageable. The adverse events identified with GT0918 
treatment in COVID-19 were gastrointestinal AEs, including diarrhea, nausea, abdominal pain 
and dyspepsia. 
In the study for subjects with COVID-19, there were no treatment related AEs or serious AEs 
during the course of the study. 
Subjects in this study will be carefully monitored for key toxicities that have been observed with 
GT0918 with the following assessments: periodic laboratory, renal, and liver function, and 
coagulation. Risk will be further minimized by adherence to inclusion/exclusion criteria, 
avoidance of prohibited medication, close safety monitoring and dose modification guidelines. 
An independent data committee (IDMC) will be constituted and will monitor safety, efficacy as 
outlined in the protocol. A steering committee (SC) will be established comprising of 
investigators and Kintor personnel participating in the study to ensure transparent management 
of the study according to the protocol. A Kintor/delegated CRO safety management team will 
periodically review and evaluate all emerging data across the GT0918 program for potential 
safety signal assessment in a timely manner. 
Furthermore, due to the short treatment duration (14 days) of 200 mg once a day, the risk of SAEs 
should be lower than completed and ongoing studies in oncology. 


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2 RATIONALE 
2.1 
 Study Rationale and Purpose 
The glycoprotein spikes on the surface of SARS-CoV-2 utilize membrane ACE2 receptors and 
TMPRSS2, to enter the host cells (6). Thus, targeting the expression or activity of ACE2 or 
TMPRSS2 plays a critical role in reducing the pathogenicity of coronavirus infection, GT0918 
can down-regulate the ACE2 and TMRPSS2 expression in prostate, lung cancer cell lines and 
lung epithelial cell lines. Furthermore, the clinical study of GT0918 in Brazil for COVID-19 
(NCT04446429) showed a clinically meaningful SARS-CoV-2 viral load reduction and 
clearance, decreased the hospitalization rate significantly in the GT0918 group compared to the 
placebo group. Therefore, GT0918 may be an efficient option to improve clinical outcome and 
reduce the rate of hospitalization in COVID-19 infected patients. Since SARS-CoV-2 replication 
is greatest just before or soon after symptom onset, GT0918 is likely to be most effective when 
used early. Therefore, in this study, GT0918 will be administered to evaluate the efficacy and 
safety in COVID-19 infected outpatients with mild or moderate symptoms. 
2.2 Rationale for Study Design  
This is a randomized, placebo-controlled two-arm study with the objective to evaluate the 
efficacy and safety of GT0918 in outpatients with mild or moderate COVID-19 illness. The 
study is designed per FDA guidance (COVID-19: Developing Drugs and Biological Products for 
Treatment or Prevention Guidance for Industry (fda.gov)). 
The randomized, double-blind, placebo-controlled, multicenter, parallel group design is the gold 
standard for a phase III study as it minimizes allocation bias, balancing both known and 
unknown prognostics factors in the assignment of treatments. The study is stratified by sex, race 
and ethnicity, the risk factors of COVID-19 severity (Section 4.1.1) The study will be conducted 
in outpatients including subjects with underlying medical conditions such as the elderly, underlying 
cardiovascular or respiratory disease, diabetes, chronic kidney disease, or other comorbidities. Both 
male and female subjects are being studied in line with the anti-androgenic mechanism of action, 
since elevated testosterone level has also been observed in most female COVID-19 subjects, and 
a positive correlation between testosterone levels and pro-inflammatory cytokines in female 
COVID-19 subjects (Maria Schroeder 2020). 
The trial will ensure to include Hispanic, Latino non-Hispanic black, and others from United 
states and other countries. 
The study drug GT0918 is evaluated in randomized, placebo-controlled, double-blind clinical studies 
using a superiority design. A futility analysis will be done for initial assessment of potential benefit 
before enrolling a large number of subjects.  
IDMC will be used to ensure subject safety and study integrity. 
The standard of care is accepted in both arms which is described in Section 6.4.  
The primary endpoint is the percentage of subjects who do not experience all-cause 
hospitalization for at least 24 hours, do not require supplemental oxygen for at least 24 hours in 
response to SpO2 ≤93% and are alive by Day 28.. Considering the incapability to hospitalize 
the subjects who meet the criteria of hospitalization, the supplemental oxygen requirement 


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provided outside for equal to or longer than 24 hours in response to SpO2 ≤93% is also 
considered as the hospitalization. All-cause death by day 28 will also be included.  
Proportion of patients alive, non-hospitalized and free of oxygen is generally considered an 
adequate composite study endpoint to measure clinical improving. Defining hospitalization as 
requiring greater than or equal 24 hours in patient care within 28 days of randomization eliminates 
the majority of patients who might attend hospital for reasons other than deterioration to severe 
disease or for necessary management of their condition.  
According to FDA guidance, the 28-day time frame of endpoint is appropriate in the outpatient 
treatment trial.  
The primary efficacy analysis will be conducted in the mITT population.  
The secondary endpoints include the symptom improvement, symptom resolution, NIAID 8-
point scoring scale, all-cause and COVID-19 related hospitalization, mechanical ventilation, 
viral load reduction and clearance at specific time points during the study and are designed to 
monitor response to GT0918 in terms of other important clinical and virological outcomes. 
In addition, Ctrough values will be monitored to establish exposure-response relationship of 
GT0918 in the treatment of SARS-CoV-2. The relevant biomarkers analysis will also be 
performed to evaluate their association with observed clinical responses to GT0918 and the 
disease state.    
2.3 Rationale for GT0918 Dose and Regimen Selection 
A dose of 200 mg was recommended based on a phase 2 study in prostate cancer with 28 days as 
a cycle, until disease progression. Fourteen days is used in this study to align with the standard 
time course of COVID-19. Based on available preliminary data from Brazil IIT study in subjects 
with COVID-19 mild/moderate illness, 200 mg, QD for 15 days has been demonstrated to be 
effective and displayed adequate safety in the treatment of COVID-19. Therefore, almost the same 
dose regimen is being used in this study with the same patient population as was used in the 
Brazilian study. 
2.4 Rationale for Choice of Comparator Drugs  
Subjects enrolled in this study will either be mild or moderate COVID-19 who are not hospitalized. 
There are no approved treatment options for this patient population except an EUA for the 
investigational monoclonal antibody therapy. Bamlanivimab alone or Casirivimab and 
Imedevimab given together or Bamlanivimab and etesevimab given in combination for the 
treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Therefore, placebo 
comparator was selected, however, best supportive therapy/standard of care except those are 
prohibited in Section 6.4.2 can be administered in both treatment and control groups as required 
at the investigator’s discretion. 
 
 


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3     OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary 
  Primary  
To evaluate the efficacy in terms of 
clinical status following treatment 
with GT0918 compared to placebo 
Percentage of subjects who do not experience any of the 
following events due to all causes by Day 28: 
• 
Hospitalization for ≥ 24 hours  
• 
Supplemental oxygen for ≥24 hours in response to 
SpO2 ≤93%  
• 
Death 
Secondary  
 Secondary 
To evaluate the clinical efficacy of 
GT0918 compared to placebo 
using the NIAID 8- point scoring 
scale 
Percentage of subjects achieving each clinical 
status on Days 7, 14 and 28 as defined below based 
on The National Institute of Allergy and Infectious 
Diseases (NIAID) 8- point scoring scale: 
1 Death 
2 Hospitalized, on invasive mechanical ventilation 
or extracorporeal membrane oxygenation 
(ECMO) 
3 Hospitalized, on non-invasive ventilation or 
high flow oxygen devices 
4 Hospitalized, requiring supplemental oxygen 
5 Hospitalized, not requiring supplemental oxygen 
- requiring ongoing medical care (COVID-19-
related or otherwise) 
6 Hospitalized, not requiring supplemental oxygen 
- no longer requires ongoing medical care 
7 Not hospitalized, limitation on activities and/or 
requiring home oxygen 
8 Not hospitalized, no limitations on activities  


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To evaluate the clinical efficacy of 
GT0918 compared to placebo 
based on clinical status 
• 
Proportion of subjects with all-cause hospitalization 
(defined as ≥24 hours) by Day 28 
• 
Proportion of subjects hospitalized (defined as ≥24 
hours) due to COVID-19 related events by Day 28 
• 
Days of hospitalization due to all causes or COVID-
19 
• 
Proportion of subjects with all-cause mortality by 
Day 28 
• 
Proportion of subjects with COVID-19 related 
mortality by Day 28 
• 
Proportion of subjects admitted to an ICU due to 
COVID-19 by Day 28 
• 
Days in intensive care unit (ICU)  
• 
Proportion of subjects requiring supplemental 
oxygen, high-flow oxygen, any ventilation or 
ECMO due to COVID-19 by Day 28 
• 
Proportion of subjects requiring mechanical 
ventilation or ECMO due to COVID-19 by Day 28 
• 
Days on supplemental oxygen/high flow oxygen 
devices/mechanical ventilation  
Characterize the effect of GT0918 
compared to placebo on symptom 
improvement or resolution 
Symptom Improvement: 
• 
Change in symptom score (total of ratings) from 
baseline to Days 3, 7, 14 and 28 
• 
Time to symptom improvement 
• 
Proportion of subjects demonstrating symptom 
improvement via the symptom questionnaire (total 
of ratings) on Days 3, 7, 14 and 28 
Symptom resolution: 
• 
Proportion of subjects demonstrating symptom 
resolution via the symptom questionnaire on Days 
3, 7, 14 and 28 
• 
Time to symptom resolution 
Characterize the effect of GT0918 
compared to placebo on 
SARS-CoV-2 viral load clearance 
• Change from baseline to Days 3, 7, 14 and 28 in SARS-
CoV-2 viral load  
• Proportion of subjects that achieve SARS-CoV-2 
clearance (Days 3, 7, 14 and 28) 
• Time to SARS-CoV-2 clearance 
• SARS-CoV-2 viral load area under the 
concentration-time curve (AUC) assessed to days 3, 7, 
14 and 28 
Characterize the effect of GT0918 
compared to placebo on safety 
Safety assessments such as AEs, SAEs and laboratory data 
Exploratory 
Exploratory  
Characterize the pharmacokinetics 
of GT0918 
• Mean trough concentration of GT0918 and GT0955 on 
Days 1, 3, 7 and 14  
• To explore relationships between GT0918 and/or 
GT0955 exposure and selected efficacy and safety 
endpoints and/or biomarkers 


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Characterize emergence of viral 
resistance to GT0918 
Screening for novel mutants in patients who do not respond 
to GT0918 
• Genotype of SARS-CoV-2 viral isolates 
To explore biomarkers predictive of 
GT0918 safety, efficacy, and/or 
disease progression and COVID-19 
clinical outcomes 
 
The association between changes in disease related 
biomarkers with clinical endpoints 


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4  STUDY DESIGN  
4.1 Description of Study Design 
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate 
the safety and efficacy of Proxalutamide (GT0918) in adult outpatients diagnosed with mild to 
moderate COVID-19. The study will be 2-arm comparison against matched placebo. The study 
will be conducted in around 100 sites in the USA and other countries.  
This study utilizes an adaptive design that maximizes our efficiency in identifying a safe and 
efficacious therapeutic agent for COVID-19 during the current outbreak. There will be an interim 
analysis after 334 subjects complete Day 28 after the first dose to allow early stopping for 
futility, efficacy, or safety. 
The study population will be subjects with mild to moderate COVID-19 illness chosen to 
evaluate if early intervention with anti-androgen therapy prior to respiratory compromise can 
effectively prevent progression to the severe form of COVID-19 illness. 
Randomization is essential for establishing efficacy of these new therapeutic agents.  
The blood samples for PK analysis need to be collected for at least 200 subjects, whom will also 
be randomized into the interventional treatment or placebo group with 1:1 ratio. 
Schema 
 
Figure 4: Study GT0918-US-3001 schema.  
 
 


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4.1.1 Screening and Randomization 
After signing the study ICF, the screening assessments will be done within 1 day prior to 
randomization for selected assessments (See SoA) for the list of assessments to be performed). 
The investigator will review symptoms, risk factors and other inclusion and exclusion criteria to 
confirm subject’s eligibility. 
Subjects will be randomized into 1 of 2 arms with 1:1 ratio, each will receive an interventional 
treatment/placebo. 
Randomization will be stratified by the following factors: 
• Sex: Male or Female  
• Race and ethnicity (non-Hispanic White or others /Hispanic or Latino /non-Hispanic 
Black) 
• Number of risk factors 0, 1-2, ≥3 (based on CDC defined conditions 
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-
medical-conditions.html). Adults with the following conditions are at increased risk of 
severe illness from the virus that causes COVID-19: 
o Age ≥ 65 years 
o Cancer 
o Chronic kidney disease 
o Chronic lung diseases, including COPD (chronic obstructive pulmonary disease) 
asthma (moderate to severe),interstitial lung disease, cystic fibrosis, and 
pulmonary hypertension 
o Dementia or other neurological conditions 
o Down Syndrome 
o Heart conditions, such as heart failure, coronary artery disease, or 
cardiomyopathies or hypertension 
o Immunocompromised state (weakened immune system) from solid organ 
transplant 
o Liver disease 
o Overweight and Obesity (body mass index [BMI] ≥25 kg/m2) 
o Sickle cell disease or thalassemia 
o Smoking, current or former 
o Diabetes Type 1 or type 2)   
o HIV infection 
o Solid organ or blood stem cell transplant 
o Stroke or cerebrovascular disease, which affects blood flow to the brain 


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o Substance use disorders 
o Others per most updated list from CDC website as above 
 
4.1.2 Treatment Duration 
Subject will receive treatment for 14 days, Day 1 to Day 14. From screening visit Day -1 to visit 
Day 28 ± 2 days post last treatment which corresponds to Day 42 Safety Follow-up visit. The 
scheduled procedure shown in the Schedule of activities (SoA)  
 
4.2 Timing of Interim Analyses and Design Adaptations 
The ongoing study may be modified based on planned interim analyses. Based on the observed 
data at the time of the interim analyses, the study may: 
• 
suspend enrollment to GT0918 treatment arm demonstrating lack of efficacy, and/or 
• 
initiate/expand enrollment to the existing GT0918 treatment arm  
The modifications proposed are done so to ensure subjects are being exposed to treatment with 
an acceptable risk-benefit profile during the ongoing study. Additionally, the potential 
modifications will provide information to characterize the dose response profile more fully. 
Monitoring of unblinded safety data (including AEs, SAEs, and selected laboratory 
measurements) will occur throughout the study and will be conducted by IDMC members.  
4.3 End of the study 
A subject is considered to have completed the study if he has completed all required phases of the 
study including the last scheduled procedure shown in the SoA. 
The end of the study is defined as the date of last scheduled procedure shown in the SoA for the 
last enrolled subject or last ongoing subject in the study, whichever comes later.  
4.4 Early Study Termination 
The study can be terminated at any time for any reason by Kintor. Should this occur, the subject 
should be seen as soon as possible and the same assessments should be performed as described in 
Section 7 for a discontinued or withdrawn subjects. The investigator may be informed of 
additional procedures to be followed in order to ensure that adequate consideration is given to 
the protection of the subject’s interest. The investigator will be responsible for informing IRBs 
and/or ECsof the early termination of the trial. 


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5 POPULATION 
5.1 Patient Population 
The target population of this study are those adult subjects with mild to moderate COVID-19 
illness with first positive SARS-CoV-2 virus test within 3 days, to evaluate if anti-androgen 
therapy may effectively prevent progression to the severe form of COVID-19 illness by treating 
this population early in their disease course and prior to respiratory compromise and failure. This 
study plans to have around 668 subjects in the US or may expand to other countries/regions for 
GT0918 and the placebo groups, the randomization rate is 1:1.  
5.2 Inclusion Criteria 
Subjects are eligible to be included in the study only if all the following criteria apply: 
1. The subject or legally authorized representative give signed informed consent which includes 
compliance with the requirements and restrictions listed in the ICF and in this protocol. 
2. Understand and agree to comply with planned study procedures. 
3. Male and non-pregnant female subjects with age ≥18 years of age at the time of 
randomization. 
4. Are currently not hospitalized. 
5. Have one or more COVID-19-related symptoms within 5 days of symptoms onset ((FDA 
COVID-19-Related symptom guidance, See Appendix 2, available at: 
https://www.fda.gov/media/142143/download) 
6. Must have first positive SARS-CoV-2 viral infection determination (has laboratory-
confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public 
health assay in any specimen) ≤3 days prior to start of the first dose. 
7. Women of child-bearing potential, defined as all women physiologically capable of 
becoming pregnant, unless they are using highly effective contraception, as shown below, 
throughout the study and for 3 months after stopping GT0918 treatment. Highly effective 
contraception methods include: 
• Total Abstinence (when this is in line with the preferred and usual lifestyle of the 
patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation 
methods) and withdrawal are not acceptable methods of contraception, or  
• Use of one of the following combinations (a+b or a+c or b+c):  
a: Use of oral, injected or implanted hormonal methods of contraception or other 
forms of hormonal contraception that have comparable efficacy (failure rate < 
1%), for example hormone vaginal ring or transdermal hormone contraception.  
b: Placement of an intrauterine device (IUD) or intrauterine system (IUS); 
c: Barrier methods of contraception: Condom or Occlusive cap (diaphragm or 
cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; 


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• Female sterilization (have had prior surgical bilateral oophorectomy with or without 
hysterectomy) or tubal ligation at least six weeks before taking study treatment. In 
case of oophorectomy alone, only when the reproductive status of the woman has 
been confirmed by follow-up hormone level assessment; 
• Male sterilization (at least 6 months prior to screening). For female subjects on the 
study, the vasectomized male partner should be the sole partner for that subject; 
In case of use of oral contraception women should have been stable for a minimum of 3 
months before taking study treatment. Women are considered post-menopausal and not of 
childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with 
an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have 
had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 
six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the 
woman has been confirmed by follow up hormone level assessment, is she considered not of 
childbearing potential 
8. Regardless of their fertility status, male subjects must agree to either remain abstinent (if this 
is their preferred and usual lifestyle) or use condoms as well as one additional highly 
effective method of contraception (less than 1% failure rate) or effective method of 
contraception with nonpregnant women of childbearing potential partners for the duration of 
the study and until 90 days after the last dose. 
9. Agree to the collection of nasopharyngeal swabs and venous blood. 
5.3 Exclusion Criteria 
Subjects are excluded from the study if any of the following criteria apply: 
1. Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per 
minute, heart rate ≥125 per minute (FDA resource page, 
https://www.fda.gov/media/137926/download) 
2. Estimated glomerular filtration rate (eGFR) < 30 ml/min 
3. Serum total bilirubin > 1.5 x ULN (upper limit of normal) and AST and ALT >3 x ULN 
4. Subjects with significant cardiovascular disease as following: 
i. heart failure NYHA class ≥3 
ii. left ventricular ejection fraction <50% 
iii. those with a history of cardiac arrhythmias, including long QT syndrome. 
5. Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at 
randomization, due to COVID-19 or requires treatment with supplemental oxygen. 
6. Have known allergies to any of the components used in the formulation of the interventions. 
7. Have hemodynamic instability requiring use of vasopressors within 24 hours of randomization. 
8. Suspected or proven serious, active bacterial, fungal, viral, or other infection (except 
COVID-19) that in the opinion of the investigator could constitute a risk when taking 
intervention (i.e. known history of human immunodeficiency virus [HIV]). 


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9. Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening 
within 30 days. 
10. Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of 
the investigator, should preclude participation in this study. 
11. Subjects with myopathy 
12. Prior, current, or planned future use of any of the following treatments: COVID-19 
convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), where prior use is 
defined as the past 30 days or less than 5 half-lives of the investigational product (which is 
longer) from screening. 
13. Have participated, within the last 30 days before dosing, in a clinical study involving an 
investigational intervention. If the previous investigational intervention has a long half-life, 
5 half-lives or 30 days, whichever is longer, should have passed. 
14. Are concurrently enrolled in any other type of medical research judged not to be scientifically 
or medically compatible with this study. 
15. Subject taking or had taken an anti-androgen of any type including androgen depravation 
therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing.  
16. Are investigator site personnel directly affiliated with this study. 
 
6 TREATMENT 
6.1 Study Treatment 
For this study, study treatment in this study refers to GT0918 in the treatment arm and placebo in 
the placebo arm. GT0918 will be supplied by Kintor or its designee as 100 mg tablets as 
individual patient supply packaged in blister. All dosages prescribed and dispensed to the patient 
and all dose changes during the study must be recorded on the Dosage Administration Record 
eCRF.  
6.1.1 Dosing Regimen 
Eligible subjects will be randomized before or on Day 1 to receive either GT0918 or matched 
placebo. GT0918/placebo will be given 200mg orally once daily on Days 1-14 during the study 
period. Days 15-28 will be the post-treatment period without dosing with GT0918/placebo. 
The study drug will be administered as a flat-fixed dose and not by body weight or body surface 
area. The dose should be given the same time each day (+/- 2 hours for medication scheduling) 
around 30 minutes after meal for consecutive 14 days. During screening visit (D-1) or D1, after 
confirmation of subject’s eligibility, the drugs or placebo as well as Subject Diary with 
Questionnaire will be provided to subjects. The subject will document the dose date/time with 
the Diary and answer the Questionnaire daily.  
The study treatment period is shown as below. 


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Figure 5. Overview of study period and group assignment 
The investigator or responsible personnel will instruct the subject to take the study drugs as 
per-protocol. Subjects will be instructed to return unused study drugs (if applicable) to the sites 
at discontinuation or completion of treatment. The site personnel will ensure that appropriate 
dose of each study drug is administered, and that drug accountability is performed. 
 
6.1.1.1 General Dosing Guidelines 
The study treatments should be taken as follows: 
• 
Subjects should be instructed to take the study treatment of GT0918/placebo two tablets 
together with a glass of water once a day at the same time each day. 
• 
In general, study treatment may be taken after normal conventional meal (±2 hours for 
medication scheduling). 
• 
Subjects will be instructed to swallow the tablets whole and not to chew or crush them. 
• 
If vomiting occurs, during the course of treatment, no re-dosing of the drug is allowed before 
the next scheduled dose. The occurrence and frequency of any vomiting during the treatment 
period must be noted in the AEs section of the eCRF. Missing dose should be documented at 
Subject Diary.  
• 
Any doses that are missed should be skipped and should not be replaced or made up on a 
subsequent day. 
• 
Subjects try to avoid consumption of grapefruit, grapefruit hybrids, pomelos, starfruit, 
Seville oranges or products containing their juice during the treatment period. These foods 
are known as CYP3A4 inhibitors and have a potential to increase exposure to GT0918. 
Orange juice is allowed. 
• 
Multivitamins are permitted. 
6.1.2 Guidelines for Continuation of Treatment  
The treatment course continues as described above even if the subject becomes SARS-CoV-2 
test negative. 


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6.1.3 Ancillary Treatments 
This section is not applicable for this study. 
6.1.4 Rescue Medication  
This section is not applicable for this study. 
6.1.5 Treatment Duration 
The treatment period starts from Day 1 (first oral administration of drug or placebo) to D14, 14 
consecutive days. 
6.2 Dose Escalation 
This section is not applicable for this study. No dose escalation or de-escalation is allowed 
through the whole study.  
6.3 Dose Modifications 
6.3.1 Dose Discontinuation 
Any subject who develops ≥ Grade 3 treatment emergent adverse events that are possibly, 
probably or definitely related to the study drug as assessed by the investigator will discontinue 
the treatment. There is no dose interruption or dose reduction in this study.  
The treatment course should be continued if the subject becomes SARS-Cov-2 test negative or 
experiences complete resolution of symptoms.  
 
For the subjects who are hospitalized during the study, the subject may continue the study 
treatment at the investigator’s discretion based on individual benefit/risk assessment. 
6.3.2 Follow-Up for Toxicities 
Subjects, whose treatment is permanently discontinued due to an AE must be followed up at least 
twice a week if applicable (or more frequently if required by institutional practices, or if 
clinically indicated) for 4 weeks or until resolution or stabilization of the event, whichever comes 
first. Appropriate clinical experts should be consulted as deemed necessary.  
All AEs/SAEs will be followed until resolution, stabilization, the event is otherwise explained, or 
the subject is lost to follow-up (Section 7.1.6). Further information on follow-up procedures is 
provided in Section 8.1. 
6.3.3 Anticipated Risks and Safety Concerns of the Study Treatment 
Appropriate eligibility criteria and stopping rules are included in this protocol. Recommended 
guideline for supportive treatment for expected toxicities, including management of study drug 
induced AEs are provided in Section 6.3.2. More anticipated risks and safety concerns, reference 
of preclinical toxicity and clinical data are in the IB.  


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6.4 Concomitant Medications 
In general, the use of any concomitant medication/therapy deemed necessary for the care of the 
subject is permitted, except when specifically prohibited.  
The subject must be told to notify the investigational site about any new medication he takes 
after the start of study treatment. All medications, including herbal/natural medications 
(excluding study treatment), surgeries, and procedures (including physical therapy) administered 
within 30 days prior to the first dose of administration of study treatment through 28 days after 
the last dose of administration study treatment will be recorded in the concomitant medications 
or surgical and medical procedures eCRF, respectively. 
 6.4.1 Permitted Concomitant Therapy 
Prior Treatment for Indication 
Any prior therapy, such as antivirals, antibiotics, or antimalarials used as treatment prior to signing 
informed consent should be recorded. 
Therapy prior to enrollment with antivirals including lopinavir/ritonavir, remdesivir, or other 
therapeutic agents (e.g., corticosteroids) are permitted. 
Concomitant Therapy During the Study  
Subjects should be treated according to standard of care, even as it evolves, and medications may 
be part of the treatment paradigm.  
Therefore, remdesivir may be initiated as standard of care for subjects hospitalized with severe 
disease (if available through the FDA Emergency Use Authorizations) outside of local standard 
of care per written policies or guidelines. 
If the local standard of care per written policies or guidelines (that is, not just an individual 
clinician decision) includes lopinavir/ritonavir, chloroquine, hydroxychloroquine or other 
investigational agents, then initiating these during the study is permitted, but may require 
additional safety monitoring by the site. 
Acetaminophen and corticosteroid use are permitted during the study per investigator’s 
discretion.  
Other concomitant medication may be considered on a case-by-case basis by the investigator in 
consultation with the Sponsor if required. 
Any medication, including not only physician prescribed medications, but also all over-the counter 
(OTC) medications, herbal medications, vitamin supplements, blood transfusion or others that the 
subject is receiving at the time of enrollment or during the study must be recorded along with： 
• Reason for use including standard of care for COVID-19. 
• Dates of administration including start and end dates. 
• Dosage information including dose and frequency for concomitant therapy. 
 


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The Sponsor should be contacted if there are any questions regarding concomitant or prior 
therapy. 
6.4.2 Prohibited Concomitant Therapy 
Strong CYP3A enzyme inhibitors and inducers and P-gp transporter inhibitors and  inducers are 
prohibited.  
Any medicine or treatment may influence evaluation of efficacy of study drug is prohibited, 
Spironolactone, anti-androgen drug or treatment including but not limited to 5α-Reductase 
Inhibitors, androgen deprivation therapy, Enzalutamide, Bicalutamide, Abiraterone. Or 
Cycloprogesterone, Androgen, Estrogen or AR antagonists. 
Convalescent COVID-19 plasma treatment is not allowed. The monoclonal antibody therapy 
Bamlanivimab alone, or Casirivimab and Imedevimab in combination under the EUA for the 
treatment of mild to moderate COVID-19 patients is prohibited in this study. 
6.4.3 Concomitant Therapy to Be Used with Caution 
Concomitant treatment of GT0918 with weak inhibitors or inducers of CYP3A4 is permitted. 
Caution is advised when GT0918 is co-administered with drugs that are moderate/strong 
inhibitors or inducers of CYP3A4. Duration of concomitant treatment should be kept as short as 
possible, or completely avoided whenever possible. Subjects receiving such medications must be 
monitored closely for any potential toxicity or decreased clinical benefit due to any individual 
concomitant medications. 
Concomitant treatment of GT0918 with medications which have narrow therapeutic 
index/sensitive substrates for CYP3A4/2D6 is allowed with caution. Detailed lists of inhibitor, 
substrates and inducers of CYP3A or pertinent medicines are listed to Appendix 1.  
Any narrow therapeutic index/sensitive CYP 3A, or 2D6, or both substrate drug(s) should be 
excluded from patient use if possible, then switch to a suitable alternative drug(s). If no suitable 
alternatives are available, it is recommended to reduce the dose of the narrow therapeutic 
index/sensitive CYP 3A, or 2D6, or the substrate drug(s). 
Inducers or nutritional supplement of cytochrome P450 3A4, such as St. John’s Wort Extract 
grapefruit, and immunosuppression medicine are needed to be used with caution.  
6.5 Patient numbering, Treatment Assignment or Randomization 
6.5.1 Patient numbering 
Each subject will be assigned with unique number after signing off the inform consent form, 
which is the screening number, composite with site number 001 and subject number 001, 002…. 
After the screened subject is confirmed eligible to randomization, the screen number will service 
as the randomization number. Screen failure subject’s number will not be assigned to other 
subjects. Re-screen may not be allowed, but retest with screening window or on D1 is allowed.  


