Clinical trial NCT05996744
Conditions: COVID-19
Sponsor: Gilead Sciences
Start date: 2023-12-26; Completion date: 2024-02-23
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this clinical study is to learn more about the safety and tolerability of obeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19).

The primary objectives are to evaluate the plasma pharmacokinetics (PK), safety and tolerability of ODV in pediatric participants with COVID-19.

Detailed description:
Pediatric participants will be enrolled as follows:

* Cohort 1: ≥ 6 years to \< 18 years and weight ≥ 40 kg
* Cohort 2: ≥ 6 years to \< 18 years and weight ≥ 20 kg to \< 40 kg
* Cohort 3: ≥ 2 years to \< 18 years and weight ≥ 12 kg to \< 20 kg
* Cohort 4: ≥ 28 days to \< 18 years and weight ≥ 3 kg to \< 12 kg
* Cohort 5: ≥ 14 days to \< 28 days of age, gestational age (GA) ≥ 37 weeks and weight ≥ 2.5 kg
* Cohort 6: 0 days to \< 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg
* Cohort 7: 0 days to \< 56 days of age, GA \< 37 weeks and birth weight ≥ 1.5 kg

Arms: arm 1: Participants received ODV tablets (350 mg twice daily) for 5 days. arm 2: Participants received ODV tablets (175 mg twice daily) for 5 days.
Interventions: intervention 1: Obeldesivir
Intervention descriptions: intervention 1: Tablet administered orally with or without food

Protocol documents:
Prot_000.pdf: 
CLINICAL STUDY PROTOCOL
Study Title:
A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, 
Pharmacokinetics and Efficacy of Obeldesivir in Pediatric 
Participants With COVID-19
Plain Language Short 
Title:
Study of Obeldesivir in Children and Adolescents With COVID-19
Sponsor:
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
USA
IND Number:
158222
EU CT Number:
2023-503282-27
ClinicalTrials.gov 
Identifier:
Not Available
Population Diagnosis 
or Condition:
COVID-19
Protocol ID:
GS-US-611-6464
Contact Information:
The medical monitor and study director names and contact 
information will be provided on the Key Study Team Contact List.
Original:
09 May 2023
Protocol 
Version/Date:
Amendment 0.1 EU:
15 November 2023
This study will be conducted under United States Food and Drug Administration investigational 
new drug application regulations (21 Code of Federal Regulations Part 312); however, sites 
located in the European Economic Area, the United Kingdom, and Switzerland are not included 
under the investigational new drug application and are not considered to be investigational new 
drug application sites. 
(r} GILEAU 


CONFIDENTIALITY STATEMENT
The information contained in this document, particularly unpublished data, is the property or 
under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, 
potential investigator, or consultant, for review by you, your staff, and an applicable 
institutional review board or independent ethics committee. The information is only to be used 
by you in connection with authorized clinical studies of the investigational drug described in 
the protocol. You will not disclose any of the information to others without written 
authorization from Gilead Sciences, Inc., except to the extent necessary to obtain informed 
consent from those persons to whom the drug may be administered.


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TABLE OF CONTENTS
TABLE OF CONTENTS................................................................................................................................................3
LIST OF IN-TEXT TABLES .........................................................................................................................................6
LIST OF IN-TEXT FIGURES........................................................................................................................................6
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ...................................................................................7
PROTOCOL SYNOPSIS................................................................................................................................................9
STUDY SCHEMA........................................................................................................................................................14
STUDY PROCEDURES TABLE ................................................................................................................................15
1.
INTRODUCTION................................................................................................................................................18
1.1.
Background..............................................................................................................................................18
1.2.
Background on Study Interventions ........................................................................................................19
1.2.1.
Obeldesivir ............................................................................................................................19
1.3.
Rationale for This Study..........................................................................................................................23
1.4.
Rationale for Dose Selection of Study Drug ...........................................................................................23
1.5.
Benefit-Risk Assessment for the Study...................................................................................................25
2.
OBJECTIVES AND ENDPOINTS......................................................................................................................27
3.
STUDY DESIGN.................................................................................................................................................29
3.1.
Study Design Overview...........................................................................................................................29
3.2.
Duration of Intervention..........................................................................................................................29
3.2.1.
Poststudy Care.......................................................................................................................29
3.3.
Protocol-Specific Discontinuation Criteria .............................................................................................30
3.3.1.
Criteria for Early Discontinuation for the Individual Participants ........................................30
3.3.2.
Criteria for Early Discontinuation of the Study ....................................................................31
3.3.3.
Loss to Follow-up..................................................................................................................31
3.4.
Definitions for Time of Primary Endpoint and End of Study .................................................................32
3.4.1.
Primary Endpoint...................................................................................................................32
3.4.2.
End of Study..........................................................................................................................32
3.5.
Source Data .............................................................................................................................................32
4.
PARTICIPANT POPULATION..........................................................................................................................33
4.1.
Number of Participants and Participant Selection...................................................................................33
4.1.1.
Participant Replacement........................................................................................................33
4.2.
Inclusion Criteria.....................................................................................................................................33
4.3.
Exclusion Criteria....................................................................................................................................34
5.
STUDY INTERVENTIONS AND CONCOMITANT MEDICATIONS ...........................................................36
5.1.
Enrollment, Blinding, and Treatment Code Access ................................................................................36
5.1.1.
Enrollment .............................................................................................................................36
5.1.2.
Blinding .................................................................................................................................36
5.2.
Description and Handling of Obeldesivir................................................................................................36
5.2.1.
Formulation ...........................................................................................................................36
5.2.2.
Packaging and Labeling ........................................................................................................36
5.2.3.
Storage and Handling ............................................................................................................37
5.3.
Prior and Concomitant Medications........................................................................................................37
5.3.1.
Prior and Concomitant Medications That Are Prohibited or Used With 
Caution ..................................................................................................................................37
5.4.
Dosage and Administration .....................................................................................................................37


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5.5.
Accountability for Study Drugs...............................................................................................................38
5.5.1.
Study Drug Return or Disposal .............................................................................................38
6.
STUDY PROCEDURES......................................................................................................................................39
6.1.
Informed Consent ....................................................................................................................................39
6.2.
Screening, Participant Enrollment, and Treatment Assignment .............................................................39
6.3.
Instructions for Study Procedures ...........................................................................................................39
6.3.1.
Adverse Events......................................................................................................................39
6.3.2.
Safety Assessments ...............................................................................................................40
6.3.3.
Hospitalization Details ..........................................................................................................41
6.3.4.
Oxygenation/Oxygen Supplementation.................................................................................42
6.3.5.
Pharmacokinetics...................................................................................................................42
6.3.6.
Clinical Virology...................................................................................................................43
6.3.7.
Participant Symptom Assessment .........................................................................................43
6.3.8.
Assessment of Palatability and Acceptability .......................................................................44
6.4.
Assessments for Early Discontinuation From Study Intervention or From the Study............................44
6.4.1.
Assessments for Early Discontinuation From Study Intervention ........................................44
6.4.2.
Assessments for End of Study...............................................................................................44
6.5.
Poststudy Care.........................................................................................................................................45
6.6.
Sample Storage........................................................................................................................................45
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT................................................................................46
7.1.
Definitions of Adverse Events and Serious Adverse Events...................................................................46
7.1.1.
Adverse Events......................................................................................................................46
7.1.2.
Serious Adverse Events.........................................................................................................46
7.1.3.
Study Drugs and Gilead Concomitant Medications Special Situations 
Reports...................................................................................................................................47
7.2.
Assessment of Adverse Events and Serious Adverse Events..................................................................48
7.2.1.
Assessment of Causality for Study Drugs and Procedures ...................................................48
7.2.2.
Assessment of Severity..........................................................................................................48
7.3.
Investigator Reporting Requirements and Instructions ...........................................................................49
7.3.1.
Requirements for Collection Before Study Drug Initiation ..................................................49
7.3.2.
Adverse Events......................................................................................................................49
7.3.3.
Serious Adverse Events.........................................................................................................49
7.3.4.
Study Drug Special Situations Reports .................................................................................49
7.3.5.
Concomitant Medications Reports ........................................................................................50
7.4.
Reporting Process for Serious Adverse Events and Special Situations Reports.....................................50
7.4.1.
Serious Adverse Event Reporting Process ............................................................................50
7.4.2.
Special Situations Reporting Process ....................................................................................51
7.5.
Gilead Reporting Requirements ..............................................................................................................53
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events...........................................................................................................................53
7.7.
Toxicity Management..............................................................................................................................54
7.7.1.
Obeldesivir ............................................................................................................................54
8.
STATISTICAL CONSIDERATIONS.................................................................................................................56
8.1.
Analysis Objectives and Endpoints.........................................................................................................56
8.1.1.
Secondary Endpoints.............................................................................................................56
8.2.
Planned Analyses.....................................................................................................................................56
8.2.1.
Interim Analysis ....................................................................................................................56
8.2.2.
Final Analysis........................................................................................................................57
8.3.
Analysis Conventions..............................................................................................................................57
8.3.1.
Analysis Sets .........................................................................................................................57
8.3.2.
Data Handling Conventions ..................................................................................................57


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8.4.
Demographic and Baseline Characteristics Analysis..............................................................................58
8.5.
Efficacy Analysis.....................................................................................................................................58
8.5.1.
Primary Analysis ...................................................................................................................58
8.5.2.
Secondary Analyses...............................................................................................................58
8.6.
Safety Analysis........................................................................................................................................59
8.6.1.
Extent of Exposure ................................................................................................................59
8.6.2.
Adverse Events......................................................................................................................59
8.6.3.
Laboratory Evaluations .........................................................................................................59
8.6.4.
Other Safety Evaluations.......................................................................................................60
8.7.
Adjustments for Multiplicity ...................................................................................................................60
8.8.
Pharmacokinetic Analysis .......................................................................................................................60
8.9.
Sample Size .............................................................................................................................................60
9.
RESPONSIBILITIES...........................................................................................................................................62
9.1.
Investigator Responsibilities ...................................................................................................................62
9.1.1.
Financial Disclosure ..............................................................................................................62
9.1.2.
Institutional Review Board/Independent Ethics Committee Review and 
Approval................................................................................................................................62
9.1.3.
Informed Consent (or Assent) ...............................................................................................62
9.1.4.
Confidentiality.......................................................................................................................63
9.1.5.
Study Files and Retention of Records ...................................................................................63
9.1.6.
Case Report Forms ................................................................................................................64
9.1.7.
Investigator Inspections.........................................................................................................65
9.1.8.
Protocol Compliance .............................................................................................................65
9.2.
Sponsor Responsibilities .........................................................................................................................65
9.2.1.
Protocol Modifications ..........................................................................................................65
9.2.2.
Study Reports and Publications.............................................................................................65
9.3.
Joint Investigator/Sponsor Responsibilities ............................................................................................66
9.3.1.
Regulatory and Ethical Consideration...................................................................................66
9.3.2.
Payment Reporting ................................................................................................................66
9.3.3.
Access to Information for Monitoring...................................................................................66
9.3.4.
Access to Information for Auditing or Inspections ...............................................................66
9.3.5.
Study Discontinuation ...........................................................................................................66
10.
REFERENCES.....................................................................................................................................................67
11.
APPENDICES......................................................................................................................................................70
11.1.
Investigator Signature Page.....................................................................................................................71
11.2.
Committees..............................................................................................................................................72
11.2.1.
Safety Review Team..............................................................................................................72
11.2.2.
Data Monitoring Committee..................................................................................................72
11.3.
Pandemic Risk Assessment and Mitigation Plan ....................................................................................73
11.4.
Pregnancy Precautions, Definition of Childbearing Potential, and Contraceptive Requirements ..........76
11.5.
Tanner Stages ..........................................................................................................................................79
11.6.
Blood Volume Tables for Clinical Laboratory Studies...........................................................................80
11.7.
Amendment History ................................................................................................................................81
11.7.1.
Amendment 0.1 (15 November 2023)...................................................................................81


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Table 1. 
Table 2. 
Table 3. 
Table 4. 
Table 5. 
Figure 1. 
Figure 2. 
Figure 3. 
CONFIDENTIAL 
LIST OF IN-TEXT TABLES 
Study Procedures Table ........................................................................................................... 15 
Study Coho1t Description ........................................................................................................ 29 
Creatinine Value Cutoff by Age Group ................................................................................... 31 
Prior and Concomitant Medications That Are to Be Used With Caution or That Are 
Prohibited Because oflmpact on Efficacy Assessments or Participant Safety ....................... 37 
Coho1ts 1 and 2 - Blood Volume ............................................................................................. 80 
LIST OF IN-TEXT FIGURES 
Schema .......................................................................................................................... 14 
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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
AE
adverse event
ALT
alanine aminotransferase
AUC
area under the concentration versus time curve
AUCx-xx
partial area under the concentration versus time curve from time “x” to time “xx”
BID
twice daily
CI
confidence interval
Cmax
maximum observed concentration of drug
CoV
coronavirus
COVID-19
coronavirus disease 2019
CRF
case report form
CSR
clinical study report
DAIDS
Division of AIDS
DMC
data monitoring committee
eCRF
electronic case report form
EDC
electronic data capture
eGFR
estimated glomerular filtration rate
EU
European Union
FAS
Full Analysis Set
FDA
Food and Drug Administration
FiO2
fraction of inspired oxygen
GA
gestational age
GCP
Good Clinical Practice
Gilead
Gilead Sciences
IB
investigator’s brochure
ICH
International Council for Harmonisation (of Technical Requirements for 
Pharmaceuticals for Human Use)
IEC
independent ethics committee
Ig
immunoglobulin
IRB
institutional review board
IRT
Interactive Response Technology
KM
Kaplan-Meier
LLOQ
lower limit of quantitation
MedDRA
Medical Dictionary for Regulatory Activities
NOAEL
no observed adverse effect level
ODV
obeldesivir (GS-5245)
PCR
polymerase chain reaction
PK
pharmacokinetic(s)
RDV
remdesivir
RNA
ribonucleic acid


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SAE
serious adverse event
SAP
statistical analysis plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
SSR
special situations report
TK
toxicokinetic(s)
ULN
upper limit of normal
US
United States


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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Study Title: A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, 
Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants With COVID-19
Plain Language Short Title: Study of Obeldesivir in Children and Adolescents With 
COVID-19
Regulatory Agency Identifier Numbers:
IND Number: 158222
EU CT Number: 2023-503282-27
ClinicalTrials.gov Identifier: Not Available
Study Sites Planned: Approximately 40 centers globally 
Objectives and Endpoints:
Primary Objectives
Primary Endpoints
•
To evaluate the plasma pharmacokinetic (PK) of 
obeldesivir (ODV; GS-5245) in pediatric 
participants with COVID-19
•
PK parameters (AUC0-12, Cmax, and Ctrough) for 
ODV metabolite, GS-441524 
•
To evaluate the safety and tolerability of ODV in 
pediatric participants with COVID-19
•
Incidence of treatment-emergent adverse events 
(AEs) by Day 35
•
Incidence of treatment-emergent laboratory 
abnormalities by Day 35
Secondary Objectives
Secondary Endpoints
•
To assess the impact of ODV on time to sustained 
alleviation of targeted COVID-19 symptoms in 
pediatric participants with COVID-19
•
Time to sustained alleviation of targeted 
COVID-19 symptoms by Day 35 
•
To evaluate the antiviral activity of ODV on severe 
acute respiratory syndrome coronavirus 2 
(SARS-CoV-2) nasal swab viral load in pediatric 
participants with COVID-19
•
Change from baseline in SARS-CoV-2 nasal swab 
viral load at Day 5
•
To assess the impact of ODV on the requirement 
for supplemental oxygen in pediatric participants 
with COVID 19
•
Proportion of participants who require 
supplemental oxygen support (low flow oxygen, 
high flow oxygen, noninvasive ventilation, 
mechanical ventilation, or extracorporeal 
membrane oxygenation) by Day 35
•
To evaluate palatability and acceptability of ODV 
in pediatric participants with COVID-19
•
Assessment of palatability and acceptability scores 
of each formulation at Day 5


