Clinical trial NCT04458948
Conditions: COVID-19
Sponsor: University of New Mexico
Start date: 2020-03-24; Completion date: 2020-08-28
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research is designed as an open-label,non-comparative prospective trial.

Detailed description:
The objects of this research are as follows:

(1) To measure the duration of viral shedding in respiratory secretions of patients with moderate or severe COVID-19 infection treated with the combination of Hydroxychloroquine and azithromycin. (2) Evaluate the case fatality rate, the clinical response and length of stay in hospitalized patients with moderate and severe COVID-19 infection. (3) To report the safety of the drug combination in hospitalized patients with moderate and severe COVID-19 infection.

Arms: arm 1: All subjects receive Hydroxychloroquine and Azithromycin.
Interventions: intervention 1: Hydroxychloroquine intervention 2: Azithromycin
Intervention descriptions: intervention 1: Hydroxychloroquine 400 mg BID, on day 1 and then 200 mg BID day 2 through 7 IV or po for 5 days. If the condition of the patient does not allow for oral therapy, HCQ can be given via a feeding or NG tube. Azithromycin can be given intravenously. intervention 2: Azithromycin 500 mg, IV or po for 5 days

Protocol documents:
ICF_005.pdf: 
Page 1 of 12
The University of New Mexico Health Sciences Center
Consent and Authorization to Participate in a Research Study
Key Information for Treatment of Coronavirus SARS-Cov2 Respiratory Infections 
with Hydroxychloroquine and Azithromycin.
You are being invited to take part in a research study about using hydroxychloroquine and azithromycin 
to treat respiratory infections caused by Coronavirus SARS-Cov2 (also called COVID-19).
WHAT IS THE PURPOSE, PROCEDURES, AND DURATION OF THE STUDY?
By doing this study, we hope to learn if these two drugs can help treat respiratory infections caused by 
Coronavirus SARS-Cov2. Your participation in this research will last about 14 days.
The purpose of this research is to gather information on the safety and effectiveness of 
hydroxychloroquine and azithromycin for the treatment of respiratory infections caused by Coronavirus 
SARS-Cov2. These two drugs are approved by the FDA for other conditions, but not for respiratory 
infections caused by Coronavirus SARS-Cov2. There are currently no drugs approved by the FDA for 
this condition.
WHAT ARE THE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS 
STUDY?
You may want to participate in this study because the drugs may help treat your current respiratory 
infection. You may also want to participate in order to help find a treatment for this condition. For a 
complete description of benefits, refer to the Detailed Consent. 
WHAT ARE THE KEY REASONS YOU MIGHT NOT CHOOSE TO VOLUNTEER FOR THIS 
STUDY?
You might choose not to volunteer for this study because the drugs may not help treat your respiratory 
infection, or because you might lose privacy and/or confidentiality. For a complete description of the 
risks, refer to the Detailed Consent and to the Appendix. 
Alternate treatments or procedures would include having access to the study medications without taking 
part in this study. There is currently no standard of care treatment for treating the viral infection. 
DO YOU HAVE TO TAKE PART IN THE STUDY?
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose 
any services, benefits or rights you would normally have if you choose not to volunteer
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS?
The person in charge of this study is Dr. Cristina Beato of the University of New Mexico Health Sciences 
Center, Department of Family Medicine. If you have questions, suggestions, or concerns regarding this 
study or you want to withdraw from the study, her contact information is (505) 272-5066.
If you have any questions or concerns about your rights as a volunteer in this research, contact staff in the 
University of New Mexico Health Sciences (UNMHSC) Human Research Review Committee (HRRC) 
between the business hours of 8AM and 5PM, Mountain Standard Time (MST), Monday-Friday at 505-
272-1129. 


Page 2 of 12
DETAILED CONSENT
Version April 27, 2020
ARE THERE REASONS WHY YOU WOULD NOT QUALIFY FOR THIS STUDY? 
You would not qualify to be in this study for the following reasons:

You are under the age of 18 or older than 74.

You are transferred from an intensive care unit from an external entity regardless of age. 

You are transferred from a nursing home regardless of age. 

You are pregnant or breastfeeding.
o
There is insufficient information regarding the safety of azithromycin during pregnancy. 
Consequently, Azithromycin is not recommended when pregnant or planning to become 
pregnant. However, investigators may prescribe it if necessary. 
o
Azithromycin is excreted in human milk, therefore participants should not breast-feed 
while taking Azithromycin, because it may cause side effects including diarrhea and 
infection in your baby. It is recommended to discard the milk during treatment and up 
until 2 days after discontinuation of treatment. However, investigators may prescribe it if 
necessary.
o
Hydroxychloroquine is not recommended during pregnancy. However, investigators may 
prescribe it if necessary.
o
hydroxychloroquine is not recommended if you are breast-feeding or planning to breast-
feed. This is because small amounts may pass into mother’s milk. However, investigators 
may prescribe it if necessary.

You have an allergy to one of the study drugs or have contraindication to treatment with study 
drugs.

You have retinopathy. 

You have Glucose-6-phosphate dehydrogenase (G6PD) deficiency.  

You have QT prolongation. Unless, it is the opinion of the treating physicians that the benefits to 
treat with the medications outweigh the risks.

You have known chronic kidney diseaseor are receiving dialysis.

You have a weight of less than 40 kg.

You are currently using hydrocholorquine.

You are currently using cardiac medicines as follows: flecainade, Tambocor; amiodarone 
Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, 
propafenone, Rythmal.
WHERE IS THE STUDY GOING TO TAKE PLACE AND HOW LONG WILL IT LAST?
The research procedures will be conducted at University of New Mexico Hospital while you are 
hospitalized. The total amount of time you will be asked to volunteer for this study is over the next 14 
days.
WHAT WILL YOU BE ASKED TO DO?
If you agree to participate in this study, you will take two drugs:
1.
Hydroxychloroquine (2 times per day for 7 days)
2.
Azithromycin (1 time per day for 5 days)


Page 3 of 12
These drugs will be given by mouth, but may be given through a feeding tube (if the patient) has one 
and/or through an IV (tube in a vein) if necessary.
We will collect the research specimen using a deep nose swab on day 3, 6 and 14. If necessary, a swab 
may be used in the trachea (windpipe) to collect the sample.
You will still receive all the other treatments, test and procedures you would get if you did not participate 
in this study. We will look into your medical record (chart) to get the information recorded to use in the 
study.
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS
If you participate in this study, there is a risk of cardiomyopathy, retinopathy, hepatic failure, and/or 
suicidal ideation. There is always a chance that any medical treatment can harm you. The research 
treatments/procedures in this study are no different. For a complete description of the risks, refer to the 
Appendix. In addition to risks described in this consent, you may experience a previously unknown risk 
or side effect.
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY? 
We do not know if you will get any benefit from participating in this study. However, some people have 
experienced having less of the virus in their respiratory secretions  when taking these two drugs. If you 
take part in this study, information learned also may help others with your condition. 
WHAT WILL IT COST YOU TO PARTICIPATE?
You and/or your insurance company, Medicare, or Medicaid will be responsible for the costs of all care 
and treatment that you would normally receive for any conditions you may have. These are costs that are 
considered medically necessary and will be part of the care you receive even if you do not take part in this 
study.
The University of New Mexico may not be allowed to bill your insurance company, Medicare, or 
Medicaid for the medical procedures done strictly for research. This means you may have to pay out-of- 
pocket for these costs. 
If a health insurance company insures you, your insurer may pay the costs. You should ask your 
insurer if you have any questions regarding your insurer’s willingness to pay these costs. 
If Medicare or Medicaid covers you, Medicare or Medicaid may cover these costs.  For questions 
regarding Medicare coverage, call 1-800-MEDICARE (1-800-633-4227).  For questions regarding 
Medicaid coverage, call 1-800-2570. Your insurer, Medicare, or Medicaid, may agree to pay for the costs. 
If you are required to expend a co-payment or deductible, the amount of this co-payment or deductible 
may be costly. 
WHO WILL SEE THE INFORMATION THAT YOU GIVE
Each person participating in this Study will be assigned a randomly generated study ID that will be linked 
to identifiers (MRN, DOB) in a linking table to be kept separate from the research data. Data and 
specimens will be labelled with the study ID only. Only HRRC-approved members of the study team who 
have the appropriate training will have access to the data and identifiers. All data that we collect in this 
study will be entered into REDCap, a secure data-base, on a password-protected computer using a secure 
network.  Any hard copy records/data will be kept in a locked file cabinet in the locked office of a 
designated member of the Study team.  The  specimens will be kept and stored in the Clinical and 
Translational Science Center at the UNM HSC and can only be accessed by the members of the study 


