Clinical trial NCT04678830
Conditions: Coronavirus Disease 2019
Keywords: COVID-19
Sponsor: CytoDyn, Inc.
Start date: 2021-03-01; Completion date: 2021-07-08
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injections in subjects experiencing prolonged symptoms (\> 12 weeks) of COVID-19.

Detailed description:
This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with prolonged symptoms caused by Coronavirus Disease 2019 (COVID-19). Patients will be randomized to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.

The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period. Total study duration is 91 days. The study will be conducted at up to 5 centers in the United States and planned number of subjects are 50 subjects.

Visit schedule:

Visit 1 - Screening assessment Visit 2 - baseline, first dose Visit 3 - no dose, baseline+3 days Visit 4 - second dose, baseline + 7 days Visit 5 - no dose, safety assessment/con med, baseline +10 days Visit 6 - third dose, baselines + 14 days Visit 7 - no dose, safety assessments, baseline + 17 days Visit 8 - fourth dose, baseline +21 days Visit 9 - no dose, safety assessment, baseline + 24 days Visit 10 - fifth dose, baseline + 28 days Visit 11 - no dose, safety assessment, baseline + 31 days Visit 12 - sixth dose, baseline + 35 days Visit 13 - no dose, safety assessment, baseline + 38 days Visit 14 - seventh dose, baseline + 42 days Visit 15 - no dose, safety assessment, baseline + 45 days Visit 16 - eighth and final dose, baseline + 49 days Visit 17 - End of treatment, baseline + 56 days

Arms: arm 1: Syringes containing normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo. arm 2: Each vial of active contains 350mg of leronlimab at a concentration of 175mg/ml (nominal 2mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections
Interventions: intervention 1: Placebos intervention 2: Leronlimab (700mg)
Intervention descriptions: intervention 1: Placebos intervention 2: Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)

Protocol documents:
Prot_SAP_ICF_001.pdf: 
CONFIDENTIAL
Page 1 of 101
A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate 
the Efficacy and Safety of Leronlimab in Patients Experiencing Prolonged 
Coronavirus Disease 2019 (COVID-19) Symptoms [Long-Haulers]
Protocol Number:
CD15_COVID-19
Version:
5.0
Date:
26-May-2021
Sponsor:
CytoDyn, Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
(360) 980-8524-Work
(360) 980-8549-Fax
www.cytodyn.com
Confidentiality Statement
This document is a confidential communication of CytoDyn, Inc. It is provided for the conduct 
of a clinical research study. The information contained in this document is confidential and, except 
to the extent necessary to obtain informed consent or IEC/IRB approval, cannot be disclosed unless 
required by governmental regulation. Persons to whom any portion of the contents of this 
document is disclosed must be informed that the information is confidential and may not be further 
disclosed by them.


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PROTOCOL APPROVAL PAGE
Protocol Number:
CD15_COVID-19
Version:
5.0
Date:
26-May-2021
We, the undersigned, have reviewed this protocol and agree that it contains all relevant information 
required to meet FDA, GCP and all applicable regulatory guidelines and statutes.
PROTOCOL APPROVAL FOR USE
Date
Date
Date
Date
Date


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INVESTIGATOR’S SIGNATURE PAGE
Protocol Number:
CD15_COVID-19
Version:
5.0
Date:
26-May-2021
I have read the protocol specified above and agree to participate in and comply with the procedures, 
as outlined herein for the conduct of this clinical trial. I also agree to comply with US Food and 
Drug Administration (FDA) and other global regulatory authority regulations and Investigational 
Review Board/Institutional Ethics (IRB/IEC) requirements for testing on human subjects. I agree 
to ensure that the requirements for obtaining informed consent are met.
Principal Investigator’s Signature
Date
Print Name
Site Number


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SPONSOR INFORMATION
Sponsor Office:
CytoDyn, Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
(360) 980-8524-Work
(360) 980-8549-Fax
www.cytodyn.com
CONTRACT RESEARCH ORGANIZATION INFORMATION


















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TABLE OF CONTENTS
PROTOCOL SYNOPSIS..............................................................................................................5
TABLE OF CONTENTS ............................................................................................................13
List of Tables.................................................................................................................................18
List of Figures ...............................................................................................................................19
List of Abbreviations.....................................................................................................................20
1
INTRODUCTION AND BACKGROUND..........................................................................22
1.1.
Statement of Intent ..............................................................................................................22
1.2.
Background of the Disease..................................................................................................22
1.3.
Leronlimab (PRO 140)........................................................................................................23
1.4.
Summary of Prior Pre-Clinical and Clinical Studies...........................................................23
1.4.1.
Pre-Clinical Studies with PRO 140...................................................................23
1.4.2.
Clinical Studies with PRO 140..........................................................................24
1.5.
Study Rationale ...................................................................................................................35
1.6.
Risks / Benefits Assessment................................................................................................37
2. STUDY OBJECTIVES..........................................................................................................39
3. STUDY DESIGN....................................................................................................................40
3.1.
Study Center........................................................................................................................41
3.2.
Study Population .................................................................................................................41
3.3.
Eligibility Criteria................................................................................................................41
3.3.1.
Inclusion Criteria...............................................................................................41
3.3.2.
Exclusion Criteria..............................................................................................42
4. STUDY SCHEDULE.............................................................................................................44
4.1.
Screening Phase...................................................................................................................49
4.1.1.
Screening Visit (V1)..........................................................................................49
4.2.
Treatment Phase ..................................................................................................................50


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4.2.1.
Visit 2 (V2)........................................................................................................50
4.2.2.
Visits 3, 5, 7, 9, 11, 13, and 15 (V3, V5, V7, V9, V11, V13, and V15) ...........51
4.2.3.
Visits 4, 6, 8, 10, 12, 14, and 16 (V4, V6, V8, V10, V12, V14, and V16) .......51
4.2.4.
End of Treatment – EOT (V17) ........................................................................52
4.3.
Follow-Up Phase.................................................................................................................53
4.3.1.
Visit 18 ..............................................................................................................53
4.4.
Unscheduled Visits..............................................................................................................53
5. SUBJECT COMPLETION, WITHDRAWAL AND CRITERIA FOR STOPPING THE 
STUDY....................................................................................................................................54
5.1.
Subject Completion .............................................................................................................54
5.2.
Early Stopping Rules...........................................................................................................54
5.3.
Removal of Subjects from Study Treatment and/or Study as a Whole...............................54
5.4.
Data Collected from Withdrawn Subjects...........................................................................55
5.5.
Screen Failures ....................................................................................................................55
6. STUDY TREATMENT .........................................................................................................56
6.1.
Leronlimab (PRO 140)........................................................................................................56
6.1.1.
Leronlimab (PRO 140) - Packaging and Labeling............................................56
6.1.2.
Leronlimab (PRO 140) - Storage and Handling................................................57
6.1.3.
Leronlimab (PRO 140) - Administration ..........................................................58
6.1.4.
Leronlimab (PRO 140) - Post Injection Monitoring .........................................58
6.1.5.
Leronlimab (PRO 140) – Toxicity Management ..............................................58
6.1.6.
Leronlimab (PRO 140) - Disposition................................................................59
6.1.7.
Leronlimab (PRO 140) - Accountability...........................................................59
7. DESCRIPTION OF PROTOCOL ASSESSMENTS AND PROCEDURES ...................61
7.1.
Informed Consent................................................................................................................61
7.2.
Assessment of Eligibility.....................................................................................................61
7.2.1.
Re-screening......................................................................................................61
7.3.
Demographic Information ...................................................................................................61
7.4.
Medical History...................................................................................................................62
7.5.
Physical Examination..........................................................................................................62
7.6.
Vital Signs, Height and Weight...........................................................................................63


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7.7.
Concomitant Medications....................................................................................................63
7.7.1.
Excluded Medications.......................................................................................64
7.7.2.
Allowable Medications and Therapies..............................................................64
7.8.
Clinical Laboratory Assessments ........................................................................................64
7.9.
Study Treatment Application ..............................................................................................65
7.10. Pulse Oxygen Saturation (SpO2) ........................................................................................65
7.11. 12-Lead Electrocardiogram.................................................................................................66
7.12. Requirement of Hospitalization...........................................................................................66
7.13. Randomization.....................................................................................................................66
7.14. Clinical Symptom Score......................................................................................................66
7.15. Patient Symptom Diary .......................................................................................................67
7.16. PROMIS® Fatigue Scale .....................................................................................................67
7.17. PROMIS® Cognitive Function............................................................................................67
7.18. PROMIS® Sleep Disturbance..............................................................................................67
7.19. Global Health Assessment...................................................................................................67
8. STATISTICAL ANALYSIS .................................................................................................68
8.1.
Treatment Groups................................................................................................................68
8.2.
Description of Study Outcomes (Endpoints).......................................................................68
8.2.1.
Primary Endpoint ..............................................................................................68
8.2.2.
Secondary Endpoints.........................................................................................68
8.2.3.
Exploratory Outcome Measures (Endpoints)....................................................69
8.2.4.
Safety Measures ................................................................................................69
8.3.
Sample Size Determination and Rationale..........................................................................70
8.4.
Randomization.....................................................................................................................70
8.5.
Stratification ........................................................................................................................70
8.6.
Blinding...............................................................................................................................70
8.7.
Time to Unblinding .............................................................................................................70
8.7.1.
Emergency Unblinding......................................................................................70
8.7.2.
Final Analysis....................................................................................................71
8.8.
Interim Analysis ..................................................................................................................71


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8.9.
General Statistical Considerations.......................................................................................71
8.9.1.
Analysis Populations.........................................................................................71
8.9.2.
Covariates..........................................................................................................72
8.9.3.
Missing Data......................................................................................................72
8.10. Analysis Methods................................................................................................................72
8.10.1.
Subject Disposition ...........................................................................................72
8.10.2.
Demographic and Baseline Characteristics.......................................................72
8.10.3.
Concomitant Medications/Therapies.................................................................73
8.10.4.
Efficacy Analyses..............................................................................................73
9. ADVERSE EVENTS (DEFINITIONS AND REPORTING) ............................................75
9.1.
Adverse event (AE).............................................................................................................75
9.2.
Reporting of Adverse Events ..............................................................................................75
9.2.1.
Impact on Study Treatment...............................................................................75
9.2.2.
CTCAE Grade (Intensity) Assessment..............................................................75
9.2.3.
Causality Assessment........................................................................................76
9.2.4.
Treatment Given as a Result of the Event.........................................................77
9.2.5.
Outcome Assessment ........................................................................................77
9.3.
Serious Adverse Events.......................................................................................................77
9.4.
Reporting of Serious Adverse Events (SAE) ......................................................................78
9.5.
SAE Follow-Up...................................................................................................................78
9.6.
Expected/anticipated events ................................................................................................79
10. DIRECT ACCESS TO SOURCE DATA/DOCUMENTATION ......................................80
11. QUALITY CONTROL AND QUALITY ASSURANCE...................................................81
11.1. Monitoring Requirements....................................................................................................81
11.2. Acceptability of Case Report Forms (CRFs) ......................................................................81
11.3. Modification of Protocol .....................................................................................................81
11.4. Reporting Protocol Deviations ............................................................................................82


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11.4.1.
Major Protocol Deviation or Violation .............................................................82
11.4.2.
Minor Protocol Deviation or Violation .............................................................82
12. DATA SAFETY MONITORING COMMITTEE (DSMC)...............................................84
13. ETHICS AND REGULATORY REQUIREMENTS .........................................................85
13.1. Institutional Review Board/Independent Ethics Committee (IRB/IEC) .............................85
13.2. Investigator’s Responsibilities ............................................................................................85
13.3. Subject Informed Consent Requirements............................................................................86
14. DATA HANDLING AND RECORD KEEPING................................................................87
14.1. Recording and Collection of Data.......................................................................................87
14.2. Clinical Data Management..................................................................................................87
14.3. Archiving.............................................................................................................................87
15. PUBLICATION PLAN .........................................................................................................89
16. REFERENCES.......................................................................................................................90
17. APPENDICES........................................................................................................................94
17.1. Appendix 1: Patient Diary Template...................................................................................94
17.2. Appendix 2: Common Terminology Criteria for Adverse Events v5.03 ............................97
17.3. Appendix 3: PROMIS® Fatigue Scale................................................................................98
17.4. Appendix 4: PROMIS® Cognitive Function- Short Form 4a.............................................99
17.5. Appendix 5: PROMIS® Sleep Disturbance – Short Form 4a...........................................100
17.6. Appendix 6 – Global Health Questionnaire ......................................................................101


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LIST OF TABLES
Table 1-1:
List of Completed Clinical Studies with Leronlimab (PRO 140) ...........................32
Table 1-2:
List of Ongoing Clinical Studies with Leronlimab (PRO 140)...............................33
Table 4-1:
Treatment Groups....................................................................................................45
Table 4-2:
Schedule of Assessments.........................................................................................46
Table 6-1:
Treatment Administration Summary.......................................................................56
Table 6-2:
Investigational Product - Leronlimab (PRO 140) ...................................................56
Table 6-3:
Leronlimab (PRO 140) - Management for Injection Site Reactions.......................59
Table 6-4:
Leronlimab (PRO 140) - Management for all Other Potential Toxicities (Attributable 
to Leronlimab).........................................................................................................59
Table 7-1:
Lab Parameters........................................................................................................65
Table 9-1:
CTCAE v5.0 General Guidelines............................................................................76


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LIST OF FIGURES
Figure 3-1:
Study Schematic......................................................................................................40
Figure 6-1:
Investigational Product - Vial Label .......................................................................57
Figure 6-2:
Investigational Product - Kit Label .........................................................................57


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LIST OF ABBREVIATIONS
Abbreviation
Term
AE
Adverse Event
ALT
Alanine Transaminase
ARDS
Acute Respiratory Distress Syndrome
ART
Antiretroviral Therapy
AST
Aspartate Aminotransferase
CCR5
C-C chemokine receptor type 5
CD
Cluster of Differentiation
CFR
Code of Federal Regulations
Cmax
Maximal Concentration 
CNS
Central Nervous System
COVID-19
Coronavirus Disease 2019
CRF
Case Report Form
CRO
Contract Research Organization
CS
Clinically Significant
CTCAE
Common Terminology Criteria for Adverse Events
eCRF
Electronic Case Report Form
CV
Curriculum Vitae
DSMC
Data Safety Monitoring Committee
ECG
Electrocardiogram
EOT
End of Treatment
FDA
U.S. Food and Drug Administration
FDP
Finished Drug Product
FUV
Follow-up Visit
GCP
Good Clinical Practice
GFR
Glomerular Filtration Rate
GMP
Good Manufacturing Practice
HEENT
Head, Ears, Eyes, Nose, and Throat
HIPAA
Health Insurance Portability Accountability Act
HIV
Human Immunodeficiency Virus
IA
Interim Analysis
IC
Inhibitory Concentration
ICF
Informed Consent Form
ICH
International Conference on Harmonization


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Abbreviation
Term
ICU
Intensive Care Unit
IEC
Independent Ethics Committee
IND
Investigational New Drug
IP
Investigational Product
IRB
Institutional Review Board
ISR
Injection Site Reaction
ITT
Intent to Treat
IV
Intravenous
IWRS
Interactive Web Based Response System
LAR
Legally Authorized Representative
LTF
Lost to Follow-Up
MedDRA
Medical Dictionary for Regulatory Activities 
mg
Milligram
MTD
Maximum Tolerated Dose
NEWS
National Early Warning Score 2
OBT
Optimized Background Therapy
PD
Pharmacodynamic
PK
Pharmacokinetic
PI
Principal Investigator
SAE
Serious Adverse Event
SARS-CoV-2
Severe Acute Respiratory Syndrome Coronavirus 2
SC
Subcutaneous
SOP
Standard Operating Procedure
SpO2
Peripheral Capillary Oxygen Saturation
SV
Screening Visit
TEAE
Treatment Emergent Adverse Event
TNBC
Triple Negative Breast Cancer
Treg
T regulatory cell
V
Visit
VL
Viral Load


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1
INTRODUCTION AND BACKGROUND
1.1.
STATEMENT OF INTENT
The design, conduct and reporting of this study shall be conducted in compliance with the protocol, 
International Conference on Harmonization/Good Clinical Practice (ICH/GCP), and all appropriate 
regulatory requirements. Investigator(s) participating in this study will have documented training 
in GCP. Independent monitoring of the trial will be accomplished utilizing a Contract Research 
Organization (CRO).
1.2.
BACKGROUND OF THE DISEASE
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the viral cause of coronavirus 
disease 2019 (Covid-19) was first identified in late 2019 in Wuhan, Hubei province, China. On 11 
March 2020, the World Health Organization declared the disease a global pandemic. The global 
burden of SARS CoV-2 infection continues to increase with estimates of more than 37 million 
people infected and over one million deaths as of October 2020.
While some individuals infected with SARS-CoV-2 may be asymptomatic, the majority of people 
display symptomatic disease varying from mild to critical in severity. Severe-to-critical illness is 
typically marked by hypoxemic respiratory failure requiring ventilatory support. Morbidity and 
mortality rates are elevated among patients with pre-existing co-morbidities such as cardiovascular 
disease, diabetes mellitus, chronic respiratory disease, hypertension and cancer. The observed case 
fatality ratio (CFR) varies considerably from country to country and over time. However, the CFR 
in the USA has been estimated at 2.8%. While public discourse on COVID-19 has largely centered 
around patients with severe or fatal illness, it has become apparent that a growing number of patients 
experience mild to moderate symptoms for a prolonged period of time.
A patients and survivors of COVID-19 from the Body Politic COVID-19 Support Group created 
and analyzed a survey targeted at patients experiencing symptoms for over two weeks. Responses 
from 
640 
patients 
were 
collected 
between 
April 
21 
and 
May 
2, 
2020 
(https://patientresearchcovid19.com/research/report-1/). 
Key findings were symptoms are not limited to cough, fever, and shortness of breath. Other widely 
reported symptoms span neurological, gastrointestinal, cardiovascular, and other systems and 
include fatigue (reported by 81.3% of respondents), chills/sweats (75.9%), body aches (73.9%), 
headache (72.2%), brain fog and concentration issues (68.6%), gastrointestinal issues (66.9%), 
trouble sleeping (66.1%), and dizziness (60.6%). An elevated temperature under 100.1°F was 
reported by 72.2% of respondents while a fever over 100.1°F was reported by only 47.8% of 
respondents. The other key finding was recovery is volatile, includes relapses, and can take six or 
more weeks. At the time respondents took the survey, 90.6% reported not being recovered and 
were, on average, on day 40 of experiencing symptoms. 89% of respondents said that their 


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symptoms fluctuated in intensity and frequency, and 70% reported new symptoms appearing at 
different stages of their illness. Based on textual responses and anecdotes from the support group, 
patients may feel better for days or weeks only to relapse into old or new symptoms soon after.
The aim of this study is to test efficacy and safety of leronlimab (PRO140) for treatment of adult 
patients with prolonged symptoms of Coronavirus disease 2019 (COVID-19).
1.3.
LERONLIMAB (PRO 140)
Leronlimab (PRO 140) is a humanized IgG4,
monoclonal antibody (mAb) to the C-C chemokine 
receptor type 5 (CCR5), under development as a therapy for human immunodeficiency virus (HIV) 
infection, Coronavirus disease 2019 (COVID-19), cancer, and other diseases, including Graft 
versus host disease (GVHD) and Nonalcoholic steatohepatitis (NASH).
Leronlimab (PRO 140) has been administered intravenously or subcutaneously to more than 1000 
patients across multiple studies. Leronlimab has been generally well-tolerated and no patterns of 
drug-related toxicities have been observed.
1.4.
SUMMARY OF PRIOR PRE-CLINICAL AND CLINICAL STUDIES
1.4.1. Pre-Clinical Studies with PRO 140
In vitro and in vivo preclinical studies have been conducted to determine the pharmacokinetic, 
immunogenicity, and toxicity profiles of leronlimab (PRO 140) following IV and SC 
administration. Several acute and chronic toxicity studies have been conducted to support the 
clinical development plan. 
Acute toxicity of leronlimab (PRO 140) was evaluated in New Zealand rabbits, following IV 
administration of 5 or 15 mg/kg. Chronic toxicity was evaluated in cynomolgus monkeys following 
biweekly administration of IV doses up to 10 mg/kg for six months and biweekly administration of 
various SC doses up to 50 mg/kg for 24 weeks. The drug was generally well tolerated. Biweekly 
administration of IV doses up to 10 mg/kg for six months resulted in minimum to mild lymphoid 
hyperplasia in assorted lymph nodes and spleen, which was considered an expected immune 
response to a foreign protein. Biweekly administration of SC doses up to 50 mg/kg for 24 weeks 
resulted in minimum injection-site reactions (minimal, multifocal, mononuclear cell infiltrates in 
the subcutis), which were considered due to an inflammatory response to the injected antigen. 
Monkeys tolerated treatment with leronlimab (PRO 140) for 24 weeks without evidence of local or 
systemic toxicity. Leronlimab (PRO 140) caused no mortality, cageside observations, in-life 
injection-site observations, or gross pathologic findings. Chronic treatment with leronlimab (PRO 
140) did not affect body weight, food consumption, hematology, clinical chemistry or coagulation 
parameters.


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Both IV and SC administration resulted in elimination half-lives of approximately 200 hours, and 
overall exposure increased with increasing doses. Following SC administration of leronlimab (PRO 
140) in monkeys, the maximal concentration (Cmax) was achieved within 56 hours and 
bioavailability for leronlimab (PRO 140) after SC dosing was approximately 70%.
1.4.2. Clinical Studies with PRO 140
Current human experience with leronlimab (PRO 140) consists of ten completed and nine ongoing 
clinical trials, mostly on healthy subjects or HIV-1 positive subjects. These studies are summarized 
in Table 1-1 and Table 1-2. In all clinical trials, the majority of adverse events (AEs) have been 
mild or moderate. No dose-limiting toxicities or patterns of drug-related toxicities were observed. 
Antiviral activity was potent, rapid, prolonged, dose-dependent, and highly significant.
1.4.2.1.
PRO 140 1101 Study
For the first-in-human trial, PRO 140 1101, the drug was administered IV at 0.1, 0.5, 2.0, or 5.0 
mg/kg to healthy subjects and was generally well tolerated, non-immunogenic, and without 
clinically relevant toxicity. Treatment Emergent Adverse Events (TEAEs) did not increase with 
rising PRO 140 dose levels. Seventy-five percent (75%) of subjects reported TEAEs, most of which 
were deemed unrelated to study treatment by the investigator.
1.4.2.2.
PRO 140 1102 Study
For PRO 140 1102, the majority of AEs, other than injection-site reactions, were considered mild 
and possibly related to drug administration. The majority of injection-site reactions were considered 
mild, self-resolving, and definitely related to drug administration. PRO 140 derived from Chinese 
Hamster Ovary (CHO) cells and administered at 100 mg/mL was generally well tolerated in 
healthy, normal volunteers. Overall, PRO 140 administered SC using Autoject® 2 appeared better 
tolerated than manual injection.
1.4.2.3.
PRO 140 1103 Study 
In PRO 140-1103, administration of PRO 140 at 350 mg using Autoject® 2 appeared well tolerated. 
Manual injections, on the other hand, were associated with a greater number of AEs. There did not 
appear, however, to be any substantial difference in subject perception of pain or discomfort related 
to site of drug administration. No anti-PRO 140 antibodies were detected in any subjects in this 
study. There was a tendency of higher exposure associated with SC administration of PRO 140 at 
350 mg in the abdomen and the thigh. A higher number of AEs were associated with injections in 
the arm. Based on these observations, thigh and abdominal administration of PRO 140 were 
preferred over arm injection.
1.4.2.4.
PRO 140 1302 Study


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The initial proof-of-concept study was a randomized, double-blind, placebo-controlled study in 
subjects with early-stage, asymptomatic HIV infection, only R5 HIV-1 detectable, and no 
antiretroviral therapy for 12 weeks [Jacobson, 2008]. Subjects (n=39) were randomized to receive 
a single IV injection of placebo or PRO 140 at doses of 0.5, 2, or 5 mg/kg. Subjects were monitored 
for antiviral effects, safety, and PRO 140 pharmacokinetics (PK) for 58 days. 
PRO 140 demonstrated potent, rapid, prolonged, and dose-dependent antiviral activity. Intravenous 
PRO 140 was generally well tolerated. No drug-related serious events or dose-limiting toxicity was 
observed [Jacobson, 2008]. The most common adverse events (headache, lymphadenopathy, 
diarrhea, and fatigue) were observed at similar frequencies across the placebo and PRO 140 dose 
groups. There was no significant effect on QTc intervals or other electrocardiographic parameters, 
and there were no remarkable laboratory findings.
1.4.2.5.
PRO 140 2301 Study
PRO 140 2301 was a multi-center, randomized, double-blind, placebo-controlled, parallel group 
study in 30 male and female adult subjects infected with HIV-1 [Jacobson, 2010]. Subjects were 
randomized to one of three groups (N=10/group), each receiving one of three treatments: (i) a single 
IV dose of 5 mg/kg by 30-minute IV infusion; (ii) a single IV dose of 10 mg/kg by 30-minute IV 
infusion; (iii) a single placebo dose by 30-minute IV infusion. The objective of the study was to 
assess and characterize the PK and PD of PRO 140 administered by IV infusion, assess efficacy at 
a new dosage level, and safety and tolerability of single doses of PRO 140.
All PRO 140-treated subjects had more than 10-fold reduction in viral loads [Jacobson, 2010]. Both 
the 5 mg/kg and 10 mg/kg doses have shown favorable tolerability and no dose-limiting toxicity 
has been observed. High levels of receptor occupancy (>85% reduction in the number of cells 
detected) were observed for 29 days after treatment with both 5 and 10 mg/kg doses. 
1.4.2.6.
PRO 140 2101 Study
A subcutaneous (SC) form of PRO 140 was tested in HIV-infected subjects. The trial was a 
randomized, double-blind, placebo-controlled study in subjects (n=44) with early-stage, 
asymptomatic HIV infection, only R5 HIV-1 detectable, and no antiretroviral therapy for 12 weeks 
[Thompson, 2009]. Placebo (n=10) and three PRO 140 doses were examined: 162 mg weekly for 
three weeks (n=11), 324 mg weekly for three weeks (n=11), and 324 mg biweekly (every other 
week) for two doses (n=12). Subjects were followed for 44 days after the final dose. 
Potent, dose-dependent and highly statistically significant antiviral activity was observed. The trial 
established the first antiviral proof of concept for a long-acting, self-administrable drug for HIV-1
infection [Thompson, 2009].
Subcutaneous PRO 140 was generally well tolerated both locally and systemically. There was no 
obvious dose-related pattern of toxicity. The most common adverse events (diarrhea, headache, 


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lymphadenopathy and hypertension) were mild to moderate and self-resolving. These events are 
common in HIV infection and were reported with similar frequencies in the placebo and PRO 140 
treatment groups. Administration-site reactions were mild, transient, and observed in a fraction of 
subjects. 
1.4.2.7.
PRO 140 CD01 Study
PRO 140_CD01 study (open-label, 43 subjects, multi-center) evaluated the efficacy, safety, and 
tolerability of PRO 140 monotherapy (350 mg subcutaneous injection weekly for up to 12 weeks) 
for the maintenance of viral suppression following substitution of antiretroviral therapy in HIV-1
infected patients (with exclusive CCR5-tropic virus). Participants in this study were experienced 
HIV-infected individuals who were virologically suppressed on combination antiretroviral therapy. 
Consenting patients were shifted from combination antiretroviral regimen to PRO 140 monotherapy 
for 12 weeks. 
Forty-three (43) subjects (M/F: 37/3) with median age of 54.5 years (26-72) and median CD4 T-
cell count of 604.5 cells/mm3 (365-1240) were enrolled in the CD01 study. Overall, twenty-two 
out of 40 (55%) enrolled subjects completed 12 weeks of PRO140 monotherapy without 
experiencing virologic failure. Virologic failure was defined as two consecutive HIV-1 RNA levels 
to have Dual/Mixed (D/M) tropism [1 at baseline and 2 at the time of virologic failure] and 37 
subjects were found to have exclusive CCR5-tropic virus. A letter of amendment was filed to 
increase the planned number of subjects from 40 to 43 subjects to compensate for the 3 Dual/Mixed 
subjects enrolled in the study.
All virologic failure subjects who had available lab data in both studies achieved viral suppression 
to < 400 HIV-1 RNA copies/mL, as well as viral suppression to ‘Non Detectable’ or < 50 HIV-1
RNA copies/mL after re-initiation of ART. 
The by-subject analysis of PhenoSense® Entry Assay data for PRO140, maraviroc, and AMD3100 
shows no significant changes in the post-treatment IC50 and IC90 values were noted when 
compared with baseline values in virologic failure and non-virologic failure groups of subjects. As 
the aggregate analysis shows for initial 40 subjects, the subjects who experienced virologic failure 
had higher IC90 value for PR0140 at baseline compared to subjects without virologic failure. The 
mean IC90 for subjects who experienced virologic failure was higher (10.84 µg/mL) than the IC90 
for subjects without virologic failure (6.70 µg/mL) in the CD01 study (p=0.0115). 
Anti-PRO140 antibodies were not identified in any post-treatment sample and data derived from 
the CD01 study further supports the favorable PRO140 PK profile data generated from both pre-
clinical as well as prior Phase 1/2 clinical trials.