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•
To provide data on the use of medications other 
than remdesivir and ODV for treatment of 
COVID-19 in pediatric participants with 
COVID-19
•
Proportion of participants with concomitant use of 
medications other than remdesivir and ODV for 
treatment of COVID-19 by Day 35
•
To assess the impact of ODV on 
COVID-19-related hospitalizations or all-cause 
death in pediatric participants with COVID-19
•
Proportion of participants with COVID-19-related 
hospitalization or all-cause death by Day 35
Study Design: This will be a single-arm, open-label study to evaluate the safety, PK, and 
efficacy of ODV in pediatric participants with COVID-19 who are at risk of progression to 
severe disease. Participants will be enrolled in a staggered manner and will receive treatment 
with ODV. Cohorts will be opened for enrollment based upon availability of a suitable pediatric 
formulation and availability of preliminary safety and PK data.
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Cohort
Description
Pediatric participants ≥ 28 days to < 18 years old
1
≥ 6 years to < 18 years and weight ≥ 40 kg
2
≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kg
3
≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kg
4
≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kg
Term neonatal participants 0 days to < 28 days old
5
≥ 14 days to < 28 days of age, gestational age (GA) ≥ 37 weeks and weight ≥ 2.5 kg
6
0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg
Preterm neonates and infants 0 days to < 56 days old
7
0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg
Number of Participants Planned: At least 52 participants
Study Population: Pediatric participants 0 days to < 18 years of age with COVID-19 who are at 
risk of progression to severe disease
Diagnosis and Main Eligibility Criteria: Participants with SARS-CoV-2 infection confirmed 
by polymerase chain reaction or an alternative molecular diagnostic assay who meet following 
criteria:
•
Age and weight criteria:
Cohort 1: ≥ 6 years to < 18 years and weight ≥ 40 kg
Cohort 2: ≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kg
Cohort 3: ≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kg
Cohort 4: ≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kg
Cohort 5: ≥ 14 days to < 28 days of age, GA ≥ 37 weeks and weight ≥ 2.5 kg
Cohort 6: 0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg
Cohort 7: 0 day to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg
•
Initial onset of COVID-19 signs/symptoms ≤ 5 days before screening with ≥ 1 sign/symptom 
such as fever, cough, fatigue, shortness of breath, sore throat, headache, myalgia/arthralgia 
present at screening
•
Presence of ≥ 1 characteristic or underlying medical condition associated with an increased 
risk of developing severe illness due to COVID-19, including:




CCI
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Test Product, Dose, and Mode of Administration: 
Final 
Amendment 0.1 EU 
• ODV- administered orally twice daily for participants aged ~ 6 years to < 18 years 
and weighing~ 40 kg (Coho1t 1). 
• ODV- administered orally twice daily for participants aged ~ 6 years to < 18 years 
and weighing~ 20 kg to < 40 kg (Cohort 2). 
Reference Therapy, Dose, and Mode of Administration: Not applicable 
Duration of Intervention: 5 days 
Study Procedures/Frequency: 
• 
Screening: within 48 hours of the baseline (Day 1) visit (screening and baseline visits may 
occur on the same day) 
• 
Study treatment period: 5 days 
-
In-person visits at Days 1 and 5 
-
In-person or remote visit at Day 3 
• 
Posttreatment follow-up period: 30 days after the last dose of study drng 
-
In-person or remote visits at Days 8 and 14 
-
Vniual visits at Days 21 and 28 
-
End-of-study in person visit at Day 35 
Table 1 outlines the schedule of study procedures. 
Statistical Methods: 
Safety: Treatment-emergent AEs and selected laborato1y test data will be summarized using 
descriptive statistics and listed by pa1ticipant. The propo1tion of paiticipants with conc01nitant 
use of medications other than RDV and ODV for treatment of COVID-19 will be provided in 
summa1y tables by coho1t and overall. Palatability and acceptability will be summarized using 
descriptive statistics by coho1t and overall. 
Phaimacokinetics: Plasma concentrations and PK pai·ameters will be listed and sUilllllai·ized for 
GS-441524 using descriptive statistics by coho1t and overall. 
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Efficacy: The efficacy endpoints will be summarized using descriptive statistics and listed by 
participant.
Sample Size: A minimum of 12 evaluable participants from each cohort (Cohorts 1-4) provides 
> 90% power to reject the null hypothesis that there is at least a 30% difference in GS-441524 
AUC0-12 and Cmax, respectively, between pediatric and adult participants, using 2 one-sided tests 
with each performed at an alpha level of 0.05. This power analysis assumes that the expected 
geometric mean ratio between the pediatric participants versus the adult group is 1, the 
equivalency boundary is 70% to 143%, and the interparticipant standard deviations of AUC0-12 
and Cmax are 0.19 h•ng/mL and 0.18 ng/mL (natural log scale, preliminary results from 
Study GS-US-611-6248).


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STUDY SCHEMA
Figure 1.
Study Schema
Screening 
within 48 hours 
prior to 
scheduled first 
dose 
Eligible 
partfoi1pants 
enrolled to 
receive GS~5245 
Study Visits (Study Days) 
Treatment Period 
Days 1 to 5 
21 
28 
Follow-up Per,iod 
Days 6 tio 35 
35 
I In-person I In-person or remote I Virtual 
An in-person visit will occur either at a medical facility or as a remote visit at home by a healthcare professional (where permitted). 
Virtual visit is defined as an interaction with a healthcare professional using telephone or online based interaction (illt te/eheofth, 
webcost, videoconferencing). 


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STUDY PROCEDURES TABLE
Table 1.
Study Procedures Table
Screening/
(D −1)a
Baseline/
D 1a
D 3
D 5
D 8
D 14
D 21
D 28
EOS/
D 35
–
–
–
–
± 1 d
± 2 d
± 2 d
± 2 d
± 5 d
In person
In person or 
remoteb
In person
In person or 
remoteb
Virtualc
In 
person
Participant and/or parent or legal guardian consent/assent
Medical historyd
Document SARS-CoV-2 infection
Complete physical examinatione
Symptom-directed physical examinatione
Body weight
Height/lengthf
Last recorded Apgar score if < 24 hours of age
Birth weight if < 56 days of age
Gestational age if < 1 years of age
Vital signsg
Tanner stage assessment if ≥ 6 years of age
Hematology, chemistry
Urinalysis
Routine coagulation test (PT/aPTT with calculated INR)
Neonatal bilirubin panel for all neonates < 14 days, and any neonate 
presenting with jaundice
Urine pregnancy testh
Midturbinate nasal swabi
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Screening/
(D −1)a
Baseline/
D 1a
D 3
D 5
D 8
D 14
D 21
D 28
EOS/
D 35
–
–
–
–
± 1 d
± 2 d
± 2 d
± 2 d
± 5 d
In person
In person or 
remoteb
In person
In person or 
remoteb
Virtualc
In 
person
Review inclusion/exclusion criteria
Participant and/or caregiver symptom assessmentj
PK samplek
Study drug dispensation
Study drug administrationl 
Study drug returnm
Concomitant medications
Hospitalization detailsn
Oxygen supplementation requiremento
Adverse eventsp
Acceptability/palatability assessment
aPTT = activated partial thromboplastin time; COVID-19 = coronavirus disease 2019; D/d = day; EOS = end of study; Ig = immunoglobulin; INR = international normalized ratio; 
MAP = mean arterial pressure; PT = prothrombin time; PK = pharmacokinetic(s); RT-qPCR = reverse transcription-quantitative polymerase chain reaction; SARS-CoV-2 = severe 
acute respiratory syndrome coronavirus 2
a
Screening window is within 48 hours of the baseline visit. Baseline visit may occur on the same day as screening. If the Day 1 and Screening visits occur within the same 
calendar day, do not repeat assessments common to Screening and Day 1 visits.
b
An in-person visit will occur either at a medical facility or as a remote visit at home by a health care professional (where permitted).
c
Virtual visit is defined as an interaction with a health care professional using telephone or online based interaction (eg, telehealth, webcast, videoconferencing). 
d
Medical history will include the date of first COVID-19 symptoms, overall COVID-19 symptoms, all COVID-19 vaccinations prior to screening, demographics, baseline 
characteristics, allergies, and all other medical history.
e
A complete physical examination includes source documentation of general appearance and the following body systems: head, neck, and thyroid; eyes, ears, nose, throat, 
mouth, and tongue; chest (excluding breasts); respiratory; cardiovascular; lymph nodes, abdomen; skin, hair, nails; musculoskeletal; and neurological. Urogenital and 
reproductive examination should only be completed if clinically indicated. A physical examination will only be conducted during an in-person visit by a qualified health care 
professional.
f
Record length and head circumference if < 28 days at enrollment.
g
Vitals signs include heart rate, temperature, blood pressure (MAP if available, systolic and diastolic), respiratory rate, and oxygen saturation. Vital signs will be collected at 
in-person visits only.
h
For female participants of childbearing potential only.
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i
The nasal swab sample will be used for SARS-CoV-2 RT-qPCR, potential infectious viral titer assessment, potential resistance testing, and viral coinfection. 
j
Participant and/or caregiver symptom assessment will be completed on stipulated days via a questionnaire (Section 6.3.7).
k
Refer to Section 6.3.5 for PK samples collection timepoints. PK samples will be collected on Days 3 and 5 for Cohorts 1 and 2.
l
Study drug administration time will be recorded by investigational site personnel or by participant/parent/caregiver via a diary. Participant to withhold their dose prior to 
arriving to the site on Day 5, as the dose will be administered at the site.
m
Study drug bottle should be returned by the participant on Day 5, if the participant has already completed both doses of study drug. If the participant has the last dose of study 
drug remaining by the conclusion of the Day 5 in-person visit, the participant may return the study drug bottle if an in-person visit is conducted on any subsequent visits 
(including EoS visit). Alternatively, the participant may courier the study drug bottle to the site.
n
To be collected for hospitalized participants. Information to be collected: hospitalization date, reason for hospitalization, discharge date, and discharge outcome.
o
To be collected for hospitalized participants. Refer to Section 6.3.4 for information collection on oxygen supplementation or oxygenation.
p
All participants presenting with multisystem inflammatory syndrome in children (MIS-C; https://emergency.cdc.gov/han/2020/han00432.asp) should be monitored and treated 
as clinically indicated.
q
To be collected for hospitalization participants.


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1.
INTRODUCTION
1.1.
Background
A novel coronavirus, SARS-CoV-2, has been identified as the cause of the global pandemic of 
COVID-19. Children of any age can get COVID-19 {Zimmermann 2020} and the incidence in 
children has been found to be similar to that in adults {Dawood 2022}. The prevalence of 
SARS-CoV-2 infection was initially reported to be low, with children and adolescents to 
represent approximately 1% to 2% of total cases, but the prevalence has increased over time, 
possibly related to increased testing rates {Nikolopoulou 2022}. As of January 2023, 17.2% of 
cases in the United States (US) were children from 0 to 17 years of age; with 3.6% cases in the 
age group 0-4 years, 6.5% cases in the age group 5-11 years, 4.5% cases in the age group 
12-15 years, and 2.6% cases in the age group 16-17 years {Centers for Disease Control and 
Prevention 2022}. In a study conducted in school-aged children in the United Kingdom, median 
illness duration was longer for children aged 12 to 17 years (7 days) than children aged 5 to 
11 years (5 days), with 4.4% of children having an illness duration of at least 28 days and longer 
duration occurring more commonly in older than younger children (5.1% vs 3.1%, respectively) 
{Molteni 2021}. Further, in addition to increased prevalence, the overall incidence of 
SARS-CoV-2 infection and COVID-19–related hospitalizations among children has increased 
over the course of the pandemic with successive SARS-CoV-2 waves and the emergence of 
unique variants {Ben-Tov 2022} {Marks 2022}. The percentage of intensive care unit 
admissions among hospitalized children is comparable to that for hospitalized adults with 
COVID-19 and hospitalization rates in the US associated with COVID-19 are higher among 
unvaccinated children than those who are vaccinated {Shi 2022} {Siegel 2021}. Both children 
and adults present with similar viral loads irrespective of hospitalization or symptom status 
{Madera 2021}, with fever and cough reported as the most common symptoms {European 
Center for Disease Prevention and Control 2022} {Nikolopoulou 2022}. Although children with 
COVID-19 are frequently asymptomatic or have symptoms that are reported as mild or 
moderate, symptoms can include nausea/vomiting, and upper respiratory complications {Swann 
2020}, {Gotzinger 2020}, {Liguoro 2020}, {Zimmermann 2020}. The signs and symptoms of 
COVID-19 in children may overlap significantly with other respiratory and enteric viral 
infections. However, as in adults, COVID-19 can result in severe disease in children, leading to 
respiratory failure and acute respiratory distress syndrome {Bhalala 2022}. Other symptoms in 
children include gastrointestinal symptoms, sore throat/pharyngitis, shortness of breath, myalgia, 
rhinorrhea/nasal congestion, and headache, consistent with symptoms observed in adults. 
Furthermore, underlying conditions such as 
, 
 and 
 
children as well as adults to more severe COVID-19 disease; prematurity in infants is also a risk 
factor for severe disease {Fernandes 2021} {Kompaniyets 2021} {Tsankov 2021} {Uka 2022}. 
Remdesivir (RDV, Veklury®) is approved for the treatment of COVID-19 in hospitalized and 
nonhospitalized patients in the US, the European Union (EU), Japan, and other countries in 
pediatric and adult patients {VEKLURY 2022a, Veklury 2022b}. The pharmacologically active 
metabolite of RDV within lung cells is the triphosphate (GS-443902), which is recognized and 
incorporated in SARS-CoV-2 viral RNA by viral RNA-dependent RNA polymerase as an 
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alternate substrate, thereby selectively inhibiting the synthesis of viral RNA {Tchesnokov 2020}. 
Recent in vitro studies confirmed potent antiviral activity of RDV and its parent nucleoside 
GS-441524 against the SARS-CoV-2 delta variant and other variants of interest, and it is 
anticipated that future coronavirus (CoV) strains are likely to remain susceptible to RDV as it 
has potent activity in vitro and in vivo toward both SARS-CoV and Middle East respiratory 
syndrome CoV, whose polymerase active sites are 100% conserved (Studies PC-540-2021, 
PC-540-2024, and PC-540-2026). The broader utility of RDV for the treatment of early infection 
with SARS-CoV-2 and other potential emerging CoV strains is limited due to intravenous 
administration; therefore, availability of more convenient treatment options using other routes of 
administration is crucial for early therapy. 
Nirmatrelvir/ritonavir (PaxlovidTM) is authorized for emergency use in the US for the treatment 
of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 
40 kg) who are at high risk for progression to severe COVID-19. No oral medications are 
currently available for the treatment of COVID-19 in pediatric patients in the EU. 
Availability of a highly effective oral treatment with a high barrier to resistance, similar to that of 
RDV, with minimal drug-drug interaction (DDIs) and with fewer tablets to take (ie, the dose of 
ODV selected for Phase 3 is one 
 tablet twice daily [BID]) has the potential to address a 
critical public health need in the ongoing COVID-19 pandemic.
Obeldesivir represents a promising oral option for the treatment of COVID-19 in patients who 
are at increased risk of progressing to severe COVID-19, that is anticipated to fulfill an unmet 
medical need.
1.2.
Background on Study Interventions
1.2.1.
Obeldesivir
1.2.1.1.
General Information
Obeldesivir is a mono-5’-isobutyryl ester prodrug of GS-441524, and following oral 
administration, is extensively hydrolyzed presystemically to yield the parent nucleoside of RDV, 
GS-441524. The prodrug ODV was designed to specifically increase the oral bioavailability of 
GS-441524.
For further information on ODV, refer to the current investigator’s brochure (IB), including 
information on the following:
•
Nonclinical pharmacology
•
Nonclinical PK
•
Toxicology
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1.2.1.2.
Clinical Studies of Obeldesivir 
1.2.1.2.1. Study GS-US-611-6248
Study GS-US-611-6248 was a Phase 1a first-in-human, single and multiple ascending dose study 
of ODV. This randomized, blinded, placebo-controlled study evaluated single and multiple doses 
with staggered dose escalation and adaptive ODV dose selection. The study also evaluated the 
impact of food on bioavailability.
The single ascending dose cohorts evaluated ODV 100 mg, 300 mg, 900 mg, and 1600 mg 
administered once daily for 5 days and multiple ascending dose cohorts evaluated ODV 500 mg 
administered BID for 5 days and ODV 900 mg administered once daily for 5 days. Obeldesivir 
tablets were administered in fasted state (morning dose) or 2 hours after a meal (evening dose) 
with approximately 240 mL of water.
A total of 70 participants were enrolled into the study, 58 participants received ODV and 
12 participants received placebo. A similar proportion of male and female participants (52.9% 
and 47.1%, respectively) were enrolled in the study. The mean (SD) age was 32 (7.5) years 
(range: 20 to 45 years).
Following single dose administration of ODV at doses of 100, 300, 900, or 1600 mg under fasted 
conditions, dose-proportional increases in the GS-441524 plasma PK parameters (AUClast, 
AUCinf, and Cmax) were observed across the dose range of 100 to 900 mg. The median Tmax of 
GS-441524 in plasma was 0.75 hours postdose and the median t1/2 ranged from 6 to 7 hours 
across the 100 to 900 mg singles doses. Following ODV 500 mg BID administration for 5 days 
under fasted condition, accumulation of GS-441524 in plasma (approximately 35% based on 
AUC values) was observed and reached steady state at 5 days. Minimal (approximately 12% 
based on AUC value) accumulation of GS-441524 was observed after ODV 1600 mg once-daily 
dosing.
Administration of ODV with high-fat meal decreased the rate but not the extent of absorption; 
thus, ODV may be administered without regard to food.
Overall, ODV at single doses of 100 mg to 1600 mg and multiple doses of 500 mg BID and 
900 mg once daily has been safe and well tolerated. No Grade 3 and severe AEs, SAEs, deaths, 
pregnancies, or discontinuation of study drug were reported. No Grade 4 laboratory 
abnormalities reported; 1 Grade 3 lipase elevation was reported on Day 3 which returned to 
normal at Day 5. Creatinine clearance decreases were generally transient and returned to baseline 
limits. There were no clinically relevant changes in vital signs, electrocardiograms, or 
ophthalmologic examinations.
1.2.1.2.2. Study GS-US-611-6409
Study GS-US-611-6409 is an ongoing Phase 1 study to evaluate transporter and 
cytochrome P450 enzyme (CYP)-mediated DDIs between ODV and probe drug. This is an 
open-label, multicenter, fixed- (Cohorts 1, 2, 3, 5, and 7) or randomized-sequence (Cohorts 4 