Page 4 of 12
team.  We will transport the specimens to TriCore Reference Laboratories for lab analysis through 
standard transport hospital procedures.  After testing, any left-over samples will be delivered in part to 
CDC for validation testing, and in part to the CTSC for genomic sequencing.  Once data collection is 
complete, data will be de-identified by destruction of the linking table. Study records will be kept for 6 
years past study closure.
When we write about or share the results from the study, we will write about the combined information. 
We will keep your name and other identifying information private. 
We will make every effort to prevent anyone who is not on the research team from knowing that you gave 
information, or what the information is. 
You should know there are some circumstances in which we may have to show your information to other 
people. For example, the law may require us to share your information with the following agencies and 
for the following reasons: 

The law requires us to share your information with authorities if you report information about a 
child being abused

If you pose a danger to yourself or someone else. 

A court or agencies, if you have a reportable disease or condition.

Authorities, if you report information about a child being abused, if you pose a danger to yourself 
or someone else. 
CAN YOU CHOOSE TO WITHDRAW FROM THE STUDY EARLY?
You can choose to leave the study at any time. You will not be treated differently if you decide to stop 
taking part in the study. 
If you choose to leave the study early, data collected until that point will remain in the study database and 
may not be removed. 
The investigators conducting the study may need to remove you from the study. The study intervention, 
medication will no longer be provided to you and may not be available for purchase. This may occur for a 
number of reasons. You may be removed from the study if you are not able to follow the direction, they 
find that your participation in the study is more risk than benefit to you, or if Dr. Beato chooses to stop 
the study early for a number of scientific reasons. 
You may be removed from the study if:

You are not able to follow the directions.

They find that your participation in the study is more risk than benefit to you.
ARE YOU PARTICIPATING, OR CAN YOU PARTICIPATE, IN ANOTHER RESEACH 
STUDY AT THE SAME TIME AS PARTICIPATING IN THIS ONE? 
You may not take part in this study if you are currently involved in another research study. It is important 
to let the investigator and your doctor know if you are in another research study. It will be up to them to 
determine if you can participate in more than one study. You should discuss this with the investigator and 
your doctor before you agree to participate in another research study while you are in this study. 
WHAT HAPPENS IF YOU GET HURT OR SICK DURING THE STUDY? 


Page 5 of 12
If you believe you are hurt or if you get sick because of something that is due to the study, you should call 
Dr. Cristina Beato at (505) 272-5066 immediately. If you need to reach someone outside of business 
hours, please call (505) 272-2121.
Dr. Beato will determine what type of treatment, if any, is best for you at that time. 
It is important for you to understand that the University of New Mexico does not have funds set aside to 
pay for the cost of any care or treatment that might be necessary because you get hurt or sick while taking 
part in this study. Also, the University of New Mexico will not pay for any wages you may lose if you are 
harmed by this study.
Medical costs related to your care and treatment because of study-related harm will be paid by you and/or 
your insurance
WILL I BE PAID FOR PARTICIPATING IN THIS STUDY?
You will not receive any rewards or payment for taking part in the study. 
WHAT IF NEW INFORMATION IS LEARNED DURING THE STUDY THAT MIGHT AFFECT 
YOUR DECISION TO PARTICIPATE?
You will be informed if the investigators learn new information that could change your mind about 
staying in the study. You may be asked to sign a new informed consent form if the information is 
provided to you after you have joined the study.
WILL YOU BE GIVEN INDIVIDUAL RESULTS FROM THE RESEARCH TESTS?
You and your doctor will be given individual results from the research tests. 
A member of the study team will contact you using the information you provided. With the help of a 
member of the study team, they will present possible risks or benefits of receiving the information. At 
that time you can choose to receive or refuse the result or finding. If you would like more information 
about this, please call Dr. Beato.
You may also withdraw your consent to be contacted with information about research results by sending a 
written request to Dr. Beato. 
A description of this clinical trial will be available on ClinicalTrials.gov as required by U.S. Law. This 
website will not include information that can identify you. At most, the website will include a 
summary of the results. You can search this website at any time. 
WHAT ELSE DO YOU NEED TO KNOW?
If you volunteer to take part in this study, you will be one of up to 10,000 people to do so. 
FUTURE USE OF YOUR INFORMATION OR PROTECTED HEALTH INFORMATION 
Identifiable information such as your name, medical record number, or date of birth will be removed from 
the information or samples collected in this study. After removal, the information or samples may be used 
for future research or shared with other researchers without your additional informed consent. 
In addition to the main study, you are being asked to allow us to keep and use your information for future 
research. 
HIPAA AUTHORIZATION FOR USE AND DISCLOSURE OF YOUR PROTECTED HEALTH 
INFORMATIN (PHI). 


Page 6 of 12
As part of this study, we will be collecting health information about you and sharing it with others.  This 
information is “protected” because it is identifiable or “linked” to you.
Protected Health Information (PHI)
By signing this Consent Document, as described in this consent form, you are allowing the investigators 
and other authorized personnel to use your protected health information for the purposes of this study.  
This information includes results of tests and exams done for your clinical care, your medical history, and 
other information related to the treatment of your condition.  
In addition to researchers and staff at UNMHS and other groups listed in this form, there is a chance that 
your health information may be shared (re-disclosed) outside of the research study and no longer be 
protected by federal privacy laws.  Examples of this include health oversight activities and public health 
measures, safety, monitors, other sites in the study, companies that sponsor this study, government 
agencies such as Food and Drug Administration (FDA). 
Right to Withdraw Your Authorization
Your authorization for the use and disclosure of your health information for this study shall not expire 
unless you cancel this authorization.  This is because the information used and created during the study 
may be analyzed for many years and it is not possible to know when this will be complete. Your health 
information will be used or disclosed as long as it is needed for this study.  However, you may withdraw 
your authorization at any time provided you notify the UNM investigators in writing.  To do this, please 
send letter notifying them of your withdrawal to:
Cristina Beato, MD 
MSC 09 5040
1 University of New Mexico
Albuquerque New Mexico 87131
Please be aware that the research team will not be required to destroy or retrieve any of your health 
information that has already been used or shared before the date that your withdrawal is received.
If you become pregnant anytime during the study or within 15 days after stopping the study drug, you 
must inform the study doctor. The study doctor must then report the outcome of your pregnancy to the 
Sponsor (and/or the FDA). 
The researchers agree to only share your health information with the people listed in this document. 
Should your health information be released to anyone that is not regulated by the privacy law, your health 
information may be shared with others without your permission; however, the use of your health 
information would still be regulated by applicable federal and state laws. 
You may not be allowed to participate in the research study if you do not sign this form. If you decide not 
to sign this form it will not affect your: 

Current or future healthcare at the University of New Mexico;

Current or future payments to the University of New Mexico;

Ability to enroll in any health plans (if applicable); or

Eligibility for benefits (if applicable).


Page 7 of 12
After signing the form, you can change your mind and NOT let the researcher(s) collect or release 
your health information (revoke the Authorization). If you revoke the authorization:

You will send a written letter to Dr. Beato to inform her of your decision. 

Researchers may use and release your health information already collected for his research study. 