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Safety data were analyzed for all 43 enrolled subjects. One (1) of 43 subjects experienced an SAE 
that was deemed not related to the study drug by the Principal Investigator. Twenty-eight (28) of 
43 subjects (67%) experienced one or more adverse events (AEs) after receiving at least one dose 
of PRO140. The most commonly occurring AEs were infections and infestation conditions which 
were reported by 14 of 43 (32.5%) subjects. The majority of the reported AEs (62/87; 71.2%) were 
deemed either unlikely or not related to study treatment by the Investigator. Similarly, the majority 
of the reported AEs (70/87; 80.4%) were deemed mild in nature. 
1.4.2.8.
PRO 140_CD01 Extension Study
PRO 140_CD01-Extension study (open-label, 28 subjects, multi-center) seeks to evaluate the 
efficacy, safety, and tolerability of PRO 140 monotherapy (350 mg subcutaneous injection weekly) 
for the continued maintenance of viral suppression following substitution of antiretroviral therapy 
in HIV patients (with exclusive CCR5-tropic virus). Participants in this study were HIV-infected 
individuals who were virologically suppressed on combination antiretroviral therapy and completed 
the first 12 weeks of CD01 study without experiencing virologic failure. As with the CD01 study, 
virologic failure was defined as two consecutive HIV-
by at least 3 days. Consenting patients may remain on PRO 140 monotherapy until PRO 140 
receives marketing approval or IND is withdrawn by Sponsor. 
A total of 17 subjects participated in the CD01-Extension study of which one subject was 
considered not eligible as subject experienced virologic failure prior to first extension treatment.
Sixteen (16) eligible subjects (M/F: 14/2) with median age of 54.9 years (26-68) and median CD4 
T-cell count of 593 cells/mm3 (365-1059) were enrolled in an extension study. One patient 
discontinued at week 37 (with viral load of <40 copies/mL) due to relocation. Two subjects were 
withdrawn due to non-treatment related SAEs at week 140 and 149, respectively. One subject was 
withdrawn due to re-starting their ART at week 99. Two subjects withdrew consent at week 81 and 
139, respectively. Five (5) subjects experienced virologic failure (VF) (two consecutive viral load 
-691). 
Five (5) subjects are currently receiving weekly 350 mg PRO140 SC monotherapy and have 
completed more than three years of treatment (176 - 198 weeks). Overall, 12 subjects completed at 
least one year of treatment and 9 subjects completed at least two years of treatment in this study
PRO140 was generally well tolerated, and no drug-related SAEs were observed. 
This clinical study is currently ongoing.
1.4.2.9.
PRO 140 CD02 Study
PRO 140_CD02 study (double blind, placebo controlled, 52 subjects, multi-center) seeks to 
evaluate the efficacy, safety, and tolerability of PRO 140 in combination with either existing ART 


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(failing regimen) or Optimized Background Therapy (OBT) in patients infected with HIV-1. The 
study population included 52 adult patients with a documented history of genotypic or phenotypic 
resistance to ART drugs within two or more drug classes who demonstrated evidence of HIV-1
replication despite ongoing antiretroviral therapy and had limited treatment options. The options 
may be limited as a result of drug antiviral class cross-resistance, documented treatment intolerance, 
documented objective assessments such as renal or hepatic insufficiency (e.g. high creatinine at 
baseline, limiting treatment options due to potential for toxicity), past adverse reactions such as 
hypersensitivity reactions or neuropsychiatric issues that could limit use of currently approved 
drugs.
In Part 1 of double-blind treatment period, virally non-suppressed subjects were to be randomized 
and treated with either PRO 140 or Placebo in combination with the failing ART regimen for 7 days 
until HIV-1 genotypic drug resistance assay results are available to construct an OBT. The primary 
-1 RNA viral load 
from baseline at the end of the 7 day functional monotherapy period.
In Part 2 of double-blind treatment period, subjects were to continue treatment with PRO 140 in 
combination with OBT within the 24-week open-label period. 
Fifty-two subjects with a mean age of 52.4 years, 73.1% male, 48.1% non-white and mean duration 
of HIV-1 infection of 20.4 years were randomized 1:1 to the PRO 140 SC or placebo arm. Subjects 
had been previously exposed to an average of 11 ART drugs and had documented resistance to >9 
ART drugs. Mean baseline VL and CD4 cell count were 21,104 c/mL and 297.8 c/mm3,
respectively. The primary efficacy endpoint-
in HIV-1 VL from baseline at the end of the 1-week double-blind, randomized, placebo-controlled 
treatment period- was met (16/25 vs 6/26 [p-value <0.0032, ITT population]). Forty-seven (47) of 
52 patients have completed the 25-week study. Approximately 81% of patients completing 25-
weeks of PRO 140 SC treatment demonstrated HIV-1 VL <50 c/mL and 92% had HIV-1 VL <400 
c/mL. Continued access to PRO 140 SC was provided through a rollover study and 40 patients 
entered the extension protocol after completing the CD02 study. PRO 140 SC was generally well 
tolerated. No drug-related SAEs or treatment discontinuations were reported in the study.
This clinical study is completed.
1.4.2.10.
PRO 140_CD02 Extension Study
PRO 140_CD02 Extension study (open label, 40 subjects, multi-center) seeks to evaluate the long 
term efficacy, safety and tolerability of PRO 140 weekly injection in combination with Optimized 
Background Therapy (OBT) in patients infected with HIV-1. The study population includes 40 
treatment-experienced HIV-infected adult patients with CCR5-tropic virus who successfully 
completed PRO 140_CD02 study and continue to demonstrate HIV-1 viral suppression.


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This clinical study is currently ongoing.
1.4.2.11.
PRO 140 CD03 HIV Study
PRO 140_CD03 HIV (open-label, 350 subjects, multi-center) is a three-part study enrolling virally 
suppressed HIV-1 patients with CCR5-tropic HIV-1 receiving combination antiretroviral (cART) 
therapy. Patients received weekly doses of PRO 140 on single-agent maintenance therapy following 
one week of overlap of the existing cART regimen that is then discontinued. In part 1, 156 
participants received 350 mg PRO 140 SC in a single-arm design. In part 2, 147 participants 
received 350 or 525 mg PRO 140 SC in a 1:1 ratio as randomized controlled, two-arm study. In an 
ongoing part 3, 51 participants have been randomized to receive 525 or 700 mg PRO 140 SC in a 
1:1 ratio. 
Despite reaching the enrollment target of 350 subjects for the PRO140_CD03 HIV study, the 
enrollment is ongoing as the goal of enrolling 20 subjects for the CNS sub-study have not achieved. 
As a result, sites that are currently participating in the CNS sub-study are permitted to continue 
enrollment in the CD03 HIV study.
Of the 354 patients enrolled, median age was 51 yrs (21-77) with the majority reported as male 
(79%) and 37% were non-white. A total of 27 subjects have been randomized to 700 mg dose. In 
addition, another 18 subjects have been exposed to 700 mg dose after rescuing from the lower doses 
(350 mg or 525mg). On average, participants were diagnosed with HIV-1 infection for 16.8 yrs and 
were on cART regimen for 14.8 yrs. The frequency and severity of injection site reactions were 
comparable between the three dose groups (350, 525 and 700mg) and the incidence or severity of 
injection site reactions was not increased in patients receiving higher doses. Overall, PRO 140 SC 
was generally well tolerated at all dose levels in this study.
This clinical study is currently ongoing.
1.4.2.12.
PRO 140_CD03 HIV Extension Study
PRO 140_CD03 study (open-label, 350 subjects, multi-center) seeks to evaluate the long term 
efficacy, safety and tolerability of PRO 140 SC as long-acting single-agent maintenance therapy in 
virologically suppressed subjects with CCR5-tropic HIV-1 infection. The study population includes 
up to 300 treatment-experienced HIV-infected adult patients who successfully completed PRO 
140_CD03 HIV study and continue to demonstrate HIV-1 viral suppression.
This clinical study is currently ongoing.
1.4.2.13.
PRO 140_CD06 Study
PRO 140_CD06 study (double-blind, 80 subjects, single-center) seeks to evaluate the evaluate 
comparability of PRO 140 formulation Batch Lot # 3-FIN-3143 versus formulation Batch Lot# 3-


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FIN-2618 as a one-time subcutaneous (SC) injection in healthy subjects under non-fasting 
conditions. 
This clinical study has been completed.
1.4.2.14.
PRO 140 CD07 Study
CD07_TNBC study (open-label, two-part [Phase Ib: Up to 18 subjects; Phase II: 30 Subjects], 
multi-center) seeks to evaluate the efficacy, safety, tolerability and maximum tolerate dose (MTD) 
of leronlimab (PRO 140) when combined with carboplatin in patients with CCR5+ metastatic triple-
negative breast cancer (mTNBC).
The study population includes patients with CCR5-positive, locally advanced or metastatic triple-
negative breast cancer (mTNBC) who are naïve to chemotherapy in metastatic setting but have been 
exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line).
This clinical study is currently ongoing.
1.4.2.15.
CD08_mCRC Study
CD08_mCRC study (open-label, 30 subjects, multi-center) seeks to evaluate the effect on overall 
response rate (ORR) of Leronlimab (PRO 140) when combined with Regorafenib in patients with 
CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC). 
The study population includes patients with CCR5+, Microsatellite Stable (MSS), metastatic 
Colorectal Cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-
and irinotecan-based chemotherapy, an antiVEGF therapy, and, if RAS wild type, an anti-EGFR 
therapy. 
This clinical study is pending start-up.
1.4.2.16.
CD07_Compassionate Use
CD07_Compassionate Use study (open-label, two-part, multi-center) seeks to evaluate the efficacy, 
safety, and tolerability of leronlimab (PRO 140) when combined Treatment of Physician’s Choice 
in the treatment of patients with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC). The 
study population includes patients with CCR5-positive, locally advanced or metastatic triple-
negative breast cancer (mTNBC).
This clinical study is currently ongoing.
1.4.2.17.
CD09_Basket Study
CD09_Basket study (open-label, 30 subjects, multi-center) seeks to evaluate the anti-tumor activity
of leronlimab (PRO 140) in patients with CCR5+, locally advanced or metastatic solid tumors who 
have disease progression on standard therapy, or receiving a standard anticancer treatment but no 


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subsequent approved treatment would be available upon progression, or unable to receive standard 
therapy, or for whom standard therapy does not exist.
This clinical study is currently ongoing.
1.4.2.18.
CD10 COVID-19
CD10_COVID-19 (two-arm, randomized, double blind, placebo controlled) study seeks to evaluate 
the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of 
respiratory illness caused by coronavirus 2019 infection. Patients were randomized to receive 
weekly doses of 700 mg leronlimab (PRO 140), or placebo via subcutaneous injection.
The study population was 60.7% female and 39.3% male, with an average age of 54.85 years. There 
were 56 subjects treated with leronlimab (PRO 140) and 28 with placebo. 
CD10 study did not meet the pre-defined primary endpoint (change in symptom score at Day 14 
analyzed as a continuous variable) or any of the pre-defined secondary efficacy endpoints (time to 
clinical resolution; change from baseline NEWS score at Days 3, 7, and 14 analyzed by ANCOVA 
method; change from baseline in pulse oxygen saturation Days 3, 7, 14; change from baseline health 
status by 7-point category ordinal scale at Days 3, 7, and 14; Incidence and Duration of 
hospitalization; incidence and duration of mechanical ventilation; incidence and duration of oxygen 
use; mortality at Day 14, or time to return to normal activity).
Post-hoc analyses described below, however did provide additional insights and information which 
helped design the further development of PRO 140 in COVID-19
Day 3 total symptom score results:
62.96% of the 56 subjects in PRO 140 group showed improvement in total symptom score, 
compared to 56% of the 28 subjects in the placebo group. In the sub-population of subjects with 
b (PRO 140) were 
reported with improvement in total symptom score, compared to 71% of subjects in the placebo 
group.
National Early Warning Score 2 (NEWS2) (reported as proportion): 
24 of 56 (50%) of subjects treated with leronlimab (PRO 140) showed improvement from 
baseline in NEWS2 score at EOT visit, compared to 5 of 28 (20.83%) of subjects in the placebo 
group .
Safety was assessed primarily via reporting of adverse events (AEs) and serious adverse events 
(SAEs) throughout the study. In total, 34% (19 of 56 subjects) treated with leronlimab compared to 
50% (14 of 28 patients) treated with placebo reported at least one AE. Additionally, 9% of subjects 
(5/56) reported SAEs in leronlimab group  compared to 21% of subjects (6/28) in the placebo group.
This clinical study has been completed.










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changes to cytokine gene expression may lead to chronic inflammation in Long COVID patients, 
predisposing development of autoimmunity [de Vega et al., 2020; Rasa et al., 2018]. An 
autoimmune model for post-infectious ME/CFS is increasingly recognized [Steiner et al., 2018; 
Sotzny et al., 2018] and could be a determining factor in the progression from post-viral syndrome 
to ME/CFS.
It is likely that chemotaxis induced by CCL5 (RANTES) or other circulating cytokines following 
the binding to the CCR5 receptor contributes to the excessive lung inflammation seen in COVID-
19. Disruption of the CCL5-CCR5 axis via leronlimab-mediated CCR5 blockade might prevent 
pulmonary trafficking of proinflammatory leukocytes and dampen pathogenic immune activation 
in COVID-19 [Patterson et al., 2020]. In Long COVID, dysregulation and chronic activation of 
cytokine signaling can cause prolonged CNS effects. Direct or indirect viral effects on the CNS can 
trigger neuroinflammation—a chronic immune response within the brain involving long-term 
activation of microglia (brain macrophages) and local release of inflammatory cytokines [Lavi & 
Cong, 2020; Barbosa-Silva et al., 2020]. Recent data from macaques is significant in suggesting 
that leronlimab may cross the blood-brain barrier, creating high CCR5 receptor occupancy on CD4+ 
T cells in brain tissue and resulting in detectable free leronlimab in multiple brain regions in 
macaques after subcutaneous dosing [Chang et al., n.d.].
Post-mortem SARS research indicated the virus had crossed the blood brain barrier into the 
hypothalamus via the olfactory pathway [Moldofsky & Patcai, 2011]. The pathway of the virus 
seemed to follow that previously suggested in CFS/ME patients, involving disturbance of lymphatic 
drainage from the microglia in the brain [Hives et al., 2017]. One of the main pathways of the 
lymphatic drainage of the brain is via the perivascular spaces along the olfactory nerves through 
the cribriform plate into the nasal mucosa [Kida et al., 1993]. If the pathogenesis of coronavirus 
affects a similar pathway, it could explain the anosmia (lack of smell) observed in a proportion of 
COVID-19 patients.
The build-up of cytokines in the CNS may lead to post-viral symptoms due to pro-inflammatory 
cytokines passing through the blood brain barrier in circumventricular organs such as the 
hypothalamus, leading to autonomic dysfunction manifesting acutely as a high fever and in the 
longer term to dysregulation of the sleep/wake cycle, cognitive dysfunction and profound 
unremitting anergia, all characteristic of CFS/ME. As happened after the SARS outbreak, a 
proportion of COVID-19 affected patients may go on to develop a severe post viral syndrome we 
term ‘Post COVID-19 Syndrome’ – a long term state of chronic fatigue characterized by post-
exertional neuroimmune exhaustion.
In conclusion, there is ample evidence that cytokine release and the attendant downstream effects 
play a role in low-grade and long-term COVID-19 pathology, and cytokine-induced chemotaxis is 
a known response to cytokine release.


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1.6.
RISKS / BENEFITS ASSESSMENT
Allergic Reaction
Leronlimab (PRO 140) belongs to the monoclonal antibody class of drugs. Monoclonal antibodies 
are sometimes associated with allergic reactions or flu-like reactions (such as fever, chills, and 
aches) or injection-site reactions. These events are usually of short duration if they occur at all. 
Severe allergic reactions, however, can be life-threatening. Although anaphylaxis has not been 
observed in prior trials of leronlimab (PRO 140), the protein infusion always carries theoretical 
risk for anaphylactic shock. Accordingly, whenever leronlimab (PRO 140) is administered to 
subjects, procedures should be available and in place to manage the occurrence of anaphylactic 
shock.
Immune Response
People who take leronlimab (PRO 140) or other monoclonal antibodies can also develop an 
immune response to leronlimab (PRO 140) that may affect their ability to receive monoclonal 
antibodies, or to benefit from diagnosis or therapy with a monoclonal antibody in the future.
Pregnancy
Risks to unborn babies exposed to leronlimab (PRO 140) are unknown at this time; thus pregnant 
females will be excluded from this study. Females of childbearing potential must have a negative 
pregnancy test prior to enrollment. Both male and female patients and their partners of 
childbearing potential must agree to use appropriate birth control methods throughout the study 
duration (excluding women who are not of childbearing potential and men who have been 
sterilized). 
Venipuncture
Blood sampling is required as part of the study protocol. Blood sampling carries a minimal risk 
of minor discomfort and the possibility of minor bruising at the site of the needle puncture and, 
rarely, the possibility of infection at the needle puncture site.
Unknown Risks
As with all research, there is the remote possibility of risks that are unknown or that cannot be 
foreseen based on current information. 
Theoretical risk for increased severity of West Nile virus infection
Individuals who lack a functional CCR5 gene are at increased risk for severe infection by West 
Nile virus [Thompson, 2009]. Because of this, treatment with CCR5 co-receptor antagonists poses 
a theoretical risk for increased severity of West Nile virus infection. However, this concern is 
mitigated by several factors. First, no increased risk was observed for individuals who possess 
one functional and one non-functional CCR5 gene, indicating that an intermediate amount of 


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CCR5 is sufficient for defense against West Nile virus [Thompson, 2009]. Second, use of CCR5 
co-receptor antagonists is unlikely to completely abrogate CCR5 function, and there has been no 
association reported to date between CCR5 co-receptor use and severe West Nile virus. 
Additionally, leronlimab (PRO 140) weakly antagonizes the natural activity of CCR5 and thus is 
less likely to adversely affect immune function. However, patients enrolled in this study may have 
immune suppression and therefore, DSMB and the investigators will be alerted to risks of West 
Nile infections. Furthermore, this has not been established to be a risk with maraviroc, the other 
FDA-approved anti-CCR5 drug already.
Collectively, the experience with both IV and SC, simulation modeling and the recent 
confirmation that a higher concentration of leronlimab (PRO 140) synthesized using a highly 
efficient CHO cell line can be conveniently and safely administered has resulted in the design of 
the current study.


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2.
STUDY OBJECTIVES
The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered 
as weekly subcutaneous injection in subjects experiencing prolonged symptoms (> 12 weeks) of 
COVID-19.




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3.1.
STUDY CENTER
Up to 5 multinational centers. Centers must have the capability of implementing appropriate 
infection-control measures to prevent infection of study staff and others who share the clinical site 
space.
3.2.
STUDY POPULATION
The target population for this study is adult patients with prolonged symptoms of Coronavirus 
disease 2019 (COVID-19).
3.3.
ELIGIBILITY CRITERIA
3.3.1. Inclusion Criteria
Potential subjects are required to meet all of the following criteria for enrollment into the study:
1.
2. Prior confirmed COVID-19 diagnosis by standard RT-PCR assay or equivalent testing
3.
listed below at the time of Screening and currently experiencing two or more of the following 
symptoms consistent with COVID-19 infection for a prolonged period of time (>12 weeks).
Clinical symptoms include the following:
Respiratory symptoms such as cough, sore throat, stuffy or runny nose, shortness of breath 
(difficulty breathing), tightness of chest.
Neurological symptoms such as difficulty in concentration (brain fog), sleep 
disturbance/insomnia, headache, dizziness, anxiety, tingling or numbness, loss of sense of 
smell or taste.
Cardiovascular and Gastrointestinal symptoms such as feeling of fast heartbeat, nausea, 
vomiting, diarrhea.
Musculoskeletal symptoms such as muscle aches/cramps, muscle weakness, joint 
pain/swelling.
General immune response symptoms such as fatigue (low energy or tiredness), chills or 
shivering, feeling hot or feverish, or exertional malaise (feeling of discomfort, illness, or 
lack of well-being after physical activity or mental stress).
Note: Clinical Symptom Score is obtained from the patient diary (refer to Appendix 1 for 
scoring instructions).
4. Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.