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6.5.2 Treatment Assignment or Randomization 
All subjects will be centrally randomized to study intervention using an interactive web response 
system (IWRS). Before the study is initiated, the log-in information and directions for the IWRS 
will be provided to each site. Subjects will be stratified by sex, race/ethnicity and risk factors of 
COVID-19 (Section 4.1.1).  
All eligible subjects will be randomized initially following an equal allocation to treatment arms. 
Given the staggered start of the treatment arms, periodic adjustments to the allocation ratio, 
informed by planned interim analyses, may be made to achieve an equal allocation across the 
treatment arms at the end of enrollment.  
6.5.3 Treatment Blinding 
This is a double-blinded study. Neither subjects, nor investigators, nor the Sponsor study team 
will be aware of treatment assignments prior to the final data base lock at the conclusion of the 
study. 
Unblinding procedures for this study 
• Emergency unblinding for AEs may be performed through the IWRS. All actions 
resulting in an unblinding event are recorded and reported by the IWRS. 
• In case of an emergency, the investigator has the sole responsibility for determining if 
unblinding of a subjects’ intervention assignment is warranted. 
• Subject safety must always be the first consideration in making such a determination. 
However, the investigator should make all attempts to contact the medical monitor in 
advance of unblinding. 
• If a subject’s intervention assignment is unblinded, the Sponsor must be notified 
immediately after breaking the blind even if consultation occurred in advance. 
• The date and reason that the blind was broken must be recorded in the source 
documentation and case report form. 
The investigator has the right to determine whether the subject is still ongoing with the treatment 
even unblinded based on the best interest of the subject. Investigator is encouraged to discuss 
with medical monitor or Sponsor.  
6.6 Study Treatment Supply 
First supply of study supplies plus the study drugs will be shipped to sites within 2 weeks before 
site initiation visit. Subsequent supplies will be provided upon sites request or automatically 
initiated via IWRS, which may be changed per local guidance and situation. The site needs to 
proactively inform Sponsor and CRO the numbers of potential subjects. Fourteen days dose of 
study drugs and placebo will be dispensed once by site staff during screening visit or D1 after 
eligibility is confirmed.  


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6.6.1 Study Treatment Preparation and Dispensation  
The investigator or designee must confirm appropriate temperature conditions (if applicable) 
have been maintained during transit for all study intervention received and any discrepancies are 
reported and resolved before use of the study intervention. 
Only subjects enrolled in the study may receive study drugs or matched placebo and only 
authorized site staff may supply and dispense them. 
All study drugs must be stored in a secure, environmentally controlled, and monitored (manual 
or automated) area in accordance with the labeled storage conditions with access limited to the 
investigator and authorized site staff. 
The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance (i.e., 
receipt, reconciliation, and final disposition records).  
Further guidance and information for the final disposition of unused study interventions are 
provided in the pharmacy manual. 
6.6.2 Study Treatment Packaging and Labeling 
GT0918 is an AR antagonist (MW 517.5 g/mol). The dosage form for clinical research is a 100 
mg tablet weighing 320 mg per tablet. The 100 mg tablet is circular in shape with 10 mm in 
diameter. The color is light yellowish. The drug product tablets are packaged in PTP aluminum 
and PVC blister foils. These packaging materials are in compliance with 21 Code of Federal 
Regulations (CFR) 174-186 – Indirect Food Additive Regulations. Table 1: Summary of Study 
Drugs provides a summary of the finished study drug products.  
 
Table 1: Summary of Study Drugs 
Study Drug Name 
GT0918 
Matched Placebo 
Dosage Formulation 
Tablet 
Tablet 
Identity of Formulation 
100mg 
placebo 
Route of Administration 
Oral 
Oral 
Dosing Instructions 
Once Daily 
Once Daily 
Packaging and Labeling 
The 100 mg tablet is 
circular in shape with 10 mm in 
diameter, color is light 
yellowish. Packaged in PTP 
aluminum and PVC blister foils. 
Each blister will contain 7 
tablets and will be labeled as 
required per country 
requirement.  
The matched placebo is 
circular in shape with 10 mm in 
diameter, color is light yellowish. 
Packaged in PTP aluminum and 
PVC blister foils. Each blister will 
contain 7 tablets and will be labeled 
as required per country requirement.  


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Number and Time of Drugs 
Treatment period: 2 tablets daily  Treatment period: 2 tablets daily  
6.6.3 Drug Supply and Storage 
The recommended storage conditions for GT0918 tablets are room temperature with a shelf-life 
of 2 years. All drug supplies will be provided by the Sponsor or CRO.  
Study treatments must be received by designated personnel at the study site, handled and stored 
safely and properly, and kept in a secured location to which only the investigator and designated 
site personnel have access. Upon receipt, the study treatment should be stored according to the 
instructions specified on the drug labels and in the [Investigator’s Brochure]. 
6.6.4 Study Treatment Compliance and Accountability  
The investigation site will maintain records of study drug delivered to the study site; the 
inventory at the site; the distribution to and use by each subject; and the return of study drug to 
the Sponsor for storage and/or disposal if applicable. These records should include dates, 
quantities, batch/blister card/pouch/serial numbers, expiration dates, in-clinic temperature log(s), 
and unique code numbers assigned to the study drugs and study subjects. 
At each visit after initiation of treatment, site staff will record compliance of subjects with their 
assigned regimen. Subjects will be instructed to bring their subject diaries at each study visit. 
Subjects are to be reminded of the importance of compliance with their assigned regimen, with 
an emphasis on taking their study drug on schedule and maintaining the prescribed interval 
between doses. 
Investigators will maintain records that document adequately that the subjects were provided 
with the correct study drugs and will reconcile the products received from the drug dispensing 
center.  
Medication containers must be returned at each visit, as compliance will be assessed by tablet 
counts. Non-compliance is defined as taking less than 80% or more than 120% of study drug 
during any outpatient evaluation period (visit to visit). Discontinuation for non-compliance is at 
the investigator’s discretion and is to be noted on the eCRF. 
6.6.5 Disposal and Destruction 
Study drugs will not be returned to the Sponsor or destroyed at the clinical site until 
accountability has been fully determined. 
After the study treatment period has ended or as appropriate over the course of the study after 
study product accountability has been performed; used or unused tablets should be returned to 
the Sponsor or destroyed on-site following applicable site procedures or by the site’s selected 
destruction vendor. Following the site’s procedure for the destruction of hazardous material or 
study product destruction policy/standard operating procedure (SOP) when destroying used and 
unused items. A certificate of destruction should be provided to the Sponsor and retained in the 
Pharmacy Binder once completed. 
 
 


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7 VISIT SCHEDULE AND ASSESSMENTS 
7.1 Study Flow and Visit Schedule 
This study contains up to 1-day screening visit (D-1), 14 days treatment (D1-D14), additional 28 
days safety follow-up period (D15-D42). See the SoA  
7.1.1 Screening 
After signing the study informed consent, the screening assessments will be done within 1 day 
prior to randomization (See SoA). Re-screening is not allowed in this study.  
7.1.1.1 Eligibility Screening  
In order to determine and conform the eligibility of the subject, once all screening procedures are 
completed, an eligibility checklist must be completed via IRT by the investigator or designee 
prior to randomization. Please refer and comply with detailed guidelines in the IRT manual. 
7.1.1.2 Information to Be Collected on Screening Failures 
A subject who signs the informed consent but fails to start on-treatment for any reason will be 
considered a screen failure. The reason for not starting on-treatment will be entered on the 
screening failure page or screening disposition page. The demographic information, informed 
consent, and inclusion/exclusion pages must also be completed for screen failure subjects. No 
other data will be entered into the clinical database for subjects who are screen failures unless the 
subject experienced a serious AE during the screening phase. 
7.1.1.3 Subject Demographics and Other Baseline Characteristics 
The data that will be collected at screening includes: 
 
Demography (date of birth and initials (where permitted), sex, race, ethnicity), BMI. 
 
Diagnosis (date and method of confirmation the positive SARS-CoV-2 test result). 
 
Days from onset of COVID-19 symptoms prior to first dosing. 
 
Medical History(including medication allergy history)/current medical conditions (e.g., all 
current medical conditions which are present at the time of signing informed consent). High-
risk status for severe COVID-19 illness (such as hypertension, diabetes, coronary artery 
disease, obesity, chronic kidney disease, smoker, androgenic alopecia etc.). Ongoing 
medical conditions, symptoms and disease which are recorded on the medical history eCRF 
should include the toxicity grade. 
 
All medications and significant non-drug therapies taken within 30 days before the first dose 
is administered, they must be recorded on the Prior and Concomitant medication or Surgical 
and medical procedures eCRF page and updated on a continual basis if there are any new 
changes to the medications. 
 
Patient reported symptom questionnaires. 
 
Counsel subjects to use adequate birth control methods required during the study to avoid 
pregnancy. 
 
Obtain vital signs (including as below) 


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o Height and weight are only needed at screening 
o Body temperature. 
o Systolic blood pressure (BP), diastolic BP. 
o Pulse rate. 
o Respiration rate. 
o Saturation of peripheral oxygen if applicable. 
o Supplemental oxygen flow rate, FiO2 if known, and method of delivery, if applicable 
or clinical indicated. 
o Additional vital signs may be measured during the study if warranted, as determined 
by the investigator.  
 
Review recent radiographic imaging (X-ray or CT-scan) if applicable 
 
A complete physical examination will be performed at the screening visit.  
o This examination excludes pelvic, rectal, and breast examinations unless clinically 
indicated.  
o A symptom directed physical examination will be performed at other visits, as 
specified in the SoA and as clinically indicated. 
o Investigators should pay special attention to clinical signs related to COVID-19, to 
ongoing medical conditions and to previous serious illnesses. 
 
Obtain blood for screening laboratory evaluations. 
 
Serum pregnancy test (regardless of childbearing potential). 
The first-time confirmed SARS-CoV-2 positive at local laboratory and/or Point of Care testing. 
Sample must be collected within 3 days prior to start of dosing. Clinical screening laboratory 
evaluations will be performed locally by the site. The overall eligibility of the subject to 
participate in the study will be assessed once all screening values are available. The screening 
process can be suspended prior to complete assessment at any time if exclusions are identified by 
the study team. Study subjects who qualify will be immediately randomized. Tests or 
assessments can be redone once per investigator’s discretion within the time window at 
screening visit. If a subject cannot meet inclusion and exclusion criteria during screening period, 
this subject is considered as screen failure, re-screening is not allowed.  
7.1.2 Treatment Period 
All subjects who are randomized to the study are considered as entering the treatment period. 
The subjects will be treated 14 consecutive days or less due to AE, lost to follow-up or consent 
withdrawal. During the treatment period, subjects will self-administrated GT0918 or matched 
placebo orally around 30 minutes after a meal, the dose should be given the same time each day 
(+/- 2 hours for medication scheduling). Subjects also need to record the time/date of dose with 
provided Subject Diary daily as well as completion of the questionnaire which allows subjects to 
self-evaluate their COVID-19 symptoms. Any dose that is delayed may be given later that 
calendar day. Any dose that is missed (not given that calendar day) is not made up, which should 


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be documented as dose missing on Subject Diary with a reason. The treatment course continues 
as described above even if the subject becomes SARS-COV-2 test negative. 
On Days 3, 7, 14 and 28, nasopharyngeal swabs will be collected for viral load tests, meantime 
vital sign or other assessments will be performed and PK samples collection will be done per 
Schedule of Activities (SoA). On Day 14, safety laboratory tests are needed to evaluate clinical 
outcome and ensure safety. The above visits are preferred subjects in person to sites. However, 
infection control or other restrictions may limit the ability of the subject to return to sites. In this 
case, the visits may be conducted as outpatient clinic or home visits. The planned visit schedules 
and visit types/location should be discussed and confirmed during screening visit with every 
subject, any future changes will be coordinated according in advance.  
Hospitalization should be closely monitored and documented with subject’s source and eCRF as 
described in Section 7.2.1.1. 
Meantime, the subjects’ clinical status as detailed in Section 7.2.1.2 will be recorded in the 
eCRF.  
7.1.3 End of Treatment  
  
7.1.3.1 Study treatment discontinuation 
 
Subjects may voluntarily discontinue from study treatment for any reason at any time. If a 
subject decides to discontinue from study treatment, the investigator must make every effort (e.g. 
telephone, e-mail, letter) to determine the primary reason for this decision and record this 
information in the subject’s chart and on the appropriate CRF pages. They may be considered 
withdrawn if they state an intention to withdraw, fail to return for visits, or become lost to 
follow-up for any other reason.  
The investigator should discontinue study treatment for a given subject if, on balance, he/she 
believes that continuation would be detrimental to the subject’s well-being. 
If oral administration of the study drugs is definitively discontinued, the subject will remain in 
the study for follow-up and any further evaluations that need to be completed as described in the 
SoA. 
Subjects who completely discontinue study treatment should be scheduled for an End of 
Treatment visit within 2 days following the date study treatment is permanently discontinued, at 
which time all of the assessment listed for the EOT visit will be performed. For details of 
assessment, refer to SoA. If the decision to discontinue occurs at a regularly scheduled visit, that 
visit may become the EOT visit rather than having the subject return for an additional visit. 
An End of treatment eCRF page should be completed, giving the date and reason for stopping 
the study treatment. If a withdrawal occurs, of if the subject fails to return for visits, the 
investigator must determine the primary reason for a subject’s premature discontinuation and 
record the information on the EOT eCRF page. The EOT visit is considered as end of study. 


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At a minimum, all subjects who discontinue study treatment, including those who refuse to 
return for a final visit, will be contacted for a safety evaluation during the 28 days following the 
last dose of study treatment. At this time the occurrence of any component of the primary 
efficacy endpoint will be assessed as well.   
If a subject discontinues study treatment, but continues study assessments, the subject remains on 
study until he/she completes protocol criteria for ending study assessments. At that time, the 
reason for study completion should be recorded on the end of study eCRF page. 
The investigator must contact the IRT to register the subject’s discontinuation. 
End of treatment/Premature withdrawal visit is not considered as the end of study. 
A subject may be withdrawn from the study treatment earlier due to following reasons: 
o AE 
o Lost to follow-up 
o Physician’s decision 
o Protocol deviation 
o Death 
o Subject/guardian decision 
o Study terminated by the Sponsor 
o Pregnancy 
o Others  
If the Sponsor or investigator identify a subject who did not meet enrollment criteria and was 
inadvertently enrolled, then the subject should be discontinued from study intervention unless 
there are extenuating circumstances that make it medically necessary for the subject to continue 
study intervention. 
If the investigator and the Sponsor agree it is medically appropriate to continue, the investigator 
must obtain documented approval from the Sponsor to allow the inadvertently enrolled subject to 
continue in the study with or without treatment with study drugs. 
7.1.4 Withdrawal of Consent 
Early withdrawal is expected to be uncommon. 
Subjects may voluntarily withdraw consent to participate in the study for any reason at any time. 
Withdrawal of consent occurs only when a subject: 
 
Does not want to participate in the study anymore, and 
 
Does not allow further collection of personal data. 
In this situation, the investigator should make a reasonable effort (e.g., telephone, email, letter) to 
understand the primary reason for the subject’s decision to withdraw his consent and record this 
information. Study treatment must be discontinued, and no further assessment conducted. Further 


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attempts to contact the subjects are not allowed unless safety findings require further 
communication or follow-up. 
All efforts should be made to complete the assessments prior to study withdrawal. A final 
evaluation should be made at the time of the subject’s study withdrawal.  
At the time of early withdrawal from the study, if possible, an early withdrawal visit should be 
conducted, which can be referred to in the SoA and the subject will continue to follow-up. If the 
subject withdraws consent for disclosure of future information, the Sponsor may retain and 
continue to use any data collected before such a withdrawal of consent. If a subject withdraws 
from the study, he may request destruction of any samples taken and not tested, and the 
investigator must document this in the site study records and inform Sponsor accordingly. 
7.1.5 Follow-Up for Safety Evaluations 
After the end of 14 days treatment period, subjects will enter a 14-day post-treatment (Day 15-
Day 28 or 14 days after last dose) and another 14-day safety follow-up periods (Day 29-Day 42 
or 14 days after post-treatment) during which information on the subject will be collected until 
Day 42 (±2). Information will be collected by clinic, sites or home visit or other means as 
appropriate on D28 (±2).  Subject Questionnaire collected daily until Day 28. Day 42 (±2)  is a 
phone call. All subjects are expected to complete follow-up visits except those lost to follow-up 
or consent withdrawal.  
Site personnel, or an independent third party, will attempt to collect the vital status of the subject 
within legal and ethical boundaries for all subjects that received study intervention. Public 
sources may be searched for vital status information. If vital status is determined to be deceased, 
this will be documented, and the subject will not be considered lost to follow-up. Sponsor 
personnel will not be involved in any attempts to collect vital status information. 
The end of treatment eCRF page will be completed once a subject has discontinued study 
treatment, then the subject will complete post-treatment and safety follow-up periods. 
On Day 28, nasopharyngeal swabs will be collected for viral load tests, meantime vital sign or 
other assessments will be performed per SoA. On Day 28, the safety laboratory tests are needed 
to evaluate clinical outcome and ensure the safety. The Day 28 visit is preferred for subjects to 
attend in person to sites. However, infection control or other restrictions may limit the ability of 
the subject to return to sites. In this case, the visit may be conducted as outpatient clinic or home 
visits. The planned visit schedules and visit types/location should be discussed and confirmed 
during screening visit with every subject, any future changes will be coordinated according in 
advance.  
Subjects whose treatment is discontinued due to an AE, must be followed until resolution or 
stabilization of the event, whichever comes first. This could include all study assessments 
appropriate to monitor the event. Data collected should be added to AE CRF and the 
Concomitant Medications CRF. 
7.1.6 Lost to Follow-Up 
For subjects whose status is unclear because they fail to appear for study visits without stating an 
intention to withdraw consent, the investigator should show “due diligence” by contacting the 


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subject, family or family physician as agreed in the informed consent and by documenting in the 
source documents steps taken to contact the subject, e.g., dates of telephone calls, registered 
letters, etc. A subject should not be considered lost to follow-up until due diligence has been 
completed. Subjects lost to follow-up should be recorded as such on the appropriate disposition 
CRF. 
7.1.7 End of Safety Follow-Up 
The end of post-treatment phase disposition eCRF page will be completed once a subject has 
discontinued study treatment, completed safety follow-up. 
End of post-treatment follow-up may occur one of the following reasons: 
• 
AE 
• 
Lost to follow-up 
• 
Physician’s decision 
• 
Progressive disease 
• 
Subject/guardian decision 
• 
Death 
• 
Protocol deviation 
• 
Pregnancy 
• 
Study terminated by the Sponsor 
• 
Others  
7.2 Assessment  
Planned time points for all safety assessments are provided in the SoA.  
7.2.1 Efficacy Assessments 
  
Non-Hospitalization events (7.2.1.1), NIAID ordinal scale (7.2.1.2) , symptom improvement and 
resolution(7.2.1.3) will be used to characterize the effect of GT0918 compared to placebo on 
clinical status from baseline to Days 14 and 28.  
7.2.1.1 Composite Events for non-Hospitalization 
The following events by Day 28 will be collected and recorded in the eCRF: 
• Hospitalization (defined as ≥24 hours) 
• Supplemental oxygen for ≥24 hours  
• Death 
The date of hospitalization events as above will be recorded in the eCRF. Additionally, the date 
for following events will also be recorded in the eCRF. 
• 
Emergency room visit 
• 
ICU admittance 


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• 
Discharge  
• 
Extended care facility admittance (refers to long term care for chronic diseases or 
prolonged rehabilitation, which is not defined as hospitalization) 
7.2.1.2 NIAID Ordinal Scale 
The National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale will be assessed 
by the site daily beginning on Day 1 through Day 28 using AE and Questionnaire data. NIAID 
Ordinal Scale outcomes will be analyzed on Day 7, Day 14 and Day 28. 
NIAID Score Description 
The NIAID scoring scale will be assessed daily and defined as the lowest score achieved for that 
day. 
The scoring is based on the clinical status of the patient as described below.  
1. Death 
2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation 
(ECMO) 
3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 
4. Hospitalized, requiring supplemental oxygen 
5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care 
(COVID-19-related or other medical conditions preventing hospital discharge) 
6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 
7. Not hospitalized, limitation on activities and/or requiring home oxygen 
8. Not hospitalized, no limitations on activities 
The subjects’ following conditions will be recorded in the CRF and include limitation on 
activities due to COVID-19: 
• Ongoing hospital medical care 
• Supplemental oxygen 
• Non-invasive ventilation or a high flow oxygen device 
• Mechanical ventilation 
• ECMO 
Subjects will also complete 3 questions about NAIDS as following in the patient questionnaire: 
• 
Home oxygen 
• 
Limited activities 
• 
Hospitalization  
 


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7.2.1.3 Symptom improvement and resolution 
Subjects will rate their overall clinical status and severity of symptoms associated with 
COVID-19 by a daily questionnaire. This questionnaire is for outpatients only. 
Subjects will complete 3 questions about their overall clinical status daily, including 
• 
Severity of symptoms 
• 
General physical health, and 
• 
Change in overall health including activity limitation, home oxygen, hospitalization, etc. 
The questionnaire contains these symptoms 
• 
Cough 
• 
Shortness of breath 
• 
Feeling feverish 
• 
Fatigue 
• 
Body aches and pain 
• 
Sore throat 
• 
Chills 
• 
Headache 
• 
Nausea 
• 
Vomiting 
• 
Diarrhea 
• 
Changes in taste and smell. 
Each symptom will be scored daily by the subject as experienced during the past 24 hours. 
Detailed list of symptoms and rating score guideline is document per Appendix 5.  
7.2.2 Safety and Tolerability Assessments 
Safety assessments are specified below with the assessment schedule detailing when each 
assessment is to be performed. 
For safety evaluations, baseline is defined as assessments done on Day 1 prior to the first dose of 
study treatment. 
The investigator will report any vital signs considered clinically significant in the eCRF. For 
details on AE collection and reporting refer to AE Section 8.1. 
7.2.2.1 Physical Examinations 
A complete physical examination will be performed at the screening visit. This examination 
excludes pelvic, rectal, and breast examinations unless clinically indicated. 


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A symptom directed physical examination will be performed at other visits, as specified in the 
SoA and as clinically indicated. 
Investigators should pay special attention to clinical signs related to COVID-19, to ongoing 
medical conditions and to previous serious illnesses. 
7.2.2.2 Vital Signs 
Vital signs will be measured as specified in the SoA and as clinically indicated. Vital sign 
measurements to be measured in the sitting position after 5 mins rest if applicable. Vital signs 
include: 
o Height and weight are only needed at screening  
o Body temperature  
o Systolic BP, diastolic BP 
o Pulse rate 
o Respiration rate 
o Saturation of peripheral oxygen  
o Supplemental oxygen flow rate, FiO2 if known, and method of delivery, if applicable 
or clinical indicated. 
Additional vital signs may be measured during the study if warranted, 12-ECG assessment as 
determined by the investigator. 
7.2.2.3 Clinical Laboratory Tests 
Local clinical laboratory parameters will be used for the analysis of scheduled hematology, 
chemistry and other blood specimens collected as part of safety monitoring (as detailed in SoA) 
and the results will be collected in the eCRF, except for specific parameters which will be 
performed centrally by a Kintor designated laboratory (as detailed in Appendix 4).  
Unscheduled assessments of these parameters can be performed more often as clinically 
indicated. It is preferable to use the same laboratory for all the assessments performed, especially 
for hematology.  
Laboratory values obtained during the screening phase will be used to assess subject’s eligibility. 
The local laboratory must provide Kintor with a copy of the certification and a tabulation of 
normal ranges and units for all local laboratories used in the study. 
Clinically significant abnormalities must be recorded as either medical history/current medical 
conditions or AEs as appropriate. 
There are no specific notable range criteria for this study; however, the local and central 
laboratory will flag laboratory values falling outside of the normal range, on the local and central 
laboratory report (as applicable) (which the investigator should sign off) as per local practice, 
and the investigator will report any values considered clinically significant in the eCRF. 


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See Appendix 4 for the list of clinical laboratory tests to be performed and the SoA for the timing 
and frequency.  
All protocol-required laboratory assessments, as defined in Appendix 4 must be conducted in 
accordance with the laboratory manual and the SoA. 
Clinically significant abnormal laboratory findings are those which are not associated with the 
underlying disease, unless judged by the investigator to be more severe than expected for the 
subject's condition. 
All laboratory tests with values considered clinically significantly abnormal during participation 
in the study or within 28 days after the dose of study intervention should be repeated until the 
values return to normal or baseline or are no longer considered clinically significant by the 
investigator or Sponsor. If such values do not return to normal/baseline within a period judged 
reasonable by the investigator, the etiology should be identified, and the Sponsor notified. 
The investigator must review the laboratory report, document this review in timely manner, and 
record any clinically relevant changes occurring during the study in the AE section of the CRF. 
The laboratory reports must be filed with the source documents. 
If laboratory values from non-protocol specified laboratory assessments performed at the 
institution’s local laboratory requires a change in subject management or are considered 
clinically significant by the investigator (e.g., SAE or AE or dose modification), report in the AE 
section of the CRF and this test is recorded as unscheduled visit in eCRF.  
7.2.2.4 Respiratory Support 
Once enrolled in the study, subjects may be managed with high flow nasal cannula, non-invasive 
positive pressure ventilation or any other form respiratory support as needed per investigator 
discretion. 
7.2.2.5 Pregnancy and assessment of fertility 
All women of childbearing potential must complete a serum pregnancy test at screening visit, 
urinary pregnancy test at subsequent visits as per the schedule of assessment. Local laboratories 
will be used for the analysis of serum and urinary pregnancy tests. 
Women who are determined not to be of childbearing potential before the study will only be 
tested at screening. 
For postmenopausal women to be considered “of non-childbearing potential”, subjects should 
meet the criteria as outlined as following: 
Women are considered post-menopausal and not of childbearing potential if they have had 12 
months of natural(spontaneous) amenorrhea with appropriate clinical profile (e.g., age 
appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with 
or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case 
of oophorectomy alone, only when reproductive status of the woman has been confirmed by 
follow up hormone level assessment is she considered not of child bearing potential. 


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Please refer to Section 8.6 for information on reporting any pregnancies that occur while the 
subject is on study. 
If pregnancy test is performed in between study visits by the subject and the result is positive, the 
subject must immediately notify the investigator. 
7.2.3 Pharmacokinetics  
The exposure-response relationship of GT0918 in the treatment of SARS-CoV-2 has not been 
established. Population PK analyses can be used to further inform dose selection in other 
populations and support concentration-response investigations with efficacy and safety outcomes. 
To accomplish this, sparse PK sampling techniques can be employed. Samples will be collected at 
pre-dose and 2h post first dose, and at pre-dose on Day 3, 7 and 14 from at least 100 subjects who 
receive intervention and have evaluable PK. 
The PK data may be analyzed using validated LC-MS/MS methods with a LLOQ of 
approximately 5.00 ng/mL for GT0918.  
7.2.4 Biomarkers 
Blood samples will be collected from all subjects for exploratory biomarker research at the time 
specified in the SoA where local regulations allow. 
The following will be monitored: 
• C-reactive protein (CRP)  
• Testosterone 
• Ferritin 
• D-dimer 
• Procalcitonin 
• Troponin 
Samples will be stored and analysis may be performed on biomarkers thought to play a role in 
immune system related responses to viral infection including, but not limited to, immune 
pathways, cellular composition, serum analytes, or epigenetic biomarkers, to evaluate their 
association with observed clinical responses to GT0918 and the disease state. 
Samples may be used for research to develop methods, assays, prognostics and/or companion 
diagnostics related to the intervention target (S protein), the COVID-19 disease state, pathways 
associated with disease, and/or the mechanism of action of the study intervention. 
7.2.5 Polymerase Chain Reaction (PCR) 
The second endpoint is the change from baseline to Day 3, 7, 14, 28 in SARS-CoV-2 viral load 
based on nasopharyngeal swab samples for reverse transcription-polymerase chain reaction (RT-
PCR) testing for SARS-CoV-2 (if it is not able to get the samples at each time point, reason 
should be documented with subject source or eCRF, for example, due to lack of testing supplies, 
limited testing capacity, subject is able to go clinic or home visit is not able to schedule, etc.).  