Your protected health information may still be used and released should you have a bad reaction 
(adverse event).
The use and sharing of your information has no time limit. 
If you have not already received a copy of the Privacy Notice, you may request one. If you have any 
questions about your privacy rights, you should contact the University of New Mexico Health Sciences 
Privacy Officer between the business hours of 8am and 5pm Mountain Pacific Time, Monday-Friday at 
(505) 272-1493.
INFORMED CONSENT SIGNATURE PAGE
You are participating or are authorized to act on behalf of the participant. This consent includes the 
following: 

Key Information Page

Detailed Consent
You will receive a copy of this consent form after it has been signed. 
Signature of research subject, or if applicable, 
Date
*research subject’s legal representative
Printed name of research subject 
*If applicable, printed name of research subject’s legal representative
*If applicable, please explain Representative’s relationship to subject and include a description of 
representative’s authority to act on behalf of subject.
I have witnessed the informed consent process. This informed consent form was verbally reviewed with 
the subject or their LAR in addition to the HRRC approved short consent form and will act as the written 
summary of the discussion.
Witness (translator) printed name 
Witness (translator) signature and date 


Page 8 of 12
I have witnessed the informed consent process that was conducted by phone call or by conference phone 
call. This informed consent form was verbally reviewed with the subject or their LAR.
Impartial Witness to phone consent printed name         Impartial Witness to phone consent signature and date 
Adult Assent (if applicable)
You are making a decision whether to participate in this study. Your signature below indicates that you 
read the information provided (or the information was read to you).
Name of Adult Participant 
 
Date
Signature of Adult Participant
       
-------------------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------------------
Printed name of [authorized] person obtaining 
Date
informed consent/HIPAA Authorization
Signature of [authorized] person obtaining 
informed consent/HIPAA Authorization


Page 9 of 12
Appendix 1: Risks
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS OF AZITHROMYCIN?
Like all medicines, Azithromycin can cause side effects, although not everybody gets them.
Tell your doctor and the study doctor, Dr. Beato, immediately if you experience any of the 
following symptoms after taking this medicine as the symptoms may be severe- you may need 
urgent medical treatment:

difficulty breathing, sudden wheeziness, swelling of the eyelids, face or lips, rash or 
itching (especially affecting the whole body)

severe or prolonged diarrhea, which may have blood or mucus in it during or after 
treatment with Azithromycin as this may be a sign of serious bowel inflammation

severe skin rash causing redness and flaking

rapid or irregular heartbeat

low blood pressure

serious skin reactions:
o
blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome 
(SJS))
o
blistering of the skin, severe skin reaction (Toxic Epidermal Necrosis (TEN))
o
skin rash accompanied by other symptoms such as fever, swollen glands and an 
increase of eosinophils (a type of white blood cell). A rash appears as small, itchy 
red bumps (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
o
skin eruption that is characterized by the rapid appearance of areas of red skin 
studded with small pustules (small blisters filled with white/yellow fluid) (Acute 
Generalized Exanthematous Pustulosis (AGEP) – rare (may affect 1-10 users in 
10,000)
The most common side effects that occur when taking Azithromycin are listed below. These may 
go away during treatment as your body adjusts to the medicine. Tell your doctor and Dr. Beato if 
any of these side effects continue to bother you.
Other side effects include:
Very common (affects more than 1 user in 10)

diarrhea, stomach cramps, feeling sick, wind
Common (affects 1 to 10 users in 100)

headache, dizziness

being sick (vomiting), indigestion

low number of lymphocytes (a type of white blood cells), higher number of eosinophils 
(a type of white blood cell)

low blood bicarbonate


Page 10 of 12

numbness or pins and needles

loss of appetite, taste disturbance

visual disturbances, deafness

skin rash and /or itching

joint pain

tiredness or weakness
Uncommon (affects 1 to 10 users in 1,000)

yeast infections of the mouth and vagina (thrush)

low numbers of leukocytes (a type of white blood cell), low number of neutrophils (a 
type of white blood cell)

allergic reactions of various severity

skin more sensitive to sunlight than normal

feeling nervous

reduced sense of touch or sensation (hypoesthesia)

sleepiness or sleeplessness (insomnia)

poor hearing or ringing in the ears

heart palpitations, chest pain

constipation, stomach pain associated with diarrhea and fever

inflammation of the liver (hepatitis), changes in liver enzymes

general loss of strength

swelling

general discomfort

abnormal laboratory test values (e.g. blood or liver tests)
Rare (affects 1 to 10 users in 10,000)

feeling agitated

changes in liver function

vertigo
Not known (frequency cannot be estimated from the available data)

fits or fainting

aggression or anxiety

feeling hyperactive

localised muscle weakness

loss of smell or altered sense of smell, loss of taste

tongue discolouration

inflammation of the pancreas (pancreatitis)

inflammation of the kidney or kidney failure

yellowing of the skin or eyes (jaundice) or liver failure (rarely life-threatening)

bruising or prolonged bleeding after injury


Page 11 of 12

abnormal electrocardiogram (ECG)

reduction in red blood cells which can make the skin pale and cause weakness or 
breathlessness
If any of the side effects gets serious, or if you get any side effects talk to your doctor and Dr. 
Beato. This includes any possible side effects not listed here. 
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS OF 
HYDROXYCHLOROQUINE?
Like all medicines, hydroxychloroquine can cause side effects, although not everybody gets 
them.
Tell your doctor and the study doctor, Dr. Beato, immediately if you experience any of the 
following symptoms after taking this medicine as the symptoms may be severe- you may need 
urgent medical treatment:
Not known (frequency cannot be estimated from available data)

You have an allergic reaction. The signs may include: a red or lumpy rash, swallowing 
or breathing problems, swelling of the eyelids, lips, face, throat or tongue.

Severe skin reactions such as blistering, widespread scaly skin, pus-filled spots together 
with a high temperature, reddening and being more sensitive to the sun.

Blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like 
symptoms and fever. This could be a condition called Stevens-Johnson Syndrome.
Common side effects (may affect less than 1 in 10 people)

You have any eye problems. This includes changes in the colour of your eye and 
problems with your eyesight such as blurring, sensitivity to light or the way you see 
colour.
Uncommon side effects (may affect less than 1 in 100 people)

You have any muscle weakness, cramps, stiffness or spasms or changes in sensation such 
as tingling. If you take this medicine for a long time, your doctor will occasionally check 
your muscles and tendons to make sure they are working properly.
Not known (frequency cannot be estimated from available data)

You have frequent infections such as fever, severe chills, sore throat or mouth ulcers. 
These could be signs of a blood problem called ‘leucopenia’ or ‘agranulocytosis’.

You may bruise more easily than usual. This could be due to a blood problem called 
‘thrombocytopenia’.

You feel tired, faint or dizzy and have pale skin. These could be symptoms of something 
called ‘anemia’.

You feel weak, short of breath, bruise more easily than usual and get infections more 
easily than usual. These could be symptoms of something called ‘aplastic anemia’.


Page 12 of 12

Weakening of the heart muscle (cardiomyopathy) resulting in difficulty breathing, 
coughing, high blood pressure, swelling, increased heart rate, low amount of urine.

Low blood sugar levels (hypoglycaemia). You may feel a sense of nervousness, shaky or 
sweaty.

You notice yellowing or your skin or your eyes or your urine becomes darker in colour. 

Fits.

Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue.
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer 
than a few days:
Very common side effects (may affect more than 1 in 10 people)

Stomach pain

Feeling sick
Common side effects (may affect less than 1 in 10 people)

Skin rashes, itching

Being sick, diarrhea

Loss of appetite (anorexia)

Headache

Changes in mood with uncontrollable laughing or crying
Uncommon side effects (may affect less than 1 in 100 people)

Changes in the colour of your skin or the inside of your nose or mouth

Hair loss or loss of hair colour

Feeling nervous

Ringing in the ear (tinnitus)

Balance problems (vertigo) or feeling dizzy

Liver problems shown by blood tests
Not known (frequency cannot be estimated from available data)

Psoriasis (red scaly patches on the skin usually affecting the knees, elbows and scalp)

Hearing loss

Mental problems (such as delusions, hallucinations and changes in mood)

Symptoms of a condition called ‘porphyria’ which may include stomach pain, being sick, 
fits, blisters, itching
If any of the side effects gets serious, or if you get any side effects talk to your doctor and Dr. 
Beato. This includes any possible side effects not listed here. 