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Note: Below are the examples of clinically significant and non-clinically significant ECG 
abnormalities:
ECG findings indicative of acute myocardial infarction or acute ischemic changes 
would be considered clinically significant abnormalities. 
ECG finding such as atrial fibrillation, atrial flutter, paced rhythms in individuals who 
have undergone permanent pacemaker placement, evidence of prior infarction, 
unchanged stable conduction abnormalities e.g. right bundle branch block, or any other 
finding which does not significantly impact mortality would be considered non-
clinically significant findings and subjects with these abnormal findings would be 
allowed to enroll in the study.
5. Subject (or legally authorized representative) provides written informed consent prior to 
initiation of any study procedures.
6. Men and women of childbearing potential and their partner must agree to use two medically 
accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, 
or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, 
combination oral contraceptives, transdermal patches, or contraceptive rings], or one of the 
following methods of birth control (intrauterine devices, bilateral tubal occlusion, or 
vasectomy)  or must practice complete sexual abstinence for the duration of the study (excluding 
women who are not of childbearing potential and men who have been sterilized).
7. Females of child-bearing potential must have a negative urine pregnancy test at Screening Visit 
and prior to receiving the first dose of study drug; and Male participants must agree to use 
contraception and refrain from donating sperm for at least 90 days after the last dose of study 
intervention.
8. Subject is willing and able to comply with scheduled visits, drug administration plan, laboratory 
tests, other study procedures and study restrictions
3.3.2. Exclusion Criteria
Potential subjects meeting any of the following criteria will be excluded from enrollment:
1.
Exhibiting signs of moderate or severe pulmonary disease (such as COPD, asthma, or 
pulmonary fibrosis)
2.
Ongoing requirement of oxygen therapy
3.
Pulse oxygen saturation (SpO2) of <94% on room air at the time of screening
4.
History of splenectomy
5.
Liver cirrhosis or patient showing signs of clinical jaundice at the time of screening
6.
Chronic kidney disease stage 4 or requiring dialysis at the time of screening


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7.
NYHA Class III or IV congestive heart failure (CHF)
8.
Exhibiting signs of uncontrolled hypo-or hyper- thyroidism at the time of Screening
9.
Uncontrolled rheumatologic disorders at the time of screening
10. History of organ transplantation or are candidates for organ transplantation at the time of 
screening
11. History of Chronic Fatigue Syndrome prior to COVID19 infection
12. History of fibromyalgia prior to COVID-19 infection
13. History of major psychiatric disorder including bipolar disorders, schizophrenia, 
schizoaffective disorder, major depression.  Patients with major depression can be enrolled if 
patient has had no episode within the past year or is considered in remission or controlled by 
treatment.  
14. Any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma 
or squamous cell carcinoma without evidence of metastases.
15. Any other clinically significant serious systemic diseases which would interfere with study 
conduct or study results interpretation per the Investigator.
16. Treatment with immunosuppressive or immunomodulatory medications within 5 half-lives
prior to screening.  Patients on replacement therapy for adrenal insufficiency will be allowed.  
Patients on stable (> 3 months) low dose corticosteroid 
5 mg Prednisone will be allowed.
17. History of allergic reactions attributed to compounds of similar chemical or biologic 
composition to leronlimab (PRO 140) are not eligible
18. Ongoing use of CCR5 antagonist
19. Inability to provide informed consent or to comply with test requirements
20. Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate 
to receive study treatment
21. Pregnancy or breast feeding
22. Participating in another study for an investigational treatment


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4.
STUDY SCHEDULE
The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period. The 
study Schedule of Assessments in presented in Table 4-2.
Screening Period (up to 1 week): 
Screening assessments will commence at Visit 1 (V1) after obtaining signed informed consent, and 
will include review of medical and medication history, eligibility evaluation, vital signs, pulse 
oxygen saturation, physical examination, electrocardiogram (ECG), clinical symptom score 
assessment, and laboratory sample collection for routine serum biochemical, hematologic, 
coagulation, urinalysis, and urine pregnancy (if applicable). These assessments must be conducted 
within 7 days of the First Treatment Visit (V2). 
All subjects who fail to meet eligibility criteria are considered screen failures, and are exited from 
the study without further evaluation.
Treatment Period (56 Days ± allowed windows): 
The schedule of visits during Treatment Period is as follows: 
Visit 2 (V2) [first treatment]: Within 1 week of the Screening Visit
Visit 3 (V3): 3 (±1) days after V2
Visit 4 (V4) [second treatment]: 7 (±1) days after V2
Visit 5 (V5): 3 (±1) days after V4
Visit 6 (V6) [third treatment]: 7 (±1) days after V4
Visit 7 (V7): 3 (±1) days after V6
Visit 8 (V8) [fourth treatment]: 7 (±1) days after V6
Visit 9 (V9): 3 (±1) days after V8
Visit 10 (V10) [fifth treatment]: 7 (±1) days after V8
Visit 11 (V11): 3 (±1) days after V10
Visit 12 (V12) [sixth treatment]: 7(±1) days after V10
Visit 13 (V13): 3 (±1) days after V12
Visit 14 (V14) [seventh treatment]: 7(±1) days after V12
Visit 15 (V15): 3 (±1) days after V14
Visit 16 (V16) [eight treatment]: 7(±1) days after V14
Visit 17 (V17) / End of Treatment (EOT) Visit: 7 (±1) days after V16. 
Subjects who meet the eligibility criteria will have completed the following evaluations and 
assessments at V2 prior to treatment: review of any changes in medical and medication history, 










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4.1.
SCREENING PHASE
The subject (or Legally Acceptable Representative (LAR)) will sign and date the informed consent 
form (ICF) and Health Insurance Portability Accountability Act (HIPAA) authorization (according 
to site policy and practices) prior to any study-related procedures. All study centers will be 
instructed to maintain the study-specific screening and enrollment logs at their sites. If a subject 
initially fails to meet inclusion/exclusion criteria and is later reconsidered for participation, the 
subject will be re-consented and assigned a new unique identification number at the time of re-
screening. Subjects who fail their first screening attempt may be re-screened a maximum of once 
and may be enrolled if they are found to meet all inclusion and no exclusion criteria when re-
screened.
4.1.1. Screening Visit (V1)
After the ICF has been signed, screening procedures and information will be obtained to confirm 
subject eligibility, including:
Demographic information (see Section 7.3);
A detailed medical history (see Section 7.4);
Physical examination (see Section 7.5);
Vital signs (see Section 7.6),
Pulse oxygen saturation (SpO2) (See Section 7.10)
12-lead electrocardiogram (see Section 7.11);
Clinical Symptom Score Assessment (see Section 7.14)
Collection of laboratory specimens (see Section 7.8) for
o
Complete blood count;
o
Biochemistry;
o
Coagulation indices;
o
Urine pregnancy test, for female subjects of childbearing potential; and
o
Urine sample for urinalysis parameters.
Prior and concomitant medications assessment (see Section 7.7).
All screening information will be fully documented in the subject’s medical records (i.e., source 
documents).


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For consented subjects who do not meet eligibility criteria, a Screen Failure Case Report 
Form (CRF) will be completed. The Screen Failure CRF will contain the following details:
the subject identification number, the date of ICF signature, demographic information (see 
Section 7.3), and the reason for screen failure. No additional information will be required 
for subjects who fail screening.
For consented subjects who meet eligibility criteria, all required screening information will 
be transcribed onto the appropriate page of the CRF.
4.2.
TREATMENT PHASE
Subjects who meet all eligibility criteria, as per data gathered from Screening Period are to be 
treated. All subjects who fail to meet eligibility criteria will be considered screen failure and will 
exit the study without further evaluation
4.2.1. Visit 2 (V2)
The following assessments will be performed at the first treatment visit prior to the first treatment 
administration. If Visit 2 (V2) takes place on the same day as the Screening Visit (V1), scheduled 
assessments performed under screening (V1) do not need to be repeated at V2.
Physical examination (see Section 7.5);
Vital Signs (see Section 7.6),
Pulse oxygen saturation (SpO2) (see Section 7.10);
Clinical Symptom Score Assessment (see Section 7.14)
PROMIS® Fatigue Scale (see Section 7.16);
PROMIS® Cognitive Function(see Section 7.17);
PROMIS® Sleep Disturbance (see Section 7.18);
Collection of blood specimens (see Section 7.8) for
o
CD4+ and CD8+ T cell count;
o
Serum cytokine and chemokine levels;
o
CCR5 receptor occupancy;
o
Immunophenotypic biomarker analysis.
Urine pregnancy test, for female subjects of childbearing potential
Subjects will be randomized 1:1 via WebView CTMS system to Leronlimab (PRO 140) or Placebo
(see Section 7.13).


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Leronlimab (PRO 140) 700 mg or
Placebo
Leronlimab (PRO 140) or placebo will be administered subcutaneously to all subjects at a weekly 
dose of 700 mg. After receiving the first leronlimab (PRO 140) dose, the following assessments 
will be performed:
Vital signs (see Section 7.6),
Pulse oxygen saturation (SpO2) (see Section 7.10),
Concomitant medications assessment (see Section 7.7), 
Review of adverse events (see Section 9)
4.2.2. Visits 3, 5, 7, 9, 11, 13, and 15 (V3, V5, V7, V9, V11, V13, and V15)
Telephone or video contact visits will be performed 3 days (±1 day) after each treatment 
administration visit.  The following assessments will be performed:
Patient Symptom Diary (see Section 7.15);
Note: Patient compliance to daily diary completion will be checked by site staff.
Assessment for the requirement of hospitalization (see Section 7.12);
Prior and concomitant medications assessment (see Section 7.7); and
Review of adverse events (see Section 9).
4.2.3. Visits 4, 6, 8, 10, 12, 14, and 16 (V4, V6, V8, V10, V12, V14, and V16)
The following assessments will be performed:
Physical examination (see Section 7.5);
Vital Signs (see Section 7.6),
Pulse oxygen saturation (SpO2) (see Section 7.10);
Patient Symptom Diary (see Section 7.15);
Note: Patient compliance to daily diary completion will be checked by site staff.
PROMIS® Fatigue Scale (see Section 7.16);
PROMIS® Cognitive Function (See Section 7.17);
PROMIS® Sleep Disturbance (see Section 7.18);
Collection of laboratory specimens at V10 only (see Section 7.8) for


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o
Complete blood count;
o
Biochemistry;
o
Coagulation indices;
o
Urine sample for urinalysis parameters;
o
CD4+ and CD8+ T cell count;
o
Serum cytokine and chemokine levels;
o
CCR5 receptor occupancy; and
o
Immunophenotypic biomarker analysis .
Urine pregnancy test, for female subjects of childbearing potential – V10 only
Leronlimab (700 mg) or Placebo Administration
Assessment for the requirement of hospitalization (see Section 7.12);
Prior and concomitant medications assessment (see Section 7.7); and
Review of adverse events (see Section 9).
4.2.4. End of Treatment – EOT (V17)
The last visit during the treatment phase will be considered at the End of Treatment (EOT) visit. 
The assessments performed at this visit will include:
Physical examination (see Section 7.5);
Vital Signs (see Section 7.6),
Pulse oxygen saturation (SpO2) (see Section 7.10);
12-lead electrocardiogram (see Section 7.11);
Patient Symptom Diary (see Section 7.15);
Note: Patient compliance to daily diary completion will be checked by site staff.
PROMIS® Fatigue Scale (see Section 7.16);
PROMIS® Cognitive Function (see Section 7.17);
PROMIS® Sleep Disturbance (see Section 7.18);
Global Health Assessment (see Section 7.19);
Collection of laboratory specimens (see Section 7.8) for
o
Complete blood count;


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o
Biochemistry;
o
Coagulation indices;
o
Urine pregnancy test, for female subjects of childbearing potential;
o
Urine sample for urinalysis parameters;
o
CD4+ and CD8+ T cell count;
o
Serum cytokine and chemokine levels;
o
CCR5 receptor occupancy; and
o
Immunophenotypic biomarker analysis.
Assessment for the requirement of hospitalization (see Section 7.12);
Prior and concomitant medications assessment (see Section 7.7); and
Review of adverse events (see Section 9).
4.3.
FOLLOW-UP PHASE
The follow-up visit is scheduled 28(±3) days after EOT Visit.  
4.3.1. Visit 18
The assessments performed at these visits will include:
Vital Signs (see Section 7.6),
Pulse Oxygen Saturation (see Section 7.10)
Physical examination (see Section 7.5);
Collection of blood specimens (see Section 7.8) for
o
Immunophenotypic biomarker analysis
Assessment for the requirement of hospitalization (see Section 7.12);
Prior and concomitant medications assessment (see Section 7.7); and
Review of adverse events (see Section 9).
4.4.
UNSCHEDULED VISITS
In the event that the subject will return to clinic at a time other than a regularly scheduled study
visit, the visit will be regarded as an unscheduled visit. Assessments at unscheduled visits are at 
the discretion of the Investigator. All pertinent findings, including adverse events or changes in 
medications, will be noted in the eCRF.


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5.
SUBJECT COMPLETION, WITHDRAWAL AND CRITERIA FOR 
STOPPING THE STUDY
5.1.
SUBJECT COMPLETION
A subject is considered to have completed the study once all follow-up visit assessments have been 
completed.
5.2.
EARLY STOPPING RULES
Upon occurrence of any of the following events, data will be reviewed by the Medical Monitor and 
the Lead Principal Investigator.
1. Death in any subject in which the cause of death is judged to be probably or definitely related 
to the study drug by the treating investigator;
2. The occurrence in any subject of a life-threatening SAE whose causal relationship to study 
drug is judged to be probable or definite by the treating investigator;
3. Two (2) occurrences of Grade 4 toxicities that are assessed to be probably or definitely related 
to the study drug by the treating investigator;
4. Two (2) occurrences of a Grade 2 or higher allergic/hypersensitivity reaction directly related 
to the study drug that lead to permanent discontinuation of study drug.
In case the above listed event(s) occurred, patient accrual will be suspended pending further review
and the FDA and other global regulatory authority will be notified. The study will be stopped if any 
of these stopping criteria are met unless, after reviewing the safety events of interest, the medical 
monitor and Sponsor, agree to allow the study to proceed. The FDA and other global regulatory 
authority will be consulted for any protocol amendment before restarting the trial if a stopping rule is 
met.
5.3.
REMOVAL OF SUBJECTS FROM STUDY TREATMENT AND/OR STUDY AS A WHOLE
Subjects can be taken off the study treatment and/or study as a whole at any time at their own 
request, or they may be withdrawn at the discretion of the investigator for safety, behavioral or 
administrative reasons. In the case that a subject is removed from the study due to safety reasons, 
the FDA and other global regulatory authority will be notified. The reason(s) for discontinuation 
must be clearly documented on the appropriate eCRF and may include:
Subject voluntarily withdraws from treatment (follow-up permitted)
Subject withdraws consent (no follow-up permitted)
Subject is unable to comply with protocol requirements


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Subject experiences unacceptable toxicity
Treating physician determines that continuation on the study would not be in the subject’s 
best interest
Subject becomes pregnant
Subject becomes lost to follow-up (LTF)
Subject will be withdrawn from the study if 2 consecutive doses of study drug are missed
Subject manifesting Grade 4 or Grade 3 toxicity attributable to the Leronlimab (PRO 140)
If a subject fails to return for the scheduled study visit or is discontinued from the study, an attempt 
will be made to determine the reason(s). If the subject is unreachable by telephone, a registered 
letter will be sent to the subject requesting that he/she contact the clinic. 
All patients with an ongoing SAE or AE attributable (definitely, probably, or possibly related) to 
the study treatment at the Post-Study (Follow-up) Visit (scheduled or premature) must be followed 
until the event is resolved (with or without sequelae) or deemed stable.
5.4.
DATA COLLECTED FROM WITHDRAWN SUBJECTS
Every attempt should be made to collect follow-up information. The reason for withdrawal from 
the study will be recorded in the source documents and on the appropriate page of the CRF.
Before a subject is identified as lost-to-follow up, the site should make all reasonable efforts to 
contact the subject. These attempts must be documented and should include at a minimum one 
phone call and one certified letter. 
In the event that a subject is withdrawn from the study at any time due to an adverse event or SAE, 
the procedures stated in Section 9 (Safety) must be followed.
5.5.
SCREEN FAILURES
A subject who signed a consent form, but did not meet the inclusion/exclusion criteria is classified 
as a screen failure. Subject number, demographics and reason for screen failure will be recorded.
In the event that a subject initially fails to meet inclusion/exclusion criteria and is later reconsidered 
for participation, the subject will be re-consented and assigned a new screening number at the time 
of re-screening. Subjects who fail their first screening attempt may be re-screened again (i.e., up to
two screenings) and may be enrolled if they are found to meet all inclusion and no exclusion criteria 
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Study drug will be packaged, labeled, and shipped by Sherpa Clinical Packaging, LLC.
The contents of each vial are described in Section 6.1. Leronlimab (PRO 140) kits will be labeled 
with information such as: study protocol #; fill volume; concentration; storage condition; a “use as 
per study protocol” statement; a cautionary statement; sponsor’s name and address; and the kit 
number.
Below are representative samples of the Investigational Product, finished drug product (FDP)
individual vial (Figure 6-1), and kit labels (Figure 6-2) designated for use in this clinical protocol. 
Each kit contains two labeled vials. 
Figure 6-1:
Investigational Product - Vial Label
Protocol: CD15_COVID-19               Kit No. xxx
Subject No. _________       
Single use 3 mL vial contains 2.4 mL of PRO 140 (175 
mg/mL) solution for subcutaneous injection
Store at 2oC to 8oC (36oF to 46oF)
USE AS PER STUDY PROTOCOL
Caution: New Drug – Limited by Federal (or United States) 
Law to Investigational Use
CytoDyn Inc., Vancouver, WA, USA
Protocol: CD15_COVID-19                    Kit No. xxx
Subject No. _________       
Single use 3 mL vial contains 2.4 mL of PRO 140 (175 
mg/mL) solution for subcutaneous injection
Store at 2oC to 8oC (36oF to 46oF)
USE AS PER STUDY PROTOCOL
Caution: New Drug – Limited by Federal (or United States) 
Law to Investigational Use
CytoDyn Inc., Vancouver, WA, USA
Figure 6-2:
Investigational Product - Kit Label
Protocol: CD15_COVID-19                            Kit No. xxx
Site No. ____________              Subject No. ________________  
This kit contains 2 single-use vials
Each 3 mL vial contains 2.4 mL of PRO 140 (175 mg/mL) solution for subcutaneous injection
Store at 2oC to 8oC (36oF to 46oF)
USE AS PER STUDY PROTOCOL
Caution: New Drug – Limited by Federal (or United States) Law to Investigational Use
CytoDyn Inc., Vancouver, WA, USA
The pharmacy manual provides the criteria regarding vial acceptance or rejection, as well as 
instructions for the preparation of the IP syringes to be used to administer drug. 
6.1.2. Leronlimab (PRO 140) - Storage and Handling
Study drug will be shipped at 2°C to 8°C (refrigerated [36°F to 46°F]) to the investigator’s site. 
Upon receipt at the site, the responsible site staff or pharmacist should verify the integrity of the 
vials. Study drug should be stored at 2°C to 8°C (refrigerated [36°F to 46°F]). The contents of the 


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vial should appear as a clear to opalescent, colorless to yellow solution; fine translucent particles 
may be present. This is normal. 
The investigator must maintain an accurate record of the shipment, storage, and dispensing of the 
study drug in a drug accountability log. An accurate record including the date and amount of study 
drug dispensed to each subject must be available for inspection at any time. A study CRA assigned 
to monitor the investigational site will review these documents once study drug has been received 
by the investigational site. Study drug will be accounted for on an ongoing basis during the study.
6.1.3. Leronlimab (PRO 140) - Administration
Guidelines for dose preparation can be found in the pharmacy manual.
Leronlimab (PRO 140) or placebo will be provided to the administering personnel in single-use 
syringes prepared from vials of study drug stored at 2-8°C at the site pharmacy prior to use. Syringes 
will be prepared by an unblinded pharmacist or designated site staff. Each of two syringes is filled 
to deliver 2 mL of study drug. 
Equivalent volumes of PRO 140 will be administered subcutaneously on opposite sides of the 
abdomen. 
A 20-guage needle should be used to remove PRO 140 from vial and a 25-guage needle is used for 
administration to subjects.
Note: After the leronlimab solution is drawn into the syringe, it can be stored at room temperature 
(20°C to 25°C, 68°F to 77°F) for up to 2 hours, or refrigerated (2°C to 8°C, 36°F to 46°F) for up to 
4 hours.
IP should be administered slowly over 15 seconds per mL. 
Following each SC delivery of drug, careful examination will be made to assess the appearance of 
any study drug Injection Site Reactions (ISRs) as per CTCAE v5.0.
Leronlimab (PRO 140) will be administered as SC injection by a qualified medical professional at 
the study clinic.
Note: It is preferred that the same injection site be used throughout the study. At the same time, it 
is not recommended to inject the study drug into areas where skin shows signs of a previous 
injection site reaction. It is advised to change the injection site if any previous injection site reaction 
remains unresolved.
6.1.4. Leronlimab (PRO 140) - Post Injection Monitoring
Subject will be observed at approximately 30 minutes post-injection or longer if necessary, for 
injection site reaction as per CTCAE v5.0.
6.1.5. Leronlimab (PRO 140) – Toxicity Management




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dispensing, the intended study participant, and the identification of the preparer. All used and 
unused study kits will be retained by the investigational site until drug accountability can be 
confirmed by study CRA during the monitoring visits. Instructions will be provided by Sponsor 
regarding final disposition of all study drugs in compliance with applicable regulations.


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7.
DESCRIPTION OF PROTOCOL ASSESSMENTS AND PROCEDURES
7.1.
INFORMED CONSENT
A written informed consent will be obtained for this study by the Investigator or designee from all 
subjects prior to performance of any protocol-specific procedure. This study will be conducted in 
accordance with the provisions of the Declaration of Helsinki. 
The Investigator must comply with applicable regulatory requirements and must adhere to the Good 
Clinical Practice (GCP) in the process of obtaining and documenting the informed consent. The 
Investigator, or designee, must also inform subjects of all pertinent aspects of the study. Before 
written informed consent is obtained from the subject, the Investigator or a person designated by 
the Investigator, must provide the subject enough time and opportunity to inquire about the details 
of the study and to decide whether or not to participate in the trial. All questions addressed by the 
subject about the study must be answered to the satisfaction of the subject. Prior to the subject’s 
participation in the trial, the written informed consent must be signed and personally dated by the 
subject and by the person who conducted the informed consent discussion. Authorization for release 
of protected health information must also be obtained, as per local policies.
7.2.
ASSESSMENT OF ELIGIBILITY
The Investigator must assess subject’s continued eligibility for the study as per the Inclusion and 
Exclusion criteria, during the Screening Phase. The eligibility criteria are described in Section 3.3.1
(Inclusion Criteria) and Section 3.3.2 (Exclusion Criteria). In the event that the subject is not 
suitable or eligible for the study, the subject will be considered “screen failure”.
7.2.1. Re-screening
If a subject fails initially to meet the eligibility criteria, and is later reconsidered for participation, 
the subject will be re-consented and assigned a new screening number at the time of re-screening. 
Subjects who fail their first screening attempt may be re-screened a maximum of once and may be 
enrolled in the study only if they meet all Inclusion and no Exclusion criteria when re-screened.
7.3.
DEMOGRAPHIC INFORMATION
In this study the demographic information will include:
Dates of ICF signature 
Date of birth
Gender
Race (American Indian or Alaska Native, Asian, Black or African American, Native 
Hawaiian or Other Pacific Islander, White, Not Reported, or Unknown)


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Ethnicity (Hispanic or Latino, Not Hispanic or Latino, Not Reported, or Unknown)
Use of tobacco products
7.4.
MEDICAL HISTORY
A medical history will be recorded during the Screening Phase and will include:
All ongoing medical conditions
All previously resolved medical conditions that are relevant in the judgment of the 
Investigator 
Any prior medical conditions that have resolved within the last year 
Events that emerge prior to the first treatment will be recorded in the medical history and not as 
AEs. Aside from being used to determine subject eligibility, this information will permit the 
Investigator to record the nature, duration and severity of any ongoing baseline medical conditions 
prior to the subject’s receiving investigational product treatment. 
Medical histories will be recorded using the body system categories outlined below:
HEENT
Lymphatic
Cardiovascular
Musculoskeletal and Extremities
Endocrinal
Hematological
Respiratory
Immunological
Gastrointestinal
Dermatologic
Substance Abuse
Psychiatric-Psychological
Neurologic
Other
Genitourinary
For each relevant history, the following will be documented: 
Disease/disorder/condition
Date of diagnosis
History status (resolved or ongoing).
Note: For COVID-19 diagnosis, the number of days between the onset of symptoms and the 
initiation of treatment for each subject will be documented. 
7.5.
PHYSICAL EXAMINATION
The physical examination will include routine examinations for the following:
Constitutional/General Appearance


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Head, Ears, Eyes, Nose, Throat (HEENT)
Neurologic 
Cardiovascular
Musculoskeletal and Extremities
Dermatologic
Respiratory 
Gastrointestinal
Genitourinary 
Lymphatic
Psychiatric 
Each abnormality will be recorded and the Investigator will record an assessment of its clinical 
significance. 
7.6.
VITAL SIGNS, HEIGHT AND WEIGHT
The following will be collected: 
Systolic Blood Pressure 
Diastolic Blood Pressure
Heart Rate
Temperature
Respiratory Rate
Height (only at V1)
Weight
Note: Body Mass Index (BMI) will be auto-calculated using height and weight information 
in the EDC. 
7.7.
CONCOMITANT MEDICATIONS
All medications and therapies administered or taken by the subject beginning 30 days prior to 
Screening Visit and throughout the study will be recorded in the source documents and on the 
appropriate page of the Case Report Form (CRF). Additionally, all other investigational and off-
label therapies for COVID-19 will be recorded. Subjects must be questioned at each study visit 
concerning any new medications or changes in current medications including over-the-counter 
medication and topical medication.
For each medication and non-study treatment, the following will be documented:
Medication/treatment name (generic name may be used if trade name is unknown)
Dose, unit, and frequency of dosing (individual dosages, not total daily dose). 