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Quantitative RT-qPCR, which should be done in the central laboratory, is to determine the viral 
load change from different time points. Samples may additionally be used for exploratory viral 
RNA sequencing or viral culture. Additional details regarding sample collection and analysis can 
be found in the laboratory manual. 
7.2.6 Patient Reported Outcomes 
Subjects will be provided Subject’s Diary which will contain the study drug administration 
information (date/time, with or without meal), and the Symptoms and Overall Clinical Status 
Subject Questionnaire for subjects to self-evaluate their health status from their own perspective. 
The questionnaire is required to be completed daily, should at the same time each day (+/- 2 
hours for medication scheduling), from screening to end of follow-up at Day 28. Symptoms of 
COVID-19 are listed per FDA guidance (https://www.fda.gov/media/142143/download) and the 
questionnaire was modified based on this FDA guidance as well, referred to Appendix 5.  
The Sponsor and investigators will make efforts to minimize the amount of missing data, include 
providing reminders (e.g., phone calls, text messages, email) to study subjects to complete 
Patient Reported Outcomes (PRO) instruments, monitoring compliance with PRO instrument 
completion throughout the assessment period, following up with study subjects who are not 
successfully completing PRO instruments (and, where permissible, close contacts if the study 
subject is not responding), and recording verbal responses for those who are unable to self-record 
because of illness or other circumstances. Sponsor and investigators/ sites will try to obtain 
contact information for close contacts of study subjects for use in case of nonresponse. This such 
close contacts include family member (s) or other close contact when subjects do not respond to 
follow-up, this process is described in the informed consent document, will be (is) approved by 
the institutional review board and agreed with subjects. The reasons for missing data should be 
documented with subject’s CRF. 
7.2.7 Virology 
Characterize the effect of GT0918 compared to placebo on SARS-CoV-2 viral load clearance: 
• 
Change from baseline to Days 3, 7, 14 and 28 in SARS-CoV-2 viral load.  
• 
Proportion of subjects that achieve SARS-CoV-2 clearance (Days 3, 7, 14 and 28) 
• 
Time to SARS-CoV-2 clearance. 
• 
SARS-CoV-2 viral load area under the concentration-time curve (AUC) assessed to 
Days 3, 7, 14 and 28. 
7.2.8 Development of resistance 
Characterize emergence of virus resistance to GT0918 
• Virus load assessment on Day -1/1(baseline prior to first dose), 3, 7, 14, 28.  
• Exploratory endpoints will include: 
o Screening for novel mutants in patients who do not respond to GT0918: 
▪ Genotype of SARS-CoV-2 viral isolates. 
For resistance analyses, include subjects who: 


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• Are not able to show two consecutive negative test results via RT-PCR testing by Day 
28,  
and/or 
• Show a positive real-time RT-PCR test result after two consecutive negative RT-PCR 
test results,  
and/or 
• A confirmed rise in SARS-CoV-2 RNA of ≥1 log10 after achieving nadir on treatment. 
 
Characterize emergence of host resistance to GT0918 
• Testosterone levels on Day -1, 3, 7, 14, 28.  
 


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8. SAFETY MONITORING AND REPORTING 
8.1 Adverse Events 
8.1.1 Definitions and Reporting 
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), 
symptom(s), or medical condition(s) that occur after subject’s signed informed consent has been 
obtained. 
Adverse events that begin or worsen after informed consent should be recorded in the AEs CRF. 
Conditions that were already present at the time of informed consent should be recorded in the 
Medical History CRF. Adverse event monitoring should be continued for 28 days following the 
last dose of study treatment. Adverse events (including lab abnormalities that constitute AEs) 
should be described using a diagnosis whenever possible, rather than individual underlying signs 
and symptoms. When a clear diagnosis cannot be identified, each sign or symptom should be 
reported as a separate AE. 
Subjects will be instructed to report AEs during the study and staff will query subjects regarding 
AEs throughout the study. The investigator (and/or designee) must document all AEs reported by 
the subject from the time subjects give consent through completion of the EOS visit. Any subject 
who is withdrawn from the study due to an AE shall be followed until the event has resolved or 
stabilized or 28 days after last dose and the investigator will document available follow-up 
information on the subject’s source documentation and CRF. 
Adverse events reported after consent but before the first dose of study treatment are still to be 
documented by the investigator but will be considered non-treatment-emergent AEs. Adverse 
events will be considered treatment emergent if the onset date is after the first dose of study drug. 
All AEs and SAEs will be assessed for severity using the Division of AIDS (DAIDS) Table for 
Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (July 2017). 
For AEs not included in the Table, the following guidelines will be used to describe severity. In 
addition, all deaths related to an AE are to be classified as grade 5 according to the DAIDS Table. 
Mild: Mild symptoms causing no or minimal interference with usual social and functional 
activities, with intervention not indicated. 
Moderate: Moderate symptoms causing greater than minimal interference with usual social and 
functional activities, with intervention indicated. 
Severe: Severe symptoms causing inability to perform usual social and functional activities, with 
intervention or hospitalization indicated. 
Potentially life-threatening: Potentially life-threatening symptoms causing inability to perform 
basic self-care functions with intervention indicated to prevent permanent impairment, persistent 
disability, or death. 
An event is defined as ‘serious’ when it meets at least 1 of the predefined outcomes as described 
in the definition of an SAE, NOT when it is rated as severe. 


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“Lack of efficacy” or “failure of expected pharmacological action” per se will not be reported as 
an AE or SAE. Such instances will be captured in the efficacy assessments. However, the signs, 
symptoms, and/or clinical sequelae resulting from lack of efficacy will be reported as AE or SAE 
if they fulfill the definition of an AE or SAE. 
8.1.2 Events NOT Meeting the AE Definition: 
• The following study-specific clinical events related to COVID-19 are exempt from AE 
reporting unless the investigator deems the event to be related to the administration of 
study drug: 
o Hypoxemia due to COVID-19 requiring supplemental oxygen; 
o Hypoxemia due to COVID-19 requiring non-invasive ventilation or high flow 
oxygen devices; 
o Respiratory failure due to COVID-19 requiring invasive mechanical ventilation 
or ECMO. 
• Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the subject’s condition.  
• The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the subject’s 
condition. 
• Medical or surgical procedure (e.g., endoscopy, appendectomy): the condition that leads 
to the procedure is the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or 
detected at the start of the study that do not worsen. 
Classification of AEs by Relationship to Study Drug 
UNRELATED: This category applies to those AEs that are clearly and incontrovertibly due 
to extraneous causes (disease, environment, etc.). 
UNLIKELY:  This category applies to those AEs that are judged to be unrelated to the test 
drug, but for which no extraneous cause may be found. An AE may be considered unlikely to 
be related to study drug if or when it meets 2 of the following criteria: (1) it does not follow a 
reasonable temporal sequence from administration of the test drug; (2) it could readily have 
been produced by the subject’s clinical state, environmental or toxic factors, or other modes of 
therapy administered to the subject; (3) it does not follow a known pattern of response to the 
test drug; or (4) it does not reappear or worsen when the drug is re-administered. 
POSSIBLY: This category applies to those AEs for which a connection with the test drug 
administration appears unlikely but cannot be ruled out with certainty. An AE may be 


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considered possibly related if or when it meets 2 of the following criteria: (1) it follows a 
reasonable temporal sequence from administration of the drug; (2) it could not readily have 
been produced by the subject’s clinical state, environmental or toxic factors, or other modes of 
therapy administered to the subject; or (3) it follows a known pattern of response to the test 
drug. 
PROBABLY: This category applies to those AEs that the investigator feels with a high degree 
of certainty are related to the test drug. An AE may be considered probably related if or when 
it meets 3 of the following criteria: (1) it follows a reasonable temporal sequence from 
administration of the drug; (2) it could not be reasonably explained by the known 
characteristics of the subject’s clinical state, environmental or toxic factors, or other modes of 
therapy administered to the subject; (3) it disappears or decreases on cessation or reduction in 
dose (note that there are exceptions when an AE does not disappear upon discontinuation of 
the drug, yet drug-relatedness clearly exists; for example, as in bone marrow depression, fixed 
drug eruptions, or tardive dyskinesia); or (4) it follows a known pattern of response to the test 
drug. 
DEFINITELY: This category applies to those AEs that the investigator feels are 
incontrovertibly related to test drug. An AE may be assigned an attribution of definitely related 
if or when it meets all of the following criteria: (1) it follows a reasonable temporal sequence 
from administration of the drug; (2) it could not be reasonably explained by the known 
characteristics of the subject’s clinical state, environmental or toxic factors, or other modes of 
therapy administered to the subject; (3) it disappears or decreases on cessation or reduction in 
dose and recurs with re-exposure to drug (if rechallenge occurs); and (4) it follows a known 
pattern of response to the test drug. 
All AEs (regardless of seriousness or relationship to study drug) including those from the time of 
consent to the EOS visit are to be recorded in the subject’s source documents and on the 
corresponding page(s) in the CRF. The investigator should specify the date of onset, intensity, 
action taken with respect to study drug, corrective treatment/therapy given, outcome and his/her 
opinion as to whether there is a reasonable possibility that the AE was caused by the study drug. 
All medications administered to treat an AE must be recorded in the subject’s source 
documentation and reported in the CRF. 
8.1.3 Laboratory Test Abnormalities 
Laboratory abnormalities that constitute an AE in their own right (are considered clinically 
significant, induce clinical signs or symptoms, require concomitant therapy, or require changes in 
study treatment), should be recorded on the AEs CRF. 
Whenever possible, a diagnosis, rather than a symptom should be provided (e.g. anemia instead of 
low hemoglobin). Laboratory abnormalities that meet the criteria for AEs should be followed until 
they have returned to normal or an adequate explanation of the abnormality is found. When an 
abnormal laboratory or test result corresponds to a sign/symptom of an already reported AE, it is 
not necessary to separately record the lab/test result as an additional event. 
Laboratory abnormalities, that do not meet the definition of an AE, should not be reported as AEs. 


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8.2 Adverse Events of Special Interest (AESI) 
The Adverse events of special interest (AESI) search table will be used to map reported AEs to 
the notable AE groupings. AESI could be updated during the course of study based on 
accumulating safety data. Therefore the clinical study report includes the AE groupings (such as 
gastrointestinal disorders, cardiovascular disorders, increased liver transaminase, and 
neurological disorders, peripheral blood cytopenia and renal disorders).  used and provide a 
listing of the corresponding AESI search table. AESI will be summarized regardless of study 
drug relationship, by grouping, PT and treatment arm. 
8.3 Serious Adverse Events 
8.3.1 Definitions 
If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions 
are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to 
progression of disease).  
An SAE is defined as one of the following: 
• Is fatal 
• Is life-threatening 
• Results inpatient hospitalization or prolongation of existing hospitalization 
• Results in a persistent or significant disability/incapacity 
• Constitutes a congenital anomaly/birth defect 
• Is medically significant, i.e., defined as an event that jeopardizes the patient or may require 
medical or surgical intervention to prevent one of the outcomes listed above 
• Note that hospitalizations for the following reasons should not be reported as SAEs: 
a. Routine treatment or monitoring of the studied indication, not associated with any 
deterioration in condition. 
b. Elective or pre-planned treatment for a pre-existing condition that is unrelated to the 
indication under study and has not worsened since signing the informed consent. 
c. Social reasons and respite care in the absence of any deterioration in the patient’s 
general condition. 
• Note that treatment on an emergency outpatient basis that does not result in hospital 
admission and involves an event not fulfilling any of the definitions of a SAE given above 
is not an SAE. 
8.3.2 SAE Reporting 
To ensure patient safety, every SAE, regardless of suspected causality, occurring after the subject 
has provided informed consent and until at least 28 days after the patient has stopped study 
treatment must be reported to Kintor/delegated CRO within 24 hours of learning of its occurrence. 


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Any SAEs experienced after this 28-day period should only be reported to Kintor/delegated CRO 
if the investigator suspects a causal relationship to the study treatment. Recurrent episodes, 
complications, or progression of the initial SAE must be reported as follow-up to the original 
episode within 24 hours of the investigator receiving the follow-up information. An SAE occurring 
at a different time interval or otherwise considered completely unrelated to a previously reported 
one should be reported separately as a new event. 
Information about all SAEs is collected and recorded on the SAE Report Form; all applicable 
sections of the form must be completed in order to provide a clinically thorough report. The 
investigator must assess and record the relationship of each SAE to each specific study treatment 
(if there is more than one study treatment), complete the SAE Report Form in English and submit 
the completed form within 24 hours to Kintor. Detailed instructions regarding the SAE submission 
process and requirements for signatures are to be found in the investigator folder provided to each 
site. 
The Investigator must also promptly notify the Institutional Review Board (IRB) /Independent 
Ethics Committee (IEC) of SAEs, including any follow-up information, in accordance with local 
institutional policy and applicable regulatory requirements. Regulatory authorities will be notified 
of any AE associated with the use of the study drug that is both serious and unexpected, in 
accordance with the appropriate local regulatory guidelines. Notification of the event will be made 
by written, expedited safety report by the Sponsor. 
The Investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and/or evaluations as medically indicated or as requested by Kintor to elucidate the nature and/or 
causality of the AE or SAE as fully as possible. This may include additional laboratory tests or 
investigations, histopathological examinations, or consultation with other health care professionals. 
Follow-up information is submitted in the same way the original SAE Report. Each re-occurrence, 
complication, or progression of the original event should be reported as a follow-up to that event 
regardless of when it occurs. The follow-up information should describe whether the event has 
resolved or continues, if and how it was treated, whether the blind was broken or not, and whether 
the patient continued or withdrew from study participation. 
If the SAE is not previously documented in the Investigator’s Brochure or Package Insert (new 
occurrence) and is thought to be related to the Kintor study treatment, the Kintor Drug Safety 
associate may urgently require further information from the investigator for Health Authority 
reporting. Kintor may need to issue an Investigator Notification (IN), to inform all investigators 
involved in any study with the same drug that this SAE has been reported. 
8.4 Suspected Unexpected Serious Adverse Reactions (SUSARs) 
Suspected Unexpected Serious Adverse Reactions (SUSARs) will be collected and reported to the 
competent regulatory authorities and relevant IECs in accordance with Directive 2001/20/EC or 
as per national regulatory requirements in participating countries. 
If the SUSAR is fatal or life-threatening, associated with study treatment, and unexpected, 
regulatory authorities and IECs will be notified immediately as per national requirements once the 
Sponsor learns of the event. Additional follow-up (cause of death, autopsy report, and hospital 
report) information should be reported as required. 


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If the SUSAR is not fatal or life-threatening but is otherwise serious, associated with study 
intervention, and unexpected, regulatory authorities and IECs will be notified as per national 
requirements once the Sponsor learns of the event. 
The Sponsor will notify the Investigators in a timely fashion of relevant information about 
SUSARs that could adversely affect the safety of subjects. Follow-up information may be 
submitted if necessary. 
The Sponsor will also provide annual safety updates to the regulatory authorities and IECs 
responsible for the study. These updates will include information on SUSARs and other relevant 
safety findings. 
8.5 Emergency Unblinding of Treatment Assignment 
Emergency unblinding should only be undertaken for safety reasons when it is essential for 
effective treatment of the subject. Most often, study treatment discontinuation and knowledge of 
the possible treatment assignments are sufficient to treat a study patient who presents with an 
emergency condition. Emergency code breaks are performed using the IWRS. When the 
investigator contacts the IWRS to unblind a subject, he/she must provide the requested subject 
identifying information and confirm the necessity to unblind the subject. The investigator will then 
receive details of the drug treatment for the specified subject and a fax and/ or email (if allowed 
per local regulatory requirement) confirming this information. The system will automatically 
inform the Kintor monitor for the site and the Study Lead that the code has been broken. 
It is the investigator’s responsibility to ensure that there is a procedure in place to allow access to 
the IWRS in case of emergency. The investigator will inform the subject how to contact his/her 
backup in cases of emergency when he/she is unavailable. The protocol number, study treatment 
name if available, subject number and instructions for contacting Kintor (or any entity to which it 
has delegated responsibility for emergency code breaks) will be provided to the subject in case 
emergency unblinding is required at a time when the investigator and backup are unavailable. 
However, if a mechanism is already in place to ensure that the investigator and/or backup can 
always be reached in case of emergency then the procedure above is not required. 
Study treatment must be discontinued once emergency unblinding. 
8.6 Pregnancies  
To ensure subject safety, each pregnancy occurring after the start of study treatment and until 90 
days after the last dose of study drugs must be reported to Kintor/delegated CRO immediately 
(within 24 hours) of learning of its occurrence. The subjects who become pregnant during the study 
must be withdrawn. 
The pregnancy will be followed up from the estimated date of delivery plus 3 months to determine 
outcome, including spontaneous or voluntary termination, details of the birth, and the presence or 
absence of any birth defects, congenital abnormalities, or maternal and/or newborn complications. 
Pregnancy should be reported on a Clinical trial pregnancy form and reported by the investigator 
to Kintor/delegated CRO safety team. Pregnancy follow-up should be recorded on the same form 
and should include an assessment of the possible relationship to the investigational treatment of 
any pregnancy outcome. Any SAE experienced during pregnancy must be reported on the SAE 
report form. 


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Details of all pregnancies in female partners of male subjects will be collected after the start of 
study treatment and until 90 days after the last dose of study drugs. A pregnancy outcome 
informed consent will be provided by Kintor. Consent to report information regarding these 
pregnancy outcomes should be obtained from the mother. 
Women of childbearing potential should be advised to use highly effective contraception 
methods while they are receiving study treatment and up to 3 months after treatment has been 
stopped.  
If a pregnancy occurs while on study treatment, the newborn will be followed for at least 3 
months. 
If a pregnancy is reported, the investigator should inform the Sponsor within 24 hours of learning 
of the pregnancy and should inform IRB as well.  
While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication or 
elective termination of a pregnancy for medical reasons will be reported as an AE or SAE. 
Abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, ectopic pregnancy) are considered SAEs. 
8.7 Warnings and Precaution 
No evidence available at the time of the approval of this study protocol indicated that special 
warnings or precautions were appropriate, other than those noted in the provided Investigator 
Brochure (IB). Additional safety information collected between IB updates will be communicated 
in the form of Investigator Notifications. This information will be included in the subject informed 
consent and should be discussed with the subject during the study as needed. 
8.8 Independent Data Monitoring Committee (IDMC) 
An IDMC will be constituted and will be responsible for monitoring and reviewing the clinical 
study data for safety and efficacy during the study prior to the final data analysis. To minimize any 
bias introduced into the analysis of the study results, analysis plans will be finalized and approved 
prior to the interim analyses. The primary goal of the IDMC is to review the interim results 
regarding the continuing safety of study subjects and the continuing validity and scientific merit 
of the study. Information that may unblind the study during the analyses will not be reported to 
study sites or the blinded study team until the study has been unblinded. Unblinding details are 
specified in the unblinding plan section of the SAP or in a separate unblinding plan document.  
Responsibilities of the IDMC, communication flow between DMC, SC, and Kintor, and timing of 
data safety and efficacy reviews, will be included in the DMC charter document. 
The IDMC will consist of at least 2 COVID-19 experts and one biostatistician and will be formed 
prior to the randomization of the first patient. Detailed recruitment status and interim analysis 
report will be provided to the IDMC. Recruitment will not be interrupted. Details will be provided 
in the IDMC charter. 
It is envisioned that the DMC may make 4 types of recommendations, namely: 
1. No safety or ethical issues, ethical to continue the study as planned 
2. Serious safety concerns precluding further study treatment, regardless of efficacy 
3. Ethical to continue the study but recommend an amendment to the protocol 


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4. Stop prematurely for lack of efficacy 
8.9 Steering Committee 
The SC will be established comprising investigators participating in the study, and Kintor 
representatives from the clinical study team. 
The SC will be an advisory board for the study according to the protocol through recommending 
modifications as circumstances require. The SC will be consulted for the protocol amendments as 
appropriate. Together with the clinical study team, the SC will also develop recommendations for 
the publications of study results. The details of the role of the SC will be defined in a SC charter. 
The SC will not have access to unblinded study data. 


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9. DATA COLLECTION AND MANAGEMENT 
9.1 Data Confidentiality 
Prior to any testing under this protocol, including screening tests and assessments, subjects must 
also provide all authorizations required by local law (e.g., PHI authorization in North America). 
The subject will not be identified by name in the CRF or in any study reports and these reports 
will be used for research purposes only. Suzhou Kintor Pharmaceuticals, Inc., its partner(s) and 
designee(s), and various government health agencies may inspect the records of this study. Every 
effort will be made to keep the subject’s personal medical data confidential. 
Suzhou Kintor Pharmaceuticals, Inc. will protect individual subject information to the fullest 
extent possible during this study. At no time will a subject become identified in any publication or 
presentation. 
However, the subject may have to become identified in the event of a regulatory authority auditor 
inspection in order to verify the accuracy of the data. Access to subject information is at the 
discretion of Suzhou Kintor Pharmaceuticals, Inc. and cannot occur prior to database lock or other 
specified events as determined solely by the discretion of Suzhou Kintor Pharmaceuticals, Inc. 
9.2 Site Monitoring 
At regular intervals during the study, the site will be contacted through monitoring visits or remote 
monitoring, letters, and telephone calls by a representative to review study progress, Investigator 
and subject compliance with study protocol requirements, and any emergent problems. During 
monitoring visits, the following points will be reviewed in accordance with all applicable 
regulatory requirements and SOPs: original medical records and other source documents, the 
Investigator site file, screening logs, subject informed consent, subject recruitment and follow-up, 
SAE documentation and reporting, documentation and reporting of endpoints, study drug 
allocation, subject compliance with the study drug regimen, study drug accountability, 
concomitant therapy use, and quality of data. In addition, other required regulatory documents will 
be reviewed, including but not limited to: IRB/IEC composition and correspondence, laboratory 
certification(s), delegation of authority, and Investigator and study personnel curricula vitae. 
9.3 Data Collections 
All data obtained for analysis in the clinical study described in this protocol will be reported in the 
CRF. Data reported in the CRFs should be consistent with and substantiated by the subject’s 
medical record and original source documents. Any discrepancies must be explained. Unless 
explicitly allowed in the CRF instructions, blank data fields are not acceptable. If a field is blank 
because the item was not done, the field will be marked “Not Done.” If the item is unknown, the 
field will be marked “Unknown.” 
Prior to the start of the study, the Principal Investigator will complete a Delegation of Authority 
form (Site Signature and Delegation Log), showing the signatures and handwritten initials of all 
individuals and the delegation of responsibilities, such as identifying those individuals who are 
authorized to make or change entries on CRFs. 
 


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9.4 Database Management 
A designated CRO will be responsible for data management. Data Management will develop a 
Data Management Plan (DMP) document and provide it to Suzhou Kintor Pharmaceuticals, Inc. 
for approval. The DMP document will define all activities in the data collection and cleaning 
process. The detailed DMP will be based on the protocol, work scope, contract, analysis plans, 
dataflows, CRFs, data cleaning procedures, other supporting documents, and data management 
standards and practices. 
The programmed data validations will be run to check for database completeness and consistency, 
and queries will be generated upon data entry or via review by a Clinical Data Manager after entry. 
The sites will respond to the data queries in a timely manner. 
Concurrent medications entered the database will be coded using a WHO Anatomical Therapeutic 
Chemical dictionary. Coexistent diseases and AEs will be coded using MedDRA. 
9.5 Quality Control 
The Sponsor or its designee will perform the quality assurance and quality control activities of this 
study; however, responsibility for the accuracy, completeness, and reliability of the study data 
presented to the Sponsor lies with the Investigator generating the data. 
The Sponsor will arrange audits as part of the implementation of quality assurance to ensure that 
the study is being conducted in compliance with the protocol, Standard Operating Procedures, 
GCP, and all applicable regulatory requirements. Audits will be independent of and separate from 
the routine monitoring and quality control functions. Quality assurance procedures will be 
performed at study sites and during data management to assure that safety and efficacy data are 
adequate and well documented.  


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10. STATISTICAL METHODS AND DATA ANALYSIS 
10.1 General Considerations 
It is planned that the data from all centers participating in the study will be combined, so that an 
adequate number of patients are available for analysis. Kintor and/or a designated CRO will 
perform all analyses. And data analyses performed independently by any investigator should be 
submitted to Kintor before publication or presentation. 
A Statistical Analysis Plan (SAP) will be prepared after the protocol is approved. It will provide 
further details regarding the definition of analysis variables and analysis methodology to address 
all study objectives. The SAP will serve as a compliment to the protocol and supersedes it in case 
of differences.  
The statistical evaluation will be performed using the Statistical Analysis Software (SAS®) 
Version 9.4 or higher (SAS Institute, Cary, NC). All data will be listed, and summary tables will 
be provided. Summary statistics will be presented by dose group. For continuous variables, data 
will be summarized with the number of subjects (N), mean, standard deviation, median, minimum, 
and maximum by treatment group. For categorical variables, data will be tabulated with the 
number and percentages of subjects for each category by treatment group.  
Interim Analysis will be conducted based on the Data Monitoring Committee SAP.  
10.2 Analysis Sets  
10.2.1 Intent-to-Treat Analysis Set (ITT) 
The intent-to-treat analysis set includes all randomized subjects. 
10.2.2 Modified Intent-to-Treat Analysis Set (mITT) 
The mITT analysis set includes all randomized subjects who have received at least one dose of 
the study treatment. The primary efficacy analysis will be conducted on the mITT Analysis Set. 
10.2.3 Safety Analysis Set (SS) 
The safety analysis set includes all subjects with at least one dose of study medication. The 
disposition, study summary, and safety analysis will be conducted on Safety Analysis Set. 
10.2.4 Per-Protocol Analysis Set (PPS) 
The per-protocol analysis set includes all ITT subjects without major protocol violations. The 
per-protocol analysis set will be defined under classification specification prior to unblinding of 
the study treatment code. 
10.2.5 Pharmacokinetic Analyses 
Pharmacokinetic analyses will be conducted on data from at least 100 subjects who receive 
intervention and have evaluable PK. 
 


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10.3 Subject Demographics/Other Baseline Characteristics  
Demographics and other baseline data including age, age group, race, ethnicity, BMI, baseline 
disease, underlying medical conditions 0, 1-2, ≥3 (as defined in Section 4.1.1.), and other disease 
characteristics will be summarized descriptively by treatment group using data from the ITT. 
Categorical data will be presented as frequencies and percentages and if appropriate their 95% 
confidence intervals. For continuous data, mean, standard deviation, median, 25th and 75th 
percentiles, minimum, and maximum will be presented. 
10.4 Treatments (Study Treatment, Concomitant Therapies, Compliance) 
The safety set will be used for the analyses below. 
The actual dose and duration of GT0918, as well as dose intensity (computed as the ratio of 
actual dose received to actual duration) and the relative dose intensity (computed as the ratio of 
the dose intensity to planned dose received/planned duration), will be listed and summarized 
using descriptive statistics. The total daily doses of GT0918 for each patient will be summarized 
using descriptive statistics (e.g., mean, median, and mode).  
Concomitant medications and significant non-drug therapies will be listed by patient and 
summarized by ATC (Anatomical Therapeutic Chemical classification system) term for each 
treatment group. These summaries will include medications starting on or after the start of study 
treatment or medications starting prior to the start of study treatment and continuing after the 
start of study treatment. Any prior concomitant medications or significant non-drug therapies 
starting and ending prior to the start of study treatment will be listed. 
Compliance to the study drug will be assessed by the investigator and/or study personnel at each 
patient visit and information provided by the patient and/or caregiver in the drug accountability 
form including dosages administered, dosing intervals, dose changes or interruptions with 
associated reasons. 
10.5 Efficacy Analysis 
10.5.1 Primary Efficacy Objective 
The primary objective is to evaluate the efficacy of GT0918 in subjects with mild to moderate 
COVID-19 illness.  
10.5.1.1 Primary Efficacy Variable 
The primary efficacy endpoint is the proportion of subjects who do not experience any of the 
following events due to all causes by Day 28: 
• 
Hospitalization for ≥ 24 hours  
• 
Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%  
• 
Death 
10.5.1.2 Statistical Hypothesis, Model, and Method of Analysis 
Primary Null Hypothesis H0: proportion of subjects who do not experience all-cause 
hospitalization (defined as ≥24 hours) and do not require supplemental oxygen for ≥24h in 


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response to SpO2≤93% and are alive  by Day 28 in the GT0918 arm (p1) is equal to the 
proportion in the placebo arm (p2) 
Primary Alternative Hypothesis Ha: the proportion of subjects who do not experience all-cause 
hospitalization (defined as ≥24 hours) and do not require supplemental oxygen for ≥24h in 
response to SpO2≤93% and are alive by Day 28 in GT0918 arm (p1) is less than the proportion 
in the placebo arm 2 (p2)  
Mathematically written as: 
H0: p1 - p2= 0 
Ha: p1 - p2>0 
The primary endpoint event rate will be compared between treatment and placebo arm using 
Cochran–Mantel–Haenszel (CMH) chi-square test using the stratification factors at time of 
randomization at the one-sided 0.025 level based on mITT. P-values and 95% exact confidence 
intervals for the treatment difference will be presented. 
10.5.1.3 Handling of Dropouts, Missing Values/Censoring/Discontinuations 
No dropouts will be replaced. Every effort will be made to avoid missing data. All subjects will 
be followed fully in the trial whenever possible. All patients who maintain consent to be 
followed for additional outcome information should remain in the study through the end of the 
double-blind period for all important safety and efficacy assessments. The only reasons for study 
withdrawal should be withdrawal of consent and loss to follow-up. To help prevent missing data, 
The following reinforcement will be taken: (1) the protocols and informed consent forms clearly 
differentiate treatment discontinuation from study withdrawal; (2) site investigators be trained 
about the importance of retention and steps to prevent missing data; (3) the consent forms 
include a statement educating patients about the continued scientific importance of their data 
even if they discontinue study treatment early; and (4) continue following patients after 
discharge via telehealth visits or other approaches (e.g., telephone calls, texts, and emails to the 
patient and close contacts); and (5) steps will be taken to ascertain vital status in all randomized 
patients. 
The extra effort to contact all subjects specifically those who discontinued treatment early to 
assess the occurrence of any component of the primary endpoint, hospitalization, need for 
oxygen, or death by day 28 will minimize missing data for the primary endpoint. For the primary 
analysis of the primary endpoint, patients with missing primary assessments will be included in 
the analysis and evaluated as treatment failures. Sensitivity analyses will be considered e.g. per 
protocol set analysis and complete case analysis (i.e. patients with non-missing primary 
assessments).  
 