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and 6) crossover study in healthy paiiicipants. The following interactions are planned to be 
evaluated in each cohort: 
• 
Coho1is 1 and 2: ODV as a victim of strong P-glycoprotein (P-gp) inhibition using ritonavir 
and ninnatrelvir/ritonavir, respectively 
• 
Coho1i 3: ODV perpetrator effect on a probe CYP3A substrate midazolam (MDZ) 
• 
Coho1i 4: ODV perpetrator effect on a probe P-gp substrate, dabigatran (DAB) 
• 
Coho1i 5: ODV pe1petrator effect on a probe organic anion transpo1iing polypeptide (OATP) 
1Bl/1B3 substrate, pitavastatin (PIT) 
• 
Coho1i 6: ODV prepetrator effect on a probe organic cation transpo1ier (OTC) 1 substrate 
metfonnin (MET) 
• 
Coho1i 7: ODV as a victim of gastric acid suppression using famotidine (FAM) 
Preliminaiy PK results ai·e available in Cohorts 1 (n=15 3 n=19), 5 (n=23), and 7 (n=14). For 
Coho1i 1, paiticipants received a single dose of ODV 
on Day 1, followed by ritonavir 
100 mg BID on Days 4 to 8 with a single dose of ODV 
coadministered on Day 6. For 
Coho1i 3, pa1ticipants received a single dose ofMDZ 2.5 mg on Day 1 and a single dose of ODV 
500 mg coadministered with a single dose ofMDZ 2.5 mg on Day 3. For Coho1t 5, paiiicipants 
received a single dose of PIT 2 mg and a single dose of ODV 500 mg coadministered with a 
~ose of PIT 2 mg on Day 4. For Cohort 7, paiiicipants received a single dose ofODV 
-
on Day 1 and a single dose of FAM 40 mg followed by a single dose ofODV-
2 
hours after FAM on Day 4. All doses were oral and administered under fasting conditions. 
Coho1i 2 was not enrolled based on emerging results from Coho1i 1. 
The safety profile of Coho1is 3 and 7 is not yet available. No SAEs, deaths, pregnancies or 
discontinuations of study dmg were repo1ied. 
Conclusion 
Prelimina1y data indicates that-
• 
ODV as a pe1petrator: ODV is not an inhibitor of CYP3A (as observed with MDZ) or a 
clinically relevant inhibitor of OATP1Bl/1B3 (as observed with PIT). 
• 
ODV as a victim: There was no clinically significant effect of P-gp inhibition (as observed 
with coadministration of ODV with ritonavir) on plasma exposure of GS-441524. There was 
no clinically significant effect of increased gastric pH (as observed with coadministration of 
ODV with FAM) plasma exposures of GS-441524; thus, ODV may be coadministered with 
acid-reducing agents including antacids, histainine 2-receptor antagonists, and proton-pump 
inhibitors. 
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1.2.1.3. 
Toxicology 
1.2.1.3 .1. Phototoxicity 
Results of a 
showed that 
was not cytotoxic and did not display an 
radiation exposure, up to the highest soluble concentration tested 
of ODY is not considered to exhibit a photosafety risk. 
1.2.1.3.2. Fe1tility Study 
Final 
Amendment 0.1 EU 
Administration 
A fe1tility and early emb1yonic development (FEED) study in male and female rats has been 
conducted. A summa1y of the results of this study, based on the audited draft repo1t, is provided 
below. 
The objectives of this FEED study were to detennine the potential adverse effects/disturbances 
in the reproductive process resulting 
administration of ODY to 
rats, from premating to conception and from conception to implantation. This included 
identification of deficits in estrous cycling, tubal transpo1t, implantation, development of the 
preimplantation stages of the emb1yo in the female, and functional reproductive effects 
(alterations in libido and e idid mal s enn maturation in the male. In addition, the 
toxicokinetics 
were detennined from a 
satellite group of nonmated animals. 
There were no ODY-related effects on male survival, clinical and macrosco 
body weights, body weight gains, food consumption, and organ weights at 
Male reproductive perfonnance (mating, fe1tility, and pregnancy indices a 
and spennatogenic parameters were unaffected by ODY administration a 
There were no ODY-related effects on female survival or clinical observations at 
or on premating and gestation body weights, body weight gains, food consm~le 
length, reproductive perfo1mance, macroscopic findings, or organ weights at_ 
Intrauterine survival was also not affected b ODY administration at any dose level. All 
parameters in the 
were comparable to the 
vehicle control group. 
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erfonnance and spe1matogenic parameters, a dose 
was considered to be the no 
reproductive toxicity of ODV when 
to- rats. Based on the lack of effects on female 
reproductive perfo1mance, estrous cyclicity, and intrauterine smvival the NOAEL for female 
re roductive toxici and emb1yonic toxicity was considered to be 
. These doses cones onded to mean 
1.3. 
Rationale for This Study 
There are cunently no approved oral therapeutic agents available for the treatment of COVID-19 
in children < 12 years of age. All approved COVID-19 mugs for childi·en 
12 to < 18 years of 
age and weighing 40 kg are adininistered via parenteral route. The availability of an effective 
oral antiviral agent with a favorable benefit-risk profile would addi·ess a serious unmet medical 
need for the treatment of childi·en with COVID-19. 
1.4. 
Rationale for Dose Selection of Study Drug 
The proposed dose for evaluation in Coho1i 1 (participants aged 6 years to < 18 years and 
weighing ~ 40 k 
is the same dose being evaluated in the adult Phase 3 Study GS-US-611-6273, 
which is ODV 
BID. Obeldesivir adininistered at single doses of 100 mg to 1600 mg and 
multiple doses o 
BID or 900 mg once daily for 5 days were generally safe and well 
tolerated in the Phase la study (Section 1.2.1.2.1). 
A population phaimacokinetic (PopPK) model developed for ODV based on available adult PK 
data from the Phase 1 Study GS-US-611-6248 was revised to incmporate allometric scaling 
based on body weight in order to extrapolate exposmes and select doses for pediatric paiiicipants 
6 years of age and 20 kg. Figure 2 displays the resulting PopPK model-predicted GS-441524 
concentration versus time profiles for the ~dininistration of-
BID to adults 
(~ 18 years of age and weighing 40 kg), -
BID to adolescents (~ 12 to < 18 years of age 
and weighing~ 40 kg) in the Phase 3 Study GS US 611-6549 and Study GS-US-611-6464 
Coho1i 1 pa1iicipants (~ 6 to < 18 years of age and weighing~ 40 kg), and- BID to Study 
GS-US-611-6464 Cohort 2 paiiicipants (~ 6 to < 18 yeai·s of age and weig~O to < 40 kg). 
This figure demonstrates that the predicted PK profiles for each of the pediatric weight groups 
ai·e predicted to be similai· to the anticipated PK profiles in adults. Figure 3 provides the boxplots 
of the conesponding PK pai·ameters for adul~ediatric weight groups. As the 
model results demonstrate, adininistration of-
for 5 days to pediatric 
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paiiicipants weighing 40 kg and- BID for 5 days to pediatric participants weighing 
20 kg to~ 
results in exposures compai·able to those anticipated in adult paiiicipants 
following- BID administrntion, and within the range of observed exposures associated 
with safe doses administered to adults in the Phase 1 Study GS-US-611-6248. 
Therefore, the proposed doses ai·e ODV- BID and- BID for Coho1i 1 and Coho1i 
2, respectively (Table 2). The weight range associated wit~
sed dose for Coho1i 2 may be 
confinned prior to enrollment, based on update to the PopPK model using available additional 
PK data from adult Phase 1 and Phase 3 studies (including but not limited to GS-US-611-6248, 
GS-US-611-6273, and GS-US-611-6549). 
The dose(s) for Coho1is 3 to 5 will be detennined prior to enrollment using PK modeling based 
on data from the relative bioavailability study for the pediatric dosing fo1mulation and any other 
available PK data from this pediatric study and adult studies (including but not limited to 
GS-US-611-6248, GS-US-611-6273, and GS-US-611-6549). Siinilai·ly, the dose(s) for Coho1is 6 
and 7 will be dete1mined using modeling based on available cumulative PK data from this 
pediatric study and adult studies prior to enrollment (including but not limited to 
GS-US-611-6248, GS-US-611-6273, and GS-US-611-6549). 
Figure 2. 
C 
0 
:;:; 
10 
'E 
C 
0 
0 
Cl 
:::, 
0 
03 
12 
24 
36 
48 
60 
72 
84 
96 
106 
120 
Time (h) 
Cohort -
Adult -
Adolescent -
Cohort 1 -
Cohort 2 
BID = twice daily; ODV = obeldesivir (GS-5245); PK = pharmacokinetic; y = year (age) 
Adolescent refers to Study GS-US-611-6549 participants :C:: 12 years to < 18 years of age and weighing :C:: 40 kg. Cohorts 1 and 2 
refer to pediatric Study GS-US-611-6464 Cohort 1 (participants :C:: 6 years to < 18 years of age and weighing :C:: 40 kg) and 
Coho,t 2 (pa,ticipants :C:: 6 years to< 18 years of age and weighing :C:: 20 kg to < 40 kg). 
CONFIDENTIAL 
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GS-5245 
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Gilead Sciences, Inc. 
Figure 3. 
" 
.... 
6 
,o 
l 
0 
0 
:::, 
<( 
,,.-... 
_J 
E 
·-... 
Ol ,o 
...s 
:i; x .. 
E 
1 
(.) 
,,.-... ,o 
_J 
E 
•••··· 
Ol 
::i. 
._, 
§ 
.c 
OJ 0. 1 
::, g 
(.) 
• -
• -
. 
+ 
• -
Group -
Group -
Oroop -
-
Final 
Amendment 0.1 EU 
AUC108-120 = pa1tial area under the concentration versus time curve from time 108 hours to time 120 hours (the evening dose 
on Day 5); BID = twice daily; Cmax = maximum observed concentration of dmg; Ctrough = concentration at the end of the dosing 
interval; ODV = obeldesivir (GS-5245); PK = phanuacokinetic; y = year (age) 
Adolescent refers to Study GS-US-611-6549 participants :C:: 12 years to < 18 years of age and weighing :C:: 40 kg. Cohorts 1 and 2 
refer to pediatric Study GS-US-611-6464 Cohort 1 (participants :C:: 6 years to < 18 years of age and weighing :C:: 40 kg) and 
Coho1t 2 (pa1ticipants :C:: 6 years to < 18 years of age and weighing :C:: 20 kg to < 40 kg). 
1.5. 
Benefit-Risk Assessment for the Study 
Obeldesivir has shown to have activity in animal models and shares the same active ti·iphosphate 
metabolite as the approved COVID-19 ti·eatment dmg, RDV. 
Obeldesivir has also been evaluated in a Phase 1 (single and ascending dose) study where it was 
safe and well tolerated. Obeldesivir is cunently being evaluated in 2 Phase 3 adult population 
studies (GS-US-611-6273 and GS-US-611-6549). Emollment in this study will be initiated 
following the review of safety data from the first occmTing Data Monitoring Committee (DMC) 
of the adult program: 
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•
Data from the first 200 participants, who completed Day 29 visit or prematurely discontinued 
from the study, in GS-US-611-6273 have been reviewed by the DMC 
OR
•
Data from the first 150 participants, who completed Day 29 visit or prematurely discontinued 
from the study, in GS-US-611-6549 have been reviewed by the DMC.
Obeldesivir has the potential benefit to be the first oral COVID treatment for children, which will 
facilitate treatment of outpatients as well as inpatients.
Potential risks of a participant’s study involvement include unknown AEs, general risks 
associated with laboratory blood draws, and the associated pain and discomfort of phlebotomy.
Strategies to mitigate these risks include close monitoring of participants’ clinical statuses, 
laboratory values, and AEs. Parameters for discontinuation of the study drug due to AEs will be 
clearly defined and closely followed.
An infectious disease pandemic may pose additional risks to study drug availability, the study 
visit schedule, and adherence to protocol-specified safety monitoring or laboratory assessments. 
Refer to Appendix 11.3 for further details on the risks and risk mitigation strategy.
Considering the above, the benefit-risk balance for this study is considered positive.


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2.
OBJECTIVES AND ENDPOINTS
Primary Objectives
Primary Endpoints
•
To evaluate the plasma PK of ODV in pediatric 
participants with COVID-19
•
PK parameters (AUC0-12, Cmax, and Ctrough) for 
ODV metabolite, GS-441524 
•
To evaluate the safety and tolerability of ODV in 
pediatric participants with COVID-19
•
Incidence of treatment-emergent AEs by Day 35
•
Incidence of treatment-emergent laboratory 
abnormalities by Day 35
Secondary Objectives
Secondary Endpoints
•
To assess the impact of ODV on time to sustained 
alleviation of targeted COVID-19 symptoms in 
pediatric participants with COVID-19
•
Time to sustained alleviation of targeted 
COVID-19 symptoms by Day 35 
•
To evaluate the antiviral activity of ODV on 
SARS-CoV-2 nasal swab viral load in pediatric 
participants with COVID-19
•
Change from baseline in SARS-CoV-2 nasal swab 
viral load at Day 5
•
To assess the impact of ODV on the requirement 
for supplemental oxygen in pediatric participants 
with COVID 19
•
Proportion of participants who require 
supplemental oxygen support (low flow oxygen, 
high flow oxygen, noninvasive ventilation, 
mechanical ventilation, or extracorporeal 
membrane oxygenation) by Day 35
•
To evaluate palatability and acceptability of ODV 
in pediatric participants with COVID-19
•
Assessment of palatability and acceptability scores 
of each formulation at Day 5
•
To provide data on the use of medications other 
than RDV and ODV for treatment of COVID-19 in 
pediatric participants with COVID-19
•
Proportion of participants with concomitant use of 
medications other than RDV and ODV for 
treatment of COVID-19 by Day 35
•
To assess the impact of ODV on 
COVID-19-related hospitalizations or all-cause 
death in pediatric participants with COVID-19
•
Proportion of participants with COVID-19-related 
hospitalization or all-cause death by Day 35
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3.
STUDY DESIGN
3.1.
Study Design Overview
This will be a single-arm, open-label study to evaluate the safety, PK, and efficacy of ODV in 
pediatric participants with COVID-19 who are at risk of progression to severe disease.
After screening procedures, eligible participants will receive treatment with ODV.
At least 52 participants aged 0 days to < 18 years will be enrolled as described in Table 2. 
Participants will be enrolled in a staggered manner. Cohorts will be opened for enrollment based 
upon availability of a suitable pediatric formulation and availability of preliminary safety and PK 
data.
Figure 1 provides an overview of study design.
Table 2.
Study Cohort Description
Cohort
Description
Pediatric participants ≥ 28 days to < 18 years old
1
≥ 6 years to < 18 years and weight ≥ 40 kg
2
≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kg
3
≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kg
4
≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kg
Term neonatal participants 0 days to < 28 days old
5
≥ 14 days to < 28 days of age, GA ≥ 37 weeks and weight ≥ 2.5 kg
6
0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg
Preterm neonates and infants 0 days to < 56 days old
7
0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg
GA = gestational age
3.2.
Duration of Intervention
Duration of dosing is 5 days.
3.2.1.
Poststudy Care 
The long-term care of the participant will remain the responsibility of his/her primary treating 
physician. 