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o
Note: Each new dose of medication should be recorded as a separate entry, with the 
exception of medications that are given on a sliding scale. For these, it is acceptable 
to enter the range of the dosage, including the start and stop dates for which the 
specified dosage range was used.
Route of dosing
Indication for use
The start date 
The stop date (if medication/therapy is not ongoing).
7.7.1. Excluded Medications
The following medications are prohibited while on study drug:
Hydroxychloroquine, oral or parenteral corticosteroids, immunosuppressants, or 
immunomodulating agents
Albuterol as nebulizer for treatment of COVID-19
Other CCR5 antagonists
Other investigational products
7.7.2. Allowable Medications and Therapies
The following medications and therapies are allowed:
Empirical antibiotic treatment for secondary bacterial infections is allowed during the 
course of study.
7.8.
CLINICAL LABORATORY ASSESSMENTS
Laboratory samples will be collected for analysis of the following parameters described in Table 
7-1.
Biochemistry, Complete Blood Count (CBC), Coagulation indices and Urinalysis: At 
Screening (V1), V10, and V17 (EOT).
CD4+ and CD8+ T cell count: At V2, V10, and V17 (EOT).
Serum cytokine and chemokine levels: At V2, V10, and V17 (EOT).
CCR5 Receptor Occupancy: At V2, V10, and V17 (EOT).
Immunophenotypic Biomarker Analysis: At V2, V10, V17 (EOT), and V18 (FU).
Urine pregnancy test (for female subjects of childbearing potential): At Screening (V1), V2, 
V10, and V17 (EOT).
All laboratory reports will be reviewed by the Investigator. Abnormal results that are considered by 
the Investigator to be clinically significant will be recorded as adverse events. If in the Investigator 
judgment, in order to make the determination of clinical significance the testing may be needed to 




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Pulse Oxygen Saturation (SPO2) will be measured at Screening and V2 (pre-dose and post-dose), 
V4, V6, V8, V10, V12, V14, V16, V17 (EOT), and V18 (Follow-Up).
Note: Post-dose values will be recorded at V4, V6, V8, V10, V12, V14, and V16.
7.11.
12-LEAD ELECTROCARDIOGRAM
A resting supine 12-lead ECG will be conducted at the Screening Visit (V1), and Visit 17 (EOT). 
A 12-lead ECG will be repeated during the study only if clinically indicated and at the discretion 
of the treating physician. The results will be evaluated by the Investigator. The following 
parameters will be recorded: ventricular rate (beats per minute), PR interval (msec), QRS interval 
(msec), QT interval (msec), and QTc interval (msec). Additionally, the Investigator will record the 
overall results of the ECG reading as either normal or abnormal, and as either not clinically 
significant or clinically significant. If abnormalities are observed, each will be recorded. 
7.12.
REQUIREMENT OF HOSPITALIZATION
The incidence and duration, in days, of subjects’ hospitalization will be assessed at beginning at V3 
through V18 (Follow-Up).
7.13.
RANDOMIZATION
Subjects who are eligible to participate in the trial will be randomized to one of the treatment groups 
via IWRS (Interactive Web Based Randomization System) at Visit 2 prior to IP administration. The 
randomization will be central with a 1:1 ratio of Active Treatment to Control Treatment to ensure 
even distribution of Active and Control subjects.
7.14.
CLINICAL SYMPTOM SCORE
Clinical symptom score will be assessed at Screening (V1) and baseline (V2) based on following 
commonly reported symptoms consistent with COVID-19 infection for a prolonged period of time 
(>12 weeks):
Respiratory symptoms such as cough, sore throat, stuffy or runny nose, shortness of breath 
(difficulty breathing), tightness of chest etc.
Neurological 
symptoms 
such 
as 
difficulty 
in 
concentration 
(brain 
fog), 
sleep 
disturbance/insomnia, headache, dizziness, anxiety, tingling or numbness, loss of sense of smell 
or taste.
Cardiovascular and Gastrointestinal symptoms such as feeling of fast heartbeat, nausea, 
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Musculoskeletal symptoms such as muscle aches/cramps, muscle weakness, joint 
pain/swelling.
General immune response symptoms such as fatigue (low energy or tirednesschills or shivering, 
feeling hot or feverish or exertional malaise (feeling of discomfort, illness, or lack of well-being 
after physical activity or mental stress).
Note: Clinical Symptom Score is obtained from the patient diary (refer to Appendix 1 for scoring 
instructions).
7.15.
PATIENT SYMPTOM DIARY
After receiving treatment, subjects will be given a diary to record all symptoms daily throughout 
the entire treatment period. See Appendix 1.
7.16.
PROMIS® FATIGUE SCALE
This score is based on questions focused on physical fatigue and psychological fatigue. The 
assessment will be performed (self-administered by the subject) at V2, V4, V6, V8, V10, V12, V14, 
V16, and V17 (EOT). See Appendix 3.
7.17.
PROMIS® COGNITIVE FUNCTION
The brief mental fatigue questionnaire evaluates subject cognitive symptoms. The assessment will 
be performed (self-administered by the subject) at V2, V4, V6, V8, V10, V12, V14, V16, and V17 
(EOT). See Appendix 4.
7.18.
PROMIS® SLEEP DISTURBANCE
The brief questionnaire evaluates subjects’ sleep quality. The assessment will be performed (self-
administered by the subject) at V2, V4, V6, V8, V10, V12, V14, V16, and V17 (EOT). See 
Appendix 5.
7.19.
GLOBAL HEALTH ASSESSMENT
The brief questionnaire evaluates general health (physical and mental health) and quality of life. 
This is an exploratory (non-validated) assessment developed (based on PROMIS® Scale v1.2 –
Global Health) with an intent to assist in identifying more appropriate global health measurement 
for the future studies in long-hauler COVID-19 population and will not be used for labeling claims. 
The assessment will be performed (self-administered by the subject) at V17 (EOT/Day 56). See 
Appendix 6.


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8.
STATISTICAL ANALYSIS 
This section presents general information about statistical considerations and concepts and a brief 
discussion on analysis methodology, as well as some data conventions. Detailed descriptions of the 
statistical analysis methods and data conventions that will be used in this study will be in a separate 
document; i.e., the Statistical Analysis Plan (SAP).
8.1.
TREATMENT GROUPS
There will be two treatment groups in the study: 
Leronlimab (PRO 140) 700 mg
Placebo
8.2.
DESCRIPTION OF STUDY OUTCOMES (ENDPOINTS)
8.2.1. Primary Endpoint
The primary endpoint for the study is:
Changes from baseline in daily COVID-19-related symptom severity score through day 56
Note: A set of common COVID-19-related symptoms (see patient diary template) will be 
evaluated daily by the patient regardless of which symptoms a subject had at baseline, as 
new symptoms may appear following the baseline assessment. 
8.2.2. Secondary Endpoints
The secondary efficacy endpoints for the study are:
Duration of COVID-19 associated symptoms from start of study treatment (Day 0) based 
on self-assessment using daily symptom diary.
Duration is defined as number of days when any symptoms scored as 
moderate or severe is defined as number of days are still scored as moderate or 
severe (i.e., not mild or absent) through Day 56, or 
mild or absent at study entry are scored as mild or worse (i.e., not absent) through 
Day 56.
Number of symptom-free days of COVID-19 associated symptoms that were present at the 
start of study treatment (Day 0) based on self-assessment using daily symptom diary.
Symptom-free days are defined as number of days when any symptoms scored as mild, 
moderate or severe at baseline are scored as absent (or none) through Day 56.


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Progression (or worsening) of COVID-19-associated symptoms through Day 56 compared 
to baseline. 
Progression or symptom worsening is defined as number of days when any symptoms scored 
as 
moderate at baseline are scored as severe through Day 56.
mild at baseline are scored as moderate or severe through Day 56.
absent at baseline are scored as mild, moderate or worse through Day 56.
Change from baseline in PROMIS® Fatigue Score at Days 28 and 56.
Change from baseline in PROMIS® Cognitive Function Score at Days 28 and 56.
Change from baseline in PROMIS® Sleep Disturbance Score at Days 28 and 56.
Incidence of hospitalization during the treatment phase
Duration (days) of hospitalization during the treatment phase
8.2.3. Exploratory Outcome Measures (Endpoints)
Change from baseline in pulse oxygen saturation (SpO2) at Day 7, 14, 21, 28, 35, 42, 49, 
and 56.
Change from baseline in serum cytokine and chemokine levels on Days 28 and 56.
Change from baseline in CD4+ and CD8+ T cell count on Days 28 and 56.
Change from baseline in Transgrowth factor beta 1 (TGF beta1) on Days 28and 56.
Change from baseline in CRP on Days 28and 56.
Change from baseline in CCR5 receptor occupancy on Days 28 and 56.
To explore biomarkers that may predict and/or act as pharmacodynamic indicators of 
pharmacologic activity of leronlimab.
Evaluation of Global Health Assessment at Day 56.
8.2.4. Safety Measures
Safety will be assessed using:
Incidence of treatment-related adverse events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs)
Incidence of serious adverse events (SAEs)
Incidence of TEAEs and SAEs leading to discontinuation of study medication. 
Changes in blood chemistry, hematology and coagulation parameter results


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Changes in vital signs including temperature, pulse, respiratory rate, systolic and diastolic 
blood pressure
Changes in physical examination results
Changes in electrocardiogram (ECG) results
8.3.
SAMPLE SIZE DETERMINATION AND RATIONALE
A total of 50 subjects will be randomized 1:1 in this study. The sample size is based on clinical 
judgment. No statistical power calculation is used to establish the sample size for this exploratory 
study.
8.4.
RANDOMIZATION
This is a multi-center randomized clinical trial. An individual, independent of the clinical trial team, 
will develop the randomization schedules. The actual randomization assignment will be made 
through an Interactive Web Based Response System (IWRS) called WebView®. Subjects who have 
provided written informed consent and have met all the inclusion criteria and none of the exclusion 
criteria will be randomized to one of the treatment groups.
8.5.
STRATIFICATION
Randomization will be stratified by symptom duration (defined as time from first reported symptom 
onset to the time of randomization) of 12 – 24 weeks or > 24 weeks.
8.6.
BLINDING
All subjects, Investigators and their staff (except unblinded pharmacist or designated site staff), and 
all Sponsor/CRO personnel involved in the management of the study will be blinded to treatment 
assignments. 
The Amarex Information Technology department will be unblinded to treatment. As noted above, 
the Amarex Technology department is not otherwise involved with the study.
Treatment unblinding for the study will occur after all clinical data have been received, data 
inconsistencies have been resolved, and the database is locked, except for safety reasons on a case-
by-case basis (i.e., emergency unblinding). 
The process for emergency unblinding will be outlined in detail in the Randomization Plan.  In 
addition, any subject that is unblinded for any reason will be identified and discussed in the final 
clinical study report.
8.7.
TIME TO UNBLINDING
8.7.1. Emergency Unblinding  


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Breaking the blind prematurely will be allowed only if the subject’s well-being requires knowledge 
of the subject’s treatment allocation. Every attempt will be made to maintain the blind throughout 
the study.
In the event of an urgent safety issue where the randomized treatment of a subject is necessary to 
manage and treat the affected study subject (e.g., unblinding subjects because of SAEs that meet 
“expedited criteria” and requires reporting to FDA and other global regulatory authority), the 
Investigator will contact the Medical Monitor. The Medical Monitor, in consultation with sponsor, 
will make a decision to unblind. If the decision has been made to unblind, a prompt written 
notification will be provided to the Investigator. The reason for unblinding must be recorded; 
however the investigator must not record the subject’s treatment assignment in study documentation 
and must not reveal the subject’s treatment assignment to the clinical monitor.
If reporting of an adverse event is to be performed unblinded as per regulatory authority guidelines, 
study-unrelated personnel will unblind the individual subject’s treatment group and will perform 
the unblinded reporting. No treatment group information would be shared with study personnel.
8.7.2. Final Analysis
Treatment unblinding and release of the randomization codes of the investigational product 
assignments for the study will occur immediately following database lock when all randomized 
subjects have completed the study or discontinued from the study and after all clinical data have 
been received and data inconsistencies have been resolved.
8.8.
INTERIM ANALYSIS
There will be no interim analysis performed in this study
8.9.
GENERAL STATISTICAL CONSIDERATIONS
All collected study data will be presented in subject data listings. Statistical analyses will be 
performed using SAS® for Windows, version 9.4 or later. Descriptive statistics (n, mean, standard 
deviation, median, minimum and maximum) will be presented for continuous variables. 
Frequencies and percentages will be presented for categorical variables.
8.9.1. Analysis Populations
8.9.1.1.
Modified Intent-to-Treat Population
The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have 
received at least one dose of study treatment (leronlimab or placebo). This population will be used 
as the primary analysis population for analysis of the primary and secondary efficacy endpoints.
8.9.1.2.
PP Population


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The Per Protocol (PP) population is defined as the set of subjects who meet the ITT Population 
requirements and are not associated with any major protocol violations. This population will be 
identified before the database lock.  This population will be used as the supportive analysis 
population for analysis of the primary and secondary efficacy endpoints.
8.9.1.3.
Safety Population
The Safety Population will include all subjects who have received one dose of study treatment 
(leronlimab or placebo). This population will be used for the analysis of safety parameters or 
measurements.
8.9.2. Covariates
For efficacy analyses important prognostic factors that need adjustment will be specified in the 
Statistical Analysis Plan (SAP) for the study
8.9.3. Missing Data
Every effort will be made to obtain required data at each scheduled evaluation from all subjects 
who have been randomized to minimize missing data. However, in the event when there is missing 
data the following imputation methods will be used.
For efficacy evaluations, multiple imputation methods will be used to handle missing data. This 
imputation method is a robust method to impute missing measurements.  The imputation will be 
carried out in SAS version 9.4 or later using PROC MI. Each imputation model will include the 
stratification factor as a covariate in the model. The details of multiple imputation will be included 
in the statistical analysis plan. 
8.10.
ANALYSIS METHODS
A Statistical Analysis Plan (SAP) will be developed and approved before the database is locked. 
The SAP will present the detailed statistical methodology to be used in analyzing the data from this 
trial.
8.10.1. Subject Disposition
The disposition of all subjects who signed an ICF will be provided. The number of subjects 
screened, screen failed, randomized, received at least one treatment, completed, and discontinued 
during the study, as well as the reasons for all discontinuations will be summarized by treatment 
group. Disposition and reason for study discontinuation will also be provided as a by-subject listing.
8.10.2. Demographic and Baseline Characteristics
Demographics and baseline characteristics including medical history, will be summarized by 
treatment group using appropriate descriptive statistics.


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8.10.3. Concomitant Medications/Therapies
Concomitant medications/therapies will be summarized separately for the Safety population. All 
prior and concomitant medications recorded in the case report form will be coded to matching 
Anatomic Therapeutic Classification codes using the most recent version of the WHO Drug 
Dictionary. Descriptive summaries by treatment group will be prepared using the coded term. All 
concomitant medications/therapies recorded in the case report form will be listed.
8.10.4. Efficacy Analyses
Primary Analysis  
The mITT population will be the primary population for the analysis of the efficacy endpoints of 
the study. 
Primary Endpoint
The primary endpoint for this study is the change from baseline in Fatigue Severity Score at Day
28.
Secondary Endpoints 
To maintain the trial-wise Type I error rate at 0.05, a closed test procedure will be used for the 
secondary endpoints. The order of the secondary endpoints will be prospectively specified in the 
SAP. 
Analysis of the secondary and exploratory endpoints will be summarized according to the variable 
type: 
Continuous data summaries will include: 
o
If the Normality assumption is met, Analysis of Covariance (ANCOVA) would be 
used. 
o
If the Normality assumption is not met, a non-parametric method or a rank –
ANCOVA analysis i.e., an ANCOVA analysis on rank-transformed data will be 
used. 
Categorical data summaries will be based on Logit model will be used.
Time-dependent data: Cox proportional hazards model will be used to analyze time 
dependent data and to depict the time to event data. 
8.10.5. Supportive Analysis 
To assess the consistency of the Primary Analysis results, supportive analysis will be conducted 
using the modified Intent to Treat (mITT) and Per Protocol (PP) populations. Statistical 
methodology for the supportive analyses will be the same as that of the primary analysis, with the 
exception of the analysis population used. 
8.10.6. Subgroup Analysis


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Subgroup analyses will be conducted for the predefined stratification factors (Section 8.5) for the 
study. Additional exploratory subgroup analysis will be conducted using the baseline clinical 
characteristics and laboratory parameters. The details will be prospectively specified in the SAP.
Safety Summaries 
8.10.6.1.
Adverse Events
Adverse events will be coded using the most recent version of Medical Dictionary for Regulatory 
Activities (MedDRA). Treatment Emergent AE’s (TEAE) are defined as events with an onset on 
or after the first treatment. TEAEs will be summarized by System Organ Class and preferred term
by treatment group. The following TEAE summaries will be provided:
Overall (i.e., regardless of severity or relationship to treatment);
By intensity (mild, moderate, severe, life threatening or death);
By causality (definitely, probably, possibly, unlikely or unrelated);
By impact on study treatment (dose increased, dose not changed, dose rate reduced, dose 
reduced, drug interrupted, drug withdrawn, not applicable, or unknown).
In addition, separate summaries of serious adverse events, and adverse events resulting in 
discontinuation of study treatment will be presented.
8.10.6.2.
Clinical Laboratory Data
All laboratory values will be listed. Laboratory measurements will also be summarized by treatment 
group and presented by time point.
8.10.6.3.
ECG
All ECG values will be listed. ECG measurements will also be summarized by treatment group and 
presented by time point.
8.10.6.4.
Vital Signs
All vital sign findings will be listed and/or summarized by treatment group.
8.10.6.5.
Physical Examination
All physical examination findings will be listed and/or summarized by treatment group.


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9.
ADVERSE EVENTS (DEFINITIONS AND REPORTING) 
The Investigator is responsible for the detection and documentation of events meeting the criteria 
and definition of an AE or SAE, as provided in this protocol. During the study when there is a safety 
evaluation, the Investigator or site staff will be responsible for detecting, documenting and reporting 
AEs and SAEs as detailed in this Section of the protocol. 
9.1.
ADVERSE EVENT (AE)
An adverse event (AE) is defined as any unfavorable or unintended sign, symptom, or disease that 
occurs or is reported by the patient to have occurred, or a worsening of a pre-existing condition. An 
adverse event may or may not be related to the study treatment. 
AEs will be elicited through direct questioning and subject reports. Any abnormality in physical 
examination findings or laboratory results that the investigator believes is clinically significant (CS)
to the research subject and that occurred after initiation of the first study treatment will be reported 
as AEs. Abnormal findings that are NOT clinically significant should not be recorded as an AE.
9.2.
REPORTING OF ADVERSE EVENTS
Report initiation for all AEs and SAEs will begin at the time of the first treatment visit and continue 
until the end of final study visit. All events will be followed to resolution or until the subject 
completes the study. A final assessment of outcome will be made at that time. 
All AEs must be recorded in the subject’s medical records and on the CRF. AEs will be reported 
using customary medical terminology along with the following information: the onset and end 
dates, whether the event is considered to be a SAE (see Section 9.3), the impact the event had on 
study treatment (see Section 9.2.1), the Common Terminology Criteria for Adverse Events 
(CTCAE) grade (intensity) of the event (see Section 9.2.2), the causality of the event (see Section 
9.2.3), whether treatment was given as a result of the event (see Section 9.2.4), and the outcome of 
the event (see Section 9.2.5)
9.2.1. Impact on Study Treatment
The impact the event had on the study treatment will be assessed as either: dose increased, dose not 
changed, dose rate reduced, dose reduced, drug interrupted, drug withdrawn, not applicable, or 
unknown. The “not applicable” assessment will be used only when the subject is no longer in the 
Treatment Phase of the protocol.
9.2.2. CTCAE Grade (Intensity) Assessment
The guidelines outlined in CTCAE v5.0 will be used for assessing the intensity of the event (See 
Appendix 17.2). The general guidelines for assessing the AE grade appear below. Full guidelines 
may be obtained at 




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treatment. 
3. Possibly related: This category applies to those AEs which, after careful medical consideration 
at the time they are evaluated, are judged unlikely but cannot be ruled out with certainty to the 
study treatment. An AE may be considered possible if or when (must have two): (1) it follows 
a reasonable temporal sequence from administration of the study treatment. (2) It could not 
readily have been produced by subject’s clinical state, environmental or toxic factors, or other 
therapies administered to the subject. (3) Disappears or is decreased upon discontinuation of 
the study treatment. (4) It follows a known response pattern to treatment with the study 
treatment. 
4. Unlikely related: In general this category can be considered applicable to those AEs which, 
after careful medical consideration at the time they are evaluated, are judged likely to be 
unrelated to the study treatment. An AE may be considered unlikely if or when (must have two): 
(1) it does not follow a reasonable temporal sequence from administration of the study 
treatment. (2) It could not readily have been produced by subject’s clinical state, environmental 
or toxic factors, or other therapies administered to the subject. (3) Disappears or is decreased 
upon discontinuation of the study treatment. (4) It does not follow a known response pattern to 
treatment with the study treatment. 
5. Unrelated: This category applies to those AEs which, after careful consideration at the time 
they are evaluated, are clearly and incontrovertibly due to extraneous causes (disease, 
environment, etc.) and determined with certainty to have no relationship to the study treatment. 
9.2.4. Treatment Given as a Result of the Event
The event impact in terms of treatment provided will be as either: none, medication administered, 
non-drug therapy administered, surgery performed, hospitalization, or other (with a specification).
9.2.5. Outcome Assessment
The outcome of the event will be assessed as either: fatal, not recovered/not resolved, 
recovered/resolved, recovered/resolved with sequelae, recovering/resolving, or unknown. Only one 
AE per subject is allowed to have an outcome assessment as “death.” If there are multiple causes 
of death for a given subject, only the primary cause of death will have an outcome of death. 
9.3.
SERIOUS ADVERSE EVENTS
A SAE is defined as any AE that:
Results in death
Is life threatening (the subject is at immediate risk of dying from the adverse experience)
Requires subject’s hospitalization or prolongs existing hospitalization
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect


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Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered a serious adverse effect when, based upon appropriate 
medical judgment, they may jeopardize the subject or subject and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition.
9.4.
REPORTING OF SERIOUS ADVERSE EVENTS (SAE)
The Investigator is required to report all SAEs that occur during the time period specified in 
Section 9.2. Once the Investigator becomes aware of an SAE, he/she must report the SAE to 
Medical Monitor within 24 hours.
Medical Monitor
The Medical Monitor may request additional supporting documentation as it becomes available, 
such as lab reports, ECG reports, discharge summary, hospital notes, etc, if applicable. Additional 
follow-up information as it becomes available must be reported to the Medical Monitor.
The Investigator is also responsible for reporting all SAEs to the appropriate Institutional Review 
Board (IRB) in accordance with local laws and regulations. The Investigator is responsible for 
maintaining documentation in the study file that indicates the IRB has been properly notified. 
9.5.
SAE FOLLOW-UP
All subjects experiencing an SAE, including the discontinued subjects, must be closely followed 
until sufficient information is obtained to indicate a return to normal status or until the event 
stabilizes at a level acceptable to the investigator (i.e., recovery, return to baseline status, no further 
improvement expected, or death).
For each SAE indicated as an unresolved event on the initial report, regardless of whether the 
subject completed the study or withdrew, the site should submit a follow-up report with updated 
information.
Study participants should be instructed to notify the investigator and discontinue investigational 
product immediately if they become pregnant at any time during the study or if they become 
pregnant within 30 days of last investigational product dose. A participant whose partner has 
become pregnant or suspects she is pregnant during the study must report the information to the 
investigator. The Investigator is required to report any notification of pregnancy to CytoDyn, 
Inc/designated CRO promptly. The participants should receive appropriate monitoring and care 


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until the conclusion of the pregnancy. Any complication experienced through the end of the 
pregnancy should be considered as an adverse event (AE), and should be recorded, and if it meets 
the seriousness criteria, it must be reported to CytoDyn, Inc/designated CRO promptly. Pregnancy 
outcomes will be reported in the clinical study report.
9.6.
EXPECTED/ANTICIPATED EVENTS
Refer to Investigator Brochure for the expected/anticipated events.


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10.
DIRECT ACCESS TO SOURCE DATA/DOCUMENTATION
Subjects will be identified on eCRFs by a unique subject identification number and on source 
documents by name and date of birth. No personal identifier will be used in any publication or 
communication used to support this research study. The subject identification number will be used 
if it becomes necessary to identify data specific to a single subject. 
The local IRB, FDA and other global regulatory authorities, the monitors, auditors and personnel 
authorized by the Sponsor are eligible to review the medical and research records related to this 
study as part of their responsibility to protect human subjects in clinical research. They will be 
given direct access to source data and documentation (e.g., medical charts/records, printouts etc.) 
for source data verification, provided that subject confidentiality is maintained in accordance with 
local requirements. Access to electronic medical records may be governed by institution policy and 
each site will be required to ensure access while remaining compliant with institutional 
requirements.


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11.
QUALITY CONTROL AND QUALITY ASSURANCE
11.1.
MONITORING REQUIREMENTS
The specific obligations outlined in 21 Code of Federal Regulations (CFR) and ICH guidelines 
require the Sponsor to maintain current personal knowledge of the progress of a study. Therefore,
the Sponsor's designated monitor will visit the site during the study as well as maintain frequent 
telephone and written communication. The Investigator will permit the Sponsor to monitor the 
study as frequently as is deemed necessary and provide access to medical records to ensure that 
data are being recorded adequately, that data are verifiable and that protocol adherence is 
satisfactory. 
As delineated above, the Investigator will permit representatives of the Sponsor and/or designated 
CRO to inspect all CRFs and corresponding study subject original medical records (source 
documents) at regular intervals throughout the study. Subject original medical records and other 
relevant data must be available to support all data recorded in the eCRF. In addition to the original 
medical records, these data may include but are not limited to study, laboratory reports, etc. 
In accordance with federal regulations, site inspections will serve to verify strict adherence to the 
protocol and the accuracy of the data that is being entered on the case report forms. A Monitoring 
Log will be maintained at each study site. The Monitoring Log will be signed by the monitor, dated
and stated the type of visit. The Investigator should be aware that the study site and subject records 
may be inspected by the Sponsor and or representatives of the designated CRO, FDA or other 
regional regulatory authority.
11.2.
ACCEPTABILITY OF CASE REPORT FORMS (CRFS)
For each subject who has signed an informed consent form, a CRF must be completed. For subjects 
who are screen failures, this would be limited to the screen failure CRF page. All source documents 
and CRFs will be completed as soon as possible after the subject's visit and corrections to data on 
the CRFs will be documented, if applicable. The Investigator will review the CRFs to indicate that, 
to his/her knowledge, they are complete and accurate. CRFs will be reviewed by the Sponsor’s or 
designated CRO’s monitor, who will make a decision as to their acceptability.
11.3.
MODIFICATION OF PROTOCOL
The Investigator will not modify or alter this protocol without first obtaining the concurrence of the 
Sponsor. Approval by the Investigator’s IRB must also be obtained prior to implementation of the 
change, with two exceptions:
1. When necessary to eliminate apparent immediate hazard to the subject; or
2. When the modification does not involve the subject’s participation in the trial.


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An amendment may also require modification of the informed consent form. The Investigator will 
provide an approval letter for the amendment and revised informed consent form, if applicable, to 
the Sponsor. An amendment must be provided in writing and it must be dated by both the Sponsor 
and the Investigator. If necessary, the Sponsor will submit protocol amendments to FDA and other 
appropriate regulatory authorities and notify other Investigators using this protocol.
11.4.
REPORTING PROTOCOL DEVIATIONS
The Investigator is obligated to follow the protocol without departure from the requirements written 
in the protocol. If the Investigator deviates from the protocol requirements, the Sponsor will make 
the determination as to whether the subject will continue in the study. The Sponsor also has the 
right to discontinue the subject for protocol violations. The IRB may also have to be contacted if 
safety to the subject or if the scientific soundness of the study is involved. All protocol deviations 
must be documented in the CRFs.
11.4.1. Major Protocol Deviation or Violation
A major protocol deviation or violation is a deviation from the IRB approved protocol that may 
affect the subject's rights, safety, or well being and/or the completeness, accuracy and reliability of 
the study data. Examples of this include:
Failure to obtain informed consent prior to initiation of study-related procedures 
A research subject does not meet the protocol's eligibility criteria but was enrolled without prior 
approval from the sponsor.
A research subject received the wrong treatment or incorrect dose.
A research subject met withdrawal criteria during the study but was not withdrawn.
A research subject received a prohibited concomitant medication.
Failure to treat research subjects per protocol procedures that specifically relate to primary 
efficacy outcomes.
Changing the protocol without prior sponsor and IRB approval.
Multiple minor violations of the same nature after multiple warnings.
11.4.2. Minor Protocol Deviation or Violation
A minor protocol deviation is any change, divergence, or departure from the study design or 
procedures of a research protocol that has not been approved by the IRB and which DOES NOT 
have a major impact on the subject's rights, safety or well-being, or the completeness, accuracy and 
reliability of the study data.  Examples of this include:


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Follow-up visits that occurred outside the protocol required time frame because of the 
participant’s schedule.
Blood samples obtained at times close to but not precisely at the time points specified in the 
protocol.