 The SoA, outlined in the protocol, specifies the allowable windows for assessments. 
Assessments performed outside these windows will not be excluded from any analysis but may 
not be reported as a protocol deviation.  
Further details for handling missing data will be specified in the SAP and appropriate sensitivity 
analyses specified.  


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10.5.1.4 Subgroup Analyses 
This study is not powered for subgroup analyses; therefore, all subgroup analyses will be treated 
as exploratory. 
Subgroup analyses will be conducted for the primary endpoint and displayed graphically in 
forest plots. Subgroups may include: 
o time from symptom onset to study randomization 
o geographic region 
o baseline severity of COVID-19 
o age group  
o sex 
o race 
o ethnicity 
o baseline BMI  
o concomitant medication of interest use (yes/no) 
o strata used at time of randomization (number of risk factors) 
o vaccination status 
10.5.1.5 Sensitivity Analyses 
Sensitivity analysis of the primary endpoint analysis will be conducted. Details will be specified 
in the SAP. 
10.5.2 Secondary Objectives Variables 
10.5.2.1 Hospitalization percentage 
The percentage of subjects with all-cause and COVID-19 related hospitalization (defined as ≥24 
hours) or requirement for supplemental oxygen for ≥24h in response to SpO2≤93% or death by 
Day 28 will be analyzed. 
The proportion of subjects that experience hospitalization, supplemental oxygen, emergency room 
visit or death by Day 28 will be summarized by treatment in frequency tables and listed.  
The total number of all-cause and COVID-19 related hospitalization and days of hospitalization 
due to all causes and COVID-19, will be summarized based on mITT. 
 
10.5.2.2 COVID-19 Ordinal Outcomes Scale  
The percentage of subjects at each clinical status using NIAID ordinal scale at Days 7, 14, and 
28 will be analyzed. 
1. Death 


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2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation 
(ECMO) 
3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 
4. Hospitalized, requiring supplemental oxygen 
5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care 
(COVID-19-related or other medical conditions preventing hospital discharge) 
6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 
7. Not hospitalized, limitation on activities and/or requiring home oxygen 
8. Not hospitalized, no limitations on activities 
Mean value by treatment group will be plotted over time. 
Comparison of the mean worst daily NIAID ordinal scale values by Days 7, 14, and 28. The 
worst ordinal scale will be fitted by a proportional odds model with treatment, age, sex, baseline 
severity and number of risk factors as covariates.  
In addition, proportion of subjects worsening from baseline will be presented, where worsening 
is defined as the proportion of subjects with any worsening on the NIAID ordinal scale from 
baseline to Days 7, 14, and 28. 
The following events (observed at any time point during the study treatment period) will be 
summarized: 
o Proportion of subjects hospitalized 
o Duration of hospitalization (DOH; in days) 
o Proportion (percentage) of subjects admitted to ICU 
All hospitalization events will be listed. 
 
10.5.2.3 Proportion of Symptom resolution 
For each symptom resolution is defined as absent for at least 48 hours. The proportion of 
subjects with symptom resolution will be analyzed by symptom. 
All symptom resolution is defined as all symptoms (those scored 0-3) on the symptom 
questionnaire scored as absent. The proportion of subjects with all symptom resolution will be 
analyzed.  
These analyses will be performed at Days 7, 14, and 28 by treatment in frequency tables and 
listed. 
In addition, the number of participants that achieve symptom resolution at Days 7, 14, and 28 
will be analyzed using logistic regression to compare GT0918 versus placebo if there are 
sufficient data available. 


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10.5.2.4 Time to symptom resolution  
Time to all symptom resolution is defined (in days) as:  
First study day when symptom resolution status is changed to “Yes” – first dosing Date + 1. 
If a patient has not experienced symptom resolution by completion or early discontinuation of 
study/study treatment, the patient will be censored at the date of their last visit during the 
treatment period.  
Time to symptom resolution will be evaluated up to Day 28 and will be summarized by treatment 
and listed. Cox proportional hazard model will be used, stratified by duration since symptom 
onset to randomization category. 
Time to symptom resolution will be presented graphically. 
10.5.2.5 Symptom Improvement 
10.5.2.5.1 Proportion of subjects demonstrating symptom improvement via the symptom 
questionnaire on Days 3, 7, 14 and 28. 
Symptom improvement is defined as a change in severity of total ratings from a higher score to a 
lower scorewhich is defined as following: 
• 
symptoms scored as moderate or severe at baseline are scored as mild or absent,  
OR 
• 
symptoms scored as mild or absent at baseline are scored as absent.  
The proportion of subjects that achieve symptom improvement at Days 7, 11, 14 and 28 will be 
summarized by treatment in frequency tables and listed. 
10.5.2.6 Time to Symptom Improvement 
Time to symptom improvement is defined (in days) as: 
(Date when symptom improvement status is changed to “Yes” – first dosing Date + 1). 
If a subject has not experienced symptom improvement by completion or early discontinuation 
of study/study treatment, the patient will be censored at the date of their last visit during the 
treatment period. 
Time to symptom improvement will be evaluated up to Day 28 and will be summarized by 
treatment and listed. In addition, a graphical presentation of the symptom improvement will be 
provided using a KM plot. 
10.5.2.7 Virus Clearance 
Proportion of subjects that achieve SARS-CoV-2 clearance at Days 3, 7, 14 and 28. 
The proportion of subjects that achieve SARS-CoV-2 clearance at Days 3, 7, 14, and 28 will be 
summarized by treatment in frequency tables and listed. 


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10.5.2.8 Time to SARS-CoV-2 clearance 
Time to SARS-CoV-2 clearance will be evaluated by day 28 and will be summarized by 
treatment and listed.  
Time to SARS-CoV-2 clearance will be presented graphically. 
10.5.2.9 Viral load reduction 
SARS-CoV-2 viral load, including changes from baseline, will be summarized and plotted by 
treatment and listed. Baseline is defined as the Day 1 pre-dose assessment. Changes from 
baseline to Day 3, 7, 14 and 28 in SARS-CoV-2 viral load data in the log base 10 scale will be 
analyzed using a linear mixed-effect model. 
The AUC from Day 1 pre-dose to Day 28 (AUC[0-D28]) will be calculated according to the 
linear trapezoidal rule using the measured SARS-CoV-2 viral load-time values above the lower 
limit of quantification. No imputations of missing data will be conducted. No AUC(0-D28) 
values will be calculated when Day 1 pre-dose and/or Day 28 values are missing, or if there are 
more than 3 values missing in the profile. 
The AUC (0-D28) will be summarized and plotted by treatment and listed. 
 
10.6 Exploratory Objectives  
10.6.1 Pharmacokinetics of GT0918  
PK concentrations of GT0918 (and any relevant metabolites such as GT0955) will be 
summarized by time point using descriptive statistics by treatment only for GT0918 arm. All PK 
concentration data will be listed as appropriate 
Data handling principles 
Plasma samples may be assayed for GT0918 concentrations by Kintor or Kintor designated 
laboratory. The PK data may be analyzed using validated LC-MS/MS methods with a LLOQ of 
approximately 5.00 ng/mL for GT0918. 
All concentrations below the LLOQ will be displayed in listings as zero with a flag and handled 
as zero in any calculations of summary statistics, but handled as missing for the calculation of the 
geometric means and their CV. Any missing PK parameter data will not to be imputed. 
10.6.2 Viral resistance to GT0918  
If appropriate, the evaluation of viral resistance will be conducted as described in a separate 
bioanalytical analysis plan. Comparison from baseline to the last evaluable time point up to Day 28 
on the emergence of viral resistance to GT0918. 


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10.7 Safety Analysis 
10.7.1 Analysis set and grouping for the analyses 
For all safety analyses, the safety set will be used. All listings and tables will be presented by 
treatment group. 
The overall observation period will be divided into 3 mutually exclusive segments: 
1. pre-treatment period: from day of patient’s informed consent to the day before first dose of study 
medication 
2. on-treatment period: from D 1 (the day of first dose of study drug) to D 14 (the day of last dose) 
3. post-treatment period: from D 15 (the day after last dose) to D 28 (14 days after last dose) 
4. safety follow up period: from D 28 (14 days after last dose) to D 42 (28 days after last dose) 
10.7.2. Adverse events 
Summary tables for AEs have to include only AEs that started or worsened during the on-treatment 
period, the treatment-emergent AEs. However, all safety data (including those from the pre and 
post-treatment periods) will be listed and those collected during the pre-treatment and post-
treatment period are to be flagged. 
The incidence of TEAEs (new or worsening from baseline) will be summarized by system organ 
class and or preferred term, severity (based on DAIDS grades), type of AE, relation to study 
treatment by treatment group. 
In an overview table, the number and percentage of subjects who experienced a TEAE, SAE, AE 
related to study drug, death due to an AE, discontinued from the study treatment, or discontinued 
from the study due to an AE will be summarized by treatment. 
Treatment-emergent AEs may be reported separately for the treatment period and follow-up 
periods. 
10.7.3 Laboratory abnormalities 
For laboratory tests covered by DAIDS Version 2.1, a Grade 0 will be assigned for all non-missing 
values not graded as 1 or higher.  
For laboratory tests where grades are not defined by DAIDS, results will be graded by the 
low/normal/high classifications based on laboratory normal ranges. 
The following by treatment summaries will be generated separately for hematology, biochemistry, 
and coagulation laboratory tests: 
• 
Frequency table for newly occurring on-treatment Grades 3 or 4. 
• 
Shift tables using DAIDS grades to compare baseline to the worst on-treatment value. 
• 
For laboratory tests where DAIDS grades are not defined, shift tables using the 
low/normal/high classification to compare baseline to the worst on-treatment value. 


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• 
Listing of all laboratory data with values flagged to show the corresponding DAIDS grades 
and the classifications relative to the laboratory normal ranges. 
In addition to the above-mentioned tables and listings, other exploratory analyses, for example 
figures plotting time course of raw or change in laboratory tests over time or box plots might be 
specified in the analysis plan. 
10.7.4 Other safety data 
10.7.4.1 Vital signs 
• 
Shift table from baseline to worst on-treatment result. 
• 
Table with descriptive statistics at baseline, one or several post-baseline time points and 
change from baseline to this/these post-baseline time points. 
10.7.4.2 Tolerability 
Tolerability will be studied in terms of dose discontinuation due to AE. 
Reasons for dose discontinuation will be listed and summarized by treatment. 
10.8 Interim Analysis 
An interim analysis will be conducted when 334 subjects completed Day 28 after first dose. The 
objective of the interim analysis to assess safety, futility, efficacy, sample size adjustment as well 
as potential enrichment of the population to enroll a population at higher risk for an infection 
requiring hospitalization or oxygen support in case the observed rates for the primary endpoint in 
the control arm are lower than expected. An independent data monitoring committee (IDMC) 
will review the unblinded interim analysis report to assess the objectives of the interim analysis 
and provide recommendations about early study closure, change study population, or change to 
study sample size. Rigorous steps will be taken (e.g., firewalls) where possible to minimize the 
information that can be inferred by observers. 
The futility criterion for the study will be based on the conditional power of the study being <10%. 
The efficacy criterion will be based on the one-sided p-value of the primary endpoint analysis as 
<0.0015. In this case the stopping boundary for efficacy is met and the study could be stopped for 
efficacy. 
The topline safety analysis will include treatment related SAE including death. The IDMC can 
recommend stopping the study.  
The conditional power will be evaluated based on primary endpoint in the interim analysis. IDMC 
could recommend a change of the subject population to enroll more subjects if the event rate is 
lower than expected. The IDMC will review the interim efficacy results and in case of substantial 
treatment differences between subpopulations, e.g., <50 years compared to ≥50 years, provide 
recommendations for modifications of further enrollment. Criteria for those recommendations will 
be defined in the DMC charter. The consequences of those recommendations on the statistical 
analysis as well as the  samples size adjustment will be summarized in a separate document and 
attached to the statistical analysis plan. 
If the conditional power of the study at the time interim analysis is between 50% to 80% (promising 
zone approach), the sample size could be increased to a maximum of 1500 subjects based on the 


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efficacy in the interim analysis for overall population. If the conditional power of the study is 
above 80% power the sample size will not be changed. The detailed exact rule for sample size re-
estimation will be pre-specified in the DMC charter. 
Assuming there is no change in the study design regarding sample size modification, the p-value 
of 0.0245 will be used to conclude the efficacy of the treatment arm. O'Brien-Fleming Alpha 
Spending Function was used to calculate the efficacy boundary and the resulting alpha levels for 
the interim analysis and the final analysis.  
10.9 Sample Size Calculation 
The primary endpoint event rate for the treatment arm is assumed at 97 % and for the placebo 
arm is assumed at 91%.  
The sample size was calculated using EAST v6.5 for a group sequential test for 2 proportions. 
With a total of 668 subjects the study will have 90% power at a one-sided 0.025 significance 
level of the hospitalization or death rate using a Chi-square test with one interim analysis at 50% 
of the information (when 334 subjects have been observed for 28 days). 
 


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11. ETHICAL CONSIDERATIONS AND ADMINISTRATIVE 
PROCEDURES 
11.1 Regulatory and Ethical Compliance 
This study will be conducted in accordance with the protocol and with the following: 
• 
Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical Sciences 
(CIOMS) International Ethical Guidelines. 
• 
Applicable International Council for Harmonization (ICH) Good Clinical Practice (GCP) 
Guidelines, and  
• 
Applicable laws and regulations.  
The protocol, protocol amendments, ICF, Investigator Brochure, and other relevant documents 
(e.g., advertisements) must be submitted to an IRB/IEC by the investigator and reviewed and 
approved by the IRB/IEC before the study is initiated. 
Any amendments to the protocol will require IRB/IEC approval before implementation of changes 
made to the study design, except for changes necessary to eliminate an immediate hazard to study 
subjects. 
The investigator will be responsible for the following: 
• 
Providing written summaries of the status of the study to the IRB/IEC annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB/IEC. 
• 
Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures, and 
• 
Providing oversight of the conduct of the study at the site and adherence to requirements 
of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 536/2014 for clinical 
studies (if applicable), and all other applicable local regulations. 
Investigator sites are compensated for participation in the study as detailed in the clinical study 
agreement. 
11.2 Responsibilities of the Investigator and IRB/IEC/REB 
All subject data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the Sponsor or designee electronically (e.g., laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or electronically 
signing the CRF. 
The investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory 
agency inspections and provide direct access to source data documents. 
 


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11.3 Informed Consent Procedures 
For each study subject, written informed consent will be obtained prior to any protocol-related 
activities. As part of this procedure, the Principal Investigator or one of his/her associates must 
explain orally and in writing the nature, duration, and purpose of the study, and the action of the 
drug in such a manner that the subject is aware of the potential risks, inconveniences, or adverse 
effects that may occur. The subject should be informed that he/she may withdraw from the study 
at any time, and the subject will receive all information that is required by local regulations and 
ICH guidelines. The investigator will provide the Sponsor or its representative with a copy of the 
IRB/IEC-approved ICF prior to the start of the study. 
Should changes to the Informed Consent form become necessary during the study, the investigator 
will ensure that the changes are approved by the Sponsor or its representative prior to submission 
to the IRB. All revisions of the protocol must be reflected in the ICF, if applicable, and reviewed 
by the IRB. Subjects must be made aware of those applicable changes in the protocol and must 
consent to participate in the revised protocol. 
11.4 Discontinuation of the Study 
Discontinuation of specific sites or of the study as a whole are handled as part of regulatory, ethical, 
and study oversight considerations. In rare instances, it may be necessary for a subject to 
permanently discontinue (definitive discontinuation) study intervention. 
11.5 Publication of Study Protocol and Results 
Both the use of data and the publication policy are detailed within the clinical study agreement. 
Intellectual property rights (and related matters) generated by the Investigator and others 
performing the clinical study will be subject to the terms of a clinical study agreement that will be 
agreed between the Institution and the Sponsor or their designee. With respect to such rights, the 
Sponsor or its designee will solely own all rights and interests in any materials, data, and 
intellectual property rights developed by Investigators and others performing the clinical study 
described in this protocol, subject to the terms of any such agreement. In order to facilitate such 
ownership, Investigators will be required to assign all such inventions either to their Institution or 
directly to the Sponsor or its designee, as will be set forth in the clinical study agreement. 
 
 


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11.6 Study Documentation, Record Keeping and Retention of Documents 
The Investigator must maintain all study documentation as confidential and take measures to 
prevent accidental or premature destruction of these documents. 
The Investigator must retain the study documents at least 2 years after the last approval of a 
marketing application/new drug application for the indication investigated or at least 2 years have 
elapsed since the formal discontinuation of clinical development of the investigational product 
(e.g., the Investigational New Drug application is withdrawn). These documents should be retained 
for a longer period, however, if required by the applicable regulatory requirements or by an 
agreement with Suzhou Kintor Pharmaceuticals, Inc. 
The Investigator must notify Suzhou Kintor Pharmaceuticals, Inc. prior to destroying any study 
essential documents. 
If the Investigator can no longer ensure archiving, he/she shall inform Suzhou Kintor 
Pharmaceuticals, Inc. The relevant records shall be transferred to a mutually agreed upon designee. 
11.7 Source Documents 
Source documents provide evidence for the existence of the subject and substantiate the integrity 
of the data collected. Source documents are filed at the Investigator’s site. 
Data reported in the eCRF that are transcribed from source documents must be consistent with the 
source documents or the discrepancies must be explained. The Investigator may need to request 
previous medical records or transfer records, depending on the study. Also, current medical records 
must be available. 
The Investigator must maintain accurate documentation (source data) that supports the information 
entered in the eCRF. 
Study monitors will perform ongoing source data verification to confirm that data entered into the 
eCRF by authorized site personnel are accurate, complete, and verifiable from source documents; 
that the safety and rights of participants are being protected; and that the study is being conducted 
in accordance with the currently approved protocol and any other study agreements, ICH GCP, 
and all applicable regulatory requirements. 
11.8 Confidentiality of Study Documents and Subject Records  
All communications, reports, and subject samples will be identified by site number, and a code 
number and/or initials to maintain subject confidentiality. All records will be kept confidential to 
the extent permitted by law. If a waiver or authorization separate from the statement in the 
Informed Consent is required for permitting access to a subject’s medical records (e.g. HIPAA), 
the Investigator will obtain such authorization prior to enrolling a subject in the study. The 
investigator should keep a separate log of subjects, codes, names, and addresses. Documents which 
identify the subject by name (for example, the ICF) should be kept in strict confidence. 
The Sponsor and its business associates agree to keep all subject information confidential. Data 
resulting from analyses will be entered into a database that is not accessible to the public. Subject 
data will be identified only by the subject screen number, randomization number and initials, and 
not by any other annotation or identifying information.  


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The Sponsor and its business associates will take every possible step to reduce the risk of releasing 
information to the public that would enable subjects to be personally identified.  
11.9 Audits and Inspections 
Suzhou Kintor Pharmaceuticals, Inc.’s Quality Assurance Unit (or representative) may conduct 
audits at the study site(s). Audits will include, but are not limited to: drug supply, presence of 
required documents, the informed consent process, laboratory specimen processing, and 
comparison of CRFs with source documents. The Investigator agrees to cooperate with audits 
conducted at a reasonable time and in a reasonable manner. 
Regulatory authorities worldwide may also audit the Investigator during or after the study. The 
Investigator should contact Suzhou Kintor Pharmaceuticals, Inc. immediately if this occurs, and 
must fully cooperate with the audits conducted at a reasonable time in a reasonable manner. 
The Investigator is required to make all study documentation promptly available for inspection, 
review or audit at the study site upon request by Sponsor, its representatives, or any appropriate 
regulatory agencies. 
11.10 Financial Disclosures 
Prior to the study commencing, the Sponsor (or its designee) and the Investigator (or the institution, 
as applicable) will agree on costs necessary to perform the study. This agreement will be 
documented in a financial agreement that will be signed by the Investigator (or the institution 
signatory) and the Sponsor (or its designee).  
The Investigator is required to have adequate current insurance to cover claims for negligence 
and/or malpractice. The Sponsor will provide insurance coverage for the clinical study as required 
by national regulations. 
 


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12. PROTOCOL ADHERENCE  
The Investigator will not make any changes to this protocol without prior written consent from the 
Sponsor Suzhou Kintor Pharmaceuticals, Inc. and subsequent approval by the IRB/IEC. Any 
permanent change to the protocol, whether it is an overall change or a change for specific study 
center(s), must be handled as a protocol amendment. Any amendment to the protocol that appears 
necessary as the study progresses will be fully discussed by the Investigator(s) and Suzhou Kintor 
Pharmaceuticals, Inc. If agreement is reached regarding the need for an amendment, it will be 
written by Suzhou Kintor Pharmaceuticals, Inc. The written amendment must be submitted to the 
chairman of the IRB/IEC identified with this responsibility. Except for administrative amendments, 
Investigators must await IRB/IEC approval of protocol amendments before implementing the 
change(s). 
Administrative amendments are defined as having no effect on the safety of the research subjects, 
scope of the investigation, or quality of the study. However, a protocol change intended to 
eliminate an apparent immediate hazard to subjects should be implemented immediately, and the 
IRB/IEC notified within 5 days. Suzhou Kintor Pharmaceuticals, Inc. will ensure submission of 
any protocol amendments to the appropriate regulatory agencies. 
When, in the judgment of the chairman of the local IRB/IEC, the Investigators, and/or Suzhou 
Kintor Pharmaceuticals, Inc., the amendment to the protocol substantially alters the study design 
and/or increases the potential risk to the subject; the currently approved written ICF will require 
similar modification. In such cases, the Investigator will obtain repeat informed consent from 
subjects enrolled in the study before expecting continued participation.  
 
 
 
 
 


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13. REFERENCES 
Hoffmann M, Kleine-Weber H, Schroeder S, Krüger N, Herrier T, Erichsen S, Schiergens TS, 
Herrler G, Wu NH, Nitsche A, Müller M, Drosten C, Pöhlmann, S. n.d.  
C., Jennison, and B. W. Turnbull. 2000. Group Sequential Methods with Applications to Clinical 
Trials.  
Damien A. Leach, Ana-Maria Isac, Charlotte L. Bevan, Greg N. Brooke. 2020. "TMPRSS2, 
required for SARS-CoV-2 entry, is downregulated in lung cells by enzalutamide, a prostate 
cancer therapeutic." research square.  
2017. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse 
Events. July. https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf. 
LAN, K. K. GORDON, and DAVID L. DEMETS. 1983. "Discrete Sequential Boundaries for 
Clinical Trials." Source: Biometrika 659-663. 
Maria Schroeder, Berfin Tuku, Dominik Jarczak,. 2020. "The majority of male patients with 
COVID-19 present low testosterone levels on admission to Intensive Care in Hamburg, 
Germany: a retrospective cohort study." medRxiv.  
Markus Hoffmann, Hannah Kleine-Weber, Simon Schroeder, Marcel A. Müller. 2020. "SARS -
CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven 
Protease Inhibitor." Cell 271-280. 
Reboussin, D.M., D.L. DeMets, K Kim, and K.K.G and Lan. 2000. "Computations for Group 
Sequential Boundaries Using the Lan-DeMets Spending Function Method." Controlled 
Clinical Trials 190-207. 
Tie Zhoua, Weidong Xua, Wei Zhang, Ye Sun, Hong hua Yan, Xu Gao,. 2020. "Preclinical profile 
and phase I clinical trial of a novel androgen receptor antagonist GT0918 in castration-
resistant prostate cancer." European Journal of Cancer 29-40. 
Wei-Jie Guan, Zheng-Yi Ni, Yu Hu, Wen-Hua Liang. 2020. "Clinical Characteristics of 
Coronavirus Disease 2019 in China. ." The new england journal o f medicine 1708-1720. 
Youzhi Tong, Chunyun Chen, Juan Wu, Jiangtao Yang, Huihui Zhang. 2014. "Proxalutamide 
(GT0918), a potent androgen receptor pathway inhibitor." AACR Annual Meeting 2014. 
San Diego, USA, CA. 
Yuanyuan Qiaoa, Xiao-Ming Wanga. 2021. "Targeting transcriptional regulation of SARS-CoV-
2 
entry 
factors 
ACE2 
and 
TMPRSS2." 
PNAS. 
https://www.pnas.org/content/118/1/e2021450118. 


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14.APPENDICES 
Appendix 1. Drugs that Should Be Used Cautiously with GT0918 
 
  
Strong Inhibitors 
Moderate Inhibitors 
Weak Inhibitors 
CYP3A4 
boceprevir, 
cobicistat(h), danoprevir and 
ritonavir(j), elvitegravir and 
ritonavir(j), grapefruit 
juice(k), indinavir and 
ritonavir(j), itraconazole(h), 
ketoconazole, lopinavir and 
ritonavir(h,j), paritaprevir 
and ritonavir and (ombitasvir 
and/or dasabuvir)(j), 
posaconazole, ritonavir(h,j), 
saquinavir and ritonavir(h,j), 
telaprevir(h), tipranavir and 
ritonavir(h,j), 
telithromycin, troleandomyci
n, voriconazole 
aprepitant, ciprofloxacin, co
nivaptan(l), crizotinib, 
cyclosporine, diltiazem(m), 
dronedarone(h), 
erythromycin, 
fluconazole(f), 
fluvoxamine(a), imatinib, 
tofisopam, verapamil(h) 
chlorzoxazone, 
cilostazol, cimetidine, 
clotrimazole, 
fosaprepitant, 
istradefylline, 
ivacaftor(h), 
lomitapide, 
ranitidine, 
ranolazine(h), ticagrel
or(h) 
  
clarithromycin(h), idelalisib, 
nefazodone, nelfinavir(h) 
 - 
 - 
CYP2C8 
gemfibrozil(e) 
clopidogrel(b), deferasirox, 
teriflunomide 
trimethoprim 
  
Strong Inducers 
Moderate Inducers 
Weak Inducers 
CYP3A 
apalutamide, 
carbamazepine(e), 
enzalutamide(g), mitotane, 
phenytoin(b), rifampin(a), 
St. John’s wort(h) 
bosentan, efavirenz(f), 
etravirine, phenobarbital, 
primidone 
armodafinil, 
modafinil(i), 
rufinamide 
CYP2C8 
- 
rifampin(a) 
- 
 
 


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Sensitive Substrates 
Moderate Sensitive Substrates 
CYP2D6 
atomoxetine, desipramine, 
dextromethorphan, eliglustat(e), 
nebivolol, nortriptyline, 
perphenazine, tolterodine, R-
venlafaxine 
encainide, 
imipramine, 
metoprolol, 
propafenone, propranolol, tramadol, 
trimipramine, S-venlafaxine 
CYP2C8 
repaglinide(b) 
montelukast, pioglitazone, 
rosiglitazone 
CYP2C9 
celecoxib(c) 
glimepiride, phenytoin, tolbutamide, 
warfarin 
CYP2C19 
S-mephenytoin, omeprazole 
diazepam, lansoprazole(d), 
rabeprazole, voriconazole 
CYP3A4 
alfentanil, avanafil, buspirone, 
conivaptan, darifenacin, 
darunavir(f), ebastine, 
everolimus, ibrutinib, lomitapide, 
lovastatin(g), midazolam, 
naloxegol, nisoldipine, 
saquinavir(f), simvastatin(g), 
sirolimus, tacrolimus, 
tipranavir(f), triazolam, vardenafil 
alprazolam, aprepitant, atorvastatin(c), 
colchicine, eliglustat(e), pimozide, 
rilpivirine, rivaroxaban, tadalafil 
  
budesonide, dasatinib, 
dronedarone, eletriptan, 
eplerenone, felodipine, 
indinavir(f), lurasidone, 
maraviroc, quetiapine, sildenafil, 
ticagrelor, tolvaptan 
  
 
 
 


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Appendix 2. Common COVID-19-Related Symptoms  
Example of an Assessment of 14 Common COVID-19-Related Symptoms: Items and Response 
Options 
Example items 
For items 1–10, sample item wording could be: “What 
was the severity of your [insert symptom] at its worst 
over the last 24 hours?” 
Example response options 
and scoring** 
1. Stuffy or runny nose 
None = 0 
Mild = 1 
Moderate = 2 
Severe = 3 
2. Sore throat 
3. Shortness of breath (difficulty breathing) 
4. Cough 
5. Low energy or tiredness 
6. Muscle or body aches 
7. Headache 
8. Chills or shivering 
9. Feeling hot or feverish 
10. Nausea (feeling like you wanted to throw up) 
11. How many times did you vomit (throw up) in the last 
24 hours? * 
I did not vomit at all = 0 
1–2 times = 1 
3–4 times = 2 
5 or more times = 3 
12. How many times did you have diarrhea (loose or 
watery stools) in the last 24 hours? * 
I did not have diarrhea at all = 0 
1–2 times = 1 
3–4 times = 2 
5 or more times = 3 
13. Rate your sense of smell in the last 24 hours 
My sense of smell is THE 
SAME AS usual = 0 
My sense of smell is LESS 
THAN usual = 1 
I have NO sense of smell = 2 


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14. Rate your sense of taste in the last 24 hours 
My sense of taste is THE SAME 
AS usual = 0 
My sense of taste is LESS 
THAN usual = 1 
I have NO sense of taste = 2 
*Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of 
Drugs and Biological Products for COVID-19 Prevention or Treatment 
Guidance for Industry 
** The response options shown for items 11 and 12 are intended only for use with a 24-hour recall period. 
 