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3.3.
Protocol-Specific Discontinuation Criteria
3.3.1.
Criteria for Early Discontinuation for the Individual Participants
3.3.1.1.
Criteria for Early Discontinuation for the Individual Participants From Study 
Intervention
Study drug will be discontinued in the following instances:
•
Any SAE suspected to be related to study drug.
•
Any ≥ Grade 3 AE suspected to be related to study drug.
•
An AE, or worsening of clinical condition requiring clinical intervention, that would, in the 
judgment of the investigator, affect assessments of clinical status to a significant degree.
•
Any ≥ Grade 3 clinically significant laboratory abnormality (if confirmed by repeat testing) 
suspected to be related to study drug.
•
eGFR < 50 mL/min/1.73 m2 (≥ 1 year of age) using the Bedside Schwartz formula. 
•
Alanine aminotransferase (ALT) ≥ 5 × upper limit of normal (ULN).
•
Bilirubin ≥ 2 ´ ULN (≥ 3 × ULN for participants with Gilbert’s syndrome).
•
Unacceptable toxicity, as defined in Section 7.7, or toxicity that, in the judgment of the 
investigator, compromises the ability to continue study-specific procedures or is considered 
not to be in the participant’s best interest.
•
Participant request to discontinue for any reason.
•
Participant noncompliance with the study protocol.
•
Pregnancy (refer to Appendix 11.4).
•
Discontinuation of the study by sponsor.
•
Creatinine level above the thresholds described in Table 3 if < 1 year or age.


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Table 3.
Creatinine Value Cutoff by Age Group
Gestational age
Chronological age
Creatinine Value Cutoff in mg/dL
≥ 24 to ≤ 27 weeks
0 to < 28 days
≥ 28 to ≤ 29 weeks
0 to < 14 days
0 to < 7 days
≥ 7 days to 1 month
≥ 1 to < 2 months
≥ 30 to < 32 weeks
≥ 2 months to < 1 year
0 to < 2 days
≥ 2 to < 7 days
≥ 7 days to 2 months
≥ 32 weeks
≥ 2 months to < 1 year
* Creatinine values 
3.3.1.2.
Criteria for Early Discontinuation for the Individual Participant From the Study 
The participant will be discontinued from the study regardless of whether treatment is ongoing in 
the following instances:
•
Withdrawal of consent/assent
•
Death
3.3.2.
Criteria for Early Discontinuation of the Study
The study will be discontinued in the following instances:
•
Discontinuation of the study at the request of Gilead Sciences (Gilead) or a regulatory 
agency, institutional review board (IRB), or independent ethics committee (IEC).
3.3.3.
Loss to Follow-up
Should the participant fail to return to the investigational site for a scheduled protocol-specific 
visit, sites will need to make at least 3 attempts by a combination of telephone, email, or mail to 
contact the participant. Sites must document all attempts to contact the participant. If a 
participant does not respond within 5 days within the third contact, the participant will be 
considered lost to follow-up and no additional contact will be required. 
CCI
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1111 
1111 
1111 
1111 
1111 
1111 
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3.4.
Definitions for Time of Primary Endpoint and End of Study
3.4.1.
Primary Endpoint
The date for the last participant visit for the primary endpoint is the date of the last visit to 
perform assessments for the primary analysis.
3.4.2.
End of Study
The end of this study will be the last participant’s last observation (or visit).
3.5.
Source Data
The source data for this study will be obtained from original records (eg, clinic notes, hospital 
records, participant charts), central laboratory, local laboratory, and specialty laboratory (for PK 
data), participant (or caregiver)-reported outcomes, and Interactive Response Technology (IRT). 
Electronic data capture is not considered source data.


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4.
PARTICIPANT POPULATION
4.1.
Number of Participants and Participant Selection
At least 52 participants will be enrolled into the study including 12 evaluable participants per 
cohort from Cohorts 1-4 and a minimum of 4 evaluable participants from Cohort 5. Participants 
in Cohorts 6 and 7 will only be enrolled once ODV exposures have been evaluated from 
preceding cohort(s) and a dose has been determined. There is no minimum number of 
participants to be enrolled in Cohorts 6 and 7 due to the rarity of such participants.
4.1.1.
Participant Replacement
If necessary, and with Gilead approval, replacement participants may be enrolled if a participant 
is considered non-evaluable for primary safety and/or PK analysis (Sections 8.3.1.2 and 8.3.1.3). 
Replacement participants will not be enrolled for participants who discontinued the study due to 
a study drug-related AE.
4.2.
Inclusion Criteria
Participants must meet all of the following inclusion criteria to be eligible for participation in this 
study:
1) Participant or legal guardian willing and able to provide written informed consent prior to 
performing study procedures. Participants will provide assent, if possible, in accordance with 
local requirements and investigator’s discretion.
2) Aged < 18 years who meet one of the following weight criteria and gestational age (GA) 
criteria where applicable (where permitted according to local law and approved nationally 
and by relevant IRB or IEC):
a) Cohort 1: ≥ 6 years to < 18 years and weight ≥ 40 kg
b) Cohort 2: ≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kg
c) Cohort 3: ≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kg
d) Cohort 4: ≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kg
e) Cohort 5: ≥ 14 days to < 28 days of age, GA ≥ 37 weeks and weight ≥ 2.5 kg
f)
Cohort 6: 0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg
g) Cohort 7: 0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg
3) SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) or an alternative 
molecular diagnostic assay ≤ 5 days before screening.


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4) Initial onset of COVID-19 signs/symptoms ::; 5 days before screening with ~ 1 sign/symptom 
such as fever, cough, fatigue, shortness of breath, sore throat, headache, myalgia/aii hralgia 
present at screening. 
5) Presence of ~ 1 characteristic or underlying medical condition associated with an increased 
risk of developing severe illness due to COVID-19, including: 
a) 
b) -
c) 
d) 
e) 
f) 
g) 
h) 
i) 
4.3. 
Exclusion Criteria 
Paiiicipants who meet any of the following exclusion criteria ai·e not eligible to be enrolled in 
this study: 
1) Anticipated access to and use of authorized or approved COVID-19 therapies dming the 
cmTent COVID-19 illness < 5 days after screening (therapies including but not limited to 
ninnatrelvir/ritonavir, molnupiravir, intravenous RDV, monoclonal antibodies). 
2) Vaccination for SARS-CoV-2 or self-repo1i ed histo1y of SARS-CoV-2 infection < 4 months 
prior to screening. 
3) Received any approved, authorized, or investigational direct acting antiviral diug against 
SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is 
longer, before enrollment. 
4) 
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5) Any of the following abnonnal laborato1y results at screening: 
a) 
b) eGFR < 
c) 
Gestational age 
c::: 24 to 27 weeks 
c::: 28 to 29 weeks 
c::: 30 to < 32 weeks 
c::: 32 weeks 
* Creatinine values 
6) 
7) 
8) 
9) 
CONFIDENTIAL 
Chronological age 
Creatinine Value Cutoff in mg/dL 
0 to < 28 days 
-
0 to < 14 days 
-
0to <7 days 
-
c::: 7 days to I month 
1111 
c::: 1 to < 2 months 
1111 
c::: 2 months to < 1 year 
1111 
0to < 2days 
1111 
c::: 2to <7 days 
-
c::: 7 days to 2 months 
1111 
c::: 2 months to < 1 year 
1111 
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5.
STUDY INTERVENTIONS AND CONCOMITANT 
MEDICATIONS
5.1.
Enrollment, Blinding, and Treatment Code Access
5.1.1.
Enrollment
Participants who meet eligibility criteria will be enrolled to receive ODV starting on Day 1 and 
assigned a participant number. 
5.1.2.
Blinding
Blinding of treatment assignments or data will not be performed in this study. 
5.2.
Description and Handling of Obeldesivir 
5.2.1.
Formulation
The ODV tablets are available in strengths of 
. 
The ODV 
 strength tablets are capsule shaped, debossed with “GSI” on one side and a 
bisect on the other side, and film-coated white. In addition to the active ingredient, each 
film-coated tablet contains the following inactive ingredients: microcrystalline cellulose, 
crospovidone, magnesium stearate, macrogol polyvinyl alcohol graft copolymer, talc, titanium 
dioxide, glyceryl mono and dicaprylocaprate (glyceryl monocaprylocaprate type I), and 
polyvinyl alcohol. 
The ODV 
 strength tablets are oval shaped, debossed with “GSI” on one side and “5245” 
on the other side, and film-coated light yellow. In addition to the active ingredient, each film-
coated tablet contains the following inactive ingredients: microcrystalline cellulose, 
crospovidone, magnesium stearate, macrogol polyvinyl alcohol graft copolymer, talc, titanium 
dioxide, glyceryl mono and dicaprylocaprate (glyceryl monocaprylocaprate type I), polyvinyl 
alcohol, and yellow iron oxide.
5.2.2.
Packaging and Labeling 
The ODV tablets, 
, are packaged in white, high-density polyethylene bottles. 
Each bottle contains 10 tablets and polyester packing material. Each bottle is enclosed with a 
white, continuous thread, child-resistant polypropylene screw cap with an induction-sealed and 
aluminum-faced liner.
Study drugs to be distributed to participating centers shall be labeled to meet applicable 
requirements of the US Food and Drug Administration (FDA), the EU Guideline to Good 
Manufacturing Practice - Annex 13 (Investigational Medicinal Products), or Annex 6 for CTR, 
the Japan-GCP (Ministerial Ordinance on GCP for Drugs), as applicable, and/or other local 
regulations, as applicable. 
CCI
CCI
CCI
CCI
-
-


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5.2.3.
Storage and Handling
ODV tablets, 
, should be stored below 30 °C (86 °F). Storage conditions are 
specified on the label. Until dispensed to the participants, all bottles of study drugs should be 
stored in a securely locked area, accessible only to authorized site personnel. 
To ensure the stability and proper identification, study drugs should not be stored in a container 
other than the container in which they were supplied. Keep the bottle tightly closed to protect 
from moisture.
Consideration should be given to handling, preparation, and disposal through measures that 
minimize drug contact with the body. Appropriate precautions should be followed to avoid direct 
eye contact or exposure when handling.
5.3.
Prior and Concomitant Medications
5.3.1.
Prior and Concomitant Medications That Are Prohibited or Used With 
Caution
Medications in Table 4 are prohibited or to be used with caution while participants are taking 
study drugs. In instances where a prohibited medication is initiated before discussion with the 
Gilead medical monitor, the investigator must notify Gilead as soon as he/she is aware of the use 
of the prohibited medication.
There are no restrictions on the symptomatic treatment of COVID-19 other than those indicated 
in Table 4. There are no restrictions on concomitant medications based on potential for PK DDI 
with ODV.
Table 4.
Prior and Concomitant Medications That Are to Be Used With 
Caution or That Are Prohibited Because of Impact on Efficacy 
Assessments or Participant Safety
Medication Class
Medications to Be Used With Caution 
Prohibited Medicationsa
COVID-19 medications
—
RDV, molnupiravir, 
nirmatrelvir/ritonavir, monoclonal 
antibodies against COVID-19
COVID-19 = coronavirus disease 2019; RDV = remdesivir
a
Concomitantly with ODV. 
5.4.
Dosage and Administration 
Participants aged ≥ 6 years to < 18 years and weighing ≥ 40 kg will receive ODV 
 
administered orally BID for 5 days. 
Participants aged ≥ 6 years to < 18 years and weighing ≥ 20 kg to < 40 kg will receive ODV 
 administered orally BID for 5 days.
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The doses should be taken approximately 12 hours apart.
Obeldesivir may be administered with or without food.
Participant to withhold their dose prior to arriving to the site on Day 5, as the dose will be 
administered at the site.
For participants aged < 6 years and weighing < 20 kg, dose will be informed by PK modeling 
(Section 1.4), and an age appropriate formulation will be developed and additional information 
will be provided in a protocol amendment.
5.5.
Accountability for Study Drugs 
The investigator is responsible for ensuring adequate accountability of all used and unused study 
drug bottles. This includes acknowledgment of receipt of each shipment of study drug (quantity 
and condition). All used and unused study drug bottles dispensed to participants must be returned 
to the site.
Each investigational site must keep accountability records that capture:
•
The date received, quantity, and condition of study drug bottles
•
The date, participant number, and the quantity of study drug bottles dispensed
•
The date, quantity of used and unused study drug bottles returned, along with the initials of 
the person recording the information
5.5.1.
Study Drug Return or Disposal
Gilead recommends that used and unused study drugs, which includes bottles, be destroyed at the 
site. If the site has an appropriate standard operating procedure for drug destruction as 
determined by Gilead, the site may destroy used (empty or partially empty) and unused study 
drug bottles in accordance with that site’s approved procedural documents. A copy of the site’s 
approved procedural document will be obtained for the electronic trial master file. If the study 
drug is destroyed at the site, the investigator must maintain accurate records for all study drugs 
destroyed. Records must show the identification and quantity of each unit destroyed, the method 
of destruction, and the person who disposed of the study drugs. Upon study completion, copies 
of the study drug accountability records must be filed at the site. Another copy will be provided 
to Gilead. 
If the site does not have an appropriate standard operating procedure for study drug destruction, 
used and unused study drugs are to be sent to the designated disposal facility for destruction. The 
study monitor will provide instructions for return.
The study monitor will review study drug supplies and associated records at periodic intervals.


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6.
STUDY PROCEDURES
The study procedures to be conducted for each participant screened or enrolled in the study are 
presented in tabular form in Table 1 and described in the sections below. 
The investigator must document any deviation from the protocol procedures and notify Gilead or 
the contract research organization.
6.1.
Informed Consent
Each participant and/or participant’s parent or legal guardian must sign an informed consent 
form (ICF) or assent form, as required by IRB/IEC/local or national requirements, prior to the 
conduct of any screening procedures. 
6.2.
Screening, Participant Enrollment, and Treatment Assignment
Participants will be screened within 48 hours before enrollment in the study. Each participant 
will be assigned a unique screening number using an IRT. Participants meeting all of the 
inclusion criteria and none of the exclusion criteria will return to the investigational site within 
48 hours for enrollment into the study. Screening and enrollment can occur on the same day, 
where possible.
Entry into screening does not guarantee enrollment into the study. In order to manage the total 
study enrollment, Gilead, at its sole discretion, may suspend screening and/or enrollment at any 
site or study wide at any time.
Once written informed consent/assent has been obtained, all screening and admission tests and 
assessments have been assessed (including recording the date of the latest COVID-19 
vaccination shot or booster), and study eligibility has been confirmed, participants will be 
enrolled to receive ODV on Day 1.
Participants will receive ODV as described in Section 5.4.
6.3.
Instructions for Study Procedures
An in-person visit will occur either at a medical facility or as a remote visit at home by a health 
care professional (where permitted).
6.3.1.
Adverse Events
From the time informed consent/assent is obtained through the first administration of study drug, 
record all SAEs, as well as any AEs related to protocol-required procedures, on the AE 
electronic case report form (eCRF). All other untoward medical occurrences observed during the 
screening period, including exacerbation or changes in medical history, are to be considered 
medical history. After study drug administration, report all AEs and SAEs. See Section 7 for 
additional details.