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12.
DATA SAFETY MONITORING COMMITTEE (DSMC)
This section is not applicable for this study.


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13.
ETHICS AND REGULATORY REQUIREMENTS
This study is to be conducted in accordance with the specifications of this protocol and in 
accordance with principles consistent with Declaration of Helsinki, GCP, 21 CFR, ICH E6, HIPAA 
regulations in 45 CFR Part 164 (US only), and the Belmont Principles of respect for persons, 
beneficence, and justice. No protocol changes will be implemented without the prior review and 
approval of the IRB, except when the modification does not involve the subject’s participation in 
the trial or where it may be necessary to eliminate an immediate hazard to a research subject. In the 
latter case, the change will be reported to the IRB as soon as possible, according to IRB regulations. 
Additionally, the study product used in this study is manufactured, handled and stored in accordance 
with applicable GMP. The study product provided for this study will be used only in accordance 
with this protocol.
13.1.
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
The Principal Investigator (PI) at each site will provide the Institutional Review Board/Independent 
Ethics Committee (IRB/IEC) with all appropriate materials as required by their IRB/IEC, including 
but not limited to the clinical study protocol, informed consent form, and any advertising materials. 
The study will not be initiated until the IRB/IEC provides written approval of the aforementioned 
documents and until approval documents have been obtained by the Principal Investigator and 
Sponsor or Sponsor designee. The Investigator will not participate in the decision. If the 
Investigator is an IRB or IEC member, documentation must be provided indicating recusal from 
the approval process. Appropriate reports on the progress of this study by the Principal Investigator 
will be made to the IRB/IEC as required by local and applicable government regulations and in 
agreement with policy established by the Sponsor. The Investigator is required to maintain an 
accurate and complete record of all written correspondence to and received from the IRB/IEC, and 
must agree to share all such documents and reports with the Sponsor.
No changes from the final approved protocol will be initiated without the IRB/IEC’s prior written 
approval or favorable opinion of a written amendment, except when necessary to eliminate 
immediate hazards to the subjects or when the modification does not involve the subject’s 
participation in the trial.
13.2.
INVESTIGATOR’S RESPONSIBILITIES
The Investigators are responsible for performing the study in full accordance with the protocol and 
the current revision of the Declaration of Helsinki, the Good Clinical Practice: Consolidated 
Guideline, approved by the ICH, and any applicable national and local laws and regulations. 


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Information regarding to the study center participating in this study that cannot comply with these 
standards will be documented.
13.3.
SUBJECT INFORMED CONSENT REQUIREMENTS
All subjects participating in this study will be given to by the Investigator and/or designee, written 
and oral information about the study in a language understandable by the subject. Written informed 
consent will be obtained from each subject prior any procedures or assessments that would not 
otherwise be required for the care of the subject are done and after the aims, methods, anticipated 
benefits, potential hazards, and insurance arrangements in force are explained and the subject has 
been given sufficient time to ask questions and consider participation in the study. It will also be 
explained to the subjects that they are free to refuse entry into the study and free to withdraw from 
the study at any time without prejudice to future treatment. It is permissible for a third person (e.g., 
a family member) to be present during the explanation of the study.
The written Informed Consent Form (ICF) will be in compliance with CFR 21 Part 50.27 and GCP 
guidelines. The Sponsor and/or designated CRO will approve the ICF and all amendments to the 
ICF prior to submission to the IRB/IEC. A copy of the ICF to be used will be submitted by the 
Investigator to the IRB/IEC for review and approval prior to the start of the study. The study site 
must provide the Sponsor with an unsigned copy of IRB/IEC-approved ICF along with applicable 
documentation to support this approval. The original signed ICF is retained in the subject's study 
records, and a copy is provided to the subject. A second copy may be filed in the subject’s medical 
record, if allowed by institutional policy. 


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14.
DATA HANDLING AND RECORD KEEPING
14.1.
RECORDING AND COLLECTION OF DATA
The primary source document for this study will be the subject's medical record. If separate research 
records are maintained by the Investigator(s), the medical record and the research records will be 
considered the source documents for the purposes of auditing the study. 
Applicable source data will be manually transcribed to approve case report forms (CRF). The 
Investigator is ultimately responsible for the accuracy of the data transcribed on the forms. All 
source documents and CRFs will be completed as soon as possible after the subject's visit.
The Investigator will review the CRFs to indicate that, to his/her knowledge, they are complete and 
accurate. Designated source documents will be signed and dated by the appropriate study personnel. 
The Investigator must agree to complete and maintain source documents and CRFs for each subject 
participating in the study.
All research data will be entered, either electronically or manually, into a computerized database. 
The clinical database will be designed by the clinical data manager in accordance with 21 CFR Part 
11 and based on protocol requirements defined by the Sponsor in association with the Lead 
Investigator. 
The Investigator will maintain a confidential list of study subjects that will include each subject’s 
study number, name, date of birth, and unique hospital identification number if applicable. This list 
will be kept by the Investigator and will not be collected by the Sponsor. A notation will be made 
in the subject’s case history/medical chart that he/she is participating in a clinical study and has 
provided a signed and dated ICF as well as a release for protected health information as required 
by local policies. The Investigator must also maintain a separate screening log of all the subjects 
screened for participation in the study; it should include gender, age, eligibility status, reason for 
ineligibility, if applicable; and study allocated subject number, if applicable. 
14.2.
CLINICAL DATA MANAGEMENT
The Sponsor and/or designated CRO will be responsible for the processing and quality control of 
the data. Data management will be carried out as described in the Sponsor’s or CRO’s standard 
operating procedures (SOPs) for clinical studies.
The handling of data, including data quality control, will comply with regulatory guidelines 
(e.g., ICH E6 GCP, and local regulations where applicable) and the Sponsor’s or the CRO’s SOPs 
as well as provisions of the study-specific Data Management Plan.
14.3.
ARCHIVING


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All study documentation at the Investigator site and Sponsor site will be archived in accordance 
with ICH GCP E6 and the Sponsor’s quality standards and SOPs.
The Investigator will maintain all research records, reports, and case history reports for a period of 
two (2) years after regulatory approval of the investigational product. If no application is filed or if 
the application is not approved, records must be maintained for two (2) years after all investigations 
have been completed, terminated or discontinued and the FDA and other global regulatory 
authorities has been notified. 
These documents should be retained for a longer period however, if required by the applicable 
regulatory requirements or if needed by Sponsor or its authorized representative (as per 
GCP 5.5.11).
At the completion of the study, details of the archival process must be provided to the Sponsor. 
Study records are subject to inspection by applicable health and regulatory agencies at any time.
Records to be retained by the Investigator include, but are not restricted to:
Source data and the primary records upon which they are based (e.g., subject’s progress 
notes, adverse event data, test results, and any other diagnostic procedures required to
evaluate the progress of the study)
Completed CRFs
Signed protocols and protocol amendments
Laboratory results, ranges, and certifications
IP and accountability records
Study personnel signature log
Monitoring logs
Correspondence to and from the Sponsor, designee and IRB
Investigator and sub-investigator CVs
Signed informed consent and protected health information consent forms
Subject screening 
SAE reports
IRB approval and re-approval letters
Completed quality of life questionnaire
Other documents pertaining to the conduct of the study
These documents must be maintained and kept on file by the Investigator so that the conduct of the 
study can be fully documented and monitored.
Study records should not be transferred from site or destroyed without prior written agreement 
between the Sponsor and the study Investigator. Study records are subject to inspection by 
applicable health and regulatory agencies at any time. 


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15.
PUBLICATION PLAN
All information supplied by CytoDyn, Inc. in connection with this study and not previously
published, is considered confidential information. This information includes, but is not limited
to, the Investigator’s Brochure, clinical protocol, case report forms and other scientific data. Any
data collected during the study are also considered confidential. This confidential information
shall remain the sole property of CytoDyn, Inc., shall not be disclosed to others without the
written consent of CytoDyn, Inc., and shall not be used except in the performance of this study.
It is understood by the Investigator that the Sponsor will use the information collected in this clinical 
trial in connection with the development of CytoDyn, Inc.. Therefore, this information may be 
disclosed as required to other Investigators or appropriate regulatory authorities. By agreeing to 
participate in this clinical trial, the Investigator understands that he/she has an obligation to provide 
the Sponsor with complete test results and all data developed during this trial.
Publication and Disclosure: The site and Investigator agree to submit any proposed manuscript, 
presentation or other public disclosure regarding the study to Sponsor for review at least thirty (30) 
days prior to submitting such proposed manuscript to a publisher or delivering or making such 
presentation or other public disclosure to any third party. Within thirty (30) days of its receipt, 
Sponsor shall advise the site and/or Investigator, as the case may be, in writing of any information 
contained therein that is confidential information (other than research results included in a proposed 
manuscript) or that may impair Sponsor’s ability to obtain patent protection. Sponsor shall have the 
right to require the site and/or Investigator, as applicable, to remove specifically identified 
confidential information (but may not require removal of research results from a proposed 
manuscript) and/or to delay the proposed submission or delivery of the proposed manuscript or 
presentation, or other public disclosure, for an additional sixty (60) days to enable Sponsor to seek 
patent protection. The site and Investigator shall not publish, publicly disclose, present or discuss 
any results of or information pertaining to the site’s and Investigator’s activities prior to completion 
of the trial, even if the study is terminated before its completion and the final clinical study report 
is signed off, or with respect to any endpoints or analyses other than those specified in this protocol.


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16.
REFERENCES
Aldinucci D, Colombatti A. The inflammatory chemokine CCL5 and cancer progression. Med 
Inflamm 2014;Article ID 292376. https://dx.doi.org/10.1155/2014/292376.
Alexander SV, Philipp G, Marion S, Joachim SH, Anton SH, Max S, Matthias K, Boris B. von 
Bergwelt-Baildon Michael S. Cytokine release syndrome. J. Immunotherapy Cancer. 2018;6(1).
Barbosa-Silva MC, Santos LE, Rangel B. The Impact of Non-Neurotropic Influenza Strains on the 
Brain: A Role for Microglial Priming? Journal of Neuroscience. 2018 Sep 5;38(36):7758-60.
Center for Disease Control (CDC) (2020, March 3). Coronavirus Disease 2019 (COVID-19) 
Situation Summary Retrieved March 5, 2020, from https://www.cdc.gov/coronavirus/2019-
ncov/summary.html
Chang XL, et al. Antibody-based CCR5 blockade recapitulates homozygous CCR5D32 protection 
from sexual HIV transmission in macaques (pending publication).
Chen, J., Lau, Y. F., Lamirande, E. W., Paddock, C. D., Bartlett, J. H., Zaki, S. R., & Subbarao, K. 
(2010). Cellular immune responses to severe acute respiratory syndrome coronavirus (SARS-CoV) 
infection in senescent BALB/c mice: CD4+ T cells are important in control of SARS-CoV 
infection. Journal of virology, 84(3), 1289-1301.
de Vega WC, Herrera S, Vernon SD, McGowan PO. Epigenetic modifications and glucocorticoid 
sensitivity in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). BMC Medical 
Genomics. 2017 Dec 1;10(1):11.
Doerschuk, C. M., Tasaka, S., & Wang, Q. (2000). CD11/CD18-dependent and-independent
neutrophil emigration in the lungs: how do neutrophils know which route to take?. American 
journal of respiratory cell and molecular biology, 23(2), 133-136.
Glass, W. G., Liu, M. T., Kuziel, W. A., & Lane, T. E. (2001). Reduced macrophage infiltration 
and demyelination in mice lacking the chemokine receptor CCR5 following infection with a 
neurotropic coronavirus. Virology, 288(1), 8-17.
Halama N, Zoernig I, Berthel A, Kahlert C, Klupp F, Suarez-Carmona M, Suetterlin T, Brand K, 
Krauss J, Lasitschka F, Lerchl T. Tumoral immune cell exploitation in colorectal cancer metastases 
can be targeted effectively by anti-CCR5 therapy in cancer patients. Cancer cell. 2016 Apr 
11;29(4):587-601.
Hives L., Bradley A., Richards J. Can physical assessment techniques aid diagnosis in people with 
chronic fatigue syndrome/myalgic encephalomyelitis? A diagnostic accuracy study. BMJ Open. 
2017;7


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Jacobson, J. M., Lalezari, J. P., Thompson, M. A., Fichtenbaum, C. J., Saag, M. S., Zingman, B. S., 
... & Maddon, P. J. (2010). Phase 2a study of the CCR5 monoclonal antibody PRO 140 administered 
intravenously to HIV-infected adults. Antimicrobial agents and chemotherapy, 54(10), 4137-4142.
Jacobson, J. M., Saag, M. S., Thompson, M. A., Fischl, M. A., Liporace, R., Reichman, R. C., ... & 
Murga, J. D. (2008). Antiviral activity of single-dose PRO 140, a CCR5 monoclonal antibody, in 
HIV-infected adults. Journal of Infectious Diseases, 198(9), 1345-1352.
Kida S., Pantazis A., Weller R.O. CSF drains directly from the subarachnoid space into nasal 
lymphatics in the rat. Anatomy, histology and immunological significance. Neuropathol Appl 
Neurobiol. 1993;19:480–488. Montoya JG.
Kohlmeier, J. E., Miller, S. C., Smith, J., Lu, B., Gerard, C., Cookenham, T., ... & Woodland, D. L. 
(2008). The chemokine receptor CCR5 plays a key role in the early memory CD8+ T cell response 
to respiratory virus infections. Immunity, 29(1), 101-113.
Lavi E, Cong L. Type I astrocytes and microglia induce a cytokine response in an encephalitic 
murine coronavirus infection. Experimental and Molecular Pathology. 2020 May 23:104474.
Law HKW, Cheung CY, Ng HY, et al. Chemokine up-regulation in SARS-coronavirus-infected, 
monocyte-derived human dendritic cells. Blood 2005;106:2366-2374.
Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current 
concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 
10;124(2):188-95.
Mogensen TH, Paludan SR. Molecular pathways in virus-induced cytokine production. 
Microbiology and Molecular Biology Reviews. 2001 Mar 1;65(1):131-50.
Moldofsky H., Patcai J. Chronic widespread musculoskeletal pain, fatigue, depression and 
disordered sleep in chronic post-SARS syndrome; a case-controlled study. BMC Neurol. 
2011;11:1–7.
Montoya JG, Holmes TH, Anderson JN, Maecker HT, Rosenberg-Hasson Y, Valencia IJ, Chu L, 
Younger JW, Tato CM, Davis MM. Cytokine signature associated with disease severity in chronic 
fatigue syndrome patients. Proceedings of the National Academy of Sciences. 2017 Aug 
22;114(34):E7150-8.
Morris G, Maes M, Berk M, Puri BK. Myalgic encephalomyelitis or chronic fatigue syndrome: how 
could the illness develop?. Metabolic Brain Disease. 2019 Apr;34(2):385-415.
Palaiodimos L, Kokkinidis DG, Karamanis LW et al. Severe obesity, increasing age and male sex 
are independently associated with worse in-hospital outcomes, and higher mortality, in a cohort of 


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patients with COVID-19 in the Bronx, New York. Metabolism 2020;108:154262. 
Doi:10.1016/j.metab.2020.154262.
Patterson BK, Seethamraju H, Dhody K, Corley MJ, Kazempour K, Lalezari J, Pang AP, Sugai C, 
Mahyari E, Francisco EB, Pise A. CCR5 Inhibition in Critical COVID-19 Patients Decreases 
Inflammatory Cytokines, Increases CD8 T-Cells, and Decreases SARS-CoV2 RNA in Plasma by 
Day 14. International Journal of Infectious Diseases. 2020 Nov 10.
Patterson, B. K., Czerniewski, M., Andersson, J., Sullivan, Y., Su, F., Jiyamapa, D., ... & Landay, 
A. (1999). Regulation of CCR5 and CXCR4 expression by type 1 and type 2 cytokines: CCR5 
expression is downregulated by IL-10 in CD4-positive lymphocytes. Clinical Immunology, 91(3), 
254-262.
Perrin R, Riste L, Hann M, et al. Into the looking glass: Post-viral syndrome post COVID-19. Med 
Hypotheses 2020;144:110055. doi.org/10.1016/j.mehy.2020.110055.
Quin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y. Dysregulation of immune response in patients 
with COVID-19 in Wuhan, China. Clin infect dis. 2020;248:1-7.
Rasa S, Nora-Krukle Z, Henning N, Eliassen E, Shikova E, Harrer T, Scheibenbogen C, Murovska 
M, Prusty BK. Chronic viral infections in myalgic encephalomyelitis/chronic fatigue syndrome 
(ME/CFS). Journal of Translational Medicine. 2018 Dec 1;16(1):268.
Russkamp, N. F., Ruemmler, R., Roewe, J., Moore, B. B., Ward, P. A., & Bosmann, M. (2015). 
Experimental design of complement component 5a-induced acute lung injury (C5a-ALI): a role of 
CC-chemokine receptor type 5 during immune activation by anaphylatoxin. The FASEB 
Journal, 29(9), 3762-3772.
Sotzny F, Blanco J, Capelli E, Castro-Marrero J, Steiner S, Murovska M, Scheibenbogen C. 
Myalgic encephalomyelitis/chronic fatigue syndrome–evidence for an autoimmune disease. 
Autoimmunity Reviews. 2018 Jun 1;17(6):601-9.
Steiner S, Becker SC, Hartwig J, Sotzny F, Lorenz S, Bauer S, Löbel M, Stittrich AB, Grabowski 
P, Scheibenbogen C. Autoimmunity-related risk variants in PTPN22 and CTLA4 are associated 
with ME/CFS with infectious onset. Frontiers in Immunology. 2020;11.


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Thompson, M., Lalezari, J., Saag, M., Jacobson, J., Zingman, B., Stambler, N., ... & Morris, S. 
(2009, February). Weekly and biweekly subcutaneous PRO 140 demonstrates potent, sustained 
antiviral activity. In 16th Conference on Retroviruses and Opportunistic Infections (pp. 8-11).
World Health Organization (WHO) (2020, March 1). Coronavirus disease 2019 (COVID-19) 
Situation Report -4 1 Retrieved March 5, 2020, from https://www.who.int/docs/default-
source/coronaviruse/situation-reports/20200301-sitrep-41-covid-19.pdf?sfvrsn=6768306d_2
Yen YT, Liao F, Hsiao CH, et al. Modeling the early events of severe acute respiratory syndrome 
coronavirus infection in vivo. J Virol 2006;80:2684-2693.






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11. What was the severity of your joint pain/swelling at its worst over the last 24 hours? 
None = 0,     Mild = 1,     Moderate = 2,     Severe = 3
12. 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
13. 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
14. What was the severity of your difficulty in concentration (brain fog) at its worst over the last 24 hours? 
None = 0,     Mild = 1,     Moderate = 2,     Severe = 3
15. What was the severity of your sleep disturbance (insomnia) at its worst over the last 24 hours? 
None = 0,     Mild = 1,     Moderate = 2,     Severe = 3
16. What was the severity of your headache at its worst over the last 24 hours? 
None = 0,     Mild = 1,     Moderate = 2,     Severe = 3
17. What was the severity of your dizziness at its worst over the last 24 hours? 
None = 0,     Mild = 1,     Moderate = 2,     Severe = 3
18. What was the severity of your anxiety at its worst over the last 24 hours? 
None = 0,     Mild = 1,     Moderate = 2,     Severe = 3
19. What was the severity of your feeling of tingling or numbness in at its worst over the last 24 hours? 
None = 0,     Mild = 1,     Moderate = 2,     Severe = 3
20. 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
21. How many times did you vomit (throw up) in the last 24 hours?*
I did not vomit at all = 0,   one or two times = 1,     three or four times = 2,       five or more times = 3
22. How many times did you have diarrhea (loose or watery stools) in the last 24 hours?*
I did not have diarrhea at all = 0,  one or two times = 1,   three or four times = 2,   five or more times = 3
23. 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
24. 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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17.2.
APPENDIX 2: COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS V5.03
For complete detailed information please refer to the link below:
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Re
ference_5x7.pdf


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17.3.
APPENDIX 3: PROMIS® FATIGUE SCALE


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17.4.
APPENDIX 4: PROMIS® COGNITIVE FUNCTION- SHORT FORM 4A


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17.5.
APPENDIX 5: PROMIS® SLEEP DISTURBANCE – SHORT FORM 4A


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17.6.
APPENDIX 6 – GLOBAL HEALTH QUESTIONNAIRE




Protocol # CD15_COVID-19
Statistical Analysis Plan
CytoDyn Inc.
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Protocol Number: 
CD15_COVID-19
Protocol Version:
Version 5.0
Protocol Name:
A Randomized, Double Blind, Placebo Controlled Study to 
Evaluate the Efficacy and Safety of Leronlimab in Patients 
Experiencing 
Prolonged 
Coronavirus 
Disease 
2019 
(COVID-19) Symptoms [Long-Haulers]
Sponsor:
CytoDyn, Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Prepared by:
SAP Version:
Final Version 1.0
SAP Date:
11 Jun 2021
I have read and approve the Statistical Analysis Plan specified above and agree with its 
content:
Date
Date


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TABLE OF CONTENTS
Section  
Page
LIST OF ABBREVIATIONS
1.
INTRODUCTION ............................................................................................................... 7
2. 
PROTOCOL DESIGN AND OBJECTIVES ........................................................................ 7
2.1
Study Objectives
2.2 
Design Overview
2.4 
Study Treatments
2.5 
Randomization
2.6 
Stratification
2.7 
Blinding
2.8
Time to Unblinding
2.8.1 
Emergency Unblinding
2.8.2 
Final Analysis
3. 
STUDY ENDPOINTS........................................................................................................ 15
3.1 
Primary Endpoints
3.2 
Secondary Endpoints
3.3 
Exploratory Endpoints
3.4 
Safety Measures
4. 
SAMPLE SIZE DETERMINATION AND RATIONALE.................................................. 17
5. 
INTERIM ANALYSIS....................................................................................................... 17
6. 
ANALYSIS POPULATIONS............................................................................................. 17
6.1 
Modified Intent-to-Treat Population
6.2 
PP Population
6.3 
Safety Population
7. 
DATA CONVENTION AND RELATED DEFINITIONS .................................................. 18
7.1 
Baseline Definition
7.2
Duplicate Data
7.3 
Handling of Missing Data
7.4 
Multiple Comparisons and Type I Error Rate Multiplicity adjustments
7.5 
Covariates and Prognostic Factors
7.6 
Subgroups
7.7 
Standard Calculations
7.7.1 
Age
7.7.2 
Body Mass Index (BMI)
7.7.3 
Change from Baseline
7.7.4 
Censoring rule for subjects with outcome of Death
8. 
STATISTICAL METHODS............................................................................................... 19
8.1 
Summarizing and Tabulating the Collected Data
8.1.1 
Subject Disposition and Withdrawals
8.1.2 
Protocol Deviations
8.1.3 
Demographics and Baseline Characteristics
8.1.4 
Prior and Concomitant Medications


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8.1.5 
Treatment Exposure
8.2
Analysis of Efficacy Data
8.2.1 
Primary Efficacy Endpoint
8.2.2 
Secondary Efficacy Endpoint
8.2.3 
Exploratory Endpoints
8.3
Analysis of Safety Data
8.3.1 
Adverse Events
8.3.2 
Clinical Laboratory Evaluations
8.3.3 
Vital Signs
8.3.4 
Electrocardiogram (ECGs)
8.3.5 
Physical Examination
8.3.6
Urine Pregnancy Test
8.3.7 
Pregnancy
8.3.8 
Leading Questions
8.3.9 
Covid-19 diagonsis
9.
APPENDIX – PLANNED TLG.......................................................................................... 27
9.1 
Planned by-subject listings
9.2 
Planned Summary Tables
10.
VERSION HISTORY ........................................................................................................ 29
11.
REFERENCES.................................................................................................................. 30


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LIST OF ABBREVIATIONS
Abbreviation
Term
AE
Adverse Event
ALT
Alanine Transaminase
ARDS
Acute Respiratory Distress Syndrome
ART
Antiretroviral Therapy
AST
Aspartate Aminotransferase
CCR5
C-C chemokine receptor type 5
CD
Cluster of Differentiation
CFR
Code of Federal Regulations
Cmax
Maximal Concentration 
CNS
Central Nervous System
COVID-19
Coronavirus Disease 2019
CRF
Case Report Form
CRO
Contract Research Organization
CS
Clinically Significant
CTCAE
Common Terminology Criteria for Adverse Events
eCRF
Electronic Case Report Form
CV
Curriculum Vitae
DSMC
Data Safety Monitoring Committee
ECG
Electrocardiogram
EOT
End of Treatment
FDA
U.S. Food and Drug Administration
FDP
Finished Drug Product
FUV
Follow-up Visit
GCP
Good Clinical Practice
GFR
Glomerular Filtration Rate
GMP
Good Manufacturing Practice
HEENT
Head, Ears, Eyes, Nose, and Throat
HIPAA
Health Insurance Portability Accountability Act
HIV
Human Immunodeficiency Virus
IA
Interim Analysis
IC
Inhibitory Concentration
ICF
Informed Consent Form
ICH
International Conference on Harmonization
ICU
Intensive Care Unit
IEC
Independent Ethics Committee
IND
Investigational New Drug


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Abbreviation
Term
IP
Investigational Product
IRB
Institutional Review Board
ISR
Injection Site Reaction
ITT
Intent to Treat
IV
Intravenous
IWRS
Interactive Web Based Response System
LAR
Legally Authorized Representative
LTF
Lost to Follow-Up
MedDRA
Medical Dictionary for Regulatory Activities 
mg
Milligram
MTD
Maximum Tolerated Dose
NEWS
National Early Warning Score 2
OBT
Optimized Background Therapy
PD
Pharmacodynamic
PK
Pharmacokinetic
PI
Principal Investigator
SAE
Serious Adverse Event
SARS-CoV-2
Severe Acute Respiratory Syndrome Coronavirus 2
SC
Subcutaneous
SOP
Standard Operating Procedure
SpO2
Peripheral Capillary Oxygen Saturation
SV
Screening Visit
TEAE
Treatment Emergent Adverse Event
TNBC
Triple Negative Breast Cancer
Treg
T regulatory cell
VL
Viral Load