Reference to Appendix 5, each symptom will be scored daily by the subject as experienced 
during the past 24 hours. Also, subject will record the change of overall health and clinical 
outcomes as below.  
o In the past 24 hours, have you returned to your usual health (before your COVID-
19 illness)? Yes or No  
o In the past 24 hours, have you returned to your usual activities (before your 
COVID-19 illness)? Yes or No  
o In the past 24 hours, what was the severity of your overall COVID-19-related 
symptoms at their worst? None, Mild, Moderate, or Severe 
o In the past 24 hours, have you been hospitalized? Yes, No 
o In the past 24 hours, have you required home oxygen? Yes, No 
o In the past 24 hours, have you had any limitation on activities? Yes, No 
 
 
 
 
 
 
 
 
 
 


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Appendix 3 COVID-19: BASELINE SEVERITY CATEGORIZATION (Developing Drugs 
and Biological Products for Treatment or Prevention Guidance for Industry ) 
SARS-CoV-2 infection without symptoms  
• Positive testing by standard reverse transcription polymerase chain reaction (RT-PCR) assay or 
equivalent test  
• No symptoms  
Mild COVID-19  
• Positive testing by standard RT-PCR assay or equivalent test  
• Symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, 
headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea  
• No clinical signs indicative of Moderate, Severe, or Critical Severity  
Moderate COVID-19  
• Positive testing by standard RT-PCR assay or equivalent testing  
• Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness 
or shortness of breath with exertion  
• Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 
breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 
beats per minute  
• No clinical signs indicative of Severe or Critical Illness Severity  
Severe COVID-19  
• Positive testing by standard RT-PCR assay or an equivalent test  
• Symptoms suggestive of severe systemic illness with COVID-19, which could include any 
symptom of moderate illness or shortness of breath at rest, or respiratory distress  
• Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥ 30 
per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 
300  
• No criteria for Critical Severity 
Critical COVID-19  
• Positive testing by standard RT-PCR assay or equivalent test  
• Evidence of critical illness, defined by at least one of the following:  


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- Respiratory failure defined based on resource utilization requiring at least one of the 
following:  
o Endotracheal intubation and mechanical ventilation, oxygen delivered by high- flow 
nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at 
flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive 
pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (i.e., clinical 
need for one of the preceding therapies, but preceding therapies not able to be 
administered in setting of resource limitation)  
- Shock (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 
mm Hg or requiring vasopressors)  
- Multi-organ dysfunction/failure  
NOTE: A clinical diagnosis of respiratory failure (in the setting of resource limitation) in which 
the management deviates from standard of care should be recorded as part of formal data collection. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix 4 Clinical Laboratory Parameters Collection Plan 
Test category  
Local/Central 
Test Name 
Hematology 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Local 
Hemoglobin 
Hematocrit 
Erythrocyte count (RBCs - Red Blood Cells) 
Leukocytes (WBCs - White Blood Cells) 
Differential 
Neutrophils, segmented 
Lymphocytes 
Monocytes 
Eosinophils 
Basophils 
Platelets 
 
  
 
Clinical Chemistry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
Local 
 
Sodium 
Potassium 
Chloride 
Bicarbonate 
Total bilirubin 
Direct bilirubin 
Alkaline phosphatase (ALP) 
Alanine aminotransferase (ALT) 
Aspartate aminotransferase (AST) 
Gamma-glutamyl transferase (GGT) 
Blood urea nitrogen (BUN) 
Creatinine 
Creatine kinase (CK) 
Uric acid 
Total protein 
Albumin 
Calcium 
Phosphorus 
Glucose 
Amylase 
Lipase 
Lactate dehydrogenase (LDH) 


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Coagulation  
 
 
 
Local 
International normalized ratio (INR), 
activated partial thromboplastin time(aPTT) 
Additional tests 
 
 
 
 
 
 
 
 
Local/Central* 
C-reactive protein (CRP); high-sensitivity 
Ferritin 
D-dimer 
Procalcitonin 
Troponin(preferably Troponin I)  
 
Virology  
 
 
 
Central 
SARS-CoV-2 viral infection determination at 
screening-local 
SARS-CoV-2 viral load test (quantitative RT-
PCR)—central 
Pharmacokinetic Analyses 
 
 
 
Central 
Analyzed using validated LC-MS/MS methods 
with a LLOQ of approximately 5.00 ng/mL for 
GT0918 
Hormones(Male &Female) 
 
 
Central 
Testosterone 
 
Hormones(Female) 
 
 
Local  
Serum Pregnancy  
Urine Pregnancy 
* Central laboratories will be used when it can’t be tested on local laboratory. 
 
 
 
 
 
 
 


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Appendix 5. Subject Questionnaire  
1. What was the severity of your stuffy or runny nose at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
 
2. What was the severity of your sore throat at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
 
3. What was the severity of your shortness of breath (difficulty breathing) at its worst over the last 
24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
 
4. What was the severity of your cough at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
 
5. What was the severity of your Low energy or tiredness at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
 
 
6. What was the severity of your muscle or body aches at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
 
7. What was the severity of your headache at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
 
 
8. What was the severity of your chills or shivering at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
 
 
9. What was the severity of your feeling hot or feverish at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
 


  Suzhou Kintor Pharmaceuticals, Inc.                           Protocol # GT0918-US-3001                      Confidential   
 
90 
 
10. What was the severity of your Nausea (feeling like you wanted to throw up) at its worst over the 
last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
 
11. How many times did you vomit (throw up) in the last 24 hours? 
I did not vomit at all 
=0 
1-2 times 
=1 
3-4 times 
=2 
5 or more times 
=3 
 
12. How many times did you have diarrhea (loose or watery stools) in the last 24 hours? 
I did not have 
diarrhea at all 
=0 
1-2 times 
=1 
3-4 times 
=2 
5 or more times 
=3 
 
13. Rate your sense of smell in the last 24 hours: 
My sense of smell is 
THE SAME AS 
usual=0 
My sense of smell is 
LESS THAN usual 
=1 
I nave NO sense of 
smell 
=2 
 
14. Rate your sense of taste in the last 24 hours: 
My sense of taste is 
THE SAME AS 
usual=0 
My sense of taste is 
LESS THAN usual 
=1 
I have NO sense of 
taste 
=2 
 
 
Overall Covid-19-related Symptoms 
1. Overall, how bad are your symptoms TODAY (check one)? 
 
 
 
2. 
Overall, how is your general physical health today? 
 
 
 
3. 
Have you returned to your usual physical health (before your COVID-19 illness) (check one)? 
 
 
4. 
Have you returned to your usual activities (before your COVID-19 illness) (check one)? 
 
 
 
No 
symptoms 
☐ 
Mild 
☐ 
Moderate 
☐ 
Severe 
☐ 
Poor 
☐ 
Fair 
☐ 
Good 
☐ 
Excellent 
☐ 
Yes 
☐ 
No 
☐ 
Yes 
☐ 
No 
☐ 


  Suzhou Kintor Pharmaceuticals, Inc.                           Protocol # GT0918-US-3001                      Confidential   
 
91 
 
NIAID Daily Questions 
1. In the past 24 hours, have you been hospitalized?  
 
 
 
2. In the past 24 hours, have you required home oxygen?  
 
 
 
3. In the past 24 hours, have you had any limitation on your activities? 
 
 
Yes 
☐ 
No 
☐ 
Yes 
☐ 
No 
☐ 
Yes 
☐ 
No 
☐ 

SAP_001.pdf: 
Parexel International 
Suzhou Kintor Pharmaceuticals, Inc. 
GT0918-US-3001 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  11 Mar 22 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 1 of 55 
 
Parexel International 
Suzhou Kintor Pharmaceuticals, Inc. 
GT0918-US-3001 
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety 
of Proxalutamide (GT0918) in Outpatients with Mild to Moderate COVID-19 Illness 
 Statistical Analysis Plan 
Version: 2.0 
Parexel Project Number: 261488 
 
 


Parexel International 
Suzhou Kintor Pharmaceuticals, Inc. 
GT0918-US-3001 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  11 Mar 22 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 2 of 55 
SPONSOR SIGNATURE PAGE 
Signature(s) below confirm that the Statistical Analysis Plan was developed in accordance with 
SOP-GDO-WW-019 and that it is approved for release. 
 
This document has been approved and signed electronically on the final page by the 
following: 
 
 
 
 
Signatory 
Approver 
Xunwei Dong 
Project Role: Chief Medical Officer, Suzhou Kintor Pharmaceuticals, Inc. 
Approver 
Ran He 
Project Role: Vice President Biostatistics, Suzhou Kintor Pharmaceuticals, Inc. 


Parexel International 
Suzhou Kintor Pharmaceuticals, Inc. 
GT0918-US-3001 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  11 Mar 22 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 3 of 55 
 
Parexel SIGNATURE PAGE 
Signature(s) below confirm that the Statistical Analysis Plan was developed in accordance with SOP-
GDO-WW-019 and that it is approved for release. 
This document has been approved and signed electronically on the final page by the following:  
 
 
Signatory 
Author 
Cralen Davis 
Project Role: Biostatistics Lead  


Parexel International 
Suzhou Kintor Pharmaceuticals, Inc. 
GT0918-US-3001 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  11 Mar 22 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 4 of 55 
TABLE OF CONTENTS 
 
1 
INTRODUCTION ...................................................................................................................... 12 
2 
STUDY OBJECTIVES .............................................................................................................. 12 
2.1 
Primary ................................................................................................................................... 12 
2.2 
Secondary ............................................................................................................................... 12 
2.3 
Exploratory ............................................................................................................................. 12 
3 
INVESTIGATIONAL PLAN .................................................................................................... 12 
3.1 
Overall Study Design and Plan .............................................................................................. 12 
3.2 
Planned Interim Analysis ....................................................................................................... 14 
3.3 
Endpoints ................................................................................................................................ 14 
3.3.1 
Primary ................................................................................................................................. 14 
3.3.2 
Secondary ............................................................................................................................. 15 
3.3.3 
Exploratory .......................................................................................................................... 16 
4 
STATISTICAL METHODS ...................................................................................................... 16 
4.1 
Data Quality Assurance .......................................................................................................... 16 
4.2 
General Presentation Considerations ..................................................................................... 16 
4.3 
Software ................................................................................................................................. 18 
4.4 
Study Subjects ........................................................................................................................ 18 
4.4.1 
Disposition of Subjects ........................................................................................................ 18 
4.4.2 
Protocol Deviations .............................................................................................................. 18 
4.5 
Analysis Sets .......................................................................................................................... 18 
4.6 
Demographic and Other Baseline Characteristics .................................................................. 19 
4.7 
Concomitant Medication ........................................................................................................ 21 
4.8 
Prior and Concomitant Procedures ......................................................................................... 21 
4.9 
Treatment Compliance ........................................................................................................... 22 
4.10 
Efficacy Evaluation ................................................................................................................ 22 
4.10.1 
Analysis and Data Conventions ........................................................................................... 22 
4.10.1.1 Handling of Dropouts or Missing Data ............................................................................. 22 
4.10.1.1.1 Handling for Primary Endpoints .................................................................................... 22 
4.10.1.1.2 Imputation of Partial Dates ............................................................................................. 22 
4.10.1.1.3 Changes in missing data handling from the protocol ..................................................... 23 
4.10.1.2 Multiple Comparisons/Multiplicity ................................................................................... 24 
4.10.1.3 Examination of Subgroups ................................................................................................ 24 
4.10.2 
Primary Efficacy Variables .................................................................................................. 24 
4.10.3 
Secondary Efficacy Variables .............................................................................................. 27 
4.11 
Safety Evaluation ................................................................................................................... 33 
4.11.1 
Extent of Exposure ............................................................................................................... 33 
4.11.2 
Adverse Events .................................................................................................................... 34 
4.11.3 
Deaths, Serious Adverse Events, and Other Significant Adverse Events ........................... 35 
4.11.4 
Clinical Laboratory Evaluation ............................................................................................ 36 
4.11.4.1 Hematology, Clinical Chemistry, and Coagulation ........................................................... 37 
4.11.4.2 Biomarkers ........................................................................................................................ 37 


Parexel International 
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GT0918-US-3001 
Statistical Analysis Plan 
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4.11.4.3 Pharmacokinetics ............................................................................................................... 37 
4.11.5 
Vital Signs, Physical Findings and Other Observations Related to Safety ......................... 38 
4.11.6 
Independent Data Monitoring Committee (IDMC) ............................................................. 39 
4.12 
Determination of Sample Size................................................................................................ 39 
5 
REFERENCES ........................................................................................................................... 40 
6 
APPENDICES ............................................................................................................................ 41 
6.1 
Schedule of Assessments (SoA) ............................................................................................. 41 
6.2 
NIAID 8-Point Ordinal Scale ................................................................................................. 44 
6.3 
Clinical Laboratory Parameters .............................................................................................. 45 
6.4 
Subject Questionnaire ............................................................................................................ 47 
6.5 
Adverse Events of Special Interest (AESI) ............................................................................ 49 
 
 
 


Parexel International 
Suzhou Kintor Pharmaceuticals, Inc. 
GT0918-US-3001 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  11 Mar 22 
Project Document Effective Date: Date of last signature 
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Page 6 of 55 
REVISION HISTORY 
 
Version 
No. 
Effective 
Date 
Summary of Change(s) 
1.0 
23 Sep 2021 
New document 
1.9 
11 Mar 2022 
• Correction of typographic errors. 
• Decimal places for p-value. 
• Lab DAIDS toxicity grade for aPTT. 
• Added more details for SARS-CoV-2 viral load. 
• Subjects with missing primary assessments will be treated as 
meeting the primary endpoint. 
• Removed sensitivity analysis of the primary endpoint using 
multiple imputation. 
• Removed sensitivity analysis of primary endpoint using 
generalized linear mixed effects model. 
• Added the following sensitivity analysis of primary endpoints: 
o Among subjects with doing days >7 days; 
o Removing the constraint of ≥24 hours in hospitalization 
and supplemental oxygen use; 
o By treating missing primary assessments as hospitalization; 
o By treating missing primary assessments as hospitalization 
and among subjects with dosing days > 7 days. 
• Added sensitivity analysis for hospitalization percentage 
(defined in protocol section 10.5.2.1) among subset of mITT 
subjects: 
o With dosing days > 7 days; 
o With hospitalization or usage of supplemental oxygen 
irrespective of 24 hours;  
o With one or two major risk factors:  
o Single risk factor: age (≥ 50 years; ≥ 60 years), major 
underlying medical conditions (overweight, obesity, 
hypertension, diabetes, smoking) 
o Combination of age factor in column 1 and other major 
risk factors in column 2 in the table below (e.g., age ≥ 
50 years and/or obesity at randomization; aged ≥ 60 
years and/or obesity at randomization); 
Age 
Major underlying medical 
conditions 
≥ 50 years 
≥ 60 years 
Overweight  
Obesity 
Hypertension 
Diabetes 
Smoking 


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o With age ≥50 years and days from symptom onset to study 
randomization ≤5 days and/or days from the positive 
SARS-CoV-2 prior to first dosing ≤3 days 
With age ≥50 years and higher than normal biomarkers 
(CRP, Ferritin, D-dimer) 
• Regarding statistical analysis of viral load, more analyses were 
added, including two sample t-tests between treatment groups 
at Days 3, 7, 14, and 28; ANCOVA analysis of change in viral 
load from baseline at days 3 and 28; and MMRM modeling of 
change in viral load at day 3, 7, 14, and 28 from baseline. 
• Added sustained 100% viral reduction and associated statistical 
analyses of GEE, KM plots, log rank test and Cox regression 
models. 
• Added subgroup analysis of primary endpoints based on (1) 
Days from the Positive SARS-CoV-2 Prior to First Dosing; (2) 
Biomarker status at baseline; and (3) Common types of viral 
variants. 
• More details were added to the time-to-event analysis. 
• Updated statistical model for viral resistance. 
• Removed the following analyses 
o  Proportion of subjects admitted to an intensive care unit 
(ICU) due to COVID-19 by Day 28 
o Days in ICU due to all causes or COVID-19 by Day 28 
o Time to ICU by Day 28 
o Proportion of subjects requiring invasive mechanical 
ventilation or ECMO due to COVID-19 by Day 28 
o Days on supplemental oxygen/high flow oxygen devices/ 
invasive mechanical ventilation due to COVID-19 by Day 
28 
o Proportion of subjects with all-cause mortality by Day 28 
and Day 42 
o Proportion of subjects with COVID-19 related mortality by 
Day 28 and Day 42 
• Corrected “RT-PCR” as “ddPCR”. 
• Removed subgroup analysis of primary endpoint based on 
Concomitant medication of interest used. 
• Section 4.10.1.1.3 was added to justify the change in the SAP 
from the protocol. 
 
2.0 
14 Mar 2022 Finalized  
 
 
 


Parexel International 
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Project Document Version No. 2.0 
Effective Date:  11 Mar 22 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
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LIST OF ABBREVIATIONS 
Abbreviation / 
Acronym 
Definition / Expansion 
AACR 
American Association for Cancer Research 
ACE2 
Angiotensin Converting Enzyme 2 
ACVPU 
Alert, Consciousness, Verbal, Pain, Unresponsive Scale 
AE 
Adverse Event 
ALT 
Alanine Transaminase 
ANC 
Absolute Neutrophil Count 
aPTT 
Activated Partial Thromboplastin Time 
AR 
Androgen Receptor 
ARDS 
Acute Respiratory Distress Syndrome 
AST 
Aspartate Transaminase 
ATC 
Anatomical Therapeutic Chemical 
AUC 
Area under the Curve 
BID 
Twice a Day 
BP 
Blood Pressure 
BMI 
Body Mass Index 
CDC 
Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
CHO 
Chinese Hamster Ovary 
CI 
Confidence Interval 
CIOMS 
Council for International Organizations of Medical Sciences 
CK 
Creatinine kinase 
CLIA 
Clinical Laboratory Improvement Amendments 
CMH 
Cochran–Mantel–Haenszel 
CMP 
Clinical Monitoring Plan 
CMS 
Clinical Material Services 
CNS 
Central Nervous System 
Cr 
Creatinine 
CR 
Complete Response 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CROMS 
Clinical Research Operations and Management Support 
CRP 
C-reactive Protein 
CRPC 
Castrate Resistant Prostate Cancer 
COVID-19 
Coronavirus Disease 2019 
CQMP 
Clinical Quality Management Plan 


Parexel International 
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GT0918-US-3001 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
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Project Document Version No. 2.0 
Effective Date:  11 Mar 22 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
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Abbreviation / 
Acronym 
Definition / Expansion 
CSR 
Clinical Study Report 
DAIDS 
Division of Allergy and Infectious Diseases 
DCR 
Disease Control Rate 
ddPCR 
Droplet Digital Polymerase Chain Reaction 
DHHS 
Department of Health and Human Services 
DMC 
Data Monitoring Committee 
DMID 
Division of Microbiology and Infectious Diseases 
DLT 
Dose Limiting Toxicity 
DMP 
Data Management Plan 
EC 
Ethics Committee 
ECOM 
Extracorporeal Membrane Oxygenation 
EOS 
End of Study 
EUA 
Emergency Use Authorization 
FDA 
Food and Drug Administration 
FiO2 
Fraction of Inspired Oxygen in the Air 
FWA 
Federal Wide Assurance 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
hEGR 
Human Ether-a-go-go-related Gene 
Hgb 
Hemoglobin 
HR 
Heart Rate 
IB 
Investigator’s Brochure 
IC50 
A quantitative measure that indicates how much of a particular 
inhibitory substance (e.g., drug) is needed to inhibit, in vitro, a given 
biological process or biological component by 50% 
ICD 
International Classification of Diseases 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonization 
ICU 
Intensive Care Unit 
IIT 
Institute Initiated Trial 
IND 
Investigational New Drug Application 
INR 
International Normalized Ratio 
iNOS 
Inducible Nitric Oxide Synthase 
IRB 
Institutional Review Board 
IV 
Intravenous 
IWRS 
Interactive Web Response System 
IxRS 
Interactive Web/Voice Response System 
LLOQ 
Lower Limit of Quantitation 
LNCaP 
Lymph Node Carcinoma of the Prostate 


Parexel International 
Suzhou Kintor Pharmaceuticals, Inc. 
GT0918-US-3001 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
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Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
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Abbreviation / 
Acronym 
Definition / Expansion 
MCG 
Microgram 
MedDRA 
Medical Dictionary for Regulatory Activities 
MERS 
Middle East Respiratory Syndrome 
MG 
Milligram 
MOP 
Manual of Procedures 
MTD 
Maximum Tolerated Dose 
N 
Number (typically refers to subjects) 
NDA 
New Drug Application 
NIAID 
National Institute of Allergy and Infectious Diseases 
NIH 
National Institutes of Health 
NP 
Nasopharyngeal 
NOAEL 
No Observed Adverse Effect Level 
NSAID 
nonsteroidal anti-inflammatory drug 
OHRP 
Office for Human Research Protections 
OP 
Oropharyngeal 
OTC 
Over-the Counter 
PCR 
Polymerase Chain Reaction 
PD 
Protocol Deviation 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PLT 
Platelet 
PP 
Per Protocol 
PR 
Partial Response 
PSA 
Prostate-Specific Antigen 
PT 
Prothrombin Time 
PTT 
Partial Thromboplastin Time 
QD 
Once A Day 
QT Interval 
Measured from the Beginning of the QRS Complex to the End of the T 
wave 
QTc 
Corrected Q-T Interval 
RNA 
Ribonucleic Acid 
RBC 
Red Blood Cell 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SARS 
Severe Acute Respiratory Syndrome 
SARS-CoV-2 
Severe Acute Respiratory Syndrome Coronavirus 2 
SC 
Steering Committee 
SD 
Stable Disease 
SDCC 
Statistical and Data Coordinating Center 


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GT0918-US-3001 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
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Related to:  SOP-GDO-WW-019 
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Abbreviation / 
Acronym 
Definition / Expansion 
SDSP 
Study Data Standardization Plan 
SMC 
Safety Monitoring Committee 
SNP 
Single Nucleotide Polymorphisms 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
SpO2 
Saturation of Peripheral Oxygen 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
T.Bili 
Total Bilirubin 
TEAE 
Treatment Emergent Adverse Events 
TMPRSS2 
Transmembrane Protease Serine 2 
TNF 
Tumor Necrosis Factor 
ULN 
Upper Limited Number 
UP 
Unanticipated Problem 
US 
United States 
WBC 
White Blood Cell 
WHO 
World Health Organization 


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Suzhou Kintor Pharmaceuticals, Inc. 
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1 
INTRODUCTION 
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the 
safety and efficacy of Proxalutamide (GT0918) in adult outpatients diagnosed with mild to moderate 
COVID-19.  
GT0918 will be administered to evaluate its effect in accelerating recovery following SARS-CoV-2 
infection, limiting spread into lung cells, improving the clinical outcome and reducing hospitalization 
in COVID-19 infected outpatients with mild or moderate symptoms. 
This Statistical Analysis Plan (SAP) provides a detailed description of the statistical methods and 
analyses to be carried out for the Clinical Study Report (CSR) in support for study GT0918-US-3001. 
The analyses described in this SAP are based upon the following study documents: 
• Study Protocol Amendment, Version 2.0 (Jul 08, 2021) 
• electronic Case Report Form (eCRF), Version 2.0 (Aug 13, 2021) 
 
2 
STUDY OBJECTIVES 
2.1 
Primary 
• The primary efficacy endpoint is the proportion of subjects who do not experience any of 
the following events due to all causes by Day 28: 
o 
Hospitalization for ≥ 24 hours  
o 
Supplemental oxygen for ≥24 hours in response to SpO2 ≤93%  
o 
Death 
2.2 
Secondary 
• To evaluate the efficacy of GT0918 compared to placebo in terms of hospitalization 
percentage  
• Characterize the effect of GT0918 compared to placebo on SARS-CoV-2 viral load 
• To evaluate the clinical efficacy of GT0918 compared to placebo using the NIAID 8- point 
scoring scale 
• Characterize the effect of GT0918 compared to placebo on symptom improvement or 
resolution 
• Characterize the effect of GT0918 compared to placebo on safety 
2.3 
Exploratory 
• Characterize the pharmacokinetics of GT0918 and its metabolite GT0955 
• Characterize emergence of viral resistance to GT0918 
• Explore biomarkers predictive of GT0918 safety, efficacy, and/or disease progression and 
COVID-19 clinical outcomes 
3 
INVESTIGATIONAL PLAN 
3.1 
Overall Study Design and Plan 
This is a randomized, placebo-controlled two-arm study with the objective to evaluate the efficacy 
and safety of GT0918 in outpatients with mild or moderate COVID-19 illness.  


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The population of subjects with mild to moderate COVID-19 illness will be chosen to evaluate if anti-
androgen therapy may effectively prevent progression to the severe form of COVID-19 illness by 
treating this population early in their disease course and prior to respiratory compromise and failure. 
The study is a multicenter trial that will be conducted in the United States (US) and other countries. 
Approximately 668 subjects will be randomized in a 1:1 ratio to either GT0918 or placebo. There 
will be an interim analysis after 334 subjects completing Day 28 after the first dose to allow early 
stopping for futility, efficacy, or safety. The blood samples for PK analysis need to be collected for 
at least 200 subjects, whom will also be randomized into the interventional treatment or placebo group 
with 1:1 ratio.  
Subjects will be randomized into 1 of 2 arms with 1:1 ratio, each will receive an interventional 
treatment/placebo. 
Randomization will be stratified by the following factors: 
• Sex: Male or Female 
• Race and ethnicity (non-Hispanic White or others /Hispanic or Latino /non-Hispanic Black) 
• Number 
of 
risk 
factors 
0, 
1-2, 
≥3 
(based 
on 
CDC 
defined 
conditions 
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-
conditions.html). Adults of any age with the following conditions are at increased risk of 
severe illness from the virus that causes COVID-19: 
o Age ≥ 65 years 
o Cancer 
o Chronic kidney disease 
o Chronic lung diseases, including COPD (chronic obstructive pulmonary disease), asthma 
(moderate to severe),interstitial lung disease, cystic fibrosis, and pulmonary hypertension 
o Dementia or other neurological conditions 
o Down Syndrome 
o Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies or 
hypertension 
o Immunocompromised state (weakened immune system) from solid organ transplant 
o Liver disease 
o Overweight and Obesity (body mass index [BMI] ≥25 kg/m2 ) 
o Sickle cell disease or thalassemia 
o Smoking, current or former 
o Diabetes Type 1 or 2 
o HIV infection 
o Solid organ or blood stem cell transplant 
o Stroke or cerebrovascular disease, which affects blood flow to the brain 
o Substance use disorders 
o Others per most updated list from CDC website as above 
GT0918 will be supplied as 100 mg tablets as individual patient supply packaged in blister. 
GT0918/placebo will be given orally once daily on Days 1-14 during the study period. Days 15-28 
will be the post-treatment period without dosing with GT0918/placebo. The safety follow-up will be 
up to 28 days after last dose making the overall duration of monitoring 42 days for each patient. 


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The study treatment period is shown as below. 
 
Figure 1: Overview of Study Period and Group Assignment 
 
3.2 
Planned Interim Analysis 
An interim analysis will be conducted when 334 subjects complete Day 28 after first dose. The 
objective of the interim analysis to assess safety, futility, efficacy, sample size adjustment as well as 
potential enrichment of the population to enroll a population at higher risk for an infection requiring 
hospitalization or oxygen support in case the observed rates for the primary endpoint in the control 
arm are lower than expected. An independent data monitoring committee (IDMC) will review the 
unblinded interim analysis report to assess the objectives of the interim analysis and provide 
recommendations about early study closure, change study population, or change study sample size. 
The futility criterion for the study will be based on the conditional power of the study being <10%.  
The efficacy criterion will be based on the one-sided p-value of the primary endpoint 
analysis as <0.0015. The boundary is estimated based on O’Brien and Fleming type 
alpha spending method. In this case the stopping boundary for efficacy is met and the 
study could be stopped for efficacy. Assuming there is no change in the study design regarding 
sample size modification, the one-sided p-value of <0.024 will be used for the final analysis to 
conclude the efficacy of the treatment group. 
The conditional power will be evaluated based on primary endpoint in the interim analysis. If the 
conditional power of the study at the time interim analysis is between 50% to 80% (promising zone 
approach), the sample size could be increased to a maximum of 1500 subjects based on the efficacy 
in the interim analysis for overall population. If the conditional power of the study is above 80% 
power and the stopping boundary for efficacy is not met, the sample size will not be changed. 
Rigorous steps will be taken (e.g., firewalls) where possible to minimize the information that can be 
inferred by observers. 
 