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6.3.2.
Safety Assessments
Safety will be evaluated throughout the study. Refer to Table 1 for schedule of assessments.
6.3.2.1.
Physical Examination
Physical examinations conducted throughout the study during in-person visits will be a complete 
physical examination or a symptom-driven physical examination, as outlined in Table 1. A 
physical examination will only be conducted by a qualified health care professional.
A complete physical examination includes source documentation of general appearance and the 
following body systems: head, neck, and thyroid; eyes, ears, nose, throat, mouth, and tongue; 
chest (excluding breasts); respiratory; cardiovascular; lymph nodes, abdomen; skin, hair, nails; 
musculoskeletal; and neurological. Urogenital and reproductive examination should only be 
completed if clinically indicated.
The complete physical examination conducted at screening will also include the following 
assessments:
•
Review medical history, including the date of first COVID-19 symptoms, overall COVID-19 
symptoms, demographics, baseline characteristics, allergies, COVID-19 vaccination, and all 
other medical history.
6.3.2.2.
Vital Signs
Refer to Table 1 for vital signs collection time points. Vital signs will be collected at in-person 
visits only.
Vital sign measurements include heart rate, temperature, blood pressure (mean arterial pressure if 
available, systolic and diastolic), respiratory rate, and oxygen saturation. 
6.3.2.3.
Concomitant Medications
Refer to Table 1 for concomitant medications assessment time points and Section 5.3 for more 
information about concomitant medications. 
6.3.2.4.
Clinical Laboratory Assessments
Refer to Table 1 for clinical laboratory assessment time points.
Following laboratory assessments will be performed:
•
Hematology: Complete blood count (CBC) with differential
•
Comprehensive metabolite panel (Chemistry 14): ALT, albumin, alkaline phosphatase, 
aspartate aminotransferase (AST), total bilirubin (and neonatal bilirubin for participants aged 
<14 days and participants presenting with jaundice), blood urea nitrogen and creatinine 


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(include BUN:Cr ratio, and eGFR using bedside Schwarz formula if ≥ 1 year of age), ionized 
calcium, carbon dioxide, chloride, total serum protein, potassium, sodium
•
Urinalysis
The smallest possible blood vials, such as microtainer tubes, must be used for participants 
weighing < 15 kg. 
Clinical laboratory assessments at other days may be conducted if required by clinical need or 
local practice. The results of all clinical laboratory tests that are performed as part of clinical 
care, even if not required by the protocol, should be reported.
6.3.2.5.
Age-Specific Assessments
Refer to Table 1 for timing of the following age-specific assessments:
•
Length and head circumference for participants < 28 days of age
•
Apgar score assessment for participants < 24 hours of age
•
Birth weight for participants < 56 days of age
•
GA assessment for participants < 1 year of age
•
Tanner stage assessment (Appendix 11.5) for participants ≥ 6 years of age. Date of first 
menses will be documented.
•
Neonatal bilirubin panel for participants < 14 days of age
6.3.2.6.
Pregnancy Tests
Urine pregnancy tests will be conducted only for female participants of childbearing potential. 
Refer to Appendix 11.4 for participants of childbearing potential.
6.3.3.
Hospitalization Details
Following information will be collected for hospitalized participants:
•
hospitalization date
•
reason for hospitalization
•
discharge date
•
discharge outcome


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6.3.4. 
Oxygenation/Oxygen Supplementation 
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Oxygenation/oxygen supplementation infonnation will be collected for hospitalized participants. 
The following infonnation need to be collected: 
• 
Oxygen supplementation: 
-
room air (no 0 2 supplementation) 
-
low-flow 02 (L/min and%) 
-
high-flow 02 (L/min and%) 
-
continuous positive ai1way pressure/bilevel positive aiiway pressure (fraction of inspii·ed 
oxygen [Fi02] or%) 
-
high-frequency oscillating ventilation (Fi02 or %) 
-
mechanical ventilation (Fi02 or % ) 
-
extracorporeal membrane oxygenation 
• 
Oxygenation: 
-
peripheral oxygen saturation or partial pressure of oxygen 
6.3.5. 
Pharmacokinetics 
As many of the specific PK samples should be obtained from each paiticipant as is feasible. 
• 
Coho1ts 1-2: samples collected on 
-
Day 3: 1 sample between 
-
Day 5: 
postdose 
postdose for hospitalized participants only 
The PK sainple collection tiinepoints for Coho1ts 3-7 will be provided in a protocol amendment. 
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6.3.6.
Clinical Virology
6.3.6.1.
Virology Testing
6.3.6.1.1.
Virology Samples to Address the Study Objectives
Midturbinate nasal swab samples will be used to assess SARS-CoV-2 viral load by reverse 
transcription-quantitative PCR at the time points specified in Table 1. Once viral load testing is 
complete, the remnant samples may be used to evaluate SARS-CoV-2 viral titer, emergence of 
viral resistance (by SARS-CoV-2 sequencing and/or phenotypic testing), and viral coinfection. 
6.3.6.1.2.
Virology Sample Storage
Any remaining specimens from midturbinate nasal swab samples collected during the study will 
be stored and retained for possible future virology-related testing. These stored samples may be 
used by the sponsor or its research partners for viral genotyping/phenotyping assays or their 
development, for retesting the amount of virus present in the sample, or for testing to learn more 
about how the study drug has worked or clinical laboratory testing to provide additional safety 
data. At the conclusion of this study, these samples may be retained in storage by Gilead for a 
period up to 15 years or per country requirements.
6.3.7.
Participant Symptom Assessment
Participant and/or parent/caregiver will complete participant symptom assessment daily from 
Day 1 through Day 14 and at Days 21, 28, and 35 via a symptom score questionnaire.
The questionnaire will consist of severity (on 4- or 5-point scale, as applicable) of select 
symptoms (listed below), frequency of select symptoms (diarrhea and vomiting) in 24 hours 
before the assessment, and smell and taste assessment. 
The select symptoms for severity assessment on 4- or 5-point scale will include:
•
Stuffy or runny nose
•
Sore throat
•
Shortness of breath
•
Cough
•
Low energy or tiredness
•
Muscle or body aches
•
Headache
•
Chills or shivering


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•
Feeling hot or feverish
•
Nausea
6.3.7.1.
Procedures to Minimize Missing Symptom Data
To minimize missing symptom data, following steps are put in place to help participants remain 
compliant with questionnaire completion per protocol required time points:
•
Participants may receive reminders/notifications on stipulated days (Table 1) to complete 
questionnaire.
•
Site staff and the study monitor will review symptom questionnaire data completion reports 
to monitor compliance.
•
Site staff will contact participants and/or parent/caregiver regarding missing data (or their 
close contact in case of nonresponse, where feasible).
•
Participants and/or parent/caregiver may be provided with a Value Sheet (if available) to 
highlight the significance of symptom questionnaire data and importance of participant 
compliance for the purpose of this study.
6.3.8.
Assessment of Palatability and Acceptability
To assess palatability and acceptability of study drug, the participant or parent/caregiver will rate 
acceptability and palatability of the applicable formulation using a 5-point facial recognition 
scale.
Parent/caregiver may answer additional questions regarding preparation and dosing of the 
age-appropriate formulation.
6.4.
Assessments for Early Discontinuation From Study Intervention or From the 
Study 
6.4.1.
Assessments for Early Discontinuation From Study Intervention
If a participant discontinues study dosing prematurely (eg, as a result of an AE), every attempt 
should be made to keep the participant in the study and continue to perform the required 
study-related follow-up and procedures (see Section 3.3). If this is not possible or acceptable to 
the participant or investigator, the participant may be withdrawn from the study.
6.4.2.
Assessments for End of Study
A participant who completes the study undergo end of study visit as specified in Table 1. 


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6.5.
Poststudy Care
The long-term care of the participant will remain the responsibility of their primary treating 
physician. There is no provision for poststudy availability. 
6.6.
Sample Storage
The stored biological samples may be used by Gilead or its research partner for additional testing 
to provide supplemental data to answer questions that relate to the main study. At the end of this 
study, these samples may be retained in storage by Gilead for a period up to 15 years or per 
country requirements. 


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7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT
7.1.
Definitions of Adverse Events and Serious Adverse Events
7.1.1.
Adverse Events
An AE is any untoward medical occurrence in a clinical study participant administered a study 
drug that does not necessarily have a causal relationship with the treatment. An AE can therefore 
be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the 
use of a study drug, whether or not the AE is considered related to the study drug. Adverse 
events may also include pretreatment or posttreatment complications that occur as a result of 
protocol-specified procedures or special situations (Section 7.1.3). 
An AE does not include the following:
•
Medical or surgical procedures such as surgery, endoscopy, tooth extraction, or transfusion. 
The condition that led to the procedure may be an AE and must be reported.
•
Preexisting diseases, conditions, or laboratory abnormalities present or detected before the 
screening visit that do not worsen.
•
Situations where an untoward medical occurrence has not occurred (eg, hospitalization for 
elective surgery, social and/or convenience admissions).
•
Overdose without clinical sequelae (Section 7.1.3).
•
Any medical condition or clinically significant laboratory abnormality with an onset date 
before the ICF is signed and not related to a protocol-associated procedure is not an AE but 
rather considered to be preexisting and should be documented as medical history.
Preexisting events that increase in severity or change in nature after study drug initiation or 
during or as a consequence of participation in the clinical study will also be considered AEs.
7.1.2.
Serious Adverse Events
An SAE is defined as an event that, at any dose, results in the following:
•
Death.
•
A life-threatening situation (Note: The term “life-threatening” in the definition of “serious” 
refers to an event in which the participant was at risk of death at the time of the event; it does 
not refer to an event that hypothetically might have caused death if it were more severe.)
•
In-patient hospitalization or prolongation of existing hospitalization.


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•
Persistent or significant disability/incapacity.
•
A congenital anomaly/birth defect.
•
A medically important event or reaction: Such events may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the participant or may 
require intervention to prevent 1 of the other outcomes constituting SAEs. Medical and 
scientific judgment must be exercised to determine whether such an event is reportable under 
expedited reporting rules. Examples of medically important events include intensive 
treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or 
convulsions that do not result in hospitalization; and development of drug dependency or 
drug abuse. 
7.1.3.
Study Drugs and Gilead Concomitant Medications Special Situations 
Reports
Special situations reports (SSRs) include all reports of medication error, abuse, misuse, overdose, 
occupational exposure, drug interactions, exposure via breastfeeding, unexpected benefit, 
transmission of infectious agents via the product, counterfeit of falsified medicine, and 
pregnancy regardless of an associated AE. 
Medication error is any unintentional error in the prescribing, dispensing, preparation for 
administration or administration of a study drug while the medication is in the control of a health 
care professional, participant, or consumer. Medication errors may be classified as a medication 
error without an AE, which includes situations of missed dose, medication error with an AE, 
intercepted medication error, or potential medication error.
Abuse is defined as persistent or sporadic intentional excessive use of a study drug by a 
participant.
Misuse is defined as any intentional and inappropriate use of a study drug that is not in 
accordance with the protocol instructions or the local prescribing information.
An overdose is defined as an accidental or intentional administration of a quantity of a study 
drug given per administration or cumulatively that is above the maximum recommended dose as 
per protocol or in the product labeling (as it applies to the daily dose of the participant in 
question). In cases of a discrepancy in drug accountability, overdose will be established only 
when it is clear that the participant has taken the excess dose(s). Overdose cannot be established 
when the participant cannot account for the discrepancy, except in cases in which the 
investigator has reason to suspect that the participant has taken the additional dose(s).
Occupational exposure is defined as exposure to a study drug as a result of one’s professional or 
nonprofessional occupation.
Drug interaction is defined as any drug/drug, drug/food, drug/alcohol, or drug/device interaction.


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Unexpected benefit is defined as an unintended therapeutic effect where the results are judged to 
be desirable and beneficial. 
Transmission of infectious agents is defined as any suspected transmission of an infected agent 
through a Gilead study drug.
Counterfeit or falsified medicine is defined as any study drug with a false representation of (a) its 
identity, (b) its source, or (c) its history.
7.2.
Assessment of Adverse Events and Serious Adverse Events
The investigator or qualified subinvestigator is responsible for assessing AEs and SAEs for 
causality and severity, and for final review and confirmation of accuracy of event information 
and assessments.
7.2.1.
Assessment of Causality for Study Drugs and Procedures
The investigator or qualified subinvestigator is responsible for assessing the relationship for each 
study drug using clinical judgment and the following considerations:
•
No: Evidence exists that the AE has an etiology other than the study drug. For SAEs, an 
alternative causality must be provided (eg, preexisting condition, underlying disease, 
intercurrent illness, concomitant medication).
•
Yes: There is reasonable possibility that the AE may have been caused by the study drug.
It should be emphasized that ineffective treatment should not be considered as causally related in 
the context of AE reporting. 
The relationship to study procedures (eg, invasive procedures such as venipuncture or biopsy) 
should be assessed using the following considerations:
•
No: Evidence exists that the AE has an etiology other than the study procedure.
•
Yes: The AE occurred as a result of protocol procedures (eg, venipuncture).
7.2.2.
Assessment of Severity 
The severity of AEs will be graded using the Division of AIDS (DAIDS) Table for Grading the 
Severity of Adult and Pediatric Adverse Events Toxicity Grading Scale, Version 2.1 (corrected, 
July 2017). For each episode, the highest grade attained should be reported as defined in the 
Toxicity Grading Scale. The DAIDS scale is available at:
https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf 


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7.3.
Investigator Reporting Requirements and Instructions 
7.3.1.
Requirements for Collection Before Study Drug Initiation
After informed consent, but before initiation of study drug, the following types of events must be 
reported on the applicable eCRFs: all SAEs and any AEs that are related to protocol-required 
procedures.
7.3.2.
Adverse Events
Following initiation of study drug, collect all AEs, regardless of cause or relationship, until 
30 days after last administration of study drug and report the AEs on the eCRFs as instructed.
All AEs and clinically significant laboratory abnormalities should be followed until resolution or 
until the AE is stable, if possible. Gilead may request that certain AEs be followed beyond the 
protocol-defined follow-up period.
7.3.3.
Serious Adverse Events
All SAEs, regardless of cause or relationship, that occur after the participant first consents to 
participate in the study (ie, signing the ICF) and throughout the duration of the study, including 
the posttreatment follow-up visit, must be reported on the applicable eCRFs and to Gilead 
Patient Safety as instructed below in this section. This also includes any SAEs resulting from 
protocol-associated procedures performed after the ICF is signed.
Any SAEs and deaths that occur after the posttreatment follow-up visit but within 30 days of the 
last dose of study drug, regardless of causality, should also be reported. 
Investigators are not obligated to actively seek SAEs after the protocol-defined follow-up period; 
however, if the investigator learns of any SAEs that occur after the protocol-defined follow-up 
period has concluded and the event is deemed relevant to the use of study drug, the investigator 
should promptly document and report the event to Gilead Patient Safety.
Instructions for reporting SAEs are described in Section 7.4.1.
7.3.4.
Study Drug Special Situations Reports
All study drug SSRs that occur from study drug initiation and throughout the duration of the 
study, including the posttreatment follow-up visit, must be reported to Gilead Patient Safety 
(Section 7.4.2). Adverse events and SAEs resulting from SSRs must be reported in accordance 
with the AE and SAE reporting guidance (Section 7.3).


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7.3.5.
Concomitant Medications Reports
7.3.5.1.
Gilead Concomitant Medications Special Situations Report
Special situations reports involving a Gilead concomitant medication (not considered study 
drug), that occur after the participant first consents to participate in the study (ie, signing of the 
ICF) and throughout the duration of the study, including the posttreatment follow-up visit, must 
be reported to Gilead Patient Safety utilizing the paper SSR (Section 7.4.2.2).
7.3.5.2.
Non-Gilead Concomitant Medications Report
Special situations involving non-Gilead concomitant medications do not need to be reported on 
the SSR form; however, for special situations that result in AEs because of a non-Gilead 
concomitant medication, the AE should be reported on the AE eCRF. 
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
All clinical sequelae in relation to these SSRs will be reported as AEs or SAEs at the same time 
using the AE eCRF and/or the SAE eCRF. Details of the symptoms and signs, clinical 
management, and outcome will be reported, when available.
7.4.
Reporting Process for Serious Adverse Events and Special Situations Reports
7.4.1.
Serious Adverse Event Reporting Process
For fatal or life-threatening events, copies of hospital case reports, autopsy reports, and other 
documents are also to be transmitted by email or fax when requested and applicable. 
Transmission of such documents should occur without personal participant identification, 
maintaining the traceability of a document to the participant identifiers.
Additional information may be requested to ensure the timely completion of accurate safety 
reports.
Any medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the participant’s eCRF and the SAE narrative section of the Safety Report 
Form eCRF.
7.4.1.1.
Electronic Serious Adverse Event Reporting Process 
Site personnel will record all SAE data on the applicable eCRFs and from there transmit the SAE 
information to Gilead Patient Safety within 24 hours of the investigator’s knowledge of the event 
from the time of the ICF signature throughout the duration of the study, including the 
protocol-required posttreatment follow-up period. 