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1.
INTRODUCTION
This Statistical Analysis Plan describes the planned analyses and reporting for the clinical trial 
protocol CD15_COVID-19, sponsored by CytoDyn Inc.  The reader of this Statistical Analysis Plan 
(SAP) is encouraged to review the complete protocol and amendments as this plan contains only a 
limited overview of protocol information.  The main objective of this plan is to provide details 
pertaining to statistical methodology, data conventions, and processes used for the analysis of data 
from this trial. 
The format and content of this Statistical Analysis Plan are structured to provide sufficient detail to 
meet the requirements specified by the International Conference on Harmonization (ICH) E9: 
Guidance on Statistical Principles in Clinical Trials. All work planned and presented in this Statistical 
Analysis Plan will follow the ethical guidelines published by the American Statistical Association 
(ASA).
The following documents and references [1-6], were reviewed in preparation of this Statistical 
Analysis Plan:
Protocol Version 5.0 / 26 May 2021
ASA Ethical Guidelines for Statistical Practice (2016)
The Royal Statistical Society: Code of Conduct (2014)
ICH Guidance on the Structure and Content of Clinical Study Reports (ICH E3, 1996)
ICH Guidance on the Structure and Content of Clinical Study Reports (ICH E3(R1), 2013)
ICH Guidance on the Statistical Principles for Clinical Trials (ICH E9, 1998)
ICH Guidance on the Statistical Principles for Clinical Trials (ICH E9(R1), 2017)
2.
PROTOCOL DESIGN AND OBJECTIVES
2.1 Study Objectives
The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered 
as weekly subcutaneous injection in subjects experiencing prolonged symptoms (> 12 weeks) of 
COVID-19.
2.2 Design Overview
This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to 
evaluate the safety and efficacy of leronlimab (PRO 140) in patients with prolonged symptoms caused 


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by COVID-19. Patients will be randomized to receive weekly doses of 700 mg leronlimab (PRO 
140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
The study flow diagram is presented in Figure 2-1.
Figure 2-1:
Study Schematic


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The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period. The 
study Schedule of Assessments in presented in Table 2-1.
Screening Period (up to 1 week): 
Screening assessments will commence at Visit 1 (V1) after obtaining signed informed consent, and 
will include review of medical and medication history, eligibility evaluation, vital signs, pulse oxygen 
saturation, physical examination, electrocardiogram (ECG), clinical symptom score assessment, and 
laboratory sample collection for routine serum biochemical, hematologic, coagulation, urinalysis, and 
urine pregnancy (if applicable). These assessments must be conducted within 7 days of the First 
Treatment Visit (V2).
All subjects who fail to meet eligibility criteria are considered screen failures, and are exited from the 
study without further evaluation.
Treatment Period (56 Days ± allowed windows): 
The schedule of visits during Treatment Period is as follows: 
Visit 2 (V2) [first treatment]: Within 1 week of the Screening Visit
Visit 3 (V3): 3 (±1) days after V2
Visit 4 (V4) [second treatment]: 7 (±1) days after V2
Visit 5 (V5): 3 (±1) days after V4
Visit 6 (V6) [third treatment]: 7 (±1) days after V4
Visit 7 (V7): 3 (±1) days after V6
Visit 8 (V8) [fourth treatment]: 7 (±1) days after V6
Visit 9 (V9): 3 (±1) days after V8
Visit 10 (V10) [fifth treatment]: 7 (±1) days after V8
Visit 11 (V11): 3 (±1) days after V10
Visit 12 (V12) [sixth treatment]: 7(±1) days after V10
Visit 13 (V13): 3 (±1) days after V12
Visit 14 (V14) [seventh treatment]: 7(±1) days after V12
Visit 15 (V15): 3 (±1) days after V14
Visit 16 (V16) [eight treatment]: 7(±1) days after V14
Visit 17 (V17) / End of Treatment (EOT) Visit: 7 (±1) days after V16. 
Subjects who meet the eligibility criteria will have completed the following evaluations and 


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assessments at V2 prior to treatment: review of any changes in medical and medication history, vital 
signs, pulse oxygen saturation, physical examination, PROMIS® Fatigue Scale, PROMIS® 
Cognitive Function, PROMIS® Sleep Disturbance, and blood sample collection for CD4+ and CD8+ 
T cell count and serum cytokine and chemokine levels.
If Visit 2 (V2) takes place on the same day as the Screening Visit (V1), scheduled assessments 
performed under screening (V1) do not need to be repeated at V2. Subjects will be given a diary to 
record all symptoms daily throughout the entire treatment period starting at baseline. 
At V2, subjects will be randomized to receive leronlimab (PRO 140) or placebo which will be 
administered subcutaneously weekly at V2, V4, V6, V8, V10, V12, V14, and V16.
The following assessments will be performed at V4, V6, V8, V10, V12, V14, V16, and V17(EOT): 
vital signs, pulse oxygen saturation, physical examination, electrocardiogram (ECG (V17 only), 
PROMIS® Fatigue Scale, PROMIS® Cognitive Function- Short Form 4a, PROMIS® Sleep 
Disturbance – Short Form 4a, Global Health Assessment (V17 only), blood sample collection for 
routine serum biochemical, hematologic, coagulation and urine laboratory assessments (V10 and 
V17). CD4+ and CD8+ T cell count and serum cytokine and chemokine levels (V10 and V17), 
assessment for the requirement of hospitalization and patient compliance to daily diary completion 
will be checked by the site staff.
Additionally, telephone or video contact visits will be performed 3 days (±1 day) after each treatment 
administration visit. The requirement of hospitalization and patient compliance to daily diary 
completion will be checked during V3, V5, V7, V9, V11, V13, and V15 via telephone.
Adverse events and concomitant medications will be monitored throughout the study.
Follow Up Period (4 weeks after EOT± 3 days)
Follow-up visit (V18) will be performed 4 weeks after the End of Treatment (EOT) visit. The 
following assessments will be performed at V18: vital signs, physical examination, pulse oxygen 
saturation, blood sample collection for immunophenotypic biomarker analysis, assessment for the 
requirement of hospitalization, review of adverse events and concomitant medications.
Note: During visits conducted at the study clinic, subjects and site personnel will use appropriate 
protective gear (e.g., masks, gloves) to prevent the spread of the infection.






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[6]
Symptom Score will be assessed for patient eligibility based on symptom score for following symptoms consistent with COVID-19 as a result of confirmed SARS-CoV-
2 infection for a prolonged period of time (>12
Screening (at V1) and prior to Randomization (at V2)
[7]
Patients will be asked to complete a daily diary during the treatment phase to record symptoms. 
[8]
All three questionnaires, PROMIS® Fatigue Scale, PROMIS® Cognitive Function, and PROMIS® Sleep Disturbance will be evaluated before study drug administration. .
[9]
Hemoglobin, Hematocrit (HCT), Red Blood Cells (RBC), White Blood Cells (WBC) with total and differential count, Absolute Neutrophil Count (ANC) and platelets.
[10] Biochemistry 
Hepatic function indicators: total bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, albumin, Lactate 
dehydrogenase (LDH)
Renal function indicators: Serum creatinine, eGFR
Electrolytes: sodium, potassium, chloride, calcium and bicarbonate
Other: glucose (random), cholesterol (total), Creatine kinase, C-reactive protein, Serum ferritin
[11] Prothrombin time (PT) and International Normalized Ratio (INR)
[12] ONLY performed on women of childbearing potential.
[13] Urine samples will be tested for color, appearance, specific gravity, pH, protein, glucose, occult blood, ketones, leukocyte esterase, nitrite, bilirubin, urobilinogen, and 
microscopic examination of urine sediment.
[14] Refer to Table 7-1 for details.
[15] Randomization via WebView CTMS system
[16] If Visit 2 (V2) takes place on the same day as the Screening Visit (V1), scheduled assessments performed under screening (V1) do not need to be repeated at V2.
[17] Visits listed as clinic will take place at the study center. The remaining visits are to be conducted as telephone or video contact visits.




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 Technology department is not otherwise involved with the study.
Treatment unblinding for the study will occur after all clinical data have been received, data
inconsistencies have been resolved, and the database is locked, except for safety reasons on a case-
by-case basis (i.e., emergency unblinding). 
The process for emergency unblinding will be outlined in details in the Randomization Plan.  In 
addition, any subject that is unblinded for any reason will be identified and discussed in the final 
clinical study report.
2.8 Time to Unblinding
2.8.1 Emergency Unblinding
Breaking the blind prematurely will be allowed only if the subject’s well-being requires knowledge 
of the subject’s treatment allocation. Every attempt will be made to maintain the blind throughout the 
study.
In the event of an urgent safety issue where the randomized treatment of a subject is necessary to 
manage and treat the affected study subject (e.g., unblinding subjects because of SAEs that meet 
“expedited criteria” and requires reporting to FDA and other global regulatory authority), the 
Investigator will contact the Medical Monitor. The Medical Monitor, in consultation with sponsor, 
will make a decision to unblind. If the decision has been made to unblind, a prompt written 
notification will be provided to the Investigator. The reason for unblinding must be recorded; however 
the investigator must not record the subject’s treatment assignment in study documentation and must 
not reveal the subject’s treatment assignment to the clinical monitor.
If reporting of an adverse event is to be performed unblinded as per regulatory authority guidelines, 
study-unrelated personnel will unblind the individual subject’s treatment group and will perform the 
unblinded reporting. No treatment group information would be shared with study personnel.
2.8.2 Final Analysis
Treatment unblinding and release of the randomization codes of the investigational product 
assignments for the study will occur immediately following database lock when all randomized 
subjects have completed the study or discontinued from the study and after all clinical data have been 
received and data inconsistencies have been resolved.
3.
STUDY ENDPOINTS
3.1 Primary Endpoints
The primary endpoint is:


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Changes from baseline in daily COVID-19-related symptom severity score through Day 56 
Note: A set of common COVID-19-related symptoms (see patient diary template) will be 
evaluated daily by the patient regardless of which symptoms a subject had at baseline, as new 
symptoms may appear following the baseline assessment. 
3.2 Secondary Endpoints
The secondary endpoints for the study are:
Duration of COVID-19 associated symptoms from start of study treatment (Day 0) based on 
self-assessment using daily symptom diary
Duration is defined as number of days when any symptoms scored as
-
2 or 3 at baseline are still scored as 2 or 3 (i.e., not 0 or 1) through Day 56, or 
-
1 or 0 at study entry are scored as 1 or worse (i.e., not 0) through Day 56.
Number of symptom-free days of COVID-19 associated symptoms that were present at the 
start of study treatment (Day 0) based on self-assessment using daily symptom diary
Symptom-free days are defined as number of days when any symptoms scored as 
1, 2 or 3 at baseline are still scored as 0 through Day 56 .
Progression (or worsening) of COVID-19-associated symptoms through Day 56 compared 
to baseline
Progression or symptom worsening is defined as number of days when any symptoms scored 
as
-
2 at baseline are still scored as 3 through Day 56, or 
-
1 at baseline are still scored as 2 or 3 through Day 56, or 
-
0 at study entry are scored as worse (i.e., not 0) through Day 56.
Change from baseline in PROMIS® Fatigue Score at Days 28 and 56
Change from baseline in PROMIS® Cognitive Function Score at Days 28 and 56
Change from baseline in PROMIS® Sleep Disturbance Score at Days 28 and 56
Incidence of hospitalization during the treatment phase
Duration (days) of hospitalization during the treatment phase
3.3 Exploratory Endpoints
Change from baseline in pulse oxygen saturation (SpO2) at Day 7, 14, 21, 28, 35, 42, 49, 
and 56


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Change from baseline in serum cytokine and chemokine levels on Days 28 and 56
Change from baseline in CD4+ and CD8+ T cell count on Days 28 and 56
Change from baseline in Transgrowth factor beta 1 (TGF beta1) on Days 28 and 56
Change from baseline in CRP on Days 28 and 56
Change from baseline in CCR5 receptor occupancy on Days 28 and 56.
To explore biomarkers that may predict and/or act as pharmacodynamic indicators of 
pharmacologic activity of leronlimab.
Evaluation of Global Health Assessment at Day 56
3.4 Safety Measures
Safety will be assessed using:
Incidence of treatment-related adverse events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs)
Incidence of serious adverse events (SAEs)
Incidence of TEAEs and SAEs leading to discontinuation of study medication. 
Changes in blood chemistry, hematology and coagulation parameter results
Changes in vital signs including temperature, pulse, respiratory rate, systolic and diastolic 
blood pressure
Changes in physical examination results
Changes in electrocardiogram (ECG) results
4.
SAMPLE SIZE DETERMINATION AND RATIONALE
This is a randomized study with two treatment groups. The subjects will be randomized to the 
treatment groups (leronlimab or placebo) in a 1:1 ratio. 
A total of 50 subjects will be randomized in this study. The sample size is based on clinical judgment. 
No statistical power calculation is used to establish the sample size for this exploratory study. 
5.
INTERIM ANALYSIS 
There will be no interim analysis performed in this study.
6.
ANALYSIS POPULATIONS 
6.1 Modified Intent-to-Treat Population
The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have 
received at least one dose of study treatment (leronlimab or placebo). This population will be used as 


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the primary analysis population for analysis of the primary and secondary efficacy endpoints..
6.2 PP Population
The Per Protocol (PP) population is defined as the set of subjects who meet the mITT Population 
requirements and are not associated with any major protocol violations. This population will be 
identified before the database lock. This population will be used as the supportive analysis population 
for analysis of the primary and secondary efficacy endpoints.
6.3 Safety Population
The Safety Population will include all subjects who have received one dose of study treatment 
(leronlimab or placebo). This population will be used for the analysis of safety parameters or 
measurements.
7.
DATA CONVENTION AND RELATED DEFINITIONS  
7.1 Baseline Definition
For all parameters, baseline will be defined as the last available value before the randomized 
treatment.
7.2 Duplicate Data 
For unplanned duplicate data within a protocol-specified visit, all collected data will be listed and the 
last measured value will be used for the analysis. If it is not possible to identify the “last measured 
value,” the average of the duplicate values will be used. 
7.3 Handling of Missing Data 
Every effort will be made to obtain required data at each scheduled evaluation from all subjects who 
have been randomized to minimize missing data. Missing data will not be imputed. 
7.4 Multiple Comparisons and Type I Error Rate Multiplicity adjustments
There will be no adjustment for multiple testing or multiplicity for this phase II trial. For all 
effectiveness endpoints, inference will be based on type I error rate of 0.05.
7.5 Covariates and Prognostic Factors
In the efficacy analysis, the stratification factors and baseline values will be used as covariates in the 
analysis of all the primary, secondary, and explorartory endpoints. 
7.6 Subgroups 
As several factors are considered to be related to treatment, subgroup analyses will be performed to 
evaluate whether the treatment effects are consistent across different subgroups. These factors 
include:




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8.1.1 Subject Disposition and Withdrawals
The disposition of all subjects who sign an ICF will be provided. The number of subjects screened,
screen failure, randomized, received at least one treatment, completed, and discontinued during the 
study, as well as the reasons for all discontinuations will be summarized by treatment group.
Disposition and reason for study discontinuation will also be provided as a by-subject listing. 
8.1.2 Protocol Deviations
Protocol deviations will be identified and classified as minor or major before un-blinding. 
Protocol deviations for all randomized subjects will be listed as by-subject listing and major  
deviations will be summarized descriptively according to the following categories: 
Did  not meet Inclusion/Exclusion criteria but entered into study
Developed withdrawal criteria during the study but not withdrawn
Received excluded concomitant medication
Study treatment dosing deviation
8.1.3 Demographics and Baseline Characteristics
Demographics and baseline characteristics (i.e., Age, Race, Gender , Tobacco use history etc.) will 
be summarized using appropriate descriptive statistics.
Medical history of the subjects will be provided as a by-subject listing. 
8.1.4 Prior and Concomitant Medications
Prior and concomitant medications will be summarized for the Safety population. All prior and 
concomitant medications recorded in the eCRFs will be coded to generic term and all matching 
Anatomic Therapeutic Classification (ATC) codes using the most recent version of the WHO Drug 
WHO Drug Dictionary. Summaries will be prepared using the coded terms. All prior and concomitant 
medications recorded in the eCRFs will also be listed.
8.1.5 Treatment Exposure
All data from administration of study drug will be presented. 
In addition, extent of exposure will be summarized using total number of injections received during 
the treatment phase for all subjects, including n, median, mean, SD, min, max. The duration (days) 
of exposure from the treatment start date to the treatment end date will be summarized.
8.2 Analysis of Efficacy Data
The primary analysis will be conducted on the mITT population. The PP population will be used as 
the supportive analysis population for analysis of the primary and secondary efficacy endpoints.


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8.2.1 Primary Efficacy Endpoint
The primary endpoint for the study is changes from baseline in daily COVID-19-related symptom 
severity score through day 56.
Daily COVID-19 related symptom score is the sum of score from Assessment of COVID-19-related 
symptoms.
For this endpoint, proportions of subjects in each category will be summarized and compared using 
proportional odds model, adjusting for baseline COVID-19 related symptom score and stratification 
factors. Odds Ratio estimates and 95% Confidence Interval will also be calculated. 
8.2.2 Secondary Efficacy Endpoint
8.2.2.1 Duration of COVID-19 associated symptoms from start of study treatment (Day 0) based on 
self-assessment using daily symptom diary.
Duration is defined as number of days when any symptoms scored as
- 2 or 3 at baseline are still scored as 2 or 3 (i.e., not 0 or 1) through Day 56, or 
- 1 or 0 at study entry are scored as 1 or worse (i.e., not 0) through Day 56.
The duration (days) of COVID-19 associated symptoms will be compared between the treatment 
groups using the a non-parametric method or a rank-ANCOVA analysis i.e., an ANCOVA analysis 
on rank-transformed data.
8.2.2.2 Number of symptom-free days of COVID-19 associated symptoms that were present at the 
start of study treatment (Day 0) based on self-assessment using daily symptom diary.
Symptom-free days are defined as number of days when any symptoms scored as 1, 2 or 3 at baseline 
are still scored as 0 through Day 56 . 
The number of symptom-free days of COVID-19 associated symptoms will be compared between 
the treatment groups. Similar analysis methods used for the section 8.2.2.1 will be applied to analyze 
the data from this endpoint. 
8.2.2.3 Progression (or worsening) of COVID-19-associated symptoms through Day 56 compared 
to baseline.
Progression or symptom worsening is defined as number of days when any symptoms scored as
- 2 at baseline are still scored as 3 through Day 56, or 
- 1 at baseline are still scored as 2 or 3 through Day 56, or 
- 0 at study entry are scored as worse (i.e., not 0) through Day 56.
The progression (or worsening) of COVID-19-associated symptoms will be compared between the 


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treatment groups.. Similar analysis methods used for section 8.2.2.1 will be applied to analyze the 
data from this endpoint. 
8.2.2.4 Change from baseline in PROMIS® Fatigue Score at Days 28 and 56.
The change from baseline in PROMIS® Fatigue Score will be compared between the treatment groups
will be presented and summarized descriptively by treatment group using ANCOVA adjusting for 
stratification factors. If the data is not normally distributed, a non-parametric method or a rank-
ANCOVA analysis i.e., an ANCOVA analysis on rank-transformed data will be used.
8.2.2.5 Change from baseline in PROMIS® Cognitive Function Score at Days 28 and 56. 
The change from baseline in PROMIS® Cognitive Score will be compared between the treatment 
groups. Similar analysis methods used for section 8.2.2.4 will be applied to analyze the data from this 
endpoint. 
8.2.2.6 Change from baseline in PROMIS® Sleep Disturbance Score at Days 28 and 56.
The change from baseline in PROMIS® Sleep Score will be compared between the treatment groups..
Similar analysis methods used for section 8.2.2.4 will be applied to analyze the data from this 
endpoint. 
8.2.2.7 Incidence of hospitalization during the treatment phase
The Incidence of hospitalization will be compared between the treatment groups. Similar analysis 
methods used for section 8.2.2.1 will be applied to analyze the data from this endpoint. 
8.2.2.8 Duration (days) of hospitalization during the treatment phase
The duration of hospitalization will be compared between the treatment groups. Similar analysis 
methods used for section 8.2.2.1 will be applied to analyze the data from this endpoint.
8.2.3 Exploratory Endpoints
Change from baseline in pulse oxygen saturation (SpO2) at Day 7, 14, 21, 28, 35, 42, 49, and 56
The Change from baseline in pulse oxygen saturation (SpO2) will be presented and summarized 
descriptively by treatment group using similar analysis methods used for section 8.2.2.4.
Change from baseline in serum cytokine and chemokine levels on Days 28 and 56
The Change from baseline in serum cytokine and chemokine levels will be presented and summarized 
descriptively by treatment group compared using using similar analysis methods used for section 
8.2.2.4.
Change from baseline in CD4+ and CD8+ T cell count on Days 28 and 56
The Change from baseline in CD4+ and CD8+ T cell count will be presented and summarized 


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descriptively by treatment group compared using similar analysis methods used for section 8.2.2.4.
Change from baseline in Transgrowth factor beta 1 (TGF beta1) on Days 28 and 56
The Change from baseline in Transgrowth factor beta 1 (TGF beta1) will be presented and 
summarized descriptively by treatment group compared using using similar analysis methods used 
for section 8.2.2.4.
Change from baseline in CRP on Days 28 and 56
The Change from baseline in CRP will be presented and summarized descriptively by treatment group
compared using similar analysis methods used for section 8.2.2.4.
Change from baseline in CCR5 receptor occupancy on Days 28 and 56.
The Change from baseline in CCR5 will be presented and summarized descriptively by treatment 
group compared using similar analysis methods used for section 8.2.2.4.
To explore biomarkers that may predict and/or act as pharmacodynamic indicators of
pharmacologic activity of leronlimab.
Biomarkers that may predict and/or act as pharmacodynamic indicators of pharmacologic activity of 
leronlimab will be explored.
Evaluation of Global Health Assessment at Day 56.
The change from baseline in Global Health Assessment will be compared between the treatment 
groups. Similar analysis methods used for section 8.2.2.4 will be applied to analyze the data from this 
endpoint. 
8.3 Analysis of Safety Data
The Safety population will be used for the analysis of safety assessments. 
8.3.1 Adverse Events
Adverse events will be coded using the most recent version of Medical Dictionary for Regulatory 
Activities (MedDRA). Treatment Emergent AE’s (TEAE) are defined as events with an onset on or 
after the first treatment. TEAEs will be summarized by System Organ Class and preferred term by 
treatment group. The following TEAE summaries will be provided:
Overall (i.e., regardless of severity or relationship to treatment);
By intensity  (mild, moderate, severe, life threatening or death);
By causality (definitely, probably, possibly, unlikely or unrelated);


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By impact on study treatment (dose increased, dose not changed, dose rate reduced, dose 
reduced, drug interrupted, drug withdrawn, not applicable, or unknown).
In addition, separate summaries of serious adverse events, and adverse events resulting in
discontinuation of study treatment will be presented.
8.3.2 Clinical Laboratory Evaluations
All available results of the clinical laboratory evaluations will be listed and/or summarized.  
Laboratory evaluations include hematology, biochemistry, serology and urinalysis.
Laboratory data will be classified into grades according to DAIDS toxicity grading.   A severity grade 
of 0 will be assigned when the value is within normal limits.
The following summaries will be produced for the hematology and biochemistry laboratory data (by 
laboratory parameter):
-
Number and percentage of patients with worst post-baseline grade (regardless of the baseline 
status). Each patient will be counted only for the worst grade observed post-baseline
-
Shift tables using DAIDS grades to compare baseline to the worst post-baseline value will be 
produced for hematology and biochemistry laboratory parameters with DAIDS grades
-
Shift tables using normal range to compare baseline to the worst post-baseline value will be 
produced for hematology and biochemistry laboratory parameters without DAIDS grades
8.3.3 Vital Signs
Vital sign assessments are performed in order to characterize basic body function. The parameters 
collected in this study are: systolic BP (mmHg), diastolic BP (mmHg), temperature (0C), heart rate 
(bpm), respiratory rate (rpm), pulse oxygen.
8.3.3.1 Clinically notable elevated values
baseline
baseline.
39.1°C
bpm
Respiration 
8.3.3.2 Clinically notable below normal values
baseline
baseline




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presented for the investigator ECG interpretation (i.e., Normal, Abnormal (not clinically significant) 
and Abnormal (clinically significant)) with counts and percentages of subjects, for shift (change) 
from baseline.
8.3.5 Physical Examination 
All abnormal physical examination finds will be listed. 
8.3.6 Urine Pregnancy Test
All data from Urine Pregnancy test will be presented as a by-subject listing. 
8.3.7 Pregnancy
All data from Outcome Description Form – Pregnancy and Notification form – pregnancy will be 
presented as a by-subject listing. 
8.3.8 Leading Questions
All data from Leading Questions will be presented as a by-subject listing. 
8.3.9 Covid-19 diagonsis
All data from covid 19 diagnosis will be presented as a by-subject listing. 


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Statistical Analysis Plan
CytoDyn Inc.
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9. APPENDIX – PLANNED TLG
9.1 Planned by-subject listings 
DISPOSITION/WITHDRAWALS (LISTINGS 16.2.1.X)
ELIGIBILTY AND PROTOCOL DEVIATIONS (LISTINGS 16.2.2.X)
EXCLUDED SUBJECTS (LISTINGS 16.2.3.X)
DEMOGRAPHICS, POPULATION, AND BASELINE CHARACTERISTICS (LISTINGS 16.2.4.X)
TREATMENT ADMINISTRATION LISTINGS (LISTINGS 16.2.5.X)
EFFICACY RESPONSE DATA (LISTINGS 16.2.6.X)
ADVERSE EVENT DATA (LISTINGS 16.2.7.X)
SAFETY DATA (LISTINGS 16.2.8.X)


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Statistical Analysis Plan
CytoDyn Inc.
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9.2 Planned Summary Tables 
POPULATION DISPOSITION AND PROTOCOL DEVIATIONS
POPULATION DEMOGRAPHICS AND BASELINE CHARACTERISTICS
CONCOMITANT MEDICATION USAGE
EFFICACY SUMMARIES
SAFETY SUMMARIES 
ADVERSE EVENT SUMMARIES 
SERIOUS ADVERSE EVENTS 
LABORATORY
VITAL SIGNS 
PE
ECG
OTHER SAFETY


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CytoDyn Inc.
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10.
VERSION HISTORY 
This is the first version of the SAP. 