3.3 
Endpoints 
3.3.1 Primary 
• Percentage of subjects who do not experience any of the following events due to all causes by 
Day 28: 
o Hospitalization for ≥ 24 hours or 
o Supplemental oxygen for ≥ 24 hours in response to SpO2 ≤93% or 
o Death 


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3.3.2 Secondary 
Hospitalization Percentage   
• Percentage of subjects who experience any of the following events due to all causes by Day 
28: 
o Hospitalization for ≥ 24 hours or 
o Supplemental oxygen for ≥ 24 hours in response to SpO2 ≤93% or 
o Death 
 
Virologic Response   
• Change from baseline to Days 3, 7, 14 and 28 in SARS CoV-2 viral load 
• Proportions of subjects that achieve sustained 100% SARS-CoV-2 viral reduction at Days 3, 
7, 14 and 28 
• Time to sustained 100% SARS-CoV-2 viral reduction 
• Proportion of subjects that achieve SARS-CoV-2 clearance (Days 3, 7, 14 and 28) 
• Time to SARS-CoV-2 clearance 
• SARS-CoV-2 viral load area under the concentration-time curve (AUC) assessed to days 3, 
7, 14 and 28 
 
NIAID Ordinal Scale 
• Percentage of subjects achieving each clinical status at Days 3, 7, 14 and 28 as defined below 
based on The National Institute of Allergy and Infectious Diseases (NIAID) 8- point ordinal 
scale 
1 Death 
2 Hospitalized, on invasive mechanical ventilation or extracorporeal membrane 
oxygenation (ECMO) 
3 Hospitalized, on non-invasive ventilation or high flow oxygen devices 
4 Hospitalized, requiring supplemental oxygen 
5 Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care 
(COVID-19-related or other medical conditions preventing hospital discharge) 
6 Hospitalized, not requiring supplemental oxygen - no longer requires ongoing 
medical care 
7 Not hospitalized, limitation on activities and/or requiring home oxygen 
8 Not hospitalized, no limitations on activities 
 
• Proportion of subjects with all-cause hospitalization (defined as ≥ 24 hours) by Day 28 
• Proportion of subjects with COVID-19 related hospitalization (defined as ≥ 24 hours) by Day 
28 
• Days of hospitalization due to all causes or COVID-19 by Day 28 
• Time to hospitalization due to all causes or COVID-19 by Day 28 
 
• Proportion of subjects requiring supplemental oxygen, high-flow oxygen, any ventilation or 
ECMO due to COVID-19 by Day 28 
 
Symptom Questionnaire 
• Symptom Improvement: 
o Change in symptom score (total of ratings) from baseline to Days 3, 7, 14 and 28 
o Time to symptom improvement 


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o Proportion of subjects demonstrating symptom improvement via the symptom 
questionnaire (total of ratings) on Days 3, 7, 14 and 28 
• Symptom Resolution: 
o Proportion of subjects demonstrating symptom resolution via the symptom questionnaire 
on Days 3, 7, 14 and 28 
o Time to symptom resolution 
 
Safety 
• Safety assessments such as AEs, SAEs and laboratory data 
3.3.3 Exploratory 
• Mean trough concentration of GT0918 and its relevant metabolite GT0955 on Days 1, 3, 7 
and 14 
• To explore relationships between GT0918 and/or GT0955 exposure and selected efficacy and 
safety endpoints and/or biomarkers 
• Screening for novel mutants in subjects who do not respond to GT0918 
o Genotype of SARS-CoV-2 viral isolates 
• The association between changes in disease related biomarkers with clinical endpoints 
 
4 
STATISTICAL METHODS 
4.1 
Data Quality Assurance 
All tables, figures and data listings to be included in the report will be independently checked for 
consistency, integrity and in accordance with standard Parexel procedures. 
 
4.2 
General Presentation Considerations 
Baseline: the last available pre-treatment assessment, unless otherwise specified.  
For subjects who are screened, randomized, and undertake the first treatment on the same 
date, the self-reported symptom questionnaire and ordinal scale at Day 1 visit will be flagged 
as baseline if baseline assessment is missing.   
End of Study (EOS): all required phases of the study including the last scheduled procedure shown 
in the SoA have been completed.   
A subject is considered to have completed the study if he has completed all required phases of the 
study including the last scheduled procedure shown in the Schedule of Activities (SoA).  
The end of the study is defined as the date of last scheduled procedure shown in the SoA for the last 
enrolled subject or last ongoing subject in the study, whichever comes later. 
Study Day will be calculated relative to the date of dose administration i.e. Study Day = Assessment 
Date - First Dose Date + 1, if Assessment Date is on or after First Dose Date. Assessment Date - First 
Dose Date, if Assessment Date is before First Dose Date. 
If more than one laboratory value is available for a given study day, the last valid observation will be 
used in summaries, unless otherwise stated. If it is not possible to determine which is the last 
measurement due to missing times, then the average of all measurements for that study day will be 
used as the value for that study day. All observations will be presented in listings. 


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For subjects with duplicate self-reported symptom questionnaire or ordinal scale on the same day for 
the same visit, the record with the worst total score for questions 1 through 14 will be used for 
summary purpose. All records will be listed.  
Continuous data will be summarized in terms of the mean, standard deviation (SD), median, 
minimum, maximum, and number of observations, unless otherwise stated. Continuous data that are 
expected to be skewed will be presented in terms of the maximum, upper quartile, median, lower 
quartile, minimum and number of observations.  The minimum and maximum will be reported to the 
same number of decimal places as the raw data recorded in the database.  The mean, median, lower 
quartile and upper quartile will be reported to one more decimal place than the raw data recorded in 
the database.  The SD will be reported to two more decimal places than the raw data recorded in the 
database.  In general, the maximum number of decimal places reported shall be four for any summary 
statistic. 
Categorical data will be summarized in terms of the number of subjects providing data at the relevant 
time point (n), frequency counts and percentages. Any planned collapsing of categories will be 
detailed in the SAP text and the data displays.   
Percentages will be presented to one decimal place. Percentages will not be presented for zero counts.  
Percentages will be calculated using n as the denominator.  If sample sizes are small, the data displays 
will show the percentages, but any textual report will describe frequencies only.   
Changes from baseline in categorical data will be summarized using shift tables where appropriate. 
P-values greater than or equal to 0.0001, in general, will be presented to four decimal places.  P-
values less than 0.0001 will be presented as “<0.0001” and p-values greater than 0.9999 will be 
presented as “>0.9999”. 
Confidence intervals will be presented to one more decimal place than the raw data. 
 
Analysis Visit Window:  
For unscheduled visits, analysis visit windows will be applied as in Table  below. Analysis visit 
windows are only used for by visit summaries, not for time to event calculation which will based on 
actual date of data collected.  
 
Table 1 Analysis Visit Window for Unscheduled Visits of blood samples 
Mapped to 
Visit Window 
Screening 
[Day -1, Day 1] 
Day 3 
[Day 2, Day 4] 
Day 7 
[Day 6, Day 8] 
Day 14 
[Day 13, Day 15]  
Day 28 
[Day 26, Day 30]  
Day 42 
[Day 40, Day 44] 
 


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4.3 
Software 
All report outputs will be produced using SAS® version 9.4 [1] or a later version in a secure and 
validated environment.   
 
4.4 
Study Subjects 
4.4.1 Disposition of Subjects 
A clear accounting of the disposition of all subjects who enter the study will be provided, from 
screening to study completion. The disposition summary will include: 
• number of patients screened 
• number of patients screened failure 
• number of patients in each analysis sets 
• number of patients completed treatment 
• number and reason of patients withdrew early from the treatment 
• number of patients completed post-treatment 
• number of patients withdrew early from the post-treatment 
• number of patients completed study 
• number and reason of patients withdrew early from the study 
By-subject listings of eligibility details, randomization details, visit dates and withdrawal/study 
completion details (including reason for discontinuation and duration of treatment prior to 
discontinuation) will be provided. Disposition data will be listed and summarized for all enrolled 
population. 
 
4.4.2 Protocol Deviations 
Protocol deviations will be identified and classified into major or minor. Major protocol deviations 
are defined as those deviations from the protocol likely to have an impact on the perceived efficacy 
and/or safety of study treatments.   
Major protocol deviations and any action to be taken regarding the exclusion of subjects or affected 
data from specific analyses are defined in the project-specific Protocol Deviation Specification. The 
final determination of major protocol deviations and the exclusion of patients from any of the analysis 
populations will be made prior to database lock. 
A summary of the number and percentage of subjects with a major protocol deviation will be provided 
by treatment group and type of deviations using ITT set. A by-subject listing will be provided for all 
reported protocol deviations. 
 
4.5 
Analysis Sets 
The Intent-to-Treat Analysis Set (ITT) includes all randomized subjects. 
The Modified Intent-to-Treat Analysis Set (mITT) includes all randomized subjects who have 
received at least one dose of study medication. The primary efficacy analysis will be conducted on 
the mITT Analysis Set. 


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The Safety Analysis Set (SS) includes all subjects with at least one dose of study medication and 
will be analyzed as treated. The disposition, study summary, and safety analysis will be conducted 
on Safety Analysis Set. 
The Per-Protocol Analysis Set (PP) includes all mITT subjects without major protocol violations 
which will be defined under classification specification prior to unblinding of the study treatment 
code. 
The Pharmacokinetic Analyses (PK) will be conducted on data from at least 200 subjects who 
receive intervention and have evaluable PK. 
 
4.6 
Demographic and Other Baseline Characteristics 
Demographic and other baseline characteristics will be summarized by treatment group using the ITT 
set. The summaries provided will include the following: 
o Demography  
o Age in years, age group (<50 years; ≥ 50 years), age group (<60 years; ≥ 60 years), and 
age group (<65 years; ≥ 65 years) 
o Sex 
o Race 
o Ethnicity 
o Baseline height 
o Baseline weight 
o Baseline BMI  
o Baseline BMI categories as below 
▪ Underweight (<18.5) 
▪ Normal (≥18.5 and <25.0) 
▪ Overweight (≥25.0 and <30.0) 
▪ Obesity (≥30.0) 
- Obesity Class 1 (≥30.0 and < 35.0) 
- Obesity Class 2 (≥35.0 and < 40.0) 
- Obesity Class 3 (≥40.0) 
o Other Baseline Characteristics 
o Days from the positive SARS-CoV-2 prior to first dosing and test type 
o Days from onset of COVID-19 symptoms prior to first dosing 
o Prior COVID-19 therapy 
o Number of high-risk medical factors (0; 1-2; ≥3) 
o High-risk medical status by below categories 
▪ Age ≥ 65 years 
▪ Cancer 
▪ Chronic kidney disease 
▪ Chronic lung diseases 
- Chronic obstructive pulmonary disease 
- Asthma 
- Interstitial lung disease 
- Cystic fibrosis 
- Pulmonary hypertension 
▪ Dementia or other neurological conditions 
- Dementia 


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- Other 
▪ Down syndrome 
▪ Heart conditions 
- Heart failure 
- Coronary Artery Disease 
- Cardiomyopathies 
- Hypertension 
▪ Immunocompromised state (weakened immune system) from solid organ transplant 
▪ Liver disease  
▪ Overweight and Obesity (BMI ≥25 kg/m2) 
- Overweight (BMI ≥25.0 kg/m2 and <30.0 kg/ m2) 
- Obesity (BMI ≥30.0 kg/ m2 and <40.0 kg/ m2) 
- Sever Obesity (BMI ≥40.0 kg/ m2) 
▪ Sickle cell disease or Thalassemia 
- Sickle cell 
- Thalassemia 
▪ Smoking (current or former) 
- Current 
- Former 
▪ Diabetes (type 1 or type 2) 
- Type 1 
- Type 2 
▪ HIV infection 
▪ Solid organ or blood stem cell transplant 
- Solid organ transplant 
- Blood stem cell transplant 
▪ Stroke or cerebrovascular disease, which affects blood flow to the brain 
- Stroke 
- Cerebrovascular disease 
▪ Substance use disorders 
▪ Other 
o Medical history will be reported by system organ class (SOC) and preferred term (PT) as 
coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 24.0 or 
higher.  
o Medication allergy history will also be reported by SOC and PT separately. 
 
o Baseline patient reported COVID-19 symptom questionnaires will be summarized. 
 
Categorical data will be presented as frequencies and percentages. For continuous data, mean, 
standard deviation, median, 25th and 75th percentiles, minimum, and maximum will be presented. By-
subject listings of demographic data, other baseline characteristics (as summarized above), high-risk 
medical status, medical history and patient reported COVID-19 symptom questionnaires at baseline 
will be provided. 
 


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4.7 
Concomitant Medication 
All medications administered within 30 days prior to the first dose of study treatment through 28 days 
after the last dose of study treatment will be recorded in the concomitant medications. Medications 
will be coded using Anatomical Therapeutic Chemical (ATC) Classification codes by World Health 
Organization Drug Dictionary (WHO-DD-March 2021) or latest version. Prior and concomitant 
medications will be summarized by ATC class level II, and Preferred Term. 
Medication start and stop dates will be compared to the date of first dose of study medication to allow 
medications to be classified as either Prior only, both Prior and Concomitant, or Concomitant only.  
Medications starting after the completion/withdrawal date will be listed but will not be classified or 
summarized. 
Medications that start and stop prior to the date of first dose of study medication will be classified as 
Prior only. If a medication starts before the date of first dose of study medication and stops on or after 
the date of first dose of study medication, then the medication will be classified as both Prior and 
Concomitant.  Medications will be classified as Concomitant only if they have a start date on or after 
the date of first dose of study medication. 
If medication start and/or stop dates are missing or partial, the dates will be compared as far as 
possible with the date of first dose of study medication. Medications will be assumed to be 
Concomitant only, unless there is clear evidence (through comparison of partial dates) to suggest that 
the medication started prior to the first dose of study medication.  If there is clear evidence to suggest 
that the medication started prior to the first dose of study medication, the medication will be assumed 
to be both Prior and Concomitant, unless there is clear evidence to suggest that the medication stopped 
prior to the first dose of study medication. If there is clear evidence to suggest that the medication 
stopped prior to the first dose of study medication, the medication will be assumed to be Prior only. 
In the summary of prior and concomitant medications, each subject will be counted once within each 
unique term. For example, if a subject takes amoxycillin on 2 separate occasions, the subject is 
counted only once under the corresponding ATC class. 
Summaries and by-subject listings will be given for Safety set. The summary will group the 
medication by Prior only, Prior and Concomitant and Concomitant only. 
Standard of Care 
Subjects should be treated according to standard of care.  
Remdesivir may be initiated as standard of care for subjects hospitalized with severe disease. 
All medications administered as the local standard of care per written policies or guidelines (that is, 
not just an individual clinician decision) such as lopinavir/ritonavir, chloroquine, hydroxychloroquine 
or other investigational agents. will be summarized separately. 
 
4.8 
Prior and Concomitant Procedures 
Prior and concomitant non-drug therapies will be summarized by System Organ Class and Preferred 
Term using the Medical Dictionary for Regulatory Activities (MedDRA) Version 24.0 or higher ATC 
class level II, and Preferred Term for each treatment group and listed using Safety set. 
 


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4.9 
Treatment Compliance 
The compliance rate will be assessed as: Compliance Rate (%) = (cumulative dose [mg] / planned 
dose [mg]) * 100. 
Non-compliance is defined as taking less than 80% or more than 120% of study drug during any 
outpatient evaluation period (visit to visit). 
A summary of treatment compliance, including the number and percentage of compliant, and non-
compliant subjects, will be provided using Safety set. A by-subject listing of treatment compliance 
data will also be provided. 
 
4.10 Efficacy Evaluation 
4.10.1 Analysis and Data Conventions 
Primary Null Hypothesis H0: proportion of subjects who do not experience all-cause hospitalization 
(defined as ≥24 hours), do not require supplemental oxygen for ≥24h in response to SpO2≤93% and 
are alive by Day 28 in the GT0918 arm (p1) is equal to the proportion in the placebo arm (p2) 
Primary Alternative Hypothesis Ha: the proportion of subjects who do not experience all-cause 
hospitalization (defined as ≥24 hours), do not require supplemental oxygen for ≥24h in response to 
SpO2≤93% and are alive by Day 28 in GT0918 arm (p1) is greater than the proportion in the placebo 
arm 2 (p2) 
Mathematically written as: 
H0: p1 - p2= 0 
Ha: p1 - p2>0 
The primary endpoint event rate will be compared between treatment and placebo arm using 
Cochran–Mantel–Haenszel (CMH) Chi-square test using age and the stratification factors at time of 
randomization at the one-sided 0.025 level based on mITT set. P-values and 95% exact confidence 
intervals for the treatment difference will be presented. The actual alpha level used for the final 
analysis will take into account the adjustment required for the interim analysis.  
 
4.10.1.1 Handling of Dropouts or Missing Data 
4.10.1.1.1 Handling for Primary Endpoints 
No dropouts will be replaced. Every effort will be made to avoid missing data. The extra effort to 
contact all subjects specifically those who discontinued treatment early to assess the occurrence of 
any component of the primary endpoint, hospitalization, need for oxygen, or death by day 28 will 
minimize missing data for the primary endpoint. Subjects with missing primary assessments by day 
28 will be treated as meeting the primary endpoint (i.e., not experiencing hospitalization (≥ 24 hours) 
or using supplemental oxygen in response to SpO2 ≤93% (≥ 24 hours), or alive). Justification for 
missing primary endpoint handling is provided in Section 4.10.1.1.3. 
4.10.1.1.2 Imputation of Partial Dates 
Imputed dates will be used only to assign reported AEs and Medications to the different study periods: 
Screening Period, Treatment Period, Post-Treatment Period and Safety-Follow Up Period; for  


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determining the category for reported Medication as ‘PRIOR ONLY’, ‘PRIOR and 
CONCOMITANT’ or ‘CONCOMITANT ONLY’ and to determine if an AE is treatment emergent. 
Both observed and imputed dates will be included into the analysis datasets. Dates will be displayed 
in listings with only the information available in the database. 
Partial date imputation will follow ADaM conventions. The ADaM approach is to populate the 
numeric date variables with the imputed date and add a flag variable to the dataset that indicates the 
level of imputation.  
The flag variable can contain the values: blank, 'D', 'M', 'Y' with 
blank: indicates that no imputation was done, 
D = 'Day': indicates that the day portion of the date is imputed, 
M = 'Month': indicates that the month and day portions of the date are imputed, 
Y = 'Year': indicates that the entire date (year, month, and day) is imputed. 
Table 2 Partial Date Imputation Rules for AEs and Medications 
Date 
Missing Element 
Rule 
Start Date 
 
 
day, month, and year 
Set to the first dose date 
day, month only 
If the year matches the first dose date, then impute to the month and day of 
the first dose date. Otherwise, assign January 1st. 
day only 
If the year and month match the first dose date, then impute to the day of 
the first dose date. Otherwise, assign the first day of the month. 
End Date 
day, month, and year 
No imputation and assign a missing value 
day, month only 
Set to December 31st or last study visit, whichever occurs first.  
day only 
Set to the last day of the month or last study visit, whichever occurs first. 
 
Thus, AEs will be assumed to be treatment-emergent, unless there is clear evidence to suggest that 
the AE started prior to treatment. 
 
4.10.1.1.3 Changes in missing data handling from the protocol 
A change was made in handling of dropout and missing data as presented in the protocol amendment 
version 2.0 of Section 10.5.1.3: For the primary analysis of the primary endpoint, patients with 
missing primary assessments will be included in the analysis and evaluated as treatment failure (i.e., 
hospitalization, supplemental oxygen use, or death). 
In the current SAP, handling of subjects with missing primary assessments by day 28 are updated to 
treat as meeting the primary endpoint (i.e., not experiencing hospitalization (≥ 24 hours) or using 
supplemental oxygen in response to SpO2 ≤93% (≥ 24 hours), or alive) for the following reasons. 
Firstly, in the latest version of Informed Consent Form (ICF), a clear statement was made to inform 
subjects that medical care related with hospitalization would be reimbursed by the sponsor to ensure 
all hospitalization events would be captured. Secondly, site-contacted subjects who were initially lost 
to follow-up as well as the majority of subjects in this study did not experience any hospitalization 
nor oxygen use through day 28. Additionally, known reasons for subjects who discontinued early 
from the study were related to reasons like “patient felt better” or “subject left out of town” rather 
than reasons related to worsening in the clinical status or treatment related adverse events. Moreover, 


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only less than two percent of hospitalization was observed in this study. Given the low hospitalization 
percentage, imputation of relatively high proportion of missing primary assessments as 
hospitalization could substantially bias or even lead to misleading conclusion of the treatment 
efficacy. 
 
4.10.1.2 Multiple Comparisons/Multiplicity 
One interim analysis is planned. The method of adjusting the Type I error rate used in this study is 
O’Brien and Fleming type alpha spending. The actual alpha spending will be calculated based on the 
actual information used for the interim analysis. 
 
4.10.1.3 Examination of Subgroups 
This study is not powered for subgroup analyses; therefore, all subgroup analyses will be treated as 
exploratory. 
Summaries of the primary efficacy variable by treatment group and subgroup will be produced.  No 
formal statistical analysis will be performed within subgroup. Forest plot will be used to evaluate the 
subgroup effects. 
Subgroups may include: 
• Sex (Male; Female) 
• Geographic region (USA vs non-USA)  
• Baseline severity of COVID-19 (Mild; Moderate) 
• Age group (<50 years vs. ≥ 50 years, <60 years vs. ≥ 60 years) 
• Race and ethnicity (Non-Hispanic White or others; Hispanic or Latino; Non-Hispanic Black) 
• Baseline BMI (BMI category: Underweight; Normal; Overweight; Obesity) 
• Days from symptom onset to study randomization (≤5 days; >5 days) 
• Number of risk factors at time of randomization (0; 1-2; ≥3) 
• Vaccination status (Non; Partial Vaccinated; Fully Vaccinated) 
• Days from the Positive SARS-CoV-2 Prior to First Dosing (≤3 days; >3 days) 
• Biomarkers like C-reactive protein (CRP), ferritin, D-dimer at baseline (Low; Normal; High) 
• Most common baseline viral variants (i.e., Gamma, Delta, Mu) 
 
4.10.2 Primary Efficacy Variables  
Clinical question of interest: Does the study drug Proxalutamide (GT0918) increase the proportion 
of subjects who do not experience all-cause hospitalization for at least 24 hours, do not require 
supplemental oxygen for at least 24h in response to SpO2≤93% and are alive by Day 28, in 
comparison to placebo? 
Intercurrent events (may occur between randomization and Day 28), not mutually exclusive:  
• IE1: subject’s withdrawal from the study prior to Day 28 
• IE2: subject lost to follow-up prior to Day 28 
• IE3: subject did not receive any dose of study treatment  


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Attributes of Estimand (following a treatment policy strategy) [ICH E9 (R1) Addendum 2019]  
• Population: all subjects in the mITT population 
• Treatment Conditions: 
o condition of interest: randomized to GT0918 + standard of care and treated 
o alternative/control condition: randomized to placebo + standard of care and treated 
• Endpoint: the proportion of subjects who do not experience all-cause hospitalization (defined 
as ≥24 hours), do not require supplemental oxygen for ≥24h in response to SpO2≤93% and 
are alive by Day 28 
Note: All-Cause Hospitalization includes: Hospitalization, Emergency room and ICU. 
Extended Care Facility Admittance is excluded. 
• Population-level Summary: estimated incidence probability for subjects not experiencing all-
cause hospitalization (defined as ≥24 hours), not requiring supplemental oxygen for ≥24h in 
response to SpO2≤93% and alive by Day 28 (in each treatment group separately) 
Main Estimator for Estimand: Odds ratio by Day 28 with adjusting stratification factors defined by 
baseline clinical status used in the stratified randomization 
• Intercurrent events IE1 and IE2 will be disregarded for the inclusion of subjects in the 
statistical analysis, IE3 restricts the inclusion of subjects to those who received at least one 
dose of study treatment. Hence, the main estimator for Estimand will be based on the mITT 
analysis set.  
• Subjects with missing primary assessments by day 28 will be treated as meeting primary 
endpoint. The primary endpoint event rate will be compared between treatment and placebo 
arm using CMH Chi-square test with adjusting age and the stratification factors (sex, race and 
ethnicity, and number of risk factors) at time of randomization. The hypothesis test will be 
performed at the one-sided 0.025 level based on mITT. Odd ratio with 95% exact confidence 
interval and p-value will be presented.  
• The number and proportion of subjects that do not experience any of the 3 components (all-
cause hospitalization, requirement of supplemental oxygen and death) of the primary endpoint 
by Day 28 will be summarized by treatment for the mITT population in frequency tables and 
listed.  
• The individual components of the primary endpoint will be summarized as well.  
 
The following sensitivity analysis will be performed for the primary endpoint: 
• Among subjects with dosing days > 7 days; 
• Per protocol analysis set; 
• Complete case analysis set (subjects without any missing primary endpoint assessments); 
• Removing the constraint of ≥24 hours in hospitalization and supplemental oxygen use; 
• By treating missing primary assessments as hospitalization; 
• By treating missing primary assessments as hospitalization and among subjects with dosing 
days > 7 days. 
All sensitivity analyses will be performed using mITT sets except the per protocol analysis. Also, all 
sensitivity analyses will be conducted using the same one-sided CMH chi-square tests introduced for 
the primary endpoint analysis. 
 
Interim analysis 


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An interim analysis will be conducted when 334 subjects complete Day 28 after first dose to assess 
safety, futility, efficacy, sample size adjustment as well as potential enrichment of the population to 
enroll a population at higher risk for an infection requiring hospitalization or oxygen support in case 
the observed rates for the primary endpoint in the control arm are lower than expected. An IDMC 
will review the unblinded interim analysis report to assess the objectives of the interim analysis and 
provide recommendations about early study closure, change study population, or change to study 
sample size. 
The one-sided Type I error rate (0.025) for the primary efficacy endpoint will be adjusted following 
O’Brien and Fleming type alpha spending method. The actual alpha spending will be calculated based 
on the actual information used for the interim analysis and used as the efficacy boundary, as shown 
below.  The efficacy criterion will be based on the one-sided p-value of the primary endpoint analysis 
as less than the actual alpha spending. In this case the stopping boundary for efficacy is met and the 
study could be stopped for efficacy. 
O’Brien and Fleming: 𝛼𝐼𝐴(𝑡∗) = 2 −2Φ(𝑍1−𝛼/2/√𝑡∗), 
where IA means interim analysis, Φ denotes the standard normal cumulative distribution function and 
t* denotes the fraction of information that has been observed at Interim Analysis timepoint. 
The futility of a study that is underway can be determined by calculating its conditional power, which 
is the probability of statistical significance at the completion of the study given the data obtained so 
far. The futility criterion for the study will be based on the conditional power of the study being <10%. 
The conditional power will be evaluated based on primary endpoint in the interim analysis. If the 
conditional power of the study at the time interim analysis performed is between 50% to 80% 
(promising zone approach), the sample size could be increased to a maximum of 1500 subjects based 
on the efficacy in the interim analysis for overall population. If the conditional power of the study is 
above 80% power and the stopping boundary for efficacy is not met, the sample size will not be 
changed. The general lower one-sided conditional power is computed as  
C𝑃𝐼𝐴(𝜃) = Φ(
−𝑍𝐼𝐴√𝐼𝐼𝐴−𝑧1−𝛼√𝐼𝐹𝐴−𝜃(𝐼𝐹𝐴−𝐼𝐼𝐴)
√𝐼𝐹𝐴−𝐼𝐼𝐴
), 
where  
IA representing interim analysis and FA representing final analysis,  
𝜃= 𝑃2 −𝑃1 (the expected difference under the alternative hypothesis),  
𝑍𝐼𝐴= (𝑝2𝐼𝐴−𝑝1𝐼𝐴)√𝐼̂𝐼𝐴 (the z-statistic computed from the observed data),  
𝐼𝐼𝐴=
1
𝜎2 (
1
𝑛1𝐼𝐴+
1
𝑛2𝐼𝐴)−1 (the interim information level), 
𝐼𝐹𝐴=
1
𝜎2 (
1
𝑛1 +
1
𝑛2)−1 (the final information level), 
 
where  
𝑝𝑗𝐼𝐴 is the sample proportion for group j, estimating  𝑝𝑗 at IA, 
𝐼̂𝐼𝐴 is the estimated information from the sample at IA, 
𝑛𝑗𝐼𝐴 is the sample size in group j at IA, 
𝑛𝑗 is the final sample size in group j, 
𝜎2 = 𝑝̅(1 −𝑝̅) with 𝑝̅ = (𝑃1 + 𝑃2)/2 
 


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The conditional power calculated based on different software may be slightly different. 
  
4.10.3 Secondary Efficacy Variables 
Hospitalization Percentage   
Hospitalization percentage is defined as the percentage of subjects who experience any of the 
following events due to all causes by Day 28: 
o Hospitalization for ≥ 24 hours or 
o Supplemental oxygen for ≥24 hours in response to SpO2 ≤93% or 
o Death 
The same process used for the primary endpoint analysis will be used to compare the difference 
between treatment groups. 
The following sensitivity analysis for hospitalization percentage will be performed among subset of 
mITT subjects: 
• With dosing days > 7 days; 
• With one or several major risk factors below:  
o Single risk factor: age (≥ 50 years; ≥ 60 years), major underlying medical conditions 
(overweight, obesity, hypertension, diabetes, smoking); 
o Combination of age factor in column 1 and other major underlying medical conditions in 
column 2 in the table below (e.g., age ≥ 50 years and/or obesity at randomization; age ≥ 
60 years and/or obesity at randomization); 
Age 
Major underlying medical 
conditions 
≥ 50 years 
≥ 60 years 
Overweight  
Obesity 
Hypertension 
Diabetes 
Smoking 
• With aged ≥50 years and days from symptom onset to study randomization ≤5 days and days 
from the positive SARS-CoV-2 Prior to first dosing ≤3 days; 
• With aged ≥50 years and higher than normal biomarkers (CRP, Ferritin, D-dimer). 
All sensitivity analyses will be conducted using one-sided CMH chi-square tests used for the primary 
endpoint analysis. Forest plots for the sensitivity analysis will be presented.   
 