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If for any reason it is not possible to record and transmit the SAE information electronically, 
record the SAE on the paper SAE reporting form and transmit within 24 hours to:
Gilead Patient Safety
Email: 
or
Fax: 
If an SAE has been reported via a paper form because the eCRF database has been locked, no 
further action is necessary. If the database is not locked, any SAE reported via paper must be 
transcribed as soon as possible on the applicable eCRFs and transmitted to Gilead Patient Safety.
7.4.2.
Special Situations Reporting Process 
7.4.2.1.
Electronic Special Situations Reporting Process for Study Drug
Site personnel will record all SSR data on the applicable eCRFs and from there transmit the SSR 
information within 24 hours of the investigator’s knowledge to Gilead Patient Safety from study 
drug initiation throughout the duration of the study, including the protocol-required 
posttreatment follow-up period. 
If for any reason it is not possible to record and transmit the SSR information electronically, 
record the SSR on the paper SSR form and transmit within 24 hours to:
Gilead Patient Safety
Email: 
 
or
Fax: 
If an SSR has been reported via a paper form because the eCRF database has been locked, no 
further action is necessary. If the database is not locked, any SSR reported via paper must be 
transcribed as soon as possible on the applicable eCRFs and transmitted to Gilead Patient Safety. 
See Section 7.4.2.2 for instructions on reporting special situations with Gilead concomitant 
medications. 
PPD
PPD
PPD
PPD


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7.4.2.2.
Reporting Process for Gilead Concomitant Medications
Special situations that involve Gilead concomitant medications that are not considered study 
drug must be reported within 24 hours of the investigator’s knowledge of the event to Gilead 
Patient Safety utilizing the paper SSR form and transmitted to:
Gilead Patient Safety 
Email: 
or
Fax: 
 
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
Special situations involving non-Gilead concomitant medications do not need to be reported on 
the SSR form; however, special situations that result in AEs because of a non-Gilead 
concomitant medication, must be reported on the AE eCRF.
7.4.2.3.
Pregnancy Reporting Process
The investigator should report pregnancies identified after initiation of study drug to 30 days 
after the last study dose in participants and/or pregnancies in partner resulting from exposure to 
sperm from a participant in study period in which contraceptive measures are needed. 
Pregnancies should be reported to Gilead Patient Safety within 24 hours of becoming aware of 
the pregnancy using the pregnancy report form. Contact details for transmitting the pregnancy 
report form are as follows:
Gilead Patient Safety 
Email:
or
Fax: 
The pregnancy itself is not considered an AE, nor is an induced elective abortion to terminate a 
pregnancy without medical reasons.
All other premature terminations of pregnancy (eg, a spontaneous abortion, an induced 
therapeutic abortion because of complications or other medical reasons) must be reported within 
24 hours as an SAE, as described in Section 7.4.1. The underlying medical reason for this 
procedure should be recorded as the AE term.
A spontaneous abortion is always considered to be an SAE and will be reported as described in 
Section 7.4.1. Furthermore, any SAE occurring as an adverse pregnancy outcome after the study 
must be reported to the Gilead Patient Safety.
PPD
PPD
PPD
PPD


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The participant should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome of the pregnancy/partner pregnancy should be reported to Gilead 
Patient Safety using the pregnancy outcome report form. If the end of the pregnancy/partner 
pregnancy occurs after the study has been completed, the outcome should be reported directly to 
Gilead Patient Safety. Gilead Patient Safety contact information is as follows: email: 
Safety_FC@gilead.com and fax: +1 (650) 522-5477. 
Refer to Appendix 11.4 for Pregnancy Precautions, Definition for Childbearing Potential, and 
Contraceptive Requirements.
7.5.
Gilead Reporting Requirements
Depending on relevant local legislation or regulations, including the applicable US FDA Code of 
Federal Regulations, the EU Regulation 536/2014 and relevant updates, and other 
country-specific legislation or regulations, Gilead may be required to expedite to worldwide 
regulatory agencies reports of SAEs, which may be in the form of line listings, serious adverse 
drug reactions, or suspected unexpected serious adverse reactions. In accordance with the EU 
Regulation 536/2014, Gilead or a specified designee will notify worldwide regulatory agencies 
and the relevant IEC in concerned Member States of applicable suspected unexpected serious 
adverse reactions as outlined in current regulations.
Assessment of expectedness for SAEs will be determined by Gilead using reference safety 
information specified in the IB or relevant local label as applicable. 
All investigators will receive a safety letter notifying them of relevant suspected unexpected 
serious adverse reaction reports associated with any study drug. The investigator should notify 
the IRB or IEC of suspected unexpected serious adverse reaction reports as soon as is practical, 
where this is required by local regulatory agencies, and in accordance with the local institutional 
policy.
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities without clinical significance are not to be recorded as AEs or SAEs. 
However, laboratory abnormalities (eg, clinical chemistry, hematology, urinalysis) that require 
medical or surgical intervention or lead to study drug interruption, modification, or 
discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, vital signs) that are associated with signs and/or 
symptoms must be recorded as an AE or SAE if they meet the definition of an AE or SAE as 
described in Sections 7.1.1 and 7.1.2. If the laboratory abnormality is part of a syndrome, record 
the syndrome or diagnosis (eg, anemia), not the laboratory result (ie, decreased hemoglobin).


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Severity should be recorded and graded according to the DAIDS for Grading the Severity of 
Adult and Pediatric Adverse Events, Version 2.1 (corrected, July 2017). For AEs associated with 
laboratory abnormalities, the event should be graded on the basis of the clinical severity in the 
context of the underlying conditions; this may or may not be in agreement with the grading of 
the laboratory abnormality.
The DAIDS scale is available at:
https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf
7.7.
Toxicity Management 
7.7.1.
Obeldesivir
All clinical and clinically significant laboratory toxicities will be managed according to the 
guidelines described below.
The Gilead medical monitor should be consulted prior to study drug discontinuation when 
medically feasible. Before discontinuation of study drug for AEs or laboratory abnormalities, an 
assessment of the participant’s medical situation should be made by the investigator.
7.7.1.1.
Laboratory Events Meeting Discontinuation Criteria
Laboratory events meeting discontinuation criteria are discussed in Section 3.3.1.1.
7.7.1.2.
Grades 1 and 2 Laboratory Abnormality or Clinical Event
Continue study drug at the discretion of the investigator.
7.7.1.3.
Grade 3 Laboratory Abnormality or Clinical Event
For a Grade 3 clinically significant laboratory abnormality or clinical event, study drug may be 
continued if the event is considered to be unrelated to study drug.
For a Grade 3 clinically significant laboratory abnormality or clinical event, confirmed by repeat 
testing, that is considered to be related to study drug, the participant will be discontinued from 
study drug. The participant should be managed according to local practice. 
Additionally, participants who have an eGFR < 50 mL/min/1.73 m2 by Bedside Schwartz 
formula will be discontinued from study drug whether considered related to the study drug or not 
(refer to Section 3.3.1.1).
Recurrence of laboratory abnormalities considered unrelated to study drug may not require 
permanent discontinuation but requires discussion with the Gilead medical monitor.


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7.7.1.4.
Grade 4 Laboratory Abnormality or Clinical Event
For a Grade 4 clinically significant laboratory abnormality or clinical event, confirmed by repeat 
testing, that is considered to be related to study drug, the participant will be discontinued from 
study drug. The participant should be managed according to local practice. The participant 
should be followed as clinically indicated until the laboratory abnormality returns to baseline or 
is otherwise explained, whichever occurs first. A clinically significant Grade 4 laboratory 
abnormality that is not confirmed by repeat testing should be managed according to the 
algorithm for the new toxicity grade.
Study drug may be continued without dose interruption for a clinically nonsignificant Grade 4 
laboratory abnormality (eg, Grade 4 creatine kinase elevation after strenuous exercise or 
triglyceride elevation that is nonfasting or that can be medically managed) or a clinical event 
considered unrelated to study drug.
Treatment-emergent toxicities will be noted by the investigator and brought to the attention of 
the Gilead medical monitor, and the appropriate course of action will be discussed and decided. 
Whether or not considered treatment-related, all participants experiencing AEs must be 
monitored periodically until symptoms subside, any abnormal laboratory values have resolved or 
returned to baseline levels or they are considered irreversible, or until there is a satisfactory 
explanation for the changes observed.
Any questions regarding toxicity management should be directed to the Gilead medical monitor.


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8.
STATISTICAL CONSIDERATIONS
Details of the statistical methods will be provided in the statistical analysis plan (SAP), including 
any deviations from the original statistical analyses planned.
8.1.
Analysis Objectives and Endpoints
Objectives and endpoints are listed in Section 2. 
8.1.1.
Secondary Endpoints
Additional information on the secondary endpoints listed in Section 2 is provided below.
•
Time (days) to sustained alleviation of targeted COVID-19 symptoms by Day 35 
This secondary efficacy endpoint will be assessed via the participant symptom assessment. 
Symptom alleviation is defined as follows: all targeted symptoms scored moderate or severe at 
baseline are scored as mild or none for at least 48 consecutive hours, and all targeted symptoms 
scored mild or none at baseline are scored as none for at least 48 consecutive hours; the first day 
of the 48 consecutive hours will be considered the symptom alleviation date. Details of the 
COVID-19 symptoms to be assessed are provided in Section 6.3.7.
8.2.
Planned Analyses
8.2.1.
Interim Analysis
Before the final analysis, interim analyses may be conducted and the analyses may be submitted 
to regulatory agencies to seek guidance for the overall clinical development program or to 
request extension of indication to include the applicable age/weight band(s).
8.2.1.1.
Planned Internal Analysis
For the purpose of assessing the dosing regimen, interim analyses of relevant safety and PK data 
will be conducted by Gilead. Further details will be provided in the safety review team (SRT) 
charter.
8.2.1.2.
Data Monitoring Committee Analysis
An external DMC will review the progress of the study and perform interim review(s) of safety 
and available PK data. The DMC membership, activities, and meeting schedule will be defined 
in a DMC charter.


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8.2.2.
Final Analysis
The final analysis will be performed after all participants have completed the study, outstanding 
data queries have been resolved or adjudicated as unresolvable, and the data have been cleaned 
and finalized. 
8.3.
Analysis Conventions
8.3.1.
Analysis Sets
8.3.1.1.
Efficacy
The primary analysis set for efficacy analyses is defined as the Full Analysis Set (FAS). This 
will include all participants who (1) are enrolled into the study and (2) have received at least 
1 dose of study drug.
8.3.1.2.
Safety
The primary analysis set for safety analyses is defined as the Safety Analysis Set. This will 
include all participants who (1) are enrolled into the study and (2) have received at least 1 dose 
of study drug.
All data collected during treatment plus 30 days will be included in the safety summaries.
8.3.1.3.
Pharmacokinetics
The PK Analysis Set will include all participants who (1) are enrolled into the study, (2) have 
received at least 1 dose of study drug, and (3) have at least 1 nonmissing PK concentration datum 
reported by the PK laboratory for GS-441524.
8.3.1.4.
Virology
The Virology Analysis Set will include all participants who (1) are enrolled into the study, 
(2) have at least 1 dose of study drug, and (3) have positive SARS-CoV-2 viral load at baseline.
8.3.2.
Data Handling Conventions
Natural logarithm transformation for PK parameters will be applied for PK analysis.
For summary statistics, PK concentration values below the limit of quantitation will be treated as 
zero at predose and one-half of the lower limit of quantitation (LLOQ) for postdose time points. 
Laboratory data that are continuous in nature but are less than the LLOQ or above the upper limit 
of quantitation, will be imputed to the value of the lower or upper limit plus or minus 
1 significant digit, respectively (eg, if the result of a continuous laboratory test is < 20, a value of 
19 will be assigned).


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Missing data can have an impact upon the interpretation of the study data. In general, values for 
missing data will not be imputed. However, a missing pretreatment laboratory result would be 
treated as normal (ie, no toxicity grade) for the laboratory abnormality summary.
All available data for participants that do not complete the study will be included in data listings.
8.4.
Demographic and Baseline Characteristics Analysis
Demographic and baseline measurements will be summarized using standard descriptive 
methods. 
Demographic summaries will include sex, race/ethnicity, and age. Baseline data will include a 
summary of weight, height, and body mass index.
No formal statistical testing is planned.
8.5.
Efficacy Analysis
For all efficacy analyses, the FAS will be used, unless specified otherwise. No formal statistical 
testing is planned.
8.5.1.
Primary Analysis
There is no primary efficacy analysis for this study; all efficacy endpoints are either secondary or 
exploratory.
8.5.2.
Secondary Analyses
The time to sustained alleviation of targeted COVID-19 symptoms by Day 35 is calculated as the 
symptom alleviation date minus the first dose date plus 1 day. In case, prior to data cutoff a 
participant:
•
Completes the study without alleviation of targeted COVID-19 symptoms
•
Discontinues from the study early prior to alleviation of targeted COVID-19 symptoms (due 
to AE, lack of efficacy, investigator's discretion, noncompliance with study drug, protocol 
violation, participant decision, lost to follow-up)
The time to sustained alleviation of targeted COVID-19 symptoms will be calculated as the last 
date on which the symptom alleviation is assessed by Day 35 minus the first dose date plus 1 day 
or Day 34, whichever occurs first.
In addition, if prior to data cutoff a participant: 
•
Dies from any cause prior to alleviation of targeted COVID-19 symptoms
•
Takes rescue medication prior to alleviation of targeted COVID-19 symptoms


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he/she will be regarded as not having the event of interest and will be censored at Day 34. 
The timing to sustained alleviation of targeted COVID-19 symptoms will be estimated by cohort 
and overall using the Kaplan-Meier (KM) method. The median time to sustained alleviation of 
targeted COVID-19 symptoms along with the 95% CI will be presented. The proportion of 
participants with sustained alleviation of targeted COVID-19 symptoms using KM estimates will 
be provided in summary tables and plots by cohort and overall.
For continuous variables, data and change from baseline at all scheduled time points will be 
summarized by cohort and overall. For categorical variables, the number and percentage of 
participants in each category within a variable will be presented by cohort and overall.
8.6.
Safety Analysis
All safety data collected on or after the date that study drug was first dispensed up to the date of 
last dose of study drug plus 30 days will be summarized for the Safety Analysis Set by cohort 
and overall. Data for the pretreatment period and after date of last dose of study drug plus 
30 days will be included in data listings. 
Descriptive summaries will be provided for the primary safety endpoints of incidence of 
treatment-emergent AEs and treatment-emergent laboratory abnormalities. No formal statistical 
testing is planned.
8.6.1.
Extent of Exposure
A participant’s extent of exposure to study drug data will be generated from the study drug 
administration data. Exposure data will be summarized by cohort and overall. 
8.6.2.
Adverse Events
Clinical and laboratory AEs will be coded using the current version of the MedDRA. System 
organ class, high-level group term, high-level term, preferred term, and lower-level term will be 
attached to the clinical database.
Events will be summarized on the basis of the date of onset for the event. A treatment-emergent 
AE will be defined as any AE that begins on or after the date of first dose of study drug up to the 
date of last dose of study drug plus 30 days.
Summaries (number and percentage of participants) of treatment-emergent AEs (by system 
organ class and preferred term) will be provided by cohort and overall.
8.6.3.
Laboratory Evaluations
Selected laboratory test data (using conventional units) will be summarized using observed data. 
Data and change from baseline at all scheduled time points will be summarized.