Prot_004.pdf: 
Page 1 of 23
Version Date: 04.27.2020
PROTOCOL TITLE:
Open label non-comparative trial of the combination of Hydroxychloroquine and 
Azithromycin in the treatment of hospitalized patients with moderate or severe 
COVID-19 infection
PRINCIPAL INVESTIGATOR:
Cristina Beato, M.D.
Executive Director of Health Policy, UNM Health Sciences Center
cbeato@salud.unm.edu
505-272-5033
VERSION NUMBER:
8
DATE: 04/27/2020
REGULATORY FRAMEWORK:
Please indicate all that apply:
DOD (Department of Defense)
DOE (Department of Energy)
DOJ (Department of Justice)
ED (Department of Education)
EPA (Environmental Protection Agency)
FDA (Food and Drug Administration)
HHS (Department of Health and Human Services)
VA
Other:      
FUNDING:
Indicate if the protocol is funded.  If so, provide sponsor and SPO Click ERA record 
number (FPXXXXX) – Not funded.
Is this a clinical trial per the NIH definition of a Clinical Trial?   
 Yes   
 No
NIH Definition of a Clinical Trial: 
A research study in which one or more human subjects are prospectively assigned to one 
or more interventions. An "intervention" is defined as a manipulation of the subject or 


Page 2 of 23
Version Date: 04.27.2020
subject’s environment for the purpose of modifying one or more health-related 
biomedical or behavioral processes and/or endpoints. Examples include: drugs/small 
molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery 
systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related 
behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment 
strategies; prevention strategies; and, diagnostic strategies (which may include placebo or 
other control) to evaluate the effects of those interventions on  health-related biomedical 
or behavioral outcomes. 
Use the following four questions to determine the difference between a clinical study 
and a clinical trial:       
1)
Does the study involve human participants? 
 Yes   
 No
2)
Are the participants prospectively assigned to an intervention? 
 Yes   
 No
3)
Is the study designed to evaluate the effect of the intervention on the participants? 
 Yes   
 No 
4)
 Is the effect being evaluated a health-related biomedical or behavioral outcome? 
 Yes   
 No
Note that if the answers to the 4 questions are yes, your study meets the NIH definition of 
a clinical trial, even if… 

You are studying healthy participants

Your study does not have a comparison group (e.g., placebo or control)

Your study is only designed to assess the pharmacokinetics, safety, and/or 
maximum tolerated dose of an investigational drug

Your study is utilizing a behavioral intervention
If yes to all 4 questions, please confirm that the research team is familiar with and agrees 
to comply with the investigator requirement to register the study on the ClinicalTrials.gov 
database. Additionally, the approved consent document(s) must be uploaded to the 
ClinicalTrials.gov database    
 Yes   
 No 
For any assistance with registration of your trial or the requirements, please contact HSC-
CTSCResearchConcierge@salud.unm.edu 


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Table of Contents
1.
Objectives.....................................................................................................................6
2.
Background ..................................................................................................................6
3.
Study Design ................................................................................................................6
4.
Inclusion and Exclusion Criteria ..................................................................................6
5.
Number of Subjects......................................................................................................6
6.
Study Timelines............................................................................................................7
7.
Study Endpoints ...........................................................................................................7
8.
Research Setting...........................................................................................................7
9.
Resources Available.....................................................................................................7
10.
Prior Approvals.........................................................................................................8
11.
Multi-Site Research ..................................................................................................8
12.
Study Procedures ......................................................................................................9
13.
Data Analysis..........................................................................................................10
14.
Provisions to Monitor the Data to Ensure the Safety of Subjects...........................10
15.
Withdrawal of Subjects...........................................................................................10
16.
Data Management/Confidentiality..........................................................................11
17.
Data and Specimen Banking...................................................................................12
18.
Risks to Subjects.....................................................................................................13
19.
Potential Benefits to Subjects .................................................................................13
20.
Recruitment Methods..............................................................................................13
21.
Provisions to Protect the Privacy Interests of Subjects ..........................................14
22.
Economic Burden to Subjects.................................................................................14
23.
Compensation .........................................................................................................15
24.
Compensation for Research-Related Injury............................................................15
25.
Consent Process......................................................................................................15
26.
Documentation of Consent .....................................................................................18
27.
Study Test Results/Incidental Findings ..................................................................19
28.
Sharing Study Progress or Results with Subjects...................................................19
29.
Inclusion of Vulnerable Populations ......................................................................20
30.
Community-Based Participatory Research.............................................................21
31.
Research Involving American Indian/Native Populations .....................................21
32.
Transnational Research...........................................................................................21
33.
Drugs or Devices ....................................................................................................22
34.
Principal Investigator’s Assurance .........................................................................22
35.
CHECKLIST SECTION ........................................................................................24
36.
Partial Waiver of Consent for Screening/Recruitment ...........................................24
37.
Partial Waiver of HIPAA Authorization for Screening/Recruitment.....................25
38.
Waiver of Documentation of Consent ....................................................................25
39.
Alteration of Consent..............................................................................................26
40.
Full Waiver of Consent/Parental Permission..........................................................27
41.
Full Waiver of Consent/Parental Permission (Public Benefit or Service Programs)
28
42.
Full Waiver of HIPAA Authorization (Checklist)..................................................28
43.
Other Waiver Types (Checklist).............................................................................29
44.
Vulnerable Populations (Checklist)........................................................................29


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45.
Medical Devices (Checklist)...................................................................................35
46.
Export Control (Checklist) .....................................................................................36
47.
Data Transfer/Sharing (Checklist)..........................................................................36
48.
Specimen Transfer/Sharing (Checklist)..................................................................37


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1. Objectives
1.1. To measure the duration of viral shedding in respiratory secretions of 
patients with moderate or severe COVID-19 infection treated with the 
combination of Hydroxychloroquine and azithromycin.
1.2. Evaluate the case fatality rate, the clinical response and length of stay in 
hospitalized patients with moderate and severe COVID-19 infection.
1.3. To report the safety of the drug combination in hospitalized patients with 
moderate and severe COVID-19 infection.
2. Background
2.1. There is in vitro evidence of activity of Chloroquine against SARSCoV 2. 
There are several studies that have shown that the use of Azithromycin 
may improve outcomes in viral respiratory tract infection. There is 
preliminary clinical data that suggest that the combination of HCQ and 
Azithromycin can decrease viral shedding in respiratory secretions and 
improve clinical outcome of patients with COVID-19 respiratory 
infection. Both drugs are relatively safe, and have been used for many 
years for other indications.
3. Study Design
3.1. Open label non-comparative prospective trial.
4. Inclusion and Exclusion Criteria
4.1. Adults aged >18 years of age to 74 years of age with lower respiratory 
infection with SARSCo2 documented by a positive RT-PCR in 
nasopharyngeal sample admitted to the University of New Mexico 
Hospital, with an oxygen saturation of less than 96%, on room air, or a 
respiratory rate >20 per minute, or HR >120 per minute of a 
PaO2/FIO2<150.
4.2. Patient with life expectancy >48 hours. 
4.3. Pregnant women may be included if deemed necessary. There is 
insufficient information regarding the safety of hydroxychloroquine and 
azithromycin during pregnancy. Consequently, these medications are not 
recommended when pregnant or planning to become pregnant. However, 
investigators may prescribe hydroxychloroquine and azithromycin if 
deemed necessary. 
4.4. Azithromycin is excreted in human milk, therefore participants should not 
breast-feed whilst taking Azithromycin, because it may cause side effects 
including diarrhoea and infection to a baby. It is recommended to discard 
the milk during treatment and up until 2 days after discontinuation of 
treatment. Additionally, hydroxychloroquine should not be taken whilst 
breast-feeding. However, investigators may prescribe 
hydroxychloroquine and azithromycin if deemed necessary.


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4.5. Adults unable to consent will be included with the consent of their Legally 
Authorized Representative (LAR). Assent will be pursued from cognitively 
impaired participants if they are able to provide assent. Note that this does not 
preclude the enrollment of cognitively impaired participants that cannot provide 
assent, but would allow those that can the opportunity to do so.  
4.6. The following will be excluded:

Prisoners

No Intensive Care Unit (ICU) transfers from outside entities regardless of 
age

No nursing home transfers regardless of ageAnyone older than 74 years

Pre-/co-existing medical conditions, including any of the following:

Known allergy to study drugs.