Change from Baseline to Days 3, 7, 14 and 28 in SARS CoV-2 Viral Load 
Change of SARS-CoV-2 viral load from baseline, which will be evaluated in 1og base 10 scale, will 
be summarized, and plotted by treatment group and listed. Two sample t-tests will be used to compare 
differences in the change of SARS-CoV-2 viral load between treatment groups at Day 3, 7, 14 and 
28, respectively. 
Also, an analysis of covariance (ANCOVA) model will be used to compare the change from baseline 
in SARS-CoV-2 viral load at Day 3 with fixed effects for treatment group, age and stratification 
factors (sex, race and ethnicity, and number of risk factors), and baseline viral load as a covariate.  If 
systematic pattern is identified from the residual of predicted values, a transformation of the baseline 
viral load will be employed to improve the performance of the model. Estimated treatment differences 


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in comparison to placebo along with corresponding two-sided 95% confidence intervals (CIs) and p-
values will also be presented. 
Additionally, change from baseline in SARS-CoV-2 viral load at Day 3, 7, 14 and 28 will be 
compared using a mixed model repeated measures (MMRM). The model will include treatment group, 
visit, treatment-by-visit interaction, age and stratification factors (sex, race and ethnicity, and number 
of risk factors) as fixed effects, baseline viral load as a covariate, and subject as a random effect. If 
the unstructured covariance matrix fails to converge, the heterogeneous Toeplitz covariance structure, 
followed by the heterogeneous autoregressive covariance structure, will be used. If systematic pattern 
is found in the residual of predicted values, a transformation of the baseline viral load will be 
employed to improve the performance of the model.  Comparisons of GT0918 to placebo for change 
from baseline in viral load and the corresponding two-sided 95% CIs along with p-values will be 
calculated and plotted based on the MMRM model at each visit. 
 
Sustained 100% SARS CoV-2 Viral Reduction  
SARS-CoV-2 viral reduction (%) is calculated as 
(viral load after baseline – viral load at baseline) / (viral load at baseline) * 100%.  
If the value of SARS-CoV-2 viral reduction is greater than or equal to 100 the result of 100% SARS 
CoV-2 viral reduction will be set as “Yes”. Otherwise, a negative result of “No” will be obtained. 
Sustained 100% SARS CoV-2 viral reduction (Yes/No) is defined when at least two consecutive 
negative (“No”) tests (≥24 hours apart) are obtained. The date of sustained 100% SARS CoV-2 viral 
reduction is defined as the earlier date of the consecutive negative tests.  
The proportion of subjects that achieve sustained 100% SARS CoV-2 viral reduction at Days 3, 7, 
14, and 28 will be summarized by treatment in frequency tables, plotted and listed. Generalized 
estimating equation (GEE) model will be used to model the proportions of achieving SARS-CoV-2 
clearance at different visits. The model will consider treatment group, visit, treatment-by-visit 
interaction, age and stratification factors (sex, race and ethnicity, and number of risk factors) as fixed 
effects, and subject as a random effect. Comparisons of GT0918 to placebo for odds ratios (ORs), 
corresponding 95% CIs and p-values will be calculated at each visit.  
 
Time to Sustained 100% SARS CoV-2 Viral Reduction  
Time to sustained 100% SARS-CoV-2 viral reduction (in days) is defined as: 
  Date when sustained 100% SARS CoV-2 viral reduction is changed to ‘Yes’ - first dosing date + 1. 
If a patient has not experienced SARS-CoV-2 clearance by completion or early discontinuation of 
study/study treatment, the patient will be censored at the date of their last visit during the post-
treatment period. 
Time to sustained 100% SARS CoV-2 viral reduction and will be summarized and plotted by 
treatment group with mITT set using the Kaplan-Meier (KM) method. The 2-sided 95% CIs for the 
25th, 50th and 75th percentiles, as well as at days 3, 7, 14 and 28 using the Brookmeyer and Crowley 
method will be reported when estimable. P-value will be obtained from the log-rank test stratified by 
age, and sex, race and ethnicity, and number of risk factors at randomization. Hazard ratios and 
corresponding 95% confidence intervals will be obtained from a Cox proportional hazard model 
which treated treatment group as a unique covariate, and age, and sex, race and ethnicity, and number 


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of risk factors as stratas. The Cox proportional hazard model will be also performed by subgroup of 
duration since symptom onset to randomization category (≤3 days; >3 days).    
 
SARS CoV-2 Viral Clearance 
SARS-CoV-2 Viral clearance (Yes/No) is defined when at least two consecutive negative tests 
proceed a positive test with all tests ≥24 hours apart. The date of viral clearance is defined as the 
earliest date between the consecutive negative tests. 
The proportion of subjects that achieve SARS-CoV-2 clearance at Days 3, 7, 14, and 28 will be 
summarized by treatment in frequency tables, plotted and listed. Viral clearance can only be achieved 
(Yes) at days with a negative result. Generalized estimating equation (GEE) model will be used to 
model the proportions of achieving SARS-CoV-2 clearance at different visits. The model will 
consider treatment group, visit, treatment-by-visit interaction, age and stratification factors (sex, race 
and ethnicity, and number of risk factors) as fixed effects, and subject as a random effect. 
Comparisons of GT0918 to placebo for odds ratios (ORs), corresponding 95% CIs and p-values will 
be calculated at each visit.  
 
Time to SARS-CoV-2 Clearance 
Time to SARS-CoV-2 clearance (in days) is defined as: 
Date when SARS-CoV-2 clearance status is changed to ‘Yes’ - first dosing date + 1. 
If a patient has not experienced SARS-CoV-2 clearance by completion or early discontinuation of 
study/study treatment, the patient will be censored at the date of their last visit during the post-
treatment period. 
Time to SARS-CoV-2 clearance will be applying the same KM methods and Cox proportional hazard 
models introduced for the time to sustained 100% SARS CoV-2 viral reduction analysis.    
 
Viral Load AUC 
SARS-CoV-2 viral load area under the concentration-time curve (AUC) will be calculated according 
to the linear trapezoidal rule using the measured SARS-CoV-2 viral load-time values above the lower 
limit of quantification (LoQ) at Days 3, 7, 14 and 28. Per ICON central lab, LoQ is 59.9 copies/mL. 
No imputations of missing data will be conducted. No AUC(0-D28) values will be calculated when 
Day 1 pre-dose and/or Day 28 values are missing, or if there are more than 3 values missing in the 
profile. The AUC (0-D28) will be summarized and plotted by treatment group and listed. 
 
Viral Resistance by Day 28 
The proportion of viral resistance at day 28 will be summarized by treatment group and listed. The 
CMH chi-square test introduced for the primary endpoint analysis will be used to compare the 
difference of proportion of viral resistance between treatment groups by day 28. 
Viral resistance is defined as when subjects: 
• Are not able to show two consecutive negative test results via ddPCR testing by Day 28 
without any missing scheduled tests, and/or 


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• Show a positive real-time ddPCR test result after two consecutive negative ddPCR test results, 
and/or 
• A confirmed rise in SARS-CoV-2 RNA of ≥1 log10 after achieving nadir on treatment. 
 
COVID-19 Ordinal Outcomes Scale 
Below summaries will be provided using mITT set: 
• The percentage of subjects at each clinical status using NIAID 8-point ordinal scale at Days 
3, 7, 14, and 28 
• Comparison of the proportion of NIAID ordinal scale by Days 3, 7, 14, and 28: ordinal  
generalized estimating equation (GEE) with treatment, age, stratification factors (sex, race 
and ethnicity, and number of risk factors), visit, and interaction of visit and treatment will 
included in the model as fixed effects, and subject will be included as a random effect. Odds 
ratios with 95% confidence intervals and p-values will be presented. If data are too sparse for 
one level of the above factors, the factor will not be included in the statistical model/test to 
avoid convergence issue. Inferential analysis will only be performed if data warrants.   
• Proportion of subjects worsening from baseline (worsening is defined as any worsening on 
the NIAID ordinal scale from baseline to Days 3, 7, 14, and 28) 
Stacked bar plot by treatment group and visits at Day 1, 3, 7, 14 and 28 will be produced for NIAID 
ordinal scale. Also, mean value by treatment group will be plotted over time.  
All NIAID ordinal scales through the study period will be listed in listing. 
 
Other Analysis for Clinical Status 
Below summaries for other analysis for clinical status will be provided as well: 
• Summary of Hospitalization and Extended Care Facility Admissions by Day 28 (COVID-19 
related will be summarized separately) 
Note: Hospitalization (≥24 hours) includes: Hospitalization, Emergency room and ICU. 
Extended Care Facility Admittance is excluded. 
o Number and proportion of subjects hospitalized 
o Duration of Hospitalization 
o Number and proportion of subjects hospitalized by admission type: Hospitalization, 
Emergency Room, Intensive Care Unit (ICU) and Extended Care Facility 
o Duration by admission type 
o Comparisons of proportion of hospitalization between treatment group will be made using 
FIRTH logistic regression. with adjusting age and the stratification factors (sex, race and 
ethnicity, and number of risk factors). Odds ratios with 95% confidence intervals and p-
values will be present. If data are too sparse for one level of the above factors, the factor 
will not be included in the statistical model/test to avoid convergence issue. Inferential 
analysis will only be performed if data warrants.     
• Summary of New Oxygen Use by Day 28 (COVID-19 related will be summarized separately) 
o Number and proportion of subjects requiring any oxygen use 
• Summary of COVID-19 Related Medical Attended Visits by Day 28 
o Proportion of subjects with COVID-19 related medical attended visits  
 


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All hospitalization events and COVID-19 related medical attended visits will be listed. 
 
Time to Hospitalization 
Time to Hospitalization (in days) is defined as: 
First hospital admission date - first dosing date + 1. 
Note: Hospitalization (≥24 hours) includes Hospitalization, Emergency room and ICU. Extended 
Care Facility Admittance is excluded.  
The following two summaries will be generated separately:  
• All-Cause Hospitalization 
• COVID-19 Related Hospitalization 
If a patient has not experienced hospitalization by completion or early discontinuation of study/study 
treatment, the patient will be censored at the date of their last visit during the post-treatment period. 
Time to hospitalization will be evaluated up to Day 28 and will be summarized and plotted by 
treatment group with mITT set using the Kaplan-Meier (KM) method. The 2-sided 95% CIs for the 
25th, 50th and 75th percentiles, as well as at days 3, 7, 14 and 28 using the Brookmeyer and Crowley 
method will be reported when estimable. P-value will be obtained from the log-rank test stratified by 
age, and sex, race and ethnicity, and number of risk factors at randomization. Hazard ratios and 
corresponding 95% confidence intervals will be obtained from a Cox proportional hazard model 
which treated treatment group as a unique covariate, and age, and sex, race and ethnicity, and number 
of risk factors as stratas. The Cox proportional hazard model will be also performed by subgroup of 
duration since symptom onset to randomization category (≤3 days; >3 days).  
If cases of hospitalization are too sparse (e.g., <1 case in one treatment group), no time to 
hospitalization analyses will be performed.   
 
Proportion of Symptom Resolution  
All symptom resolution is defined as  
all symptoms (those scored 0-3*) on the symptom questionnaire scored as absent (scored 0), 
with each symptom resolution absent for at least 48 hours. 
Note: * Seven individual questions from COVID-19-Related Symptom Questionnaire are 
included here: questions 3, 4, 5, 6, 7, 8 and 9. 
Additionally, all symptom resolution will be defined differently to include all individual questions 
scored 0-3 and related outputs will be noted as sensitivity analysis. It is defined as  
all symptoms (those scored 0-3*) on the symptom questionnaire scored as absent (scored 0), 
with each symptom resolution absent for at least 48 hours. 
Note: * Nine individual questions from COVID-19-Related Symptom Questionnaire are 
included here: questions 1 through 9. 
The proportion of subjects with all symptom resolution will be performed at Days 3, 7, 14, and 28 by 
treatment in frequency tables and listed using mITT set. Generalized estimating equation (GEE) 
model will be fitted with the response of symptom resolution mapped to categories of Yes or No and 
with treatment, age, stratification factors (sex, race and ethnicity, and number of risk factors), time 


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effect and time*treatment interaction terms included in the model as covariates. Odds ratios with 95% 
confidence intervals and p-values will be present. 
Total symptom score (seven individual questions from COVID-19-Related Symptom Questionnaire 
included here are questions 3, 4, 5, 6, 7, 8 and 9) and change from baseline in total symptom score to 
Days 3, 7, 11, 14 and 28 will be summarized by treatment group. Change from baseline will be 
compared using mixed model repeated measures (MMRM) with the fixed effects of baseline total 
symptom score, age and stratification factors (sex, race and ethnicity, and number of risk factors) and 
the random effect of subjects and with time effect and time*treatment interaction terms included in 
the model. Change from baseline in total symptom score will also be graphically displayed. 
Additionally, total symptom score will be calculated differently to include nine individual questions 
(1 through 9) and related outputs will be noted as sensitivity analysis. 
A summary of overall COVID-19 related symptoms, including overall symptoms severity, overall 
general physical health and returned to usual physical health, at Days 3, 7, 11, 14 and 28 will be 
provided in frequency table and listed.  
Additionally, the proportion of subjects with at least 2 points decrease in symptom score (total of 
ratings) from baseline to Days 3, 7, 14 and 28 will be summarized and listed as well. Generalized 
estimating equation (GEE) model will be fitted with the response of at least 2 points decrease mapped 
to categories of Yes or No and with treatment, age, stratification factors (sex, race and ethnicity, and 
number of risk factors), time effect and time*treatment interaction terms included in the model as 
covariates. Odds ratios with 95% confidence intervals and p-values will be present.  
 
Time to All Symptom Resolution 
Time to all symptom resolution (in days) is defined as: 
First date when all symptom resolution status is changed to ‘Yes’ - first dosing date + 1. 
If a patient has not experienced symptom resolution by completion or early discontinuation of 
study/study treatment, the patient will be censored at the date of their last visit during the post-
treatment period. 
Time to all symptom resolution will be applying the same KM methods and Cox proportional hazard 
models introduced in the time to hospitalization section.    
 
Symptom Improvement 
Symptom improvement is defined as a change in severity of overall symptoms * from a higher score 
to a lower score, which is defined as following: 
symptoms scored as moderate or severe at baseline are scored as mild or absent,  
OR 
symptoms scored as mild or absent at baseline are scored as absent.  
Note: * The overall symptoms question (overall question 1) under overall COVID-19 related 
symptoms from COVID-19-Related Symptom Questionnaire is included here. 
Additionally, symptom improvement will be defined by individual symptom questions from symptom 
questionnaire as below and related outputs will be noted as sensitivity analysis. It is defined as a 
patient experiencing both: 


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symptoms * scored as moderate or severe at baseline are subsequently scored as mild or 
absent,  
AND 
symptoms * scored as mild or absent at baseline are subsequently scored as absent. 
Note: * Seven individual questions from COVID-19-Related Symptom Questionnaire are 
included here: questions 3, 4, 5, 6, 7, 8 and 9. 
The proportion of subjects with symptom improvement at Days 3, 7, 11, 14 and 28 will be 
summarized by treatment in frequency tables and listed using mITT set. Generalized estimating 
equation (GEE) model is fitted with the response of symptom improvement mapped to categories of 
Yes or No and with treatment, age, stratification factors (sex, race and ethnicity, and number of risk 
factors), time effect and time*treatment interaction terms included in the model as covariates. Odds 
ratios with 95% confidence intervals and p-values will be present. 
 
Time to Symptom Improvement 
Time to symptom improvement (in days) is defined as: 
Date when symptom improvement status is changed to ‘Yes’ - first dosing date + 1. 
If a patient has not experienced symptom improvement by completion or early discontinuation of 
study/study treatment, the patient will be censored at the date of their last visit during the post-
treatment period. 
Time to symptom improvement will be applying the same KM methods and Cox proportional hazard 
models introduced in the time to hospitalization section.    
 
4.11 Safety Evaluation 
All safety analyses will be based upon the Safety set. All listings and tables will be presented by 
treatment group. 
The overall observation period will be divided into 5 segments: 
1. pre-treatment period: from day of patient’s informed consent to the day before first dose of 
study medication 
2. on-treatment period: from the day of first dose of study drug (D1) to the day of last dose (up 
to D14). 
3. post-treatment period: from the day after last dose (up to D15) to D28. 
4. treatment and post-treatment period: from D1 to D28. 
5. safety follow up period: from D29 to D42. 
4.11.1 Extent of Exposure  
Duration of study treatment exposure, the actual cumulative dose (mg), dose intensity (DI) and 
relative dose intensity (RDI) will be summarized by treatment.  
Duration of treatment exposure is defined as the time from initial dose to last non-zero dose. Duration 
of treatment is calculated as: (Last Dose Date - First Dose Date) + 1.  
Dose intensity is computed as the ratio of actual dose received to actual duration. 


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Relative dose intensity is computed as the ratio of the dose intensity to planned dose received/planned 
duration. 
In addition, the duration of exposure to study treatment will be categorized into time intervals (0-4 
days, 0-7 days and 0-14 days); frequency counts and percentages will be presented for the number of 
patients in each interval. The number of patients, who have dose reductions or interruptions, and the 
reasons, will be summarized by treatment. 
Listings of all doses of the study treatment along with dose change reasons will be produced. 
The safety population will be used for all summaries and listings of study treatment. 
The actual dose and duration of GT0918, as well as dose intensity and the relative dose intensity, will 
be listed and summarized using descriptive statistics. The total daily doses of GT0918 for each patient 
will be summarized using descriptive statistics (e.g., mean, median, and mode). 
4.11.2 Adverse Events 
Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) 
Version 24.0 or higher.   
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), 
symptom(s), or medical condition(s) that occur after subject’s signed informed consent has been 
obtained.  
Treatment-emergent AEs (TEAE) are defined as AEs that either start or worsen in severity on or after 
the date/time of study drug administration and through the end of study. 
 
Overview of AEs 
An overall summary table of AEs will be provided with the number and percentage of subjects 
(incidence) reporting an event for the following categories: 
• All AEs 
• All TEAEs 
o TEAEs Related to Study Drug 
o TEAEs with Toxicity Grade 3 and Higher  
o TEAEs Related to Study Drug with Toxicity Grade 3 and Higher  
Note: Related is defined as “Definitely”, “Probably”, “Possibly” related, or missing 
relationship to study treatment. 
o TEAEs Leading to Study Drug Discontinuation 
o TEAEs of Special Interest 
• TEAEs by Maximum Toxicity Grade (based on the Division of AIDS (DAIDS) [2]) 
o Grade 1  
o Grade 2 
o Grade 3 
o Grade 4  
o Grade 5 
o Not Gradable 
• TEAEs by Maximum Severity 
o Mild  
o Moderate 


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o Severe or Medically Significant 
o Life Threatening 
o Died 
• All Serious AEs (SAEs) 
o SAEs Related to Study Drug 
o SAEs with Outcome Fatal 
 
TEAE Summaries by System Organ Class and Preferred Term 
The incidence for the following will be summarized by SOC and PT, unless otherwise specify: 
• All TEAEs 
• TEAEs Related to Study Drug 
• TEAEs with Toxicity Grade 3 and Higher  
• TEAEs Related to Study Drug with Toxicity Grade 3 and Higher  
• TEAEs by Maximum Toxicity Grade 
• TEAEs Related to Study Drug by Maximum Toxicity Grade 
• TEAEs by Maximum Severity 
Adverse event summaries will be ordered by decreasing incidence for SOC, and PT within SOC, in 
the GT0918 treatment group. In case of equal number of subjects sorting will be done alphabetically.  
For each subject and each adverse event, the worst toxicity recorded will be attributed and used in the 
by-maximum-toxicity summaries.  
Separate tables for on-treatment period and safety follow up period will be provided, and below by-
subject listings will be provided: 
• All AEs 
• All AEs Related to Study Drug 
• All AEs with Toxicity Grade 3 and Higher 
 
4.11.3 Deaths, Serious Adverse Events, and Other Significant Adverse Events 
SAE 
An SAE is defined as one of the following: 
• Is fatal 
• Is life-threatening 
• Results inpatient hospitalization or prolongation of existing hospitalization 
• Results in a persistent or significant disability/incapacity 
• Constitutes a congenital anomaly/birth defect 
• Is medically significant, i.e., defined as an event that jeopardizes the patient or may require 
medical or surgical intervention to prevent one of the outcomes listed above 
• Note that hospitalizations for the following reasons should not be reported as SAEs: 
o Routine treatment or monitoring of the studied indication, not associated with any 
deterioration in condition. 
o Elective or pre-planned treatment for a pre-existing condition that is unrelated to the 
indication under study and has not worsened since signing the informed consent. 


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o Social reasons and respite care in the absence of any deterioration in the patient’s general 
condition. 
• Note that treatment on an emergency outpatient basis that does not result in hospital admission 
and involves an event not fulfilling any of the definitions of a SAE given above is not an SAE. 
 
AE Summaries by System Organ Class and Preferred Term 
The incidence for the following will be summarized by SOC and PT, unless otherwise specify: 
• SAEs 
• SAEs Related to Study Drug 
• SAEs with Outcome Fatal 
• TEAEs Leading to Study Drug Discontinuation 
Separate tables for on-treatment period and safety follow up period will be provided, and below by-
subject listings will be provided: 
• All SAEs 
• All Fatal SAEs 
• All AEs leading to Study Drug Discontinuation 
 
Adverse Events of Special Interest (AESI) 
Adverse events of special interest to be monitored include gastrointestinal, cardiovascular, hepatic, 
and neurological adverse events (dizziness, headache), hematological (anemia, leukopenia, 
neutropenia) and elevated creatinine kinase. (Appendix 6.5) 
TEAEs of special interest will be summarized by SOC and PT. 
 
Time to TEAEs of Special Interest 
Time to TEAEs of special interest (in days) is defined as: 
First date when TEAEs of special interest onset - first dosing date + 1. 
If a patient has not experienced TEAEs of special interest by completion or early discontinuation of 
study/study treatment, the patient will be censored at the date of their last visit. 
Time to TEAEs of special interest will be summarized for Safety set using the Kaplan-Meier (KM) 
method. Log-rank test will be used. P-values and hazard ratios with 95% confidence intervals based 
on Cox proportional hazard model stratified by duration since symptom onset to randomization 
category (≤3 days; >3 days) will be present. 
 
4.11.4 Clinical Laboratory Evaluation 
Local clinical laboratory parameters will be used for the analysis of scheduled hematology, chemistry 
and other blood specimens collected as part of safety monitoring (as detailed in SoA), except for 
specific parameters which will be performed centrally. For a list of the parameters to be evaluated, 
see Table Clinical Laboratory Parameters in appendices.  
For parameters where a DAIDS Version 2.1 scale exists, laboratory results will be graded according 
to DAIDS Version 2.1 toxicity grade. A Grade 0 will be assigned for all non-missing values not 


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graded as 1 or higher. For laboratory tests where grades are not defined by DAIDS, results will be 
graded by the low/normal/high classifications based on laboratory normal ranges. 
A single measure for partial thromboplastin time (PTT) will be collected and both non-activated and 
activated PTT (aPTT) can be captured in the measure. DAIDS toxicity grading scale for partial 
thromboplastin time (PTT) will be used for the PTT/aPTT measure. 
Laboratory values obtained during the screening phase will be used to assess subject’s eligibility, and 
therefore it will be listed only, but not summarized in tables.  
Laboratory values reported as a character value, such as <40, will be transformed into numerical 
values for summary reasons.   
 
4.11.4.1 Hematology, Clinical Chemistry, and Coagulation  
The following by treatment summaries will be generated separately for hematology, clinical 
chemistry, and coagulation laboratory tests: 
• Frequency table for newly occurring on-treatment Grades 3 or 4. 
• Shift tables using DAIDS grades to compare baseline to the worst on-treatment value. 
• For laboratory tests where DAIDS grades are not defined, shift tables using the 
low/normal/high classification to compare baseline to the worst on-treatment value. 
• Listing of all laboratory data with values flagged to show the corresponding DAIDS grades 
and the classifications relative to the laboratory normal ranges. 
 
4.11.4.2 Biomarkers 
Blood samples will be collected from all subjects for exploratory biomarker research at the time 
specified in the SoA where local regulations allow. 
The following will be monitored: 
• C-reactive protein (CRP) 
• Testosterone 
• Ferritin 
• D-dimer 
• Procalcitonin 
• Troponin 
The by visit biomarker data will be summarized by treatment group for the Safety set. Biomarker data 
over time will also be plotted for each biomarker type.  
 
4.11.4.3 Pharmacokinetics 
PK analysis will be performed on the PK set.  
Samples will be collected at pre-dose and 2h post first dose, and at pre-dose on Day 3, 7 and 14, from 
at least 200 subjects who receive intervention and have evaluable PK. 
PK concentrations of GT0918 (and any relevant metabolites such as GT0955) will be summarized by 
time point using descriptive statistics for GT0918 treatment group. All PK concentration data will be 
listed as appropriate. 


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All concentrations below the LLOQ will be displayed in listings as zero with a flag and handled as 
zero in any calculations of summary statistics, but handled as missing for the calculation of the 
geometric means and their CV. Any missing PK parameter data will not to be imputed. 
 
4.11.5 Vital Signs, Physical Findings and Other Observations Related to Safety 
Vital Signs  
Vital signs include: 
• Height and weight at screening only 
• Body temperature 
• Systolic blood pressure (BP), diastolic BP  
• Pulse rate 
• Respiration rate 
• Saturation of peripheral oxygen 
• Supplemental oxygen flow rate, FiO2 if known, and method of delivery, if applicable or 
clinical indicated 
• Additional vital signs if applicable or clinical indicated 
The observed Vital Signs value and change from baseline to each post-baseline time point will be 
summarized using descriptive statistics.  
A by-subject listing of vital sign parameters will be provided. 
 
Physical Findings  
Full physical exam should be done at screening visit. For the subsequent visits, symptom directed 
physical exam can be done per investigator’s discretion. 
A by-subject listings of physical examination results will be provided.  
 
ECG 
A 12-lead ECG can be done per investigator’s discretion. All ECG findings including interpretation 
and clinically significant status will be listed by subject. 
 
Chest X-ray and CT-scan 
Chest X-ray or CT-Scan can be done per investigator’s discretion. The results will be listed by subject 
if any. 
 
Pregnancy Test 
Pregnancy test results at Day 28 visit will be listed by subject. 
 


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4.11.6 Independent Data Monitoring Committee (IDMC) 
An IDMC will be responsible for monitoring and reviewing the clinical study data for safety and 
efficacy during the study prior to the final data analysis. The primary goal of the IDMC is to review 
the interim results regarding the continuing safety of study subjects and the continuing validity and 
scientific merit of the study. An IDMC will review the interim analysis report to conclude early 
efficacy, make recommendations about early study closure, change study population, or change to 
study sample size. More details please refer to section 4.11.2.1. Rigorous steps will be taken (e.g., 
firewalls) where possible to minimize the information that can be inferred by observers. 
 
4.12 Determination of Sample Size 
The primary endpoint event rate for the treatment arm is assumed at 97% and for the placebo arm is 
assumed at 91%. 
The sample size was calculated using EAST v6.5 software for a group sequential test for 2 
proportions. With a total of 668 subjects the study will have about 90% power at a one-sided 0.025 
significance level of the hospitalization or death rate using a Chi-square test with one interim analysis 
at 50% of the information (when 334 subjects have been observed for 28 days). 
 