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11.
REFERENCES
1.
ASA. (2016) Ethical Guidelines for Statistical Practice. Prepared by the 
Committee on Professional Ethics, April, 2016. 
2.
The Royal Statistical Society: Code of Conduct (2014).
3.
E8 General Considerations for Clinical Trials, ICH Guidance, Federal Register, 
1997.
4.
E9 Statistical Principles for Clinical Trials, ICH Guideline, Federal Register, 
1998
5.
Guideline for the Format and Content of the Clinical and Statistical Section of an 
Application, 1988.
6.
Guideline for Industry:  Structure and Content of Clinical Study Reports (ICH 
E3), July 1996.


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IRB Version [Number] 
Screening ICF, dated 22-Apr-21 for Protocol V4.0 
Protocol CD15_COVID-19 
RESEARCH SUBJECT INFORMATION AND CONSENT FORM AND 
AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH 
INFORMATION 
 
TITLE: 
A Phase 2, Two-Part Study (8-Week, Randomized, Double 
Blind, Placebo Controlled Period Followed by a 4-Week, 
Open-Label Extension Period) to Evaluate the Efficacy and 
Safety of Leronlimab in Patients Experiencing Prolonged 
Coronavirus Disease 2019 (COVID-19) Symptoms [Long-
Haulers] 
 
PROTOCOL NO.: 
CD15_COVID-19 
IRB Protocol #20210354 
 
SPONSOR: 
CytoDyn, Inc. 
 
INVESTIGATOR:  
Name 
Address 
City, State Zip 
Country 
 
STUDY RELATED 
PHONE NUMBER(S): 
Phone Number 
 
Phone Number (24 hours) 
 
[24-hour number is required] 
 
 
This consent form contains important information to help you decide whether to 
participate in a research study. 
The study staff will explain this study to you. Ask questions about anything that is not clear at 
any time. You may take home an unsigned copy of this consent form to think about and discuss 
with family or friends. 
 Being in this study is voluntary – your choice. 
 If you join this study, you can still stop at any time. 
 No one can promise that a study will help you. 
 Do not join this study unless all of your questions are answered. 
 
After reading and discussing the information in this consent form you should know: 
 Why this research study is being done; 
 What will happen during the study; 
 Any possible benefits to you; 
 The possible risks to you; 


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 Other options you could choose instead of being in this study; 
 How your personal health information will be treated during the study and after the study 
is over; 
 Whether being in this study could involve any cost to you; and 
 What to do if you have problems or questions about this study. 
 
Please read this consent form carefully. 
 
INTRODUCTION 
You are being invited to take part in a clinical research study because you have been diagnosed 
with Coronavirus Disease 2019, known as COVID-19, and are experiencing prolonged 
symptoms of the disease. This research study is using an investigational drug as a possible 
treatment for this diagnosis.   
 
The name of the investigational study drug involved in this study is: 
 
 Leronlimab (PRO 140). It belongs to a class (group) of drugs called C-C Chemokine 
Receptor Type-5 (CCR5) antagonists. 
 
For purposes of this research, you will be referred to as a “participant”.   
 
CytoDyn, Inc., a pharmaceutical company is supporting this research study by providing funding 
for this research study.  
 
This research consent form explains why this research study is being done, what is involved in 
participating in the research study, the possible risks and benefits of participation, alternatives to 
participation, and your rights as a research participant. The decision to participate is yours. If you 
decide to participate, please sign and date at the end of this form. We will give you a copy so that 
you can refer to it while you are involved in this research study. If you choose not to participate 
in this research study, the research doctors will discuss other treatment options with you and/or 
refer you back to your primary doctor.  
 
Before you decide to take part in this study, it is important for you to understand why the 
research is being done and what it will involve. 
 
WHY IS THIS RESEARCH STUDY BEING DONE?  
This research study is a Phase 2 clinical trial. Phase 2 clinical trials test the safety and 
effectiveness of an investigational drug to learn whether the drug works in treating a specific 
disease.   
 
Your study doctor and medical team are conducting a research study with CytoDyn, Inc. This 
study will help determine the safety and efficacy of Leronlimab (PRO 140) in the treatment of 
prolonged symptoms of coronavirus disease 2019 (COVID-19). 


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The safety of Leronlimab (PRO 140) has been previously evaluated in over 750 people in 
previous studies. The product you will be using is an investigational drug. “Investigational” 
means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not 
approved this drug, Leronlimab (PRO 140) as a treatment for any disease. The results of these 
studies will be used to design future studies to improve treatment of patients suffering from 
COVID-19. 
 
In Part 1 of this study, subjects will be randomly assigned (by chance, like drawing straws) to 
receive weekly doses of Leronlimab (PRO 140) or placebo. You have a 1 in 2 chance (50%) of 
receiving the study drug and 1 in 2 chance (50%) of receiving the placebo. Neither you nor the 
study doctor will know which one you will receive. This information can be made available in 
case of an emergency. 
 
During the study, you will be asked to discontinue use of any of the following medications:  
 Hydroxychloroquine, oral or parenteral corticosteroids, immunosuppressants, or 
immunomodulating agents 
 Albuterol as nebulizer for treatment of COVID-19 
 Other CCR5 antagonists 
 Other investigational products (medications prescribed through another clinical study) 
 
About 50 subjects will enroll in the study across up to 5 centers within the USA. 
 
HOW DOES Leronlimab (PRO 140) WORK? 
Leronlimab (PRO 140) belongs to the monoclonal antibody class of medicines. Monoclonal 
antibodies are synthetic versions of the disease-fighting proteins (antibodies) that are naturally 
produced by the body. Antibodies that are normally circulating in the blood typically react to any 
foreign organisms or materials (bacteria, viruses, etc.) that enter our body. However, Leronlimab 
(PRO 140) binds to a protein (CCR5) that is present on the surface of one kind of our blood cells. 
By doing so, it is hoped that it reduces the bad inflammation results from infection with the 
coronavirus, and thus might be useful in the treatment of COVID-19. 
 
In the disease COVID-19, the body may respond to the viral infection by overproducing immune 
cells and their signaling molecules in a dangerous phenomenon called cytokine storm, which is 
often associated with a surge of activated immune cells in the body.  
 
Leronlimab (PRO 140) does not kill the novel coronavirus. Based on in vitro data, it is our 
hypothesis that Leronlimab acts by blocking pro-inflammatory cytokines, which prevents 
cytokine storm and thus could be useful in treatment of COVID-19 symptoms. 
 
A small Phase II study of 86 patients with mild to moderate coronavirus disease 2019 (COVID-
19) did not meet its study goal to demonstrate difference between Leronlimab and placebo. 


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However, some additional analyses of the data indicated a possibility of benefit in more severe 
patients. Safety results showed no new safety risk was identified in patients receiving 
Leronlimab. 
 
This document uses words such as treatment, drug, medication, and patient. Please remember 
this is a research study and the use of these terms does not mean the use of the Leronlimab (PRO 
140) has been found to be safe or effective for your condition. 
 
WHAT OTHER OPTIONS ARE THERE? 
Taking part in this research study is voluntary. You will always be free to withdraw from the 
study at any time. If you withdraw during the study, you will be asked to come in for a final visit 
for study evaluations. You do not have to give a reason for your withdrawal from the study. This 
will not affect the standard of care that you will receive, and it will not result in any penalty or 
loss of benefits to which you are entitled. The data collected up to that point will be kept with 
your medical records and will be kept confidential. Your identity will not be disclosed. 
 
Instead of being in this research study, you have other options which may include the following:  
 
 Hydroxychloroquine or chloroquine with or without azithromycin, Veklury 
(remdesivir), Dexamethasone (or other corticosteroids), monoclonal antibodies (such 
as bamlanivimab, casirivimab, imdevimab), immunomodulatory agents (such as 
baricitinib, sarilumab, clazakizumab, tocilizumab, anakinra), or Convalescent plasma 
therapy. 
 Other standard supportive care to help relieve symptoms 
 Taking part in another research study being explored for COVID-19 treatment 
 
Please talk to the research doctor about your options and their risks and benefits before you 
decide whether you will take part in this research study. 
 
WHAT IS INVOLVED IN THE RESEARCH STUDY? 
 
There are two parts to this study. If you sign this consent form, you will take part in the first part. 
At the end of the first part, you will then have the option to continue into the second part of the 
study. 
 
IN THE FIRST PART OF THE STUDY:  
 
 You will take once weekly dose of 700 mg Leronlimab (PRO 140) or placebo for eight 
weeks, for a total of eight doses. 
 Leronlimab (PRO 140) or placebo will be injected via a very thin needle slightly below 
the surface of your skin in your stomach, by the research staff or visiting nurse. You will 
receive two injections (of 2 mL) on opposite sides of your abdomen every week for eight 
weeks. 


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 Your participation involves 3 periods: 
o Screening phase will take up to 1 week and will include one visit to the study 
clinic. 
o Treatment phase will last for eight weeks and include eight visits to the study 
clinic, when you will receive treatment with Leronlimab (PRO 140), as well as 
telephone or video “visits” in between treatment administration visits. The final 
visit during the treatment phase will take place one week after the final treatment 
administration and will be at the study clinic. There will be a total of sixteen 
“visits” during the treatment phase. 
o Follow-up phase is applicable only if you decide not to continue into Part 2 of the 
study, and will last for four weeks. The follow-up phase includes one visit to the 
study clinic, four weeks after the last visit in the treatment phase.  
 In total, the expected Part 1 duration is 91 days (13 weeks).  
 At visits conducted at the study clinic, you and the study staff will be provided the 
appropriate protective gear (e.g., masks, gloves) to prevent the spread of the infection.  
 Sometimes it is hard to keep track of all of the details and procedures that are part of a 
research study. We will describe them in this consent form and you can refer to this at 
any time during the research study. 
 
Screening Period (before the research starts):   
During this part of the study you will be evaluated to determine if you would be eligible to enter 
the study. The screening period may last up to seven days (1 week). 
 
After signing this consent form, you will be asked to undergo some screening tests or procedures 
to find out if you can participate in the research study. If you have had some of these tests or 
procedures recently, they may not have to be repeated. 
 
Screening Visit 
After signing this consent form, the following procedures will be done at the screening visit: 
 
 You will be asked a number of general questions about your age, race, ethnicity, your 
medical and surgical history, including any illnesses or health problems, and your prior or 
current medications. 
 Your study doctor will give you a Physical Exam. 
 Your height, weight, heart rate, body temperature, blood pressure, and breathing rate will 
also be assessed. 
 Your study doctor will assess your COVID-19 clinical symptom score.  
 Your doctor will perform a test (pulse oximetry) to measure your blood oxygen level 
 Your study doctor will perform an ECG (electrocardiogram – a test to check your heart). 
 A series of blood tests will be performed. The amount of blood needed for these tests is 
about 3-4 teaspoons. 


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o A blood test for general health screening, such as chemistry, complete blood count 
and coagulation. 
 If you are a female and able to become pregnant, a pregnancy test will be required. If the 
pregnancy test is positive, you will not be able to be in the study. 
 A urine sample will be needed for lab tests.  
 
Note that all of the procedures listed above may not be done if at any point during the evaluation, 
you fail eligibility. If you are not eligible for the study, your study doctor will explain the reasons 
and arrange for your prescribed standard care to continue. 
 
Within this 1-week period, you will be informed if you are eligible to enter the study. If Visit 2 
takes place on the same day as the Screening Visit, scheduled assessments performed under 
screening visit (V1) do not need to be repeated. 
 
Treatment Period 
 
Visit 2 (Day 0) 
The treatment will start within 1 week of the Screening Visit.  
 
Before you receive any study treatment, your study doctor will reconfirm your study eligibility 
by completing the following procedures: 
 
 Your heart rate, breathing rate, body temperature, and blood pressure will be assessed.  
 Your study doctor will measure your weight and give you a physical exam.  
 Your study doctor will assess your COVID-19 clinical symptom score to confirm your 
eligibility for participation in the study.  
 Your study doctor will ask a series of questions related to your fatigue and energy level. 
 Your study doctor will ask a series of questions related to your concentration and ability 
to perform tasks requiring thinking. 
 Your study doctor will ask a series of questions related to sleep quality. 
 Your doctor will perform a test (pulse oximetry) to measure your blood oxygen level. 
 A blood test to check the levels of immune cells (CD4/CD8 T cells), certain proteins and 
substances (cytokines and chemokines) in your blood cells, as well as to check the levels 
of CCR5 receptors and other biomarkers, will be performed. The amount of blood needed 
for these tests is about 6 teaspoons. 
 If you are a female and able to become pregnant, a urine pregnancy test will be required. 
If the pregnancy test is positive, you will not be able to be in the study. 
 You will be randomly assigned (by chance) to one of the two study treatment groups. The 
study treatment assignment will be in a 1:1 ratio to one of the following:  
 Leronlimab (PRO 140), 700mg; Or 
 Placebo  


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Neither you nor the study doctor will know which one you will receive. This information can 
be made available in case of an emergency. You will be asked to report any symptoms that 
you experienced. 
 
Once all of the above assessments have been completed, your study doctor will perform for 
the following procedures: 
 You will receive your treatment injections of Leronlimab (PRO 140) or placebo.  
Leronlimab (PRO 140) or Placebo will be given under your skin as two 2mL shots on 
opposite sides of the stomach. 
 Your essential body functions like heart rate, body temperature, breathing rate, and blood 
pressure will be recorded. Your weight will also be measured. 
 Your doctor will perform a test (pulse oximetry) to measure your blood oxygen level. 
You will be asked about your past or current medications. 
 You will be asked to report any unfavorable signs or symptoms that you experienced.  
 You will be given a diary to record all symptoms daily throughout the entire treatment 
phase (56 days). 
 
Visits 3, 5, 7, 9, 11, 13, and 15 (Days 3, 10, 17, 24, 31, 38, and 45) 
The following assessments will be performed via telephone at Visits 3, 5, 7, 9, 11, 13, and 15: 
 
 You will be asked if you have been using your diary to record all symptoms since your 
last visit. 
 You will be asked if there have been any hospital or ER visits since the last study visit.  
 You will be asked if there have been any changes to the medications you are taking. 
 You will be asked to report any unfavorable signs or symptoms that you experienced. 
 
Visits 4, 6, 8, 10, 12, 14, and 16 (Days 7, 14, 21, 28, 35, 42, and 49) 
The following assessments will be performed at the clinic at Visits 4, 6, 8, 10, 12, 14, and 16: 
 
 Your study doctor will give you a physical exam based on symptoms you have 
experienced. 
 Your weight, heart rate, body temperature, blood pressure, and breathing rate will also be 
assessed. 
 You doctor will perform a test (pulse oximetry) to measure your blood oxygen level 
 You will be asked whether you have used your diary to record all symptoms you have 
experienced since the last visit. 
 Your study doctor will ask a series of questions related to your fatigue and energy level. 
 Your study doctor will ask a series of questions related to your concentration and ability 
to perform tasks requiring thinking. 
 Your study doctor will ask a series of questions related to sleep quality. 
 You will receive your treatment injections of Leronlimab (PRO 140) or placebo.   


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 You will be asked if there have been any hospital or ER visits since the last study visit. 
 You will be asked if there have been any changes to the medications you are taking. 
 You will be asked to report any unfavorable signs or symptoms that you experienced. 
 At Visit 10 only, a series of blood and urine tests will be performed. The amount of 
blood needed for these tests is about 8 teaspoons. 
 
o A blood test for general health screening, such as chemistry, complete blood 
count and coagulation 
o A blood test to check the levels of immune cells (CD4/CD8 T cells) and certain 
proteins and substances (cytokines and chemokines), as well as to check the levels 
of CCR5 receptors and other biomarkers.  
o A urine sample will be needed for lab tests 
o If you are a female and able to become pregnant, a urine pregnancy test will be 
required. If the pregnancy test is positive, you will not be able to be in the study. 
 
Visit 17, End of Treatment (Day 56) 
One week after your last treatment, you will be asked to visit the clinic for the end of treatment 
(EOT) visit during which the following assessments will be performed: 
 
 Your study doctor will give you a physical exam. 
 Your weight, heart rate, body temperature, blood pressure, and breathing rate will also be 
assessed. 
 You doctor will perform a test (pulse oximetry) to measure your blood oxygen level. 
 Your study doctor will perform an ECG (electrocardiogram – a test to check your heart). 
 You will be asked whether you have used your diary to record all symptoms you have 
experienced since the last visit. 
 Your study doctor will ask a series of questions related to your fatigue and energy level. 
 Your study doctor will ask a series of questions related to your concentration and ability 
to perform tasks requiring thinking. 
 Your study doctor will ask a series of questions related to sleep quality. 
 A series of blood and urine tests will be performed. The amount of blood needed for 
these tests is about 8 teaspoons. 
 
o A blood test for general health screening, such as chemistry, complete blood 
count and coagulation. 
o A blood test to check the levels of immune cells (CD4/CD8 T cells), certain 
proteins and substances (cytokines and chemokines) made by a kind of your blood 
cells, as well as to check the levels of CCR5 receptors and other biomarkers. 
o A urine sample will be needed for lab tests 
 If you are a female and able to become pregnant, a urine pregnancy test will be required. 
If the pregnancy test is positive, you will not be able to be in the study. 
 You will be asked if there have been any hospital or ER visits since the last study visit. 


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 You will be asked if there have been any changes to the medications you are taking. 
 You will be asked to report any unfavorable signs or symptoms that you experienced. 
 
Follow-Up Period (only if you decide NOT to continue into Part 2)  
 
Follow-up Visit (Day 84) 
The follow-up period will last up to four weeks and include one visit. The following assessments 
will be performed at the follow-up visit: 
 
 Your heart rate, body temperature, blood pressure, breathing rate, and weight will also be 
assessed. 
 You doctor will perform a test (pulse oximetry) to measure your blood oxygen level. 
 Your study doctor will give you a physical exam. 
 Your study doctor will assess your clinical status based on your hospitalization status. 
 A blood test for general health screening, to check the levels of immune cells (CD4/CD8 
T cells) and certain proteins and substances (cytokines and chemokines) in your blood 
cells, as well as to check the levels of CCR5 receptors and other biomarkers. 
 You will be asked if there have been any changes to the medications you are taking.  
 You will be asked to report any symptoms that you experienced.  
 
Unscheduled Visits 
In the event that you come to the clinic at a time other than a regularly scheduled study visit, the 
visit will be regarded as an unscheduled visit. Assessments at unscheduled visits are at the 
discretion of the study doctor. 
 
IF YOU DECIDE TO CONTINUE TO THE SECOND PART OF THE STUDY: 
 
 You will take once weekly dose of 350 mg Leronlimab (PRO 140) for four weeks, for a 
total of four doses, regardless of whether you were assigned to leronlimab (PRO 140) or 
placebo in Part 1. 
 Leronlimab (PRO 140) will be injected via a very thin needle slightly below the surface 
of your skin in your stomach, by the research staff or visiting nurse. You will receive one 
injection (of 2 mL) every week for four weeks. 
 Your participation involves 2 periods: 
o Treatment phase will last for four weeks and include four visits to the study clinic, 
when you will receive treatment with Leronlimab (PRO 140), as well as telephone 
or video “visits” in between treatment administration visits. The final visit during 
the treatment phase will take place one week after the final treatment 
administration and will be at the study clinic. There will be a total of eight “visits” 
during the treatment phase. 


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o Follow-up phase will last for four weeks. The follow-up phase includes one visit 
to the study clinic, four weeks after the last visit in the treatment phase.  
 In total, the expected duration of Part 2 is 56 days.  
 At visits conducted at the study clinic, you and the study staff will be provided the 
appropriate protective gear (e.g., masks, gloves) to prevent the spread of the infection.  
 Sometimes it is hard to keep track of all of the details and procedures that are part of a 
research study. We will describe them in this consent form and you can refer to this at 
any time during the research study. 
 
Visit 17 (Day 56) 
 
 Your study doctor will give you a physical exam based on symptoms you have 
experienced. 
 Your weight, heart rate, body temperature, blood pressure, and breathing rate will also be 
assessed. 
 Your doctor will perform a test (pulse oximetry) to measure your blood oxygen level 
 Your doctor will assess your COVID-19 clinical symptom score. 
 You will be asked whether you have used your diary to record all symptoms you have 
experienced since the last visit. 
 Your study doctor will ask a series of questions related to your fatigue and energy level. 
 Your study doctor will ask a series of questions related to your concentration and ability 
to perform tasks requiring thinking. 
 Your study doctor will ask a series of questions related to sleep quality. 
 You will receive your treatment injection of Leronlimab (PRO 140).   
 You will be asked if there have been any hospital or ER visits since the last study visit. 
 You will be asked if there have been any changes to the medications you are taking. 
 You will be asked to report any unfavorable signs or symptoms that you experienced. 
 A blood test for general health screening, such as chemistry, complete blood count and 
coagulation 
 A blood test to check the levels of immune cells (CD4/CD8 T cells) and certain proteins 
and substances (cytokines and chemokines), as well as to check the levels of CCR5 
receptors and other biomarkers will be performed. 
 A urine sample will be needed for lab tests 
 If you are a female and able to become pregnant, a urine pregnancy test will be required. 
If the pregnancy test is positive, you will not be able to be in the study. 
 
Visits 18, 20, and 22 (Days 59, 66, and 73) 
The following assessments will be performed via telephone at Visits 18, 20, and 22: 
 
 You will be asked if you have been using your diary to record all symptoms since your 
last visit. 


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 You will be asked if there have been any hospital or ER visits since the last study visit.  
 You will be asked if there have been any changes to the medications you are taking. 
 You will be asked to report any unfavorable signs or symptoms that you experienced. 
 
Visits 19, 21, and 23 (Days 63, 70, and 77) 
The following assessments will be performed via telephone at Visits 17, 19, 21, and 23: 
 
 Your study doctor will give you a physical exam based on symptoms you have 
experienced. 
 Your weight, heart rate, body temperature, blood pressure, and breathing rate will also be 
assessed. 
 Your doctor will perform a test (pulse oximetry) to measure your blood oxygen level 
 You will be asked whether you have used your diary to record all symptoms you have 
experienced since the last visit. 
 Your study doctor will ask a series of questions related to your fatigue and energy level. 
 Your study doctor will ask a series of questions related to your concentration and ability 
to perform tasks requiring thinking. 
 Your study doctor will ask a series of questions related to sleep quality. 
 You will receive your treatment injection of Leronlimab (PRO 140).   
 You will be asked if there have been any hospital or ER visits since the last study visit. 
 You will be asked if there have been any changes to the medications you are taking. 
 You will be asked to report any unfavorable signs or symptoms that you experienced. 
 A blood test to check the levels of immune cells (CD4/CD8 T cells) and certain proteins 
and substances (cytokines and chemokines), as well as to check the levels of CCR5 
receptors and other biomarkers will be performed. 
Visit 24, End of Treatment (Day 56) 
One week after your last treatment, you will be asked to visit the clinic for the end of treatment 
(EOT) visit during which the following assessments will be performed: 
 
 Your study doctor will give you a physical exam. 
 Your weight, heart rate, body temperature, blood pressure, and breathing rate will also be 
assessed. 
 You doctor will perform a test (pulse oximetry) to measure your blood oxygen level. 
 Your study doctor will perform an ECG (electrocardiogram – a test to check your heart). 
 You will be asked whether you have used your diary to record all symptoms you have 
experienced since the last visit. 
 Your study doctor will ask a series of questions related to your fatigue and energy level. 
 Your study doctor will ask a series of questions related to your concentration and ability 
to perform tasks requiring thinking. 
 Your study doctor will ask a series of questions related to sleep quality. 


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 A series of blood and urine tests will be performed. The amount of blood needed for 
these tests is about 8 teaspoons. 
 
o A blood test for general health screening, such as chemistry, complete blood 
count and coagulation. 
o A blood test to check the levels of immune cells (CD4/CD8 T cells), certain 
proteins and substances (cytokines and chemokines) made by a kind of your blood 
cells, as well as to check the levels of CCR5 receptors and other biomarkers.  
o A urine sample will be needed for lab tests 
 If you are a female and able to become pregnant, a urine pregnancy test will be required. 
If the pregnancy test is positive, you will not be able to be in the study. 
 You will be asked if there have been any hospital or ER visits since the last study visit. 
 You will be asked if there have been any changes to the medications you are taking. 
 You will be asked to report any unfavorable signs or symptoms that you experienced. 
 
Follow-Up Period  
 
Follow-up Visit (Day 112) 
The follow-up period will last up to four weeks and include one visit. The following assessments 
will be performed at the follow-up visit: 
 
 Your heart rate, body temperature, blood pressure, breathing rate, and weight will also be 
assessed. 
 You doctor will perform a test (pulse oximetry) to measure your blood oxygen level. 
 Your study doctor will give you a physical exam. 
 Your study doctor will assess your clinical status based on your hospitalization status. 
 A blood test for general health screening, to check the levels of immune cells (CD4/CD8 
T cells) and certain proteins and substances (cytokines and chemokines) in your blood 
cells, as well as to check the levels of CCR5 receptors and other biomarkers. 
 You will be asked if there have been any changes to the medications you are taking.  
 You will be asked to report any symptoms that you experienced.  
 
Unscheduled Visits 
In the event that you come to the clinic at a time other than a regularly scheduled study visit, the 
visit will be regarded as an unscheduled visit. Assessments at unscheduled visits are at the 
discretion of the study doctor. 
 
HOW LONG WILL I BE IN THIS RESEARCH STUDY? 
Part 1 of the research study lasts for a total of 91 days (including screening period, treatment 
period and follow-up period). Part 2 of the study lasts for an additional 56 days. You can 
participate for as long as you do not have serious side effects and your disease does not get 
worse. 