Contraindication to treatment with study drugs, including 
retinopathy, and QTc prolongation defined by QTc>450 in 
males and >470 in females. Unless, it is the opinion of the 
treating physician(s) that the benefits to treat with medications 
outweigh the risks. 

Known chronic kidney diseaseor receiving dialysis.

Glucose-6-phosphate dehydrogenase (G6PD) deficiency. 
Weight <40 kg.

Current use of: hydrocholoroquine or cardiac medicines of: 
flecainade, Tambocor; amiodarone Cordarone, Pacerone; 
digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, 
Procanbid, propafenone, Rythmal.
4.7. English and Spanish speaking participants only will be enrolled.
5. Number of Subjects
5.1. This is a single-site study at the University of New Mexico Hospital.
5.2. Up to 10,000 participants will be enrolled.
5.3. As an observational trial conducted during a national emergency, no power 
analysis is necessary.
6. Study Timelines
6.1. Description of Study timelines are as follows:

Participants will participate in the study for the duration of their stay at 
UNMH and after discharge, as determined by the PI and treating physician.

Participants will be enrolled on an on-going basis with no defined end date.

The anticipated completion of the study is 5 years from date of IRB 
approval/study initiation.


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7. Study Endpoints
7.1 Negative PCR test from nasopharyngeal swabs or oropharyngeal swabs in non- 
ventilator dependent patient or tracheal secretions in ventilator dependent patient on 
days 3, 6, and 14.
7.2 Resolution of clinical signs and symptoms of COVID19 infection, LOS, and 
patient outcome.
7.3 Drug related adverse event that motivates therapy discontinuation.
8. Research Setting
8.1. The study will be conducted at the University of New Mexico Hospital and 
Health Sciences Center.
8.2. Laboratory analysis will be performed at the UNM HSC, Tricore Reference 
Laboratories and/or the NM Department of Health.
9. Resources Available
9.1. Cristina Beato, MD is the principal investigator for this research study. Dr. Beato 
is an Associate Professor with the Department of Family and Community 
Medicine. She also serves as the UNM School of Medicine Chancellor’s Office 
as the Executive Director of Health Policy. 
9.2. Meghan Brett, MD is an Associate Professor within the Division of Infectious 
Diseases, Department of Internal Medicine.
9.3.  Nestor Sosa, MD, FACP is the Division Chief of Infectious Diseases, 
Department of Internal Medicine. 
9.4. David Pitcher, MD, FACS is a  Senior Associate Dean for Clinical 
Affairs, UNM School of Medicine, the Chief Medical Officer, UNM 
Hospitals and a Clinician Ed - Professor: SOM Surgery General.
9.5. Patients will be recruited from those admitted to UNM Hospital and diagnosed 
with COVID-19, and will be dependent upon the number of patients actually 
admitted and progression of their disease as determined by the treating physician.
9.6. Depending on the patient´s condition, care will be provided by the Hospital 
Medicine Teams or Intensive Care unit teams in general wards and ICU specially 
selected for COVID-19 patients.
9.7. Investigators will utilize the medications under an IND. At this time, it is unclear 
what company will supply the medications. Most probably, the supplier will have 
obtained and IND from the FDA. A modification will be submitted to clarify 
who will supply the study drugs. 
9.8. The Executive Director of Research at the UNM Health Sciences Center Office 
of Research will be working with institutional officials to ensure the use of viral 
transport media and swabs during the study do not interfere with adequate 
supplies available for clinical use. A modification will be submitted to clarify 
who will supply the swabs and the transport media (i.e. TriCore, UNMH). 
10.Prior Approvals


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10.1. Departmental Scientific Review will be submitted as a modification once study 
has received approval. 
10.2. Drug attachment included
10.3. Material Transfer Agreement(s) will be secured before any material is 
transferred in or out of UNM. The fully executed MTA will be provided in a 
future modification. 
11.Multi-Site Research: Not applicable 
The PI will be responsible for conducting the following:

Trial Monitoring

Investigational Product Accountability

Safety and other interim reporting to investigators and FDA

Unanticipated Problem reporting to investigators, IRBs, and FDA
12.Study Procedures 
12.1.
Eligibility of the potential study participants will be identified by their 
treating providers (Hospital Medicine and Intensive Care Unit). The treating 
providers will notify representatives of the research team. Members of the 
research team will verify the eligibility of the potential subjects and will obtain 
informed consent from them or their LAR. 
12.2.
Once the participant or their LAR gives their written informed 
consent, the research team will notify the treating provider so they can 
place the medical order for the investigational products. If LAR consented 
via phone or conference phone call, a copy of the consent form will be 
mailed, faxed or sent by secure email to LAR. 
12.3.
The Investigational regimen consisted of Hydroxychloroquine 
(HCQ) 200mg po tid for 10 days and Azythromycin 500mg IV or po for 5 
days. After extensive review of the latest literature, investigators are 
revising the HCQ dose. The new doseage is as follows: HCQ 400 mg BID 
on day 1 and then 200 mg BID day 2 through 7 and Azithromycin 500 mg 
IV or po for 5 days. If the condition of the patient does not allow for oral 
therapy, HCQ can be given via a feeding or NG tube. Azithromycin can 
be given intravenously.
12.4.
Sample collection:
Nasopharyngeal and oropharyngeal swabs will be collected from the participants 
on day 3, 6 and 14.  In intubated patients in which an oropharyngeal sample 
cannot be obtained, alternatively a tracheal secretion sample can be obtained.
12.5.
Information from clinical parameters will be obtained from the electronic 
medical record. A separate electronic dataset (using RedCap) will be constructed 
to capture the most important clinical information on the patients at the time of 
presentation including the following: demographic information (gender, age, 


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DOB, place of residence, ethnicity and race), presenting and daily symptoms and 
signs (including fever, cough, SOB, sputum production, anosmia, hyposmia, 
fatigue, sore throat, nasal congestion, diarrhea, headache, vital signs, pulmonary 
auscultatory findings), initial and subsequent  results of laboratory tests (Arterial 
blood gases WBC, lymphocyte count, Hbg, platelet count, , PaO2, O2 saturation, 
AST, ALT, LDH, Alkaline phosphatase, creatinine, urea nitrogen, lactate level, , 
Fibrinogen or IL-6 levels if available) results of radiographic studies and 
microbiological results, need for oxygen or mechanical ventilation.
12.6.
Each person participating in this Study will be assigned a randomly 
generated study ID that will be linked to identifiers (MRN, DOB) in a linking 
table to be kept separate from the research data. Data and specimens will be 
labelled with the study ID only. Only HRRC-approved members of the study 
team who have the appropriate training will have access to the data and 
identifiers. All data that we collect in this study will be entered into REDCap, a 
secure data-base, on a password-protected computer using a secure network.  Any 
hard copy records/data will be kept in a locked file cabinet in the locked office of 
a designated member of the Study team.  The specimens will be kept and stored 
in the Clinical and Translational Science Center at the UNM HSC and can only 
be accessed by the members of the study team.  Investigators will transport the 
specimens to TriCore Reference Laboratories for lab analysis through standard 
transport hospital procedures.  After testing, any left-over samples will be 
delivered in part to CDC for validation testing, and in part to the CTSC for 
genomic sequencing.  Once data collection is complete, data will be de-identified 
by destruction of the linking table. 
12.7.
 EKG or direct QtC calculation based on telemetry strip will be obtained at 
baseline as well as daily to exclude individuals with prolonged QT while on both 
agents.  Investigators are limiting exposure and PPE use for a technician doing 
these tests.  As such, this should not need to be done daily. Investigators calculate 
the QtC on the telemetry and are working on getting an EKG machine to be put in 
the ICU so the nurse could do it as needed.  Investigators are having a hard time 
getting echos or any other procedure done in the ICU unless the investigators do 
it as no one wants to come in and we are running through our PPE supply.   
12.8.
Continue to follow-up with participants at home via phone call if 
participants discharged <14 days. 
12.9.
Continue to follow-up with participants if they are in the hospital > 14 
days. 
12.10.
There are 5 patients who received the combination product before the 
approval of the protocol. These patients will be contacted via phone, consented 
via phone, after which, their data will be extracted as outlined in the protocol. 
12.11.
Important variables are as follows: 
-
Result of the RT PCR test done on days 3, 6 and 14 as well as the 
determination i.e. positive or negative. 