 


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5 
REFERENCES 
[1] SAS® Version 9.4 of the SAS System for Personal Computers. Copyright ©
2002-2003. SAS 
Institute Inc. SAS and all other SAS Institute Inc. product or service names are registered trademarks 
or trademarks of SAS Institute Inc., Cary, NC, USA. 
[2] Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric DAIDS 
Adverse Event Grading Tables | DAIDS Regulatory Support Center (RSC) (nih.gov) 
 
 
 


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6 
APPENDICES 
6.1 
Schedule of Assessments (SoA) 
Table 4 Schedule of Activities 
  
Screen 
Treatment Period 
Early 
Withdrawal 
19 
Post-
treatment 
Safety 
Follow 
Up 20 
Study Day (Visit Window ± 
days) 
D-1 
D1 
D3 
D7 
(±1) 
D14 
(+1) 
(+2) 
D15 
D28 
(±2) 
D42 
Phone 
Call (±2) 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Review 1 
X 
 
 
 
 
 
 
 
 
Demographics 2 
X 
 
 
 
 
 
 
 
 
Preexisting Conditions and 
Medical History 3 
X 
 
 
 
 
 
 
 
 
NIAID Ordinal Scale4 
X 
Daily 
 
Prior Treatment 5 
X 
 
 
 
 
 
 
 
 
Tobacco Use 
X 
 
 
 
 
 
 
 
 
Physical Examination 6 
X 
Symptom Directed PE only if Clinical Indicated 
 
Vital Signs 7 
X 
 
X 
X 
X 
X 
 
X 
 
Nasopharyngeal swabs 8 
X 
 
X 
X 
X 
X 
 
X 
 
Randomization 9 
X 
X 
 
 
 
 
 
 
 
Hematology 10 
X 
 
 
X 
X 
X 
 
X 
 
Chemistry 10 
X 
 
 
X 
X 
X 
 
X 
 
Biomarkers 10  
X 
 
X 
 
X 
X 
 
X 
 
Coagulation 10 
X 
 
 
 
X 
X 
 
X 
 


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Drugs and Diary Dispense 11 
X 
X 
 
 
 
 
 
 
 
GT0918 or Placebo 
Administration 11 
 
Daily from D1 to D14 
 
 
 
 
Subject Diary 11 
X 
Daily from D1 to D14 
 
 
 
 
Questionnaire (Symptoms; 
Overall Clinical Status; ) 11 
Daily 
 
Chest X-ray or CT Scan 12 
Clinically Indicated 
 
12-ECG 12 
Clinically Indicated 
 
Hospitalization events 13 
 
Daily 
Clinical status and 
concomitant procedures if 
subject is hospitalized 14 
 
Daily if hospitalized 
Adverse Events 15 
X 
Concomitant Medications 16 
X 
Pharmacokinetics  17 
 
X 
X 
X 
X 
 
 
 
 
Pregnancy test18 
X 
 
 
 
 
 
 
X 
 
COVID-19 vaccination status 
X 
 
 
 
 
 
 
 
 
 
Annotation: 
1. Inclusion/Exclusion review: every subject needs to meet all inclusion and exclusion criteria. The eligibility 
checklist needs to be signed by the investigator or sub-investigator.  
2. Demographics: includes age, gender, race, and ethnicity. 
3. Pre-existing conditions and medical history: obtained from interview or available information and including timing 
of exposure and onset of symptoms suggestive of SARS-CoV-2 infection. 
4. NIAID ordinal scale to be completed daily through Day 28 or 14 days after last dose. This information can be 
collected from questionnaire; reported events; or directly from the patient. 
5. Prior treatments within last 30 days. 
6. Physical exam (PE): Full physical exam should be done at screening visit. For the subsequent visits, symptom 
directed PE can be done per investigator’s discretion. If the result is clinically significant, the PE result should be 
recorded in eCRF.  
7. Vital sign: documentation of hospital-based exam is acceptable. Vital signs include body temperature, pulse rate, 
systolic and diastolic blood pressure, respiratory rate. For screening visit, SpO2, and supplemental oxygen flow 
rate, FiO2 if known and method of delivery if applicable, also need to be recorded.  Record blood pressure and 
SpO2 while subject is at rest.  
8. Nasopharyngeal (NP) swabs: Only NP swab sample is acceptable. The method of taking samples should be 
consistent for each subject during the whole period of this study. This does not need to be the same before 
screening visit, when the subject is first time confirmed SARS-CoV-2 positive at local laboratory and/or Point of 


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Care testing. Sample for first positive test must be collected within 3 days prior to start of dosing. Local laboratory 
and/or Point of Care testing are acceptable. 
9. Randomization: randomization should be via the Interactive Voice/Web (IxRS) Response System. Randomization 
should be done after confirmation the subject meets all inclusion/exclusion criteria. Drugs and Diary Dispense 
should occur after randomization. It is allowed for the subject to take the drug on the same day of the screening 
visit after confirmation of eligibility and randomization (the screening visit is counted as D1 too). The Subject 
Diary should start to be completed.   
10. Laboratory tests: Hematology, Chemistry (including Creatinine Kinase), Biomarkers (including Procalcitonin, C-
reactive protein, D-dimer, Ferritin, Troponin, Testosterone), Coagulation. For details refer to Section 7.2.2 and 
7.2.4.  
11. GT0918 or placebo administration: GT0918 or placebo will be given orally once daily on Days 1-14 during the 
study period after a meal (±2 hours for medication scheduling). The drug taken time should be recorded with 
subject diary. If the screening day is also D1, the subject does not need to follow the drug taken window on 
screening day/D1. For details refer to Section 6.1. 
Subject Diary should be completed every day since screening visit until D14 or the last dose.  
Questionnaire should be completed every day since screening visit to the end of post-treatment. For details 
refer to Section 7.2.6.  
12. Chest X-ray or CT-Scan or 12-ECG can be done per investigator’s discretion. If investigator deems the result is 
clinically significant, the result should be recorded with eCRF. 
13. Hospitalization events: if the subject is hospitalized, the treatment may be continued to the 14 days per PI. 
Hospitalization is defined as ≥24 hours in hospital of care. For details refer to Section 7.1.2. 
Record if the following events occur: 
• 
Emergency room visits 
• 
Hospitalized  
• 
ICU admittance 
• 
Extended care facility admittance 
• 
Discharge 
14. Documentation from hospital records is acceptable. 
Includes: 
• 
Limitation on activities due to COVID- 19 
• 
Ongoing hospital medical care 
• 
Supplemental oxygen 
• 
Non-invasive ventilation or high flow oxygen device 
• 
Mechanical ventilation 
• 
ECMO, or 
15. Adverse events: any events that occur after signing the informed consent are considered AEs as defined in Section 
10.3. 
16. Concomitant medications: all medications administered within 30 days prior to the first dose of study treatment 
through 30 days after the last dose of study treatment will be recorded in the concomitant medications, for details 
refer to Section 6.4.  
17. Pharmacokinetics (PK) samples only need to be taken for at least 200 subjects, who will be assigned according. For 
details refer to Section 7.2.3. 
18. All women regardless of childbearing potential must complete a serum pregnancy test at screening visit, urinary 
pregnancy test on day 28 as per the schedule of assessment for women of childbearing potential. Local laboratories 
will be used for the analysis of serum and urinary pregnancy tests. 
19. Early withdrawal (EW): if the subject is early withdrawn from this study for any reason (Section 7.1.4), the subject 
should complete the EW visit, and the visit should occur within 2 days of the EW day. The subject will go to the 
safety follow-up period for additional 28 days after his last dose.   
20. D42 (or 28 days ±2 post last dose if subject is withdrawn early) safety follow-up visit is phone call visit.  
 
 
    
 
 


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6.2 
NIAID 8-Point Ordinal Scale 
1 Death 
2 Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation 
(ECMO) 
3 Hospitalized, on non-invasive ventilation or high flow oxygen devices 
4 Hospitalized, requiring supplemental oxygen 
5 Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-
19-related or other medical conditions preventing hospital discharge) 
6 Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 
7 Not hospitalized, limitation on activities and/or requiring home oxygen 
8 Not hospitalized, no limitations on activities 
 
 


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6.3 
Clinical Laboratory Parameters 
Table 5 Clinical Laboratory Parameters 
Test category  
Local/Central 
Test Name 
Hematology 
 
 
 
 
 
 
 
  
Local 
Hemoglobin 
Hematocrit 
Erythrocyte count (RBCs - Red Blood Cells) 
Leukocytes (WBCs - White Blood Cells) 
Differential 
Neutrophils, segmented 
Lymphocytes 
Monocytes 
Eosinophils 
Basophils 
Platelets 
Clinical Chemistry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Local 
Sodium 
Potassium 
Chloride 
Bicarbonate 
Total bilirubin 
Direct bilirubin 
Alkaline phosphatase (ALP) 
Alanine aminotransferase (ALT) 
Aspartate aminotransferase (AST) 
Gamma-glutamyl transferase (GGT) 
Blood urea nitrogen (BUN) 
Creatinine 
Creatine kinase (CK) 
Uric acid 
Total protein 
Albumin 
Calcium 
Phosphorus 
Glucose 
Amylase 
Lipase 
Lactate dehydrogenase (LDH) 
Coagulation  
Local 
International normalized ratio (INR), partial 
thromboplastin time: non-activated (PTT) or activated 
(aPTT) 
Additional tests 
Local/Central* 
C-reactive protein (CRP); high-sensitivity 
Ferritin 
D-dimer 
Procalcitonin 
Troponin (preferably Troponin I) 


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Test category  
Local/Central 
Test Name 
Virology  
Central 
SARS-CoV-2 viral infection determination at screening - 
local 
SARS-CoV-2 viral load test (quantitative ddPCR) - 
central 
Pharmacokinetic 
Analyses 
Central 
Analyzed using validated LC-MS/MS methods with a 
LLOQ of approximately 5.00 ng/mL for GT0918 
Hormones (Male 
&Female) 
Central 
Testosterone 
 
Hormones (Female) Local  
Serum Pregnancy  
Urine Pregnancy 
* Central laboratories will be used when it can’t be tested on local laboratory. 
 
 


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6.4 
Subject Questionnaire 
1. What was the severity of your stuffy or runny nose at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
2. What was the severity of your sore throat at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
3. What was the severity of your shortness of breath (difficulty breathing) at its worst over the last 24 
hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
4. What was the severity of your cough at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
5. What was the severity of your Low energy or tiredness at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
6. What was the severity of your muscle or body aches at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
7. What was the severity of your headache at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
8. What was the severity of your chills or shivering at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
9. What was the severity of your feeling hot or feverish at its worst over the last 24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
10. What was the severity of your Nausea (feeling like you wanted to throw up) at its worst over the last 
24 hours? 
None 
=0 
Mild 
=1 
Moderate 
=2 
Severe 
=3 
11. How many times did you vomit (throw up) in the last 24 hours? 
I did not vomit at all 
=0 
1-2 times 
=1 
3-4 times 
=2 
5 or more times 
=3 
12. How many times did you have diarrhea (loose or watery stools) in the last 24 hours? 
I did not have 
diarrhea at all 
=0 
1-2 times 
=1 
3-4 times 
=2 
5 or more times 
=3 
13. Rate your sense of smell in the last 24 hours: 
My sense of smell is 
THE SAME AS 
usual=0 
My sense of smell is 
LESS THAN usual 
=1 
I have NO sense of 
smell 
=2 
 
14. Rate your sense of taste in the last 24 hours: 
My sense of taste is 
THE SAME AS 
usual=0 
My sense of taste is 
LESS THAN usual 
=1 
I have NO sense of 
taste 
=2 
 


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Overall Covid-19-related Symptoms 
1. Overall, how bad are your symptoms TODAY (check one)? 
 
 
 
2. 
Overall, how is your general physical health today? 
 
 
 
3. 
Have you returned to your usual physical health (before your COVID-19 illness) (check one)? 
 
 
4. 
Have you returned to your usual activities (before your COVID-19 illness) (check one)? 
 
 
NIAID Daily Questions 
1. In the past 24 hours, have you been hospitalized?  
 
 
 
2. In the past 24 hours, have you required home oxygen?  
 
 
 
3. In the past 24 hours, have you had any limitation on your activities? 
 
 
 
 
No 
symptoms 
☐ 
Mild 
☐ 
Moderate 
☐ 
Severe 
☐ 
Poor 
☐ 
Fair 
☐ 
Good 
☐ 
Excellent 
☐ 
Yes 
☐ 
No 
☐ 
Yes 
☒ 
No 
☐ 
Yes 
☐ 
No 
☒ 
Yes 
☐ 
No 
☐ 
Yes 
☐ 
No 
☐ 


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6.5 
Adverse Events of Special Interest (AESI) 
SMQ 
Preferred Term 
Liver related investigations, signs and symptoms 
Alanine aminotransferase abnormal 
Liver related investigations, signs and symptoms 
Alanine aminotransferase increased 
Liver related investigations, signs and symptoms 
Ammonia abnormal 
Liver related investigations, signs and symptoms 
Ammonia increased 
Liver related investigations, signs and symptoms 
Ascites 
Liver related investigations, signs and symptoms 
Aspartate aminotransferase abnormal 
Liver related investigations, signs and symptoms 
Aspartate aminotransferase increased 
Liver related investigations, signs and symptoms 
AST/ALT ratio abnormal 
Liver related investigations, signs and symptoms 
Bacterascites 
Liver related investigations, signs and symptoms 
Bile output abnormal 
Liver related investigations, signs and symptoms 
Bile output decreased 
Liver related investigations, signs and symptoms 
Biliary ascites 
Liver related investigations, signs and symptoms 
Bilirubin conjugated abnormal 
Liver related investigations, signs and symptoms 
Bilirubin conjugated increased 
Liver related investigations, signs and symptoms 
Bilirubin urine present 
Liver related investigations, signs and symptoms 
Biopsy liver abnormal 
Liver related investigations, signs and symptoms 
Blood bilirubin abnormal 
Liver related investigations, signs and symptoms 
Blood bilirubin increased 
Liver related investigations, signs and symptoms 
Blood bilirubin unconjugated increased 
Liver related investigations, signs and symptoms 
Bromosulphthalein test abnormal 
Liver related investigations, signs and symptoms 
Child-Pugh-Turcotte score abnormal 
Liver related investigations, signs and symptoms 
Child-Pugh-Turcotte score increased 
Liver related investigations, signs and symptoms 
Computerised tomogram liver abnormal 
Liver related investigations, signs and symptoms 
Congestive hepatopathy 
Liver related investigations, signs and symptoms 
Foetor hepaticus 
Liver related investigations, signs and symptoms 
Galactose elimination capacity test 
abnormal 
Liver related investigations, signs and symptoms 
Galactose elimination capacity test 
decreased 
Liver related investigations, signs and symptoms 
Gamma-glutamyltransferase abnormal 
Liver related investigations, signs and symptoms 
Gamma-glutamyltransferase increased 
Liver related investigations, signs and symptoms 
Guanase increased 
Liver related investigations, signs and symptoms 
Hepaplastin abnormal 
Liver related investigations, signs and symptoms 
Hepaplastin decreased 
Liver related investigations, signs and symptoms 
Hepatic artery flow decreased 
Liver related investigations, signs and symptoms 
Hepatic enzyme abnormal 
Liver related investigations, signs and symptoms 
Hepatic enzyme decreased 
Liver related investigations, signs and symptoms 
Hepatic enzyme increased 
Liver related investigations, signs and symptoms 
Hepatic function abnormal 


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Liver related investigations, signs and symptoms 
Hepatic hydrothorax 
Liver related investigations, signs and symptoms 
Hepatic hypertrophy 
Liver related investigations, signs and symptoms 
Hepatic hypoperfusion 
Liver related investigations, signs and symptoms 
Hepatic mass 
Liver related investigations, signs and symptoms 
Hepatic pain 
Liver related investigations, signs and symptoms 
Hepatic sequestration 
Liver related investigations, signs and symptoms 
Hepatic vascular resistance increased 
Liver related investigations, signs and symptoms 
Hepatic venous pressure gradient abnormal 
Liver related investigations, signs and symptoms 
Hepatic venous pressure gradient increased 
Liver related investigations, signs and symptoms 
Hepatobiliary scan abnormal 
Liver related investigations, signs and symptoms 
Hepatomegaly 
Liver related investigations, signs and symptoms 
Hepatosplenomegaly 
Liver related investigations, signs and symptoms 
Hyperammonaemia 
Liver related investigations, signs and symptoms 
Hyperbilirubinaemia 
Liver related investigations, signs and symptoms 
Hypercholia 
Liver related investigations, signs and symptoms 
Hypertransaminasaemia 
Liver related investigations, signs and symptoms 
Kayser-Fleischer ring 
Liver related investigations, signs and symptoms 
Liver function test abnormal 
Liver related investigations, signs and symptoms 
Liver function test decreased 
Liver related investigations, signs and symptoms 
Liver function test increased 
Liver related investigations, signs and symptoms 
Liver induration 
Liver related investigations, signs and symptoms 
Liver palpable 
Liver related investigations, signs and symptoms 
Liver scan abnormal 
Liver related investigations, signs and symptoms 
Liver tenderness 
Liver related investigations, signs and symptoms 
Magnetic resonance imaging hepatobiliary 
abnormal 
Liver related investigations, signs and symptoms 
Magnetic resonance proton density fat 
fraction measurement 
Liver related investigations, signs and symptoms 
Mitochondrial aspartate aminotransferase 
increased 
Liver related investigations, signs and symptoms 
Molar ratio of total branched-chain amino 
acid to tyrosine 
Liver related investigations, signs and symptoms 
Oedema due to hepatic disease 
Liver related investigations, signs and symptoms 
Perihepatic discomfort 
Liver related investigations, signs and symptoms 
Retrograde portal vein flow 
Liver related investigations, signs and symptoms 
Total bile acids increased 
Liver related investigations, signs and symptoms 
Transaminases abnormal 
Liver related investigations, signs and symptoms 
Transaminases increased 
Liver related investigations, signs and symptoms 
Ultrasound liver abnormal 
Liver related investigations, signs and symptoms 
Urine bilirubin increased 
Liver related investigations, signs and symptoms 
White nipple sign 
Liver related investigations, signs and symptoms 
X-ray hepatobiliary abnormal 


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Page 51 of 55 
Haematopoietic erythropenia 
Anaemia macrocytic 
Haematopoietic erythropenia 
Aplasia pure red cell 
Haematopoietic erythropenia 
Aplastic anaemia 
Haematopoietic erythropenia 
Erythroblast count decreased 
Haematopoietic erythropenia 
Erythroid maturation arrest 
Haematopoietic erythropenia 
Erythropenia 
Haematopoietic erythropenia 
Hypoplastic anaemia 
Haematopoietic erythropenia 
Microcytic anaemia 
Haematopoietic erythropenia 
Proerythroblast count decreased 
Haematopoietic erythropenia 
Red blood cell count decreased 
Haematopoietic erythropenia 
Reticulocyte count decreased 
Haematopoietic erythropenia 
Reticulocytopenia 
Haematopoietic leukopenia 
Agranulocytosis 
Haematopoietic leukopenia 
Band neutrophil count decreased 
Haematopoietic leukopenia 
Band neutrophil percentage decreased 
Haematopoietic leukopenia 
Basophil count decreased 
Haematopoietic leukopenia 
Basophilopenia 
Haematopoietic leukopenia 
B-lymphocyte count decreased 
Haematopoietic leukopenia 
Cyclic neutropenia 
Haematopoietic leukopenia 
Eosinopenia 
Haematopoietic leukopenia 
Eosinophil count decreased 
Haematopoietic leukopenia 
Febrile neutropenia 
Haematopoietic leukopenia 
Granulocyte count decreased 
Haematopoietic leukopenia 
Granulocytes maturation arrest 
Haematopoietic leukopenia 
Granulocytopenia 
Haematopoietic leukopenia 
Idiopathic neutropenia 
Haematopoietic leukopenia 
Leukopenia 
Haematopoietic leukopenia 
Lymphocyte count decreased 
Haematopoietic leukopenia 
Lymphopenia 
Haematopoietic leukopenia 
Metamyelocyte count decreased 
Haematopoietic leukopenia 
Monoblast count decreased 
Haematopoietic leukopenia 
Monocyte count decreased 
Haematopoietic leukopenia 
Monocytopenia 
Haematopoietic leukopenia 
Myeloblast count decreased 
Haematopoietic leukopenia 
Myelocyte count decreased 
Haematopoietic leukopenia 
Neutropenia 
Haematopoietic leukopenia 
Neutropenic infection 
Haematopoietic leukopenia 
Neutropenic sepsis 
Haematopoietic leukopenia 
Neutrophil count decreased 
Haematopoietic leukopenia 
Promyelocyte count decreased 
Haematopoietic leukopenia 
Pure white cell aplasia 


Parexel International 
Suzhou Kintor Pharmaceuticals, Inc. 
GT0918-US-3001 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  11 Mar 22 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 52 of 55 
Haematopoietic leukopenia 
Radiation leukopenia 
Haematopoietic leukopenia 
T-lymphocyte count decreased 
Haematopoietic leukopenia 
White blood cell count decreased 
Haematopoietic thrombocytopenia 
Acquired amegakaryocytic 
thrombocytopenia 
Haematopoietic thrombocytopenia 
Megakaryocytes decreased 
Haematopoietic thrombocytopenia 
Platelet count decreased 
Haematopoietic thrombocytopenia 
Platelet maturation arrest 
Haematopoietic thrombocytopenia 
Platelet production decreased 
Haematopoietic thrombocytopenia 
Platelet toxicity 
Haematopoietic thrombocytopenia 
Thrombocytopenia 
Haematopoietic cytopenias affecting more than 
one type of blood cell 
Aplastic anaemia 
Haematopoietic cytopenias affecting more than 
one type of blood cell 
Autoimmune aplastic anaemia 
Haematopoietic cytopenias affecting more than 
one type of blood cell 
Bicytopenia 
Haematopoietic cytopenias affecting more than 
one type of blood cell 
Bone marrow failure 
Haematopoietic cytopenias affecting more than 
one type of blood cell 
Cytopenia 
Haematopoietic cytopenias affecting more than 
one type of blood cell 
Febrile bone marrow aplasia 
Haematopoietic cytopenias affecting more than 
one type of blood cell 
Full blood count decreased 
Haematopoietic cytopenias affecting more than 
one type of blood cell 
Gelatinous transformation of the bone 
marrow 
Haematopoietic cytopenias affecting more than 
one type of blood cell 
Immune-mediated cytopenia 
Haematopoietic cytopenias affecting more than 
one type of blood cell 
Myelosuppression 
Haematopoietic cytopenias affecting more than 
one type of blood cell 
Pancytopenia 
Haematopoietic cytopenias affecting more than 
one type of blood cell 
Panmyelopathy 
Agranulocytosis 
Agranulocytosis 
Agranulocytosis 
Aplastic anaemia 
Agranulocytosis 
Autoimmune aplastic anaemia 
Agranulocytosis 
Bone marrow failure 
Agranulocytosis 
Cytopenia 
Agranulocytosis 
Febrile bone marrow aplasia 
Agranulocytosis 
Febrile neutropenia 
Agranulocytosis 
Immune-mediated cytopenia 
Agranulocytosis 
Myelosuppression 


Parexel International 
Suzhou Kintor Pharmaceuticals, Inc. 
GT0918-US-3001 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  11 Mar 22 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 53 of 55 
Agranulocytosis 
Neutropenic colitis 
Agranulocytosis 
Neutropenic infection 
Agranulocytosis 
Neutropenic sepsis 
Agranulocytosis 
Pancytopenia 
Agranulocytosis 
Panmyelopathy 
Agranulocytosis 
Pure white cell aplasia 
Agranulocytosis 
Granulocyte count decreased 
Agranulocytosis 
Granulocytopenia 
Agranulocytosis 
Granulocytopenia neonatal 
Agranulocytosis 
Laryngopharyngitis 
Agranulocytosis 
Mucosal ulceration 
Agranulocytosis 
Neutropenia 
Agranulocytosis 
Neutrophil count decreased 
Agranulocytosis 
Neutrophil percentage decreased 
Agranulocytosis 
Parapharyngeal space infection 
Agranulocytosis 
Peritonsillar abscess 
Agranulocytosis 
Peritonsillitis 
Agranulocytosis 
Pharyngeal abscess 
Agranulocytosis 
Pharyngeal ulceration 
Agranulocytosis 
Pharyngitis 
Agranulocytosis 
Pharyngitis bacterial 
Agranulocytosis 
Pharyngitis mycoplasmal 
Agranulocytosis 
Pharyngitis streptococcal 
Agranulocytosis 
Pharyngotonsillitis 
Agranulocytosis 
Stomatitis necrotising 
Agranulocytosis 
Thrombophlebitis septic 
Agranulocytosis 
Tonsillar ulcer 
Agranulocytosis 
Tonsillitis 
Agranulocytosis 
Tonsillitis bacterial 
Gastrointestinal nonspecific inflammation 
Acute oesophageal mucosal lesion 
Gastrointestinal nonspecific inflammation 
Chronic gastritis 
Gastrointestinal nonspecific inflammation 
Colitis 
Gastrointestinal nonspecific inflammation 
Cryptitis 
Gastrointestinal nonspecific inflammation 
Duodenitis 
Gastrointestinal nonspecific inflammation 
Enteritis 
Gastrointestinal nonspecific inflammation 
Erosive duodenitis 
Gastrointestinal nonspecific inflammation 
Erosive oesophagitis 
Gastrointestinal nonspecific inflammation 
Feline oesophagus 
Gastrointestinal nonspecific inflammation 
Functional gastrointestinal disorder 
Gastrointestinal nonspecific inflammation 
Gastric mucosa erythema 
Gastrointestinal nonspecific inflammation 
Gastritis 


Parexel International 
Suzhou Kintor Pharmaceuticals, Inc. 
GT0918-US-3001 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  11 Mar 22 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 54 of 55 
Gastrointestinal nonspecific inflammation 
Gastritis erosive 
Gastrointestinal nonspecific inflammation 
Gastrointestinal erosion 
Gastrointestinal nonspecific inflammation 
Gastrointestinal mucosa hyperaemia 
Gastrointestinal nonspecific inflammation 
Gastrointestinal mucosal exfoliation 
Gastrointestinal nonspecific inflammation 
Haemorrhagic erosive gastritis 
Gastrointestinal nonspecific inflammation 
Intestinal angioedema 
Gastrointestinal nonspecific inflammation 
Oesophageal mucosa erythema 
Gastrointestinal nonspecific inflammation 
Oesophagitis 
Gastrointestinal nonspecific inflammation 
Reactive gastropathy 
Gastrointestinal nonspecific inflammation 
Reflux gastritis 
Gastrointestinal nonspecific inflammation 
Remnant gastritis 
Gastrointestinal nonspecific inflammation 
Ulcerative duodenitis 
Gastrointestinal nonspecific inflammation 
Ulcerative gastritis 
Gastrointestinal nonspecific dysfunction 
Acid peptic disease 
Gastrointestinal nonspecific dysfunction 
Duodenogastric reflux 
Gastrointestinal nonspecific dysfunction 
Dyspepsia 
Gastrointestinal nonspecific dysfunction 
Gastrooesophageal reflux disease 
Gastrointestinal nonspecific dysfunction 
Gastrooesophageal sphincter insufficiency 
Gastrointestinal nonspecific dysfunction 
Rebound acid hypersecretion 
Arrhythmia related investigations, signs and 
symptoms 
Chronotropic incompetence 
Arrhythmia related investigations, signs and 
symptoms 
Electrocardiogram repolarisation 
abnormality 
Arrhythmia related investigations, signs and 
symptoms 
Electrocardiogram RR interval prolonged 
Arrhythmia related investigations, signs and 
symptoms 
Electrocardiogram U wave inversion 
Arrhythmia related investigations, signs and 
symptoms 
Electrocardiogram U wave present 
Arrhythmia related investigations, signs and 
symptoms 
Electrocardiogram U-wave abnormality 
Arrhythmia related investigations, signs and 
symptoms 
Sudden cardiac death 
Torsade de pointes/QT prolongation 
Electrocardiogram QT interval abnormal 
Torsade de pointes/QT prolongation 
Electrocardiogram QT prolonged 
Torsade de pointes/QT prolongation 
Long QT syndrome 
Torsade de pointes/QT prolongation 
Long QT syndrome congenital 
Torsade de pointes/QT prolongation 
Torsade de pointes 
Torsade de pointes/QT prolongation 
Ventricular tachycardia 
Torsade de pointes/QT prolongation 
Cardiac arrest 
Torsade de pointes/QT prolongation 
Cardiac death 
Torsade de pointes/QT prolongation 
Cardiac fibrillation 
Torsade de pointes/QT prolongation 
Cardio-respiratory arrest 


Parexel International 
Suzhou Kintor Pharmaceuticals, Inc. 
GT0918-US-3001 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  11 Mar 22 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 55 of 55 
Torsade de pointes/QT prolongation 
Electrocardiogram repolarisation 
abnormality 
Torsade de pointes/QT prolongation 
Electrocardiogram U wave inversion 
Torsade de pointes/QT prolongation 
Electrocardiogram U wave present 
Torsade de pointes/QT prolongation 
Electrocardiogram U-wave abnormality 
Torsade de pointes/QT prolongation 
Loss of consciousness 
Torsade de pointes/QT prolongation 
Sudden cardiac death 
Torsade de pointes/QT prolongation 
Sudden death 
Torsade de pointes/QT prolongation 
Syncope 
Torsade de pointes/QT prolongation 
Ventricular arrhythmia 
Torsade de pointes/QT prolongation 
Ventricular fibrillation 
Torsade de pointes/QT prolongation 
Ventricular flutter 
Torsade de pointes/QT prolongation 
Ventricular tachyarrhythmia 
  
Dizziness 
  
Headache 
  
Creatine Kinase increase 
  
Proteinuria 
 


Signature Page for VV-TMF-1451626 v1.0
Signature Page for VV-TMF-1451626 v1.0
Reason for signing: Approved
Name: Cralen Davis
Role: Biostatistics
Date of signature: 14-Mar-2022 19:51:25
GMT+0000
Reason for signing: Approved
Name: Ran He
Role: Sponsor
Date of signature: 14-Mar-2022 22:09:51
GMT+0000
Reason for signing: Approved
Name: Xunwei Dong
Role: Sponsor
Date of signature: 14-Mar-2022 22:40:58
GMT+0000