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Graded laboratory abnormalities will be defined using the grading scheme in DAIDS Table for 
Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 (corrected, July 2017). 
The DAIDS scale is available at:
https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf 
Incidence of treatment-emergent laboratory abnormalities, defined as values that increase at least 
1 toxicity grade from baseline at any time postbaseline up to 30 days after the date of the last 
dose of study drug, will be summarized by cohort and overall. If baseline data are missing, then 
any graded abnormality (ie, at least a Grade 1) will be considered treatment emergent.
Laboratory abnormalities that occur before the first dose of study drug or after the participant has 
been discontinued from treatment for at least 30 days will be included in a data listing.
8.6.4.
Other Safety Evaluations
The proportion of participants with concomitant use of medications other than RDV and ODV 
for treatment of COVID-19 will be provided in summary tables by cohort and overall.
Palatability and acceptability will be summarized using descriptive statistics by cohort and 
overall.
8.7.
Adjustments for Multiplicity
No adjustments for multiplicity are planned for this study.
8.8.
Pharmacokinetic Analysis 
For all PK analyses, the PK Analysis Set will be used. 
Plasma concentrations and PK parameters will be listed and summarized for GS-441524 using 
descriptive statistics by cohort and overall. 
8.9.
Sample Size
The total sample size will be at least 52 participants.
A minimum of 12 evaluable participants from each cohort (Cohorts 1-4) provides > 90% power 
to reject the null hypothesis that there is at least a 30% difference in GS-441524 AUC0-12 and 
Cmax, respectively, between pediatric and adult participants, using 2 one-sided tests with each 
performed at an alpha level of 0.05. This power analysis assumes that the expected geometric 
mean ratio between the pediatric participants versus the adult group is 1, the equivalency 
boundary is 70% to 143%, and the interparticipant standard deviations of AUC0-12 and Cmax are 
0.19 h•ng/mL and 0.18 ng/mL (natural log scale, preliminary results from 
Study GS-US-611-6248).


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A sample size of at least 52 participants will provide a reasonable assessment of the safety 
profile of ODV.
Sample size and power calculations were made using the software package nQuery Advisor(R), 
Version 8.5. 


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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Financial Disclosure
The investigator and subinvestigators will provide prompt and accurate documentation of their 
financial interest or arrangements with the sponsor or proprietary interests in the study drug. This 
documentation must be provided before the investigator’s (and any subinvestigator’s) 
participation in the study. The investigator and subinvestigator agree to notify Gilead of any 
change in reportable interests during the study and for 1 year following completion of the study. 
Study completion is defined as the date when the last participant completes the protocol-defined 
activities.
9.1.2.
Institutional Review Board/Independent Ethics Committee Review and 
Approval
The investigator (or Gilead as appropriate according to local regulations) will submit this 
protocol, ICF, and any accompanying material to be provided to the participant (such as 
advertisements, participant information sheets, or descriptions of the study used to obtain 
informed consent) to an IRB/IEC. The investigator will not begin any study participant activities 
until approval from the IRB/IEC has been documented and provided as a letter to the 
investigator.
Before implementation, the investigator will submit to and receive documented approval from 
the IRB/IEC for any modifications made to the protocol or any accompanying material to be 
provided to the participant after initial IRB/IEC approval, with the exception of those necessary 
to reduce immediate risk to study participant.
9.1.3.
Informed Consent (or Assent)
The investigator is responsible for obtaining informed consent from parents and/or legal 
guardians as well as assent (age < 18 years, where locally and nationally approved) from each 
individual participating in this study after adequate explanation of the aims, methods, objectives, 
and potential hazards of the study before undertaking any study-related procedures. The 
investigator must use the most current IRB/IEC-approved ICF (or assent as applicable) for 
documenting written informed consent and assent. Each ICF (and assent as applicable) will be 
appropriately signed and dated by the participant or the participant’s parent or legal guardian and 
the person conducting the consent discussion, and an impartial witness (if required by IRB/IEC 
or local requirements). 


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9.1.4.
Confidentiality
The investigator must ensure that participants’ anonymity will be strictly maintained and that 
their identities are protected from unauthorized parties. Only an identification code and any other 
unique identifier(s) as allowed by local law (such as date or year of birth, as applicable) will be 
recorded on any form or biological sample submitted to Gilead, IRB/IEC, or the laboratory. 
Laboratory specimens must be labeled in such a way as to protect participant identity while 
allowing the results to be recorded to the proper participant. Note: The investigator must keep a 
screening log with details for all participants screened and enrolled in the study, in accordance 
with the site procedures and regulations. Participant data will be processed in accordance with all 
applicable regulations.
The investigator agrees that all information received from Gilead, including but not limited to the 
IB, this protocol, eCRF, study drug information, and any other study information, remains the 
sole and exclusive property of Gilead during the conduct of the study and thereafter. This 
information is not to be disclosed to any third party (except employees or agents directly 
involved in the conduct of the study or as required by law) without prior written consent from 
Gilead. The investigator further agrees to take all reasonable precautions to prevent the 
disclosure by any employee or agent of the investigational site to any third party or otherwise 
into the public domain.
9.1.5.
Study Files and Retention of Records
The investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified. These documents should 
be classified into at least the following 2 categories: (1) investigator’s study file and 
(2) participant clinical source documents.
The investigator’s study file will contain the protocol/amendments, eCRF, IRB/IEC, and 
governmental approval with correspondence, the ICF(s), drug records, staff curriculum vitae and 
authorization forms, and other appropriate documents and correspondence.
The required source data should include sequential notes containing at least the following 
information for each participant:
•
Participant identification
•
Documentation that participant meets eligibility criteria (ie, medical history, physical 
examination, and confirmation of diagnosis [to support inclusion and exclusion criteria])
•
Documentation of the reason(s) a consented participant is not enrolled
•
Participation in study (including study number)
•
Study discussed and date of informed consent


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•
Dates of all visits
•
Documentation that protocol-specific procedures were performed
•
Results of efficacy parameters, as required by the protocol
•
Start and end date (including dose regimen) of study drug, including dates of dispensing and 
return
•
Record of all AEs and other safety parameters (start and end date; causality and severity) and 
documentation that adequate medical care has been provided for any AE
•
Concomitant medication (start and end date; dose if relevant; dose changes)
•
Date of study completion and reason for early discontinuation, if it occurs
All clinical study documents must be retained by the investigator for at least 2 years or according 
to local laws, whichever is longer, after the last approval of a marketing application in an ICH 
region (ie, the US, Europe, or Japan) and until there are no pending or planned marketing 
applications in an International Council for Harmonisation (ICH) region; or, if no application is 
filed or if the application is not approved for such indication, for 2 years after the investigation is 
discontinued and regulatory authorities have been notified. Investigators may be required to 
retain documents longer if specified by regulatory requirements, by local regulations, or by an 
agreement with Gilead. The investigator must notify Gilead before destroying any clinical study 
records.
Should the investigator wish to assign the study records to another party or move them to another 
location, Gilead must be notified in advance.
If the investigator cannot provide for this archiving requirement at the investigational site for any 
or all of the documents, special arrangements must be made between the investigator and Gilead 
to store these records securely away from the site so that they can be returned sealed to the 
investigator in case of an inspection. When source documents are required for the continued care 
of the participant, appropriate copies should be made for storage away from the site.
9.1.6.
Case Report Forms
An eCRF casebook will be completed by an authorized study personnel member whose training 
for this function is completed in the electronic data capture (EDC) system unless otherwise 
directed. The eCRF casebook will only capture the data required per the protocol schedule of 
events and procedures, unless collected by a non-EDC vendor system (eg, central laboratory). 
The Inclusion/Exclusion Criteria and Enrollment eCRFs should be completed only after all data 
related to eligibility are available. Data entry should be performed in accordance with the CRF 
Completion Guidelines provided by the sponsor. Subsequent to data entry, a study monitor may 
perform source data verification. System-generated or manual queries will be issued in the EDC 
system as data discrepancies are identified by the study monitor or Gilead personnel who 


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routinely review the data for completeness, correctness, and consistency. The site investigator, 
site coordinator, or other designee is responsible for responding to the queries in a timely 
manner, within the system, either by confirming the data as correct or updating the original entry, 
and providing the reason for the update (eg, data entry error). Original entries as well as any 
changes to data fields will be stored in the audit trail of the system. Regular oversight by the 
principal investigator of the data entered into the EDC system is expected to occur on an ongoing 
basis throughout the study to ensure quality and completeness. At a minimum, before any 
interim, final, or other time points (as instructed by Gilead), the investigator will apply his/her 
electronic signature to confirm that the forms have been reviewed and that the entries accurately 
reflect the information in the source documents. At the conclusion of the study, Gilead will 
provide the site investigator with a read-only archive copy of the data entered. This archive must 
be stored in accordance with the records retention requirements outlined in Section 9.1.5.
9.1.7.
Investigator Inspections
The investigator will make available all source documents and other records for this study to 
Gilead’s appointed study monitors, to IRB/IEC, or to regulatory authority or health authority 
inspectors.
9.1.8.
Protocol Compliance
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol.
9.2.
Sponsor Responsibilities
9.2.1.
Protocol Modifications
Protocol modifications, except those intended to reduce immediate risk to study participant, may 
be made only by Gilead. The investigator must submit all protocol modifications to the IRB/IEC 
in accordance with local requirements and receive documented IRB/IEC approval before 
modifications can be implemented.
9.2.2.
Study Reports and Publications
A clinical study report (CSR) will be prepared and provided to the regulatory agency(ies) when 
applicable and in accordance with local regulatory requirements. Gilead will ensure that the 
report meets the standards set out in the ICH Guideline for Structure and Content of Clinical 
Study Reports (ICH E3). Note that an abbreviated report may be prepared in certain cases. For 
studies with sites in countries following the EU Regulation No. 536/2014, a CSR will be 
submitted within 1 year (6 months for pediatric studies, in accordance with Regulation [EC] 
No. 1901/2006) after the global end of study (as defined in Section 3.4.2).
Investigators in this study may communicate, orally present, or publish study data in scientific 
journals or other scholarly media in accordance with the Gilead clinical trial agreement.


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9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Regulatory and Ethical Consideration
This study will be conducted in accordance with the protocol and the following:
•
The ethical principles of the Declaration of Helsinki
•
ICH Good Clinical Practice (GCP)
•
Applicable laws and regulatory requirements, including Regulation [EU] No 536/2014 
(Regulation [EU] no 536/2014 Annex I, Section D, No. 17, letter a).
9.3.2.
Payment Reporting
Investigators and their study personnel may be asked to provide services performed under this 
protocol (eg, attendance at investigator meetings). If required under the applicable statutory and 
regulatory requirements, Gilead will capture and disclose to federal and state agencies any 
expenses paid or reimbursed for such services, including any clinical study payments, meal 
and/or travel expenses or reimbursements, consulting fees, and any other transfer of value.
9.3.3.
Access to Information for Monitoring
In accordance with regulations and guidelines, the study monitor must have direct access to the 
investigator’s source documentation and any participant records in order to verify the adherence 
to the protocol and the accuracy of the data recorded in the eCRF. The study monitor is 
responsible for routine review of the case report form/eCRF at regular intervals throughout the 
study to verify adherence to the protocol and the completeness, consistency, and accuracy of the 
data being entered on them. The investigator agrees to cooperate with the study monitor to 
ensure that any problems detected through any type of monitoring (central, off-site, on-site) are 
resolved.
9.3.4.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or Gilead may conduct inspections or audits of the 
clinical study. If the investigator is notified of an inspection by a regulatory authority, the 
investigator agrees to notify the Gilead study monitor immediately. The investigator agrees to 
provide to representatives of a regulatory agency or Gilead access to records, facilities, and 
personnel for the effective conduct of any inspection or audit.
9.3.5.
Study Discontinuation
Gilead reserves the right to terminate the study at any time, and the investigator has the right to 
terminate the study at his or her site. Should this be necessary, both parties will arrange 
discontinuation procedures and notify the participants, appropriate regulatory authority(ies), and 
IRB/IEC. In terminating the study, Gilead and the investigator will ensure that adequate 
consideration is given to the protection of the participant’s interests.


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10.
REFERENCES
Ben-Tov A, Lotan R, Gazit S, Chodick G, Perez G, Mizrahi-Reuveni M, et al. Dynamics in 
COVID-19 symptoms during different waves of the pandemic among children 
infected with SARS-CoV-2 in the ambulatory setting. Eur J Pediatr 2022;181 
(9):3309-18.
Bhalala US, Gist KM, Tripathi S, Boman K, Kumar VK, Retford L, et al. Characterization and 
Outcomes of Hospitalized Children With Coronavirus Disease 2019: A Report 
From a Multicenter, Viral Infection and Respiratory Illness Universal Study 
(Coronavirus Disease 2019) Registry. Critical care medicine 2022;50 (1):e40-e51.
Centers for Disease Control and Prevention. Demographic Trends of COVID-19 cases and 
deaths in the US reported to CDC. Available at: https://covid.cdc.gov/covid-data-
tracker/#demographics. Accessed: 25 September 2022. Last updated: 23 
September 2022.  2022:
Colantonio DA, Kyriakopoulou L, Chan MK, Daly CH, Brinc D, Venner AA, et al. Closing the 
Gaps in Pediatric Laboratory Reference Intervals: A CALIPER Database of 40 
Biochemical Markers in a Healthy and Multiethnic Population of Children. Clin 
Chem 2012;58 (5):854-68.
Dawood FS, Porucznik CA, Veguilla V, Stanford JB, Duque J, Rolfes MA, et al. Incidence 
Rates, Household Infection Risk, and Clinical Characteristics of SARS-CoV-2 
Infection Among Children and Adults in Utah and New York City, New York. 
JAMA pediatrics 2022;176 (1):59-67.
European Center for Disease Prevention and Control. Clinical characteristics of COVID-19. 
Available at: https://www.ecdc.europa.eu/en/covid-19/latest-evidence/clinical. 
Accessed: 17 June 2022. Last updated: 17 February 2022.  2022:
Fernandes DM, Oliveira CR, Guerguis S, Eisenberg R, Choi J, Kim M, et al. Severe Acute 
Respiratory Syndrome Coronavirus 2 Clinical Syndromes and Predictors of 
Disease Severity in Hospitalized Children and Youth. J Pediatr 2021;230:23-31 
e10.
Gotzinger F, Santiago-Garcia B, Noguera-Julian A, Lanaspa M, Lancella L, Calo Carducci FI, et 
al. COVID-19 in children and adolescents in Europe: a multinational, multicentre 
cohort study. Lancet Child Adolesc Health 2020;4 (9):653-61.
Kompaniyets L, Agathis NT, Nelson JM, Preston LE, Ko JY, Belay B, et al. Underlying Medical 
Conditions Associated With Severe COVID-19 Illness Among Children. JAMA 
Netw Open 2021;4 (6):e2111182.


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Liguoro I, Pilotto C, Bonanni M, Ferrari ME, Pusiol A, Nocerino A, et al. SARS-COV-2 
infection in children and newborns: a systematic review. Eur J Pediatr 2020;179 
(7):1029-46.
Madera S, Crawford E, Langelier C, Tran NK, Thornborrow E, Miller S, et al. Nasopharyngeal 
SARS-CoV-2 viral loads in young children do not differ significantly from those 
in older children and adults. Sci Rep 2021;11 (1):3044.
Marks KJ, Whitaker M, Agathis NT, Anglin O, Milucky J, Patel K, et al. Hospitalization of 
Infants and Children Aged 0-4 Years with Laboratory-Confirmed COVID-19 - 
COVID-NET, 14 States, March 2020-February 2022. MMWR. Morbidity and 
mortality weekly report 2022;71 (11):429-36.
Molteni E, Sudre CH, Canas LS, Bhopal SS, Hughes RC, Antonelli M, et al. Illness duration and 
symptom profile in symptomatic UK school-aged children tested for SARS-CoV-
2. Lancet Child Adolesc Health 2021;5 (10):708-18.
Nikolopoulou GB, Maltezou HC. COVID-19 in Children: Where do we Stand? Archives of 
medical research 2022;53 (1):1-8.
Shi DS, Whitaker M, Marks KJ, Anglin O, Milucky J, Patel K, et al. Hospitalizations of Children 
Aged 5-11 Years with Laboratory-Confirmed COVID-19 - COVID-NET, 14 
States, March 2020-February 2022. MMWR. Morbidity and mortality weekly 
report 2022;71 (16):574-81.
Siegel DA, Reses HE, Cool AJ, Shapiro CN, Hsu J, Boehmer TK, et al. Trends in COVID-19 
Cases, Emergency Department Visits, and Hospital Admissions Among Children 
and Adolescents Aged 0-17 Years - United States, August 2020-August 2021. 
MMWR. Morbidity and mortality weekly report 2021;70 (36):1249-54.
Swann OV, Holden KA, Turtle L, Pollock L, Fairfield CJ, Drake TM, et al. Clinical 
characteristics of children and young people admitted to hospital with covid-19 in 
United Kingdom: prospective multicentre observational cohort study. BMJ 
2020;370:m3249.
Tchesnokov EP, Gordon CJ, Woolner E, Kocinkova D, Perry JK, Feng JY, et al. Template-
dependent inhibition of coronavirus RNA-dependent RNA polymerase by 
remdesivir reveals a second mechanism of action. J Biol Chem 2020;295 
(47):16156-65.
Tsankov BK, Allaire JM, Irvine MA, Lopez AA, Sauve LJ, Vallance BA, et al. Severe COVID-
19 Infection and Pediatric Comorbidities: A Systematic Review and Meta-
Analysis. Int J Infect Dis 2021;103:246-56.