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-
Overall clinical evaluation of the patients as determined by the treating 
provider. 
-
Frequency of Complications related to COVID19 (ARDS, AKI, Metabolic 
Acidosis, Shock, Secondary infections, Multi-organ failure and death)  
-
Final disposition of the patient.
-
Frequency of adverse events (including GI symptoms, QTc prolongation, 
visual disturbances, retinopathy)
13. Provisions to Monitor the Data to Ensure the Safety of Subjects
13.1. A DSMB will be convened to include clinicians specializing in infectious 
diseases and biostatisticians. The roster will be provided in a Modification for 
HRRC approval once the DSMB has been created.
.
13.2. Review of data after 20 participants have been enrolled. 
13.3. Considering the novelty and rapidly changing situation of the COVID-19 
pandemic, the investigators will review relevant publications that may help 
informed decisions related to the efficacy and safety of the investigational 
products.
13.4. The procedures for analysis and interpretation of the safety data.
The occurrence of any serious adverse event will be notified to the HRRC in 
accordance to GCP regulations. An analysis of all adverse events will be 
presented with the analysis of the first 20 patients enrolled and periodically 
thereafter. We propose to conduct periodic analysis every 20 patients.
13.5. The conditions that would trigger a suspension or termination of the research 
(i.e., stopping rules), are as follows:
If available published information convincingly reports non-efficacy or  
significant safety concerns about HCQ+Azithromycin combination
If in the opinion of the investigators an unexpectedly high incidence of serious 
adverse events is detected during the trial. 
If during the preliminary analyses less that 15% of the patients achieve and 
undetectable viral load on day 6.
13.6. The plan for reporting findings to the sponsor, investigators, and HRRC.
A preliminary analysis of the study end points will be performed after 20 
patients have been enrolled and end-points reached. The results will be 
presented to the HRRC and investigators.
14. Withdrawal of Subjects
14.1. Subjects will be withdrawn if the PI determines, in consultation with the 
treating clinician(s) that continuation in the study is not in the participant’s best 
interest. Subjects may also withdraw (or be withdrawn by their LAR at their 


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request at any time during their participation in the study by contacting a 
member of the study team.
14.2. If a patient develops a serious adverse event that may be probably or definitely 
related to either drug, that may trigger the discontinuation of the offending drug.
14.3. If a participant is withdrawn from the study, chart review will continue to be 
performed to track the participant’s clinical outcomes.
14.4. Data and specimens collected before withdrawal will not be removed from the 
study.
15. Data Management/Confidentiality
15.1. Participants will be assigned a randomly generated study ID that will be linked 
to identifiers (MRN, DOB) in a linking table to be kept separate from the 
research data. Data and specimens will be labelled with the study ID only.
15.2. Only HRRC-approved members of the study team who have the appropriate 
training will have access to the data and identifiers.
15.3. Data will be entered into REDCap on a password-protected computer using a 
secure network.
15.4. Any hard copy records/data will be kept in a locked file cabinet in the locked 
office of a designated member of the study team
15.5. The specimens will be kept and stored in the Clinical and Translational Science 
Center at the UNM HSC and can only be accessed by the members of the study 
team.  Then specimens will be transported to TriCore Laboratory and can only 
be accessed by laboratory personnel for the purpose specified in the protocol. 
15.6. Once data collection is complete, data will be de-identified by destruction of the 
linking table. Study records will be kept for 6 years past study closure.
16. Data and Specimen Banking: Not applicable 
17. Risks to Subjects
17.1.
Risks of hydroxychloroquine include headache, dizziness, loss of 
appetite, nausea, diarrhea, stomach pain, vomiting and skin rash.
17.2.
 Risks of azithromycin include mainly gastro-intestinal symptoms, 
as well as cardiovascular, genitourinary, nervous system, allergic reaction 
and fatigue.
17.3.
Risk of retinopathy. 
17.4.
Administration of study drugs individually or in combination may have 
risks to the subjects that are currently unforeseeable. Review of the clinical record 
as well as monitoring by the DSMB as described above will be conducted to 
mitigate these risks.


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17.5.
Risks also include a loss of privacy and/or confidentiality. This will be 
mitigated by conducting all study activity in private areas of the hospital and 
labelling all data/specimens with a study ID. 
17.6.
Suicidal ideation is also potential risk. 
17.7.
Unforeseen risk to participants, and if applicable, to an unborn fetus. 
17.8.
Refer to the Protocol Appendix for the detailed list of risks associated with 
hydroxychloroquine and azithromycin. 
18. Potential Benefits to Subjects
18.1. Participants may benefit from reduction in/elimination of the viral load 
associated with their condition, and a reduction of morbidity and mortality 
associated with COVID-19 infection and sequelae. 
19. Recruitment Methods
19.1. Once the result of the initial COVID19 test is reported as positive, the provider 
will ask potential participants and/or their LAR for permission to be approached 
by a member of the research team for recruitment.
19.2. The study staff will screen the patient’s electronic medical record for potential 
eligibility. This will allow the research team to review the potential participant’s 
medical records in detail and assist in determining eligibility. Once consent is 
obtained, specific research tests or procedures for determining eligibility for the 
study can then be conducted.  Investigators will inform a potential participant or 
their LAR that eligibility must be checked and verified prior to enrollment on 
the study.  There is still a possibility that potential subjects may not ultimately 
be eligible and thus cannot participate in the research study.
19.3. The member of the research team will verify if the potential participant fulfills 
the inclusion/exclusion criteria and will proceed to enroll the patient.
20. Provisions to Protect the Privacy Interests of Subjects
20.1.
 All study procedures will be conducted in the participant’s room or other 
private area of the hospital.
21. Economic Burden to Subjects
21.1.
 The study is responsible for the cost of any research-related procedures. 
The participant and/or third party payer us responsible for any standard of care 
procedures. However, if the University of New Mexico cannot bill the 
participant’s insurance company, Medicare, or Medicaid for the medical 
procedures done strictly for research, a participant may have to pay out-of- pocket 
for these costs.
21.2.
Investigators do not anticipate any additional costs. 
22. Compensation: Not applicable 
23. Compensation for Research-Related Injury


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23.1. The University of New Mexico does not have funds set aside to pay for the cost 
of any care or treatment that might be necessary or for any wages lost as a result of 
participating in this study. Medical costs to care and treatment of study related harm 
will be billed to the participant and/or third party payer. 
24. Consent Process
24.1.
An approved member of the study team will conduct the consent process 
with the participant and/or their LAR, and if applicable, their witnesses 
(witness/translator for Spanish speaking participant and impartial witness of 
phone consent) in a private area of the hospital or by phone if needed. If the 
consent is performed over the phone, an impartial witness of the phone consent 
will be utilized. 
24.2.
It may not be possible to have an in-person discussion of the study with 
participants or their LAR, and their witnesses as applicable. Investigators may 
need to conduct a phone consent via conference phone call because the 
investigator, participant or their LAR and the witnesses (as applicable) may not 
be in the same location. Documenting written informed consent in these instances 
must involve a process as follows: the participant or their LAR and witnesses 
receives a copy of the informed consent document in advance of a telephone 
discussion. The investigator obtains consent over the telephone with the 
participant or their LAR and if applicable the impartial witness of the phone 
consent and if applicable the witness/translator for a Spanish speaking participant. 
If the participant or their LAR consented via phone, a copy of the consent will be 
mailed, faxed or sent via secure email to participant or their LAR. 
24.3.
The informed consent form may be mailed, emailed or faxed to the 
participant or their LAR and to their witnesses (as applicable). The consent 
discussion may then be conducted by phone, conference phone call or in person 
so that  the participant  or participcant’s LAR and participant’s witnesses (as 
applicable) can read the consent form during the discussion.
24.4.
Investigators will explain the study to the potential participant or their 
LAR and if applicable to their witnesses by reading the  informed consent 
document to the participant and/or LAR and if applicable their witnesses, 
providing all pertinent information (purpose, procedures, risks, benefits, 
alternatives to participation), and allowing the potential participant or their LAR 
ample opportunity to ask questions. This can be done by phone, conference phone 
callor in person. 
24.5.
Investigators will ensure a thorough verbal discussion was conducted by 
phone, conference phone call or in person of the consent form. Investigators will 
allow the potential participant or LAR time to read the consent form and allow 
the participant or their LAR sufficient time to consider whether or not to 
participate in the research.