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You may be taken off the research study for many reasons including if: 
 
 It is considered to be in your best interest. 
 The study treatment or procedures are found to be unsafe or ineffective. 
 There is any problem with following study treatments and procedures. 
 Your condition worsens. 
 You become pregnant. 
 If you miss two consecutive doses of the investigational drug. 
 The study is canceled by the sponsor or the FDA. 
 Or for other unforeseen reasons that make it necessary to stop your participation in the 
research study. 
 
If you are removed from the research study, the research doctor will explain to you why you 
were removed.   
 
In addition, you can stop participating in the research study at any time, however, the FDA 
requires that any information collected up to the point of your withdrawal cannot be removed 
from the study. If you decide to stop participating in this research study, we encourage you to 
talk to the research doctor and your primary doctor first. 
 
WHAT ARE THE RISKS/SIDE EFFECTS OF TAKING PART? 
There are risks to taking part in any research study. One risk is that you may get a study drug that 
does not help treat your disease or that makes your condition or disease worse. Another risk is 
that there may be side effects. You need to tell your doctor or a member of the study team 
immediately if you experience any side effects.  
 
Everyone in the research study will be watched carefully for side effects. You will be monitored 
during the administration of study drugs to keep track of your essential body functions- blood 
counts and organ function, particularly your kidney and liver function. If you experience side 
effects, they may go away after you stop taking the study drug. Some side effects can be mild; 
but others can be long lasting and may never go away. Some may be life-threatening or fatal.  
 
In other studies of Leronlimab (PRO 140), possibly related side effects observed in subjects 
receiving the 700 mg dose included: 
 
 Reactions at the site of the injection such as: 
 
o Bruising 
o Redness of the skin 
o Fluid leakage 


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o Itch 
o Rash 
 
 Headache 
 Diarrhea 
 Fatigue 
 
All of these side effects occurred in less than 2% of subjects.  
 
Since the effect of the study drug(s) taken with other medications may not be known, it is 
important that you tell the research doctor about all prescription and non-prescription drugs, 
herbal preparations and nutritional supplements that you are taking or planning to take. There 
may also be some foods that you should avoid while on this research study and your research 
doctor will review this information with you. 
 
During the research study, you will be notified of newly discovered side effects or significant 
findings, which may affect your health or willingness to participate. You may be asked to sign a 
new consent form that shows that you have been informed of new information relating to this 
research study. 
 
Side effects that you could experience during or after the Leronlimab (PRO 140) treatment: 
 
 The most common potential study drug-related side effect that has been seen using the 
drug formulation that you will be using is mild headache. Other side effects likely to be 
related to the drug include mild to moderate diarrhea, nausea, and fatigue. There may be 
other side effects associated with Leronlimab (PRO 140) that we do not know about.  
 Leronlimab (PRO 140) belongs to the monoclonal antibody class of drugs. Monoclonal 
antibodies are sometimes associated with allergic reactions (fatigue, diarrhea, fever, 
vomiting, headache, nausea, pain at the site of injection, low blood pressure, rash, itching, 
and chills) or flu-like reactions such as fever, chills, and aches. These events usually do 
not last long if they occur at all. Severe allergic reactions, however, can be life-
threatening. 
 Rare severe acute hypersensitivity reactions or anaphylaxis can occur. If anaphylaxis or 
severe allergic reactions occur, therapy with Leronlimab (PRO 140) will be permanently 
discontinued and appropriate medications (e.g., epinephrine) and supportive care will be 
provided. 
 People who take Leronlimab (PRO 140) or other monoclonal antibodies can also develop 
an immune response to Leronlimab (PRO 140) that may affect their ability to receive 
monoclonal antibodies, or to benefit from diagnosis or therapy with a monoclonal 
antibody in the future. 


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 Side effects that may be associated within a short period of time after receiving drugs 
similar to Leronlimab (PRO 140) through an injection include chills, headache, backache, 
overall feeling of being ill, fever, skin rash, nausea, tingling and high blood pressure. 
Your study doctor may give you medicine to help with these side effects. 
 People who lack a functional CCR5 gene are at increased risk for severe infection by 
West Nile virus. Please ask your study doctor about this. 
 Local pain, redness, tenderness, bruising, itching and rarely, an infection might occur at 
the site of injection in your stomach or at the site of the needle stick in your arm for blood 
draws or you may faint when blood is taken. 
 Studies on Leronlimab (PRO 140) to determine its capability to cause harm to an unborn 
child have not been performed. If you are a woman of childbearing potential, you will be 
tested for pregnancy at the beginning of the study. 
 It is unknown if Leronlimab (PRO 140) can pass through breast milk and it is unknown if 
this can cause harm to your child. 
 
In addition to the risks or discomforts listed here, there may be other risks that are currently not 
known.    
 
Reproductive Risks:  
The drug used in this research study may affect and involve unforeseeable risks to a fetus. While 
participating in this research study, you should not become pregnant and should not nurse a 
baby. We can provide counseling about preventing pregnancy. You must use two medically 
accepted method of birth control (barrier contraceptives such as male condom, female condom, 
or diaphragm with a spermicidal gel, hormonal contraceptives such as implants, injectables, 
combined oral pills, patches or rings; intrauterine devices (IUDs), tubal ligation (two fallopian 
tubes that connect ovaries and uterus are blocked, tied, clamped, sealed, or cut) or sexual 
abstinence) throughout the course of this study. Let your doctor know immediately if you or your 
partner become pregnant. 
 
Male participants with a partner who can become pregnant must also agree to use birth control 
methods as above, and must not donate sperm, during the study and for 90 days after the last 
dose of study drug. 
 
If you or your partner become pregnant during the course of this study, the study doctor will ask 
to follow you or your partner until 3 months after the birth of the child. This will consist of 
telephone contact to determine what side effects may have happened. 
 
Non-Physical Risks:  
Because of side effects or the time required for tests and clinic visits while you are on this 
research study, you may be unable to keep up with your normal daily activities.  
 


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WHAT ARE THE POSSIBLE BENEFITS OF TAKING PART IN THIS STUDY? 
We do not know if taking part in this study will help you. This study may help researchers learn 
information that could help people in the future. If you receive Leronlimab and it is effective, it 
may help reduce the bad inflammation that resulted from COVID-19 infection. 
 
WILL I BE PAID TO TAKE PART IN THIS RESEARCH STUDY? 
The study sponsor may reimburse you for qualifying study-related travel costs and/or expenses.  
Study staff will review the reimbursement plan and any requirements for reimbursement with 
you.  
 
[Patients will receive $[Amount] for each completed study visit. If you do not complete the 
study, you will be paid for the visits which you have completed. You will be paid at the end of 
the designated study visits.] 
 
OR  
 
[You will not receive any payment for taking part in this research study.] 
 
WHAT IF SOMETHING IS DEVELOPED FROM THIS RESEARCH? 
We may use your samples and information to develop a new product or medical test to be sold.  
The sponsor and hospital may benefit if this happens. There are no plans to pay you if your 
samples are used for this purpose. 
 
ARE THERE COSTS FOR PARTICIPATING IN THIS STUDY? 
Taking part in this research study might lead to added costs to you or your insurance company. 
 
You will not be charged for Leronlimab (PRO 140). It is possible that Leronlimab (PRO 140) 
may not continue to be supplied free for some reason. If this would occur, your research doctor 
will talk with you about your options.  
 
You or your insurance company will be charged for portions of your care during this research 
study that are considered standard care. You may be responsible for co-payments and deductibles 
that are typical for your insurance coverage. 
 
If you have questions about your insurance coverage, or the items you might be required to pay 
for, please call financial services of the hospital for information. You should also check with 
your insurance to see what services will be covered by your insurance and what you will have to 
pay. 
 
WHAT HAPPENS IF I AM INJURED OR BECOME SICK BECAUSE I TOOK PART IN 
THIS RESEARCH STUDY? 
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doctor as soon as possible. The research doctor’s name and phone number are listed in this 
consent form. The study doctor will treat you or refer you for care. 
 
The treating hospital will offer you the care needed to treat injuries directly resulting from taking 
part in this research. These treatments will be billed to you or your insurance company. You will 
be billed for deductibles and co-payments. There are no plans to pay you or give you other 
compensation for the injury. You do not give up your legal rights by signing this form.  
 
We will need to collect certain personal information about you for insurance or payment 
reporting purposes, such as your name, date of birth, gender, social security number or Medicare 
identification number and information related to this research study. We may be required to 
report this information to the Centers for Medicare & Medicaid Services. We will not use this 
information for any other purpose. 
 
WILL MY TAKING PART IN THIS STUDY BE KEPT CONFIDENTIAL? 
We will take measures to protect the privacy and security of all your personal information, but 
we cannot guarantee complete confidentiality of study data. The information collected about you 
usually will not directly identify you (for example, by name, address, or social security number).  
Instead, your initials and a code number will be used for your information.   
 
Medical information created by this research study may become part of your hospital medical 
record and may be forwarded to your primary doctor. Information that does not become part of 
your medical record will be stored in your study file. 
 
If you consent to take part in this study, your medical records may be reviewed by relevant 
employees of CytoDyn, Inc., the company sponsoring the study, or Amarex Clinical Research, 
LLC (Amarex), the company to which CytoDyn has given the management of this study, for 
purposes of analyzing the study results and monitoring the study. Regulatory authorities such as 
the U.S. Food and Drug Administration (FDA), the Institutional Review Board (IRB) and other 
foreign regulatory bodies may review study results and subject records to check that the study is 
being conducted correctly. They also want to make sure that your health information has been 
collected the right way, or for other reasons that are allowed under the law. Your identity and 
medical records will be kept confidential and will not be disclosed outside of the 
hospital/clinic/family physician’s office. 
 
The study team plans to publish the results of this research study and when we do, we may be 
asked to make the data we collect available to other researchers. We will not include information 
that identifies you in any publications or to the researchers who request the data to do additional 
research. 
 
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. 


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WHAT IF NEW INFORMATION BECOMES AVAILABLE? 
During the course of a research study, new information may become available about your disease 
or the treatment that is being studied that might change your decision to be in this study. If this 
happens, your study doctor will discuss this with you and whether you want to continue in the 
study. If you decide to withdraw, your study doctor will make arrangements for your prescribed 
standard care to continue. If you decide to continue in the study, you will be asked to sign an 
updated consent form. 
 
In addition, on receiving new information your study doctor might consider it to be in your best 
interest to withdraw you from the study. Your study doctor will explain the reasons and arrange 
for your prescribed standard care to continue. 
 
WHAT WILL HAPPEN TO THE RESULTS OF THE RESEARCH STUDY? 
This study is expected to start in 2021. Once the study is finished, the information will be 
analyzed and a clinical report will be written to record the results. This process can take about 6 
months. Your study doctor will be kept informed of the results from the study, and a paper 
detailing these results will probably be published in an appropriate medical journal. You can also 
ask your study doctor for the results of the study. 
 
RESEARCH FUNDING 
The company sponsoring and funding this research is CytoDyn, Inc. 
 
The study center and/or your study doctor are receiving financial support from the sponsor for 
holding this study.  
 
CAN I STOP BEING IN THE RESEARCH STUDY AND WHAT ARE MY RIGHTS? 
You have the right to choose not to sign this form. If you decide not to sign this form, you cannot 
participate in this research study.  
 
You can stop being in the research study at any time. Tell the research doctor if you are thinking 
about stopping or decide to stop. He or she will tell you how to stop. Leaving the research study 
will not affect your medical care outside of the research study.   
 
If you choose not to participate, are not eligible to participate, or withdraw from this research 
study, this will not affect your present or future care and will not cause any penalty or loss of 
benefits to which you are otherwise entitled.  
 
It is important to tell the research doctor if you are thinking about stopping so your research 
doctor can evaluate the risks from stopping Leronlimab (PRO 140). In some cases, the abrupt 
stopping of a drug can have risks in itself. Another reason to tell your research doctor that you 
are thinking about stopping is to discuss what follow-up care and testing could be most helpful 
for you. 
 


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WHOM DO I CONTACT IF I HAVE QUESTIONS ABOUT THE RESEARCH STUDY? 
If you have questions, concerns, or complaints about the study or problems relating to your 
participation in this study, please contact: 
 
[Name] at [Number] 
 
If, at any time, you feel you have experienced a research-related injury or reaction to the study 
drug, contact your study doctor: 
 
[Name] at [Number] (24 hours) 
 
This research is being overseen by an Institutional Review Board (“IRB”). An IRB is a group of 
people who perform independent review of research studies. You may talk to them at 855-818-
2289 or researchquestions@wcgirb.com if 
 You have questions, concerns, or complaints that are not being answered by the research 
team. 
 You are not getting answers from the research team. 
 You cannot reach the research team. 
 You want to talk to someone else about the research. 
 You have questions about your rights as a research subject. 
 
The IRB will not be able to answer some study-specific questions, such as questions about 
appointment times. However, you may contact the IRB if the research staff cannot be reached or 
if you wish to talk to someone other than the research staff. 
 
Do not sign this consent form unless you have had a chance to ask questions and have received 
satisfactory answers to all of your questions. 
 
If you agree to be in this study, you will receive a signed and dated copy of this consent form for 
your records. 
 
If you choose to participate in this study, please read the following and sign where indicated. 
 
PARTICIPANT STATEMENT OF CONSENT 
I confirm that I have read this consent form (or it has been read to me) and have had the 
opportunity to ask questions. I agree to participate in this study and comply with the 
requirements to the best of my ability. 
 
My signature below indicates: 
 
 I have had enough time to read the consent and think about participating in this study; 
 I have had all of my questions answered to my satisfaction; 
 I am willing to participate in this study; 
 I have been told that my participation is voluntary and I can withdraw at any time. 


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By signing this consent form, I have not given up any of my legal rights. I will receive a signed 
and dated copy of this consent form. 
 
 
 
 
Printed Name of Participant 
 
 
 
 
 
 
 
 
Participant’s Signature 
Date 
Time 
 
STATEMENT OF PERSON CONDUCTING INFORMED CONSENT DISCUSSION 
I, the undersigned, certify that to the best of my knowledge that subject named above had the 
study fully and carefully explained, including the nature, risks, and benefits of his/her 
participation in the research study; and all questions were answered to his/her satisfaction. I 
confirm that he/she freely and voluntarily gave consent to participate in this research study 
before any study-related procedures were performed. A medical problem or language or 
educational barrier has not precluded this understanding. 
 
I reviewed the consent form with the subject and answered his/her questions. The subject 
appeared to have understood the information and was able to answer the following questions 
correctly: 
 
 What is the purpose of this study? 
 If you decide to be in the study, what will you be asked to do? 
 What is the possible benefit of participating in this study? 
 What are the possible risks of participating in this study? 
 If you decide not to participate in this study, what options do you have? 
 Will participating in this study cost you anything? If so, what will you have to pay for? 
 Do you have to be in this study? 
 If you decide to be in the study, can you leave the study when you want to? 
 
 
 
 
 
 
 
 
Signature of Person Conducting 
Date 
Time 
Informed Consent Discussion 
 
 
 
 
Name of Person Conducting Informed  
Consent Discussion 


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---------------------------- Use this witness section only if applicable ------------------------- 
If this consent form is read to the subject because he/she is unable to read the form, an impartial 
witness not affiliated with the research or investigator must be present for the consent and sign 
the following statement: 
 
I confirm that the information in the consent form and any other written information was 
accurately explained to, and apparently understood by, the subject. He/she freely consented to be 
in the research study. 
 
 
 
 
Printed Name of Impartial Witness 
 
 
 
 
 
 
Signature of Impartial Witness 
Date 
 
An impartial witness is: 
 
 a person who is independent of the trial,  
 who cannot be unfairly influenced by people involved with the trial, 
 who attends the informed consent process, and  
 who reads the informed consent form and any other written information supplied to the 
subject. 
 


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AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH 
INFORMATION 
 
While you are participating in this research study, the study doctor and his study 
staff will collect and create personal health information about you and record it on 
study forms. This information may include health histories, examinations and 
results of tests. The study doctor will keep this information in study records. He 
may also gather information regarding your past, present, and/or future medical 
conditions from your primary medical doctor. These records may also include 
personal information such as your birth date, social security number, or medical 
record numbers which could be used to identify you. This type of information is 
called “Protected Health Information” (PHI). 
 
The terms “you” and “your” in this Authorization refer to the research subject. 
 
Under a United States federal law called the “Privacy Rule” or Health Insurance 
Portability and Accountability Act of 1996 (HIPAA), your PHI that is gathered and 
obtained during research cannot be used to conduct the research or be given to 
anyone for research purposes without your permission. Because of this rule, you 
may not participate in this study unless you give your permission to use and 
disclose your PHI. You do not have to sign this form, but if you do not, you cannot 
participate in this study. 
 
By signing this consent form, you are giving permission for the study doctor and 
his study staff to use your PHI to conduct this study, to monitor your health status, 
and possibly to develop new tests, procedures and commercial products. 
 
You are also agreeing to allow your PHI to be disclosed to the study sponsor and 
any representatives working with them. The sponsor may also give your PHI to the 
FDA or other regulatory agencies which are responsible for ensuring that the 
research is being done correctly.  
 
Study staff will assign a code number to you for this study. This will help to 
protect your identity; however, the sponsor may look at your complete study 
records which will identify you. The sponsor will also send representatives to your 
study doctor’s office to oversee how the study is being conducted. These 


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representatives will review your PHI to make sure the information is correct. The 
Institutional Review Board (IRB) may also have access to your PHI. These 
disclosures help to make sure that all information related to the research is 
available to those who need it. 
 
Your identity will remain confidential and except for the disclosures described 
above and detailed specifically in the consent page, will not be shared with others, 
unless it is required by law. If your PHI is given to the parties listed above or to 
anyone who is not required to follow federal law, your PHI will no longer be 
protected by the “Privacy Rule” and could possibly be used or disclosed in ways 
other than are listed here. 
 
You have the right to see and make copies of your PHI. You are agreeing, 
however, not to see or make copies of your PHI until all of the sponsor work has 
been completed. At that time, you may ask to see your records. 
 
Your HIPAA Authorization will expire 50 years from the date you sign and date it 
unless you revoke (cancel or withdraw) it sooner. You have the right to cancel or 
withdraw this authorization at any time. If you cancel this authorization, your PHI 
will no longer be used for this study, unless it is necessary (based on your earlier 
authorization) to complete analysis (test) and reports for this research. If you 
withdraw your permission, no new health information will be gathered unless you 
have a side effect related to the study.   
 
If you withdraw from the study but do not withdraw your Authorization, new 
health information may be collected until this study ends.   
 
In the event of an adverse drug reaction/serious side effect following revocation of 
Authorization, your information may still be used and disclosed as necessary for 
study purposes. 
 
To cancel your permission to use PHI, you must send a written notice to your study 
doctor’s office stating that you are canceling your authorization to use or disclose 
your protected health information. If you cancel this authorization, you will not be 
allowed to continue in this study. 
 


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Your decision to withdraw your Authorization or not to participate will not involve 
any penalty or loss of access to treatment or other benefits to which you are 
otherwise entitled.   
 
AUTHORIZATION 
I authorize the use and disclosure of my health information to the parties listed in 
the authorization section of this consent for the purposes described above. I will 
receive a signed and dated copy of this Authorization. 
 
 
 
 
Printed Name of Participant  
(Study Subject) 
 
 
 
 
 
 
 
 
Participant’s Signature 
Date 
Time 
 
Statement of the Witness (when applicable*) 
The information in the authorization was accurately explained to, and appeared to 
be understood by the subject. Authorization was freely given. 
 
 
 
 
Printed Name of Impartial Witness  
 
 
 
 
Signature of Impartial Witness 
Date 
 
*Impartial Witness: If the subject cannot read, the signature of an Impartial 
Witness is needed.   
 
An impartial witness is: 
 
 a person who is independent of the trial,  


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Apr 29, 2021 
 
 
Page 25 of 25 
IRB Version [Number] 
Screening ICF, dated 22-Apr-21 for Protocol V4.0 
Protocol CD15_COVID-19 
 who cannot be unfairly influenced by people involved with the trial, 
 who attends the informed consent process, and  
 who reads the informed consent form and any other written information 
supplied to the subject.  


ADDENDUM TO CONSENT FORM 
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Apr 30, 2021 
 
 
Page 1 of 4 
Addendum to Consent Form dated 26-Apr-2021  
Protocol CD15_COVID-19 
Subject's Initials____________ 
RESEARCH SUBJECT INFORMATION AND CONSENT FORM 
 
 
TITLE: 
A Phase 2, Two-Part Study (8-Week, Randomized, Double Blind, 
Placebo Controlled Period Followed by a 4-Week, Open-Label 
Extension Period) to Evaluate the Efficacy and Safety of Leronlimab in 
Patients Experiencing Prolonged Coronavirus Disease 2019 (COVID-19) 
Symptoms [Long-Haulers] 
 
PROTOCOL NO.: 
CD15_COVID-19 
 
IRB Protocol #20210354 
 
SPONSOR: 
CytoDyn, Inc. 
 
INVESTIGATOR: 
Name 
Address 
City, State Zip 
Country 
 
STUDY-RELATED 
PHONE NUMBER(S): 
Phone Number 
 
Phone Number (24 hours) 
 
[24-hour number is required] 
 
You have already agreed to participate in the above mentioned research study. We are asking for your 
consent to collect additional data using Global Health Assessment Questionnaire.  
 
 
You will be asked to complete a series of questions related to your general health (physical and 
mental health) and quality of life at V17 (EOT/Day 56). 
 
Note: This addendum to the consent form is applicable for all patients completing 8-week, double blind, 
placebo controlled period and is regardless of whether you decide to (or eligible for) participation in the  
4-week, open-label extension period.  
 
REIMBURSEMENT FOR PARTICIPATION 
 
There is no change in the reimbursement for qualifying study-related travel costs and/or expenses.  You 
will not receive any additional payment for completing this questionnaire.  
 
VOLUNTARY PARTICIPATION AND WITHDRAWAL  
 
Your participation for completing this questionnaire is voluntary.   
 
 
 


ADDENDUM TO CONSENT FORM 
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Apr 30, 2021 
 
 
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Addendum to Consent Form dated 26-Apr-2021  
Protocol CD15_COVID-19 
Subject's Initials____________ 
WHOM DO I CONTACT IF I HAVE QUESTIONS ABOUT THE RESEARCH STUDY? 
 
If you have questions, concerns, or complaints about the study or problems relating to your participation 
in this study, please contact: 
 
[Name] at [Number] 
 
If, at any time, you feel you have experienced a research-related injury or reaction to the study drug, 
contact your study doctor: 
 
[Name] at [Number] (24 hours) 
 
This research is being overseen by an Institutional Review Board (“IRB”). An IRB is a group of people 
who perform independent review of research studies. You may talk to them at 855-818-2289 or 
researchquestions@wcgirb.com if 
 
 
You have questions, concerns, or complaints that are not being answered by the research team. 
 
You are not getting answers from the research team. 
 
You cannot reach the research team. 
 
You want to talk to someone else about the research. 
 
You have questions about your rights as a research subject. 
 
The IRB will not be able to answer some study-specific questions, such as questions about appointment 
times. However, you may contact the IRB if the research staff cannot be reached or if you wish to talk to 
someone other than the research staff. 
 
Do not sign this consent form unless you have had a chance to ask questions and have received 
satisfactory answers to all of your questions. 
 
If you agree to complete this additional Questionnaire in this study, you will receive a signed and dated 
copy of this consent form addendum for your records. 
 
If you choose to participate in this study, please read the following and sign where indicated. 
 
 
 


ADDENDUM TO CONSENT FORM 
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Apr 30, 2021 
 
 
Page 3 of 4 
Addendum to Consent Form dated 26-Apr-2021  
Protocol CD15_COVID-19 
Subject's Initials____________ 
PARTICIPANT STATEMENT OF CONSENT 
 
I confirm that I have read this consent form (or it has been read to me) and have had the opportunity to 
ask questions. I agree to participate in this study and comply with the requirements to the best of my 
ability. 
 
My signature below indicates: 
 
 
I have had enough time to read the consent and think about participating in this study; 
 
I have had all of my questions answered to my satisfaction; 
 
I am willing to participate in this study; 
 
I have been told that my participation is voluntary and I can withdraw at any time. 
 
By signing this consent form, I have not given up any of my legal rights. I will receive a signed and dated 
copy of this consent form. 
 
 
 
 
Printed Name of Participant 
 
 
 
 
 
 
 
 
Participant’s Signature 
Date 
Time 
 
 
STATEMENT OF PERSON CONDUCTING INFORMED CONSENT DISCUSSION 
 
I, the undersigned, certify that to the best of my knowledge that subject named above had the study fully 
and carefully explained, including the nature, risks, and benefits of his/her participation in the research 
study; and all questions were answered to his/her satisfaction. I confirm that he/she freely and voluntarily 
gave consent to participate in this research study. A medical problem or language or educational barrier 
has not precluded this understanding. 
 
I reviewed the consent form with the subject and answered his/her questions. The subject appeared to 
have understood the information. 
 
 
 
 
 
 
 
 
Signature of Person Conducting 
Date 
Time 
Informed Consent Discussion 
 
 
 
 
Name of Person Conducting Informed  
Consent Discussion 
 


ADDENDUM TO CONSENT FORM 
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Apr 30, 2021 
 
 
Page 4 of 4 
Addendum to Consent Form dated 26-Apr-2021  
Protocol CD15_COVID-19 
Subject's Initials____________ 
---------------------------- Use this witness section only if applicable ------------------------- 
 
If this consent form is read to the subject because he/she is unable to read the form, an impartial witness 
not affiliated with the research or investigator must be present for the consent and sign the following 
statement: 
 
I confirm that the information in the consent form and any other written information was accurately 
explained to, and apparently understood by, the subject. He/she freely consented to be in the research 
study. 
 
 
 
 
Printed Name of Impartial Witness 
 
 
 
 
 
 
Signature of Impartial Witness 
Date 
 
An impartial witness is: 
 
 
a person who is independent of the trial,  
 
who cannot be unfairly influenced by people involved with the trial, 
 
who attends the informed consent process, and  
 
who reads the informed consent form and any other written information supplied to the subject.