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24.6.
Investigators will ensure the potential participant or their LAR’s additional 
questions have been addressed. 
24.7.
Participants and/or their LAR will be asked to explain the purpose of the 
study, procedures involved, and/or conditions for participation to confirm 
understanding.
24.8.
If the participant or LAR agrees to participation, s/he signs the consent 
form and returns it to the investigator for signature and date. If informed consent 
took place via the phone or via conference phone call, the signed and dated 
consent form can be returned to investigators by mail, fax, or by scanning the 
consent form and returning it through a secure e-mail account by the participant 
or their LAR and by the witnesses as applicable. It is possible that multiple 
consent forms will be obtained for a single participant because the investigator 
obtaining consent, the participant or their LAR, and their witnesses (as 
applicable) were not in the same location but together via conference phone call. 
In this instance, each separate consent will be signed and dated by each individual 
appropriately. All dates on the multiple consent forms will be congruent for the 
day the consent took place. In these instances, a note-to-file will explain that 
separate consent forms exist for a single participant because all individuals could 
not be in the same room and that the consent took place over a conference phone 
call in an effort to decrease the contact and exposure to the novel coronavirus. 
24.9.
Once the signed consent form or if applicable forms are received, the 
investigator who conducted the informed consent will ensure the participant or 
their LAR receives a copy of the signed consent form or forms as applicable. The 
fully signed original consent form or forms will be filed with the participant’s 
study records along with the note-to-file that details the consent process.
24.10.
Alternately, on a case-by-by case basis, and per the FDA regulation 21 
CFR 50.23 Exception from general requirements, the following will be done:
(a) The obtaining of informed consent shall be deemed feasible unless, before use 
of the test article (except as provided in paragraph (b) of this section), both the 
investigator and a physician who is not otherwise participating in the clinical 
investigation certify in writing all of the following: 
(1) The human subject is confronted by a life-threatening situation necessitating 
the use of the test article. 
(2) Informed consent cannot be obtained from the subject because of an inability 
to communicate with, or obtain legally effective consent from, the subject. 
(3) Time is not sufficient to obtain consent from the subject's legal representative. 
(4) There is available no alternative method of approved or generally recognized 
therapy that provides an equal or greater likelihood of saving the life of the 
subject. 


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(b) If immediate use of the test article is, in the investigator's opinion, required 
to preserve the life of the subject, and time is not sufficient to obtain the 
independent determination required in paragraph (a) of this section in advance 
of using the test article, the determinations of the clinical investigator shall be 
made and, within 5 working days after the use of the article, be reviewed and 
evaluated in writing by a physician who is not participating in the clinical 
investigation.
(c) The documentation required in paragraph (a) or (b) of this section shall be 
submitted to the HRRC as a Reportable New Information (RNI) within 5 
working days after the use of the test article.
The documentation to be used within the RNI is titled “Informed Consent 
Exception from General Requirements”. The form can be completed via 
eSignatures by utilizing the fillable form or hand written signatures by 
utilizing the non-fillable form.
24.11.
Ongoing consent from participants and and/or their LAR will be 
ascertained as research procedures are being conducted.
Subjects not fluent in English
24.11.1.
Given the public health emergency surrounding this research, non-
English speaking patients may be included in the study, and this will only 
include Spanish speaking individuals. 
24.11.2. The consent process will be conducted by a member of the study team 
fluent in the Spanish language and/or with the assistance of a qualified 
interpreter.
24.11.3. The qualified interpreter can serve as the witness of the informed 
consent process. If the interpreter is a study team member, they will not 
serve as the impartial witness to the informed consent process when there 
is a phone consent or conference call informed consent. The interpreter 
can sign the informed consent form in the section that states they have 
witnessed the informed consent process. Additionally, the interpreter, by 
signing, confirms the informed consent was verbally reviewed with the 
participant or the LAR in addition to the HRRC approved short consent 
form and the informed consent form functioned as the summary of the 
discussion.  
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally 
Authorized Representative
24.11.4. Some participants are expected to be cognitively impaired, either due to 
a pre-existing condition, or because of conditions related to their infection 
with COVID-19. Cognitively impaired participants will be enrolled in the 
study with the consent of their LAR.


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24.11.5. The study team, in consultation with the clinical care provider, will 
determine if a participant has capacity to consent. Specifically, the 
investigators will utilize the Capacity to Consent Quiz with the consent 
form. After the consent form has been discussed with the participant, the 
investigator will administer the Capacity to Consent Quiz. Based on the 
results, the investigators will determine if the participant has the ability to 
consent. 
24.11.6. Capacity to consent will be evaluated by the study team, in consultation 
with the clinical care provider, as part of the ongoing consent process as 
described above. If the participant regains capacity to consent, a member 
of the study team will conduct the consent process as described above.
24.11.7. We will obtain evidence of agency under a durable power of attorney or 
surrogate health decision maker status under the NM Uniform Health Care 
Decisions Act, NMSA 1978, 24-7A-1 et seq.  
Subjects who are not yet adults (infants, children, teenagers)
N/A
Waiver or Alteration of Consent Process (consent will not be obtained, required 
element of consent will not be included, or one or more required elements of 
consent will be altered) 
Waivers of consent and HIPAA authorization are requested for screening/ 
recruitment purposes. For the waiver of HIPAA authorization, the Data 
Warehouse will generate a daily list of patients with documented positive 
COVID-19 with their locations in the hospital. The attending will be contacted via 
tigerconnect to consent and start the treatment. 
25. Documentation of Consent
25.1. For English-speaking participants (or LARs), consent will be documented using 
an HRRC-approved consent document.
25.2. For Spanish speaking participants (or LARs), a Short Form of Consent in their 
preferred language will be used to document consent.
26. Study Test Results/Incidental Findings
26.1. Results of the nasopharyngeal RT-PCR will be share with study participants and 
their inpatient medical attending. Test result will be posted in the electronic 
medical record. The information on clinical parameters will be available in the 
electronic medical record as is customary .All laboratories are performed in a 
CLIA certified Laboratory.
27. Sharing Study Progress or Results with Subjects
See section 26.1
28. Inclusion of Vulnerable Populations


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N/A
29. Community-Based Participatory Research
N/A 
30. Research Involving American Indian/Native Populations
N/A 
31. Transnational Research
N/A 
32. Drugs or Devices
32.1. The investigational drugs will be store and handle by the inpatient pharmacy of 
the Institution in accordance to their standard operating procedures and 
investigational product requirements.
33. Principal Investigator’s Assurance
By submitting this study in the Click IRB system, the principal investigator of this study 
confirms that:
☒ The information supplied in this form and attachments are complete and correct.  
☒ The PI has read the Investigator’s Manual and will conduct this research in accordance 
with these requirements. 
 ☒ Data will be collected, maintained and archived or destroyed per HSC Data Security 
Best Practices, including:
1. Best Practice for data collection is for it to be directly entered onto a data 
collection form that is in a secured access folder on an HS drive behind a firewall, 
or in a secure UNM Data Security approved system such as RedCap.
2. Data collection of de-identified data, if done in a clinical setting or other setting 
that does not allow direct entry into a secured system, may be done temporarily 
using a personal or university owned electronic storage device or hard copy 
document. The important security safeguard is that no identifiers be include if 
the data is entered or stored using an untrusted device or storage.
3. Permanent (during data analysis, after study closure) storage must reside on 
HSC central IT managed storage. Processing of data (aggregation, etc.) are to be 
carried out in such a way as to avoid creating/retaining files on untrusted storage 
devices/computers. Trusted devices are HSC managed and provide one or more 
of following safeguards: access logs, encryption keys, backups, business 
continuity and disaster recovery capabilities.


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4. Alternate storage media must be approve by HSC IT Security as meeting or 
exceeding HSC central IT provided security safeguards.


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34. CHECKLIST SECTION
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB.  Please complete all checklists relevant to your research.
35. Partial Waiver of Consent for Screening/Recruitment
Complete this checklist if you are requesting a partial waiver of consent so that you can review 
private information to identify potential subjects and/or determine eligibility prior to 
approaching potential subjects for consent or parental permission.
A. Describe the data source that you need to review (e.g., medical records):
Medical record
B. Describe the purpose for the review (e.g., screening):
Screening and recruitment 
C. Describe who will conducting the reviews (e.g., investigators, research staff):
Principal Investigator or other member of the study team
D. Do all persons who will be conducting the reviews already have permitted access to the 
data source?
      
 Yes
            
 No. Explain:      
i. Verify that each of the following are true or provide an alternate 
justification for the underlined regulatory criteria:
1. The activity involves no more than minimal risk to the subjects 
because the records review itself is non-invasive and the results of the 
records review will not be used for any purposes other than those 
described above.
 True
 Other justification:      
2. The waiver or alteration will not adversely affect the rights and 
welfare of the subjects because eligible subjects will be approached for 
consent to participate in the research and are free to decline.  Further, 
the information accessed during the records review will not be 
disclosed to anyone without a legitimate purpose (e.g., verification of 
eligibility).
 True
 Other justification:      


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3. The research could not practicably be carried out without the waiver or 
alteration because there is no other reasonably efficient and effective 
way to identify who to approach for possible participation in the 
research.  
 True
 Other justification:      
4. Whenever appropriate, potentially eligible subjects will be presented 
with information about the research and asked to consider 
participation.  (Regulatory criteria: Whenever appropriate, the 
subjects will be provided with additional pertinent information after 
participation.)
 True
 Other justification:      
36. Partial Waiver of HIPAA Authorization for Screening/Recruitment
Complete the following additional questions/attestations if the records you will review to identify 
potential subjects and/or determine eligibility include Protected Health Information (PHI).
A. Will you be recording any PHI when conducting the records review to identify potential 
subjects and/or determine eligibility?
            
 Yes. Describe:      
            
 No
B. If you answered “Yes” to question 6 above, please describe when you will destroy 
identifiers (must be the earliest opportunity consistent with the conduct of the research) 
or provide justification for why they must be retained:
     
C. The PHI accessed or recorded for identification/screening purposes will not be reused or 
disclosed to (shared with) any other person or entity, except as required by law, for 
authorized oversight of the research study, or for other research for which the use or 
disclosure of the PHI would be permitted under the Privacy Rule.
      
 True
            
 False
37. Vulnerable Populations (Checklist)
A. Adults with Cognitive Impairments


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Complete this checklist if the subject population will include adults with cognitive 
impairments.  
This checklist does not need to be completed if the research doesn’t involve 
interactions or interventions with subjects and will be conducted under a waiver of 
consent.
1. Describe why the objectives of the study cannot be met without inclusion of 
adults with cognitive impairments.
COVID-19 infection may affect persons with pre-existing cognitive 
impairment for whom no SOC treatment exists. COVID-19 infection can cause 
conditions resulting in cognitive impairment.
2. Describe how capacity to consent will be evaluated.
By the research team in consultation with clinical care provider
3. If subjects may regain capacity to consent, or if subjects may have fluctuating 
capacity to consent, describe your plans to evaluate capacity to consent 
throughout the research and to obtain consent to continue participation if 
capacity is regained.
Capacity to consent will be assessed as part of the ongoing consent process
4. Describe your plans, if any, to provide information about the research to 
subjects and the steps you will take to assess understanding.
The investigators will utilize the Capacity to Consent Quiz with the consent 
form. After the consent form has been discussed with the participant, the 
investigator will administer the Capacity to Consent Quiz. Based on the 
results, the investigators will determine if the participant has the ability to 
consent.
5. Describe your plans to obtain assent, including whether assent will be 
obtained from none, some, or all subjects.
Assent will be obtained from those participants able to give assent. 
6. Describe why risks to subjects are reasonable in relation to anticipated 
benefits to the subjects.
There is no SOC treatment for COVID-19 infection
7. If this study involves a health or behavioral intervention, describe why the 
relation of the anticipated benefit to the risk of the research is at least as 
favorable to the subjects as that presented by alternative procedures.
There is no SOC treatment for COVID-19 infection


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8. Describe your plans for monitoring the well-being of subjects including any 
plans to withdraw subjects from the research if they appear to be unduly 
distressed.
     
38. Data Transfer/Sharing (Checklist)
Complete this checklist if the research involves transferring/sharing of data with an external 
entity (institution, company, etc.). 
A. Will data be transferred/shared with an external entity (institution, company, etc.)?  
 Yes
 No. The remainder of this section does not apply. 
B. Indicate if the data is incoming and/or outgoing:        
C. Provide the name of the entity that data will be transferred/shared with:      
D. Provide the contact name, email and phone number with whom data is being             
transferred/shared with:      
E. Who is responsible for transmission of the data?           
F. Who is responsible for receiving the data?      
G. Describe how the data will be transferred/shared. Please note data cannot be 
transferred/shared without assistance from UNM HSC IT. Requesting HSC Central IT 
Transfer is detailed on the Sponsored Projects website:           
H. For data being transferred/shared with outside locations or entities, describe the 
following:

Where is data storage and how will it be maintained in a secure manner (i.e. 
encryption, password protection, use of Qualtrics or REDCap, etc)?      

What is method in which data will be collected and stored (i.e. electronic, hard 
copy, etc)?           

How long will the data be stored?           

Who will have access to data?        
I.
 Please list all specific data elements, variables, etc. to be sent out and/or received. 
Indicate if the data contains identifiers and health information. Please note that identifiers 
that MUST be removed to make health information de-identified are as follows: Names, 
All geographic subdivision smaller than a State, All elements of year (except year), 
Telephone, Fax numbers, E-mail addresses, Social Security, Medical record number, 
Health plan beneficiary, Account numbers, Certificate/license numbers, Vehicle 
identifiers and serial numbers, Device identifiers and serial numbers, Web URLs, IP 
address numbers, Biometric identifiers, full face photographic images, and Any other 
unique identifying number, characteristic or code.)           
J.
If the research requires the access, use, or disclosure of any of the 18 individually 
identifiable protected health information (PHI) identifiers that can be used to identify, 
contact, or locate a person (e.g., name, medical record number, etc.), are the subjects 


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going to consent to or authorize the disclosure of their individually identifiable health 
information?       
a.
Or is HIPAA authorization altered or waived?          
K. What is the classification of the data (de-identified, limited data set, protected health 
information, other).      
L. Does the request to transfer/share data include clinical data that belongs to the UNM 
Health Systems?      
M. Does the data to be transferred/shared include information about patients seen at external 
health system or at a third party medical provider?      
N. Is the external entity a “covered entity”?        
O. Is the data that is going to be transferred/shared owned or partially owned by another 
party or have any type of restrictions including regulatory restrictions (i.e. HIPAA, 
FERPA, etc.)?      
P. Is the data publically available? If yes, please provide details:      
Q. Does the data include information about substance abuse treatment, sexually transmitted 
diseases, genetic testing results, HIV/AIDS testing results, and/or mental health?         
39. Specimen Transfer/Sharing (Checklist)
Complete this checklist if the research involves transferring/sharing of specimens with an 
external entity (institution, company, etc.). 
A. Will specimens be transferred/shared with an external entity (institution, company, etc.)? 
      
 Yes
 No. The remainder of this section does not apply. 
B. Indicate if the specimens are incoming and/or outgoing: TriCore, CDC
C. Provide the name of the entity that specimens will be being transferred/shared with: 
     
D. Provide the contact name, email and phone number with whom specimens are being 
transferred/shared with:      
E. Who is responsible for sending out the specimens? Please note specimens cannot be sent 
out without a fully executed material transfer agreement.      
F. Who is responsible for receipt of the specimens? Please note specimens cannot be 
received without a fully executed material transfer agreement.            
G. For specimens being transferred/shared with outside locations or entities, describe the 
following:

Where is specimen storage and how will it be maintained in a secure manner?      

What is method in which specimens will be collected and stored?      

How long will the specimens be stored?      

Who will have access to the specimens?