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Uka A, Buettcher M, Bernhard-Stirnemann S, Fougere Y, Moussaoui D, Kottanattu L, et al. 
Factors associated with hospital and intensive care admission in paediatric SARS-
CoV-2 infection: a prospective nationwide observational cohort study. Eur J 
Pediatr 2022;181 (3):1245-55.
VEKLURY, Gilead Sciences Inc. VEKLURY® (remdesivir) for injection, for intravenous use. 
VEKLURY® (remdesivir) injection, for intravenous use. U.S. Prescribing 
Information. Foster City, CA. Revised: June.  2022a:
Veklury, Gilead Sciences Ireland UC. Veklury 100 mg powder for concentrate for solution for 
infusion. Summary of Product Characteristics. County Cork, Ireland. Revised 
April.  2022b:
Vieux R, Hascoet JM, Merdariu D, Fresson J, Guillemin F. Glomerular Filtration Rate Reference 
Values in Very Preterm Infants. Pediatrics 2010;125 (5):e1186-92.
Zimmermann P, Curtis N. Coronavirus Infections in Children Including COVID-19. An 
Overview of the Epidemiology, Clinical Features, Diagnosis, Treatment and 
Prevention Options in Children. Pediatr Infect Dis J 2020.


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11.
APPENDICES


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11.1.
Investigator Signature Page
GILEAD SCIENCES, INC.
334 LAKESIDE DRIVE
FOSTER CITY, CA 94404
A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and 
Efficacy of Obeldesivir in Pediatric Participants With COVID-19
GS-US-611-6464, Original Protocol, 09 May 2023
CLINICAL STUDY PROTOCOL ACKNOWLEDGMENT
INVESTIGATOR STATEMENT
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated.
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Gilead Sciences, Inc. I will discuss this material with them to ensure 
that they are fully informed about the drugs and the study.
Principal Investigator Name (Printed)
Signature
Date
Site Number


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11.2.
Committees
11.2.1.
Safety Review Team
An SRT will make dose selection decision for future cohorts based on data described in 
Section 1.4.
An SRT charter defining the team membership, meeting conduct, and decision-making process 
will be agreed upon by all team members before the first participant is dosed for cohorts required 
dose selection. The data reviewed at the team meeting to make dose selection decisions will be 
defined in the charter. The quality control checks performed on the data reviewed and used for 
making dose selection will also be described in the charter.
Source data verification may not be performed before SRT meetings. Alternative data quality 
control checks that are performed on data used to make selection decisions are described in the 
SRT charter (or similar document).
11.2.2.
Data Monitoring Committee
A multidisciplinary DMC consisting of non-Gilead personnel will review the progress of the 
study, perform interim reviews of safety and PK (if available) data, and provide recommendation 
to Gilead whether the nature, frequency, and severity of AEs associated with study treatment 
warrant the early termination of the study in the best interests of the participant, whether the 
study should continue as planned, or whether the study should continue with modifications. The 
DMC may also provide recommendations as needed regarding study design. 
The DMC’s specific activities will be defined by a mutually agreed charter, which will define the 
DMC’s membership, conduct, and meeting schedule.
While the DMC will be asked to advise Gilead regarding future conduct of the study, including 
possible early study termination, Gilead retains final decision-making authority on all aspects of 
the study.


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11.3.
Pandemic Risk Assessment and Mitigation Plan
During an ongoing pandemic, potential risks associated with participants being unable to attend 
study visits have been identified for this study. 
These risks can be summarized as follows:
1) Study drug supplies to participants and sites:
a.
Participants may be unable to return to the site for a number of visits to get the study 
drug, or the site may be unable to accept any participant visits. Without study drugs, the 
participant would not be able to continue receiving the study drug as planned per 
protocol.
Mitigation plan: Study drug supplies may be provided to the participant from the site 
without a clinic visit, once it is confirmed that the participant may safely continue on 
study drug as determined by the principal investigator. A remote study visit, via phone, or 
videoconferencing, must be performed before remote study drug resupply. At the earliest 
opportunity, the site will schedule in-person participant visits and return to the protocol’s 
regular schedule of assessments. A qualified courier may be utilized to ship the study 
drug from sites to study participant if permitted by the local ethics 
committee/IRB/regulatory authority as applicable and with sponsor's approval.
b. Shipments of study drug could be delayed because of transportation issues. Without study 
drug, the participant would not be able to continue receiving the study drug as planned 
per protocol.
Mitigation plan: The site’s study drug inventory should be closely monitored. Site staff 
should notify the sponsor or delegate if they foresee shortage in study drug inventory or if 
there is any interruption in local shipping service. The sponsor will continue to monitor 
inventory at the study drug depot and investigational sites. Manual shipments will be 
triggered as necessary.
2) Participant safety monitoring and follow-up:
a.
Participant may be unable or unwilling to come to the investigational site for their 
scheduled study visits as required per protocol.
Mitigation plan: For participant who may be unable or unwilling to visit the 
investigational site for their scheduled study visits as required per protocol, the principal 
investigator or qualified delegate will conduct a remote study visit, via phone, or 
videoconferencing, to assess the participant within the target visit window date whenever 
possible. During the remote study visit, the following information at minimum will be 
reviewed: 


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i.
Confirm if participant has experienced any AEs/SAEs/special situations (including 
pregnancy) and follow up on any unresolved AEs/SAEs.
ii.
Review the current list of concomitant medications and document any new 
concomitant medications.
iii.
If applicable, confirm electronic diary questionnaires and participant-reported 
outcomes have been completed and transmitted.
iv.
If applicable, confirm the participant’s study drug supply is sufficient to last until the 
next planned visit date. If study drug resupply is needed, it will be provided as 
described above in (1).
v.
If applicable, remind the participant to maintain current dosing and to keep all 
dispensed study drug kits for return at the next on-site visit.
b. Participant may be unable or unwilling to travel to the site for planned assessments (eg, 
safety blood draws); hence samples may not be sent for central laboratory analyses.
Mitigation plan: Local laboratories or other vendors may be utilized as appropriate to 
monitor participant safety until the participant can return to the site for their regular 
follow-up per protocol. Any changes in the party conducting laboratory assessments for 
the study because of the pandemic will be documented accordingly. Pregnancy testing 
may be performed using a home urine pregnancy test if local laboratory pregnancy 
testing is not feasible.
6) Participant may be unable or unwilling to attend the study visit to sign an updated ICF 
version.
Mitigation plan: The site staff will follow their approved consent process and remain in 
compliance with the local ethics committee/IRB and national laws and regulations. 
Remote consent will be allowed if has been approved by the local ethics committee/IRB. 
The consent process will be documented and confirmed by normal consent procedure at 
the earliest opportunity.
3) Protocol and monitoring compliance:
7) Protocol deviations may occur in case scheduled visits cannot be conducted as planned per 
protocol.
Mitigation plan: If it is not possible to complete a required procedure, an unscheduled 
visit should be conducted as soon as possible when conditions allow. The situation should 
be recorded and explained as a protocol deviation. Any missed participant visits or 
deviation to the protocol because of the pandemic must be reported in the eCRF and 
described in the CSR. Any remote study visits that are conducted in lieu of clinic visits 
because of the pandemic will be documented as a protocol deviation related to the 
pandemic.


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a.
Study monitors may be unable to carry out source data review or source data verification, 
or study drug accountability or assess protocol and GCP compliance. This may lead to 
delays in source data verification, an increase in protocol deviations, or underreporting of 
AEs.
Mitigation plan: The study monitor is to remain in close communication with the site to 
ensure data entry and query resolution. Remote source data verification may be arranged 
if allowed by local regulation and the Study Monitoring Plan. The study monitor is to 
reference the Study Monitoring Plan for guidance on how to conduct an off-site 
monitoring visit. The study staff is to save and document all relevant communication in 
the study files. The status of sites that cannot accept monitoring visits and/or participant 
on site, must be tracked centrally and updated on a regular basis.
4) Missing data and data integrity:
a) There may be an increased amount of missing data because of participant missing 
visits/assessments. This could have an impact on the analysis and the interpretation of 
clinical study data. 
b) Mitigation plan: Implications of a pandemic on methodological aspects for the study will 
be thoroughly assessed and documented, and relevant actions will be taken as appropriate 
(eg, modification of the SAP) and in compliance with regulatory authorities’ guidance. 
Overall, the CSR will describe the impact of the pandemic on the interpretability of study 
data. 
Risks will be assessed continuously, and temporary measures will be implemented to mitigate 
these risks as part of a mitigation plan, as described above. These measures will be 
communicated to the relevant stakeholders as appropriate and are intended to provide alternate 
methods that will ensure the evaluation and assessment of the safety of participant who are 
enrolled in this study. 
Since these potential risks are considered mitigated with the implementation of these measures, 
the expected benefit-risk assessment of ODV in study participant remains unchanged. 


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11.4.
Pregnancy Precautions, Definition of Childbearing Potential, and 
Contraceptive Requirements
1) Definitions
a) Definition of Childbearing Potential
For the purposes of this study, a participant assigned female at birth is considered of childbearing 
potential following the initiation of puberty (Tanner stage 2, Tanner staging only required if the 
participant is believed to be prepubescent) until becoming postmenopausal, or unless the 
participant is permanently sterile or has medically documented ovarian failure. Permanent 
sterilization includes hysterectomy, bilateral oophorectomy, or bilateral salpingectomy in a 
participant assigned female at birth of any age.
Participants assigned female at birth are considered to be in a postmenopausal state when they 
are at least 54 years of age with cessation of previously occurring menses for at least 12 months 
without an alternative cause. In addition, participants assigned female at birth younger than 
54 years with amenorrhea of at least 12 months also may be considered postmenopausal if their 
follicle-stimulating hormone level is in the postmenopausal range and they are not using 
hormonal contraception or hormonal replacement therapy.
b) Definition of Fertility in a Participant Assigned Male at Birth
For the purposes of this study, a participant assigned male at birth is considered fertile after the 
initiation of puberty unless the participant is permanently sterile by bilateral orchidectomy or 
with medical documentation.
2) Contraception Requirements for Participants Assigned Female at Birth and of Childbearing 
Potential
a) Study Drug Effects on Pregnancy and Hormonal Contraception
Obeldesivir is contraindicated in pregnancy as a malformative effect is noted in early pregnancy 
based on nonclinical data. An increased rate of adverse fetal effects, including postimplantation 
loss and fetal visceral malformations related to the development of the heart, blood vessels, and 
liver, were noted in rabbits administered ODV 
 Data from clinical 
pharmacokinetic interaction studies of ODV have demonstrated that there is no reduction in the 
clinical efficacy of hormonal contraception. Refer to the latest version of the investigator’s 
brochure for additional information.
b) Contraception Requirements for Participants Assigned Female at Birth and of 
Childbearing Potential
The inclusion of participants assigned female at birth and of childbearing potential requires the 
use of highly effective contraceptive measures with a failure rate of less than 1% per year. They 
must have a negative pregnancy test at the screening visit before randomization. A pregnancy 
test will also be performed at the EOS visit. 
CCI


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Amendment 0.1 EU
CONFIDENTIAL
Page 77
15 November 2023
Duration of required contraception for participants assigned female at birth and of childbearing 
potential in this clinical study should start from the screening visit until 14 days after the last 
study dose. 
Participants assigned female at birth and of childbearing potential must agree to 1 of the 
following contraceptive methods:
Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable 
method of contraception only when it is in line with the participant’s preferred and usual 
lifestyle. 
Or
Consistent and correct use of 1 of the following methods of birth control listed below: 
•
Nonhormonal intrauterine device 
•
Bilateral tubal occlusion (upon medical assessment of surgical success)
•
Vasectomy in the partner assigned male at birth (upon medical assessment of surgical 
success)
Or 
Participants assigned female at birth and of childbearing potential who wish to use a hormonally 
based method must use it in conjunction with a barrier method, preferably a male condom. 
Hormonal methods are restricted to those associated with the inhibition of ovulation. Hormonally 
based contraceptives and barrier methods permitted for use in this protocol are as follows:
•
Hormonal methods (each method must be used with a barrier method, preferably male 
condom)
Oral contraceptives (either combined or progesterone only)
Injectable progesterone
Transdermal contraceptive patch
Contraceptive vaginal ring
•
Barrier methods (each method must be used with a hormonal method)
Male condom (with or without spermicide)
Female condom (with or without spermicide)
Diaphragm with spermicide
Cervical cap with spermicide


GS-5245
Protocol GS-US-611-6464
Final
Gilead Sciences, Inc.
Amendment 0.1 EU
CONFIDENTIAL
Page 78
15 November 2023
Sponge with spermicide
Inclusion of methods of contraception in this list of permitted methods does not imply that the 
method is approved in any country or region. Methods should only be used if locally approved. 
Participants assigned female at birth and of childbearing potential must also refrain from egg 
donation and in vitro fertilization during treatment and until the end of contraception 
requirement.
The above requirements apply only as specified, and not to sexual encounters in which 
pregnancy is not a possible outcome. 
3) Contraception Requirements for Participants Assigned Male at Birth
It is theoretically possible that a relevant systemic concentration of study drug may be achieved 
in a partner assigned female at birth from exposure to the participant’s seminal fluid and pose a 
potential risk to an embryo/fetus. A participant assigned male at birth with a partner assigned 
female at birth and of childbearing potential must use highly effective contraceptive measures 
with a failure rate of less than 1% per year through at least 14 days after last dose of study drug. 
Please refer to the contraceptive requirements listed above for female participants. 
Participants assigned male at birth must also refrain from sperm donation or cryopreservation of 
germ cells during treatment and until the end of contraception requirement.
The above requirements apply only as specified, and not to sexual encounters in which 
pregnancy is not a possible outcome. 
4) Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, 
symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhea method. A female condom and a male condom should not be used 
together.
5) Procedures to Be Followed in the Event of Pregnancy
Participants assigned female at birth will be instructed to notify the investigator if they become 
pregnant or suspect they are pregnant at any time from start of the study to 30 days after the last 
study drug dose. Study drug must be discontinued immediately, and medical monitor should be 
notified. 
Participants assigned male at birth whose partner has become pregnant or suspects they are 
pregnant from start of study to 30 days after the last study drug dose must also report the 
information to the investigator. Instructions for reporting pregnancy, partner pregnancy, and 
pregnancy outcome are outlined in Section 7.4.2.3.


GS-5245
Protocol GS-US-611-6464
Final
Gilead Sciences, Inc.
Amendment 0.1 EU
CONFIDENTIAL
Page 79
15 November 2023
11.5.
Tanner Stages
1. Pubic hair (male and female)
Tanner I
No pubic hair at all (prepubertal Dominic state)
Tanner II
Small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum 
(males) or on the labia majora (females)
Tanner III
Hair becomes more coarse and curly, and begins to extend laterally
Tanner IV
Adult-like hair quality, extending across pubis but sparing medial thighs
Tanner V
Hair extends to medial surface of the thighs
2. Genitals (male) (One standard deviation around mean age)
Tanner I
Testes, scrotum, and penis about same size and proportion as in early childhood
Tanner II
Enlargement of scrotum and testes; skin of scrotum reddens and changes in texture; little or no 
enlargement of penis (10.5-12.5)
Tanner III
Enlargement of penis, first mainly in length; further growth of testes and scrotum (11.5-14)
Tanner IV
Increased size of penis with growth in breadth and development of glans; further enlargement of 
testes and scrotum and increased darkening of scrotal skin (13.5-15)
Tanner V
Genitalia adult in size and shape
3. Breasts (female)
Tanner I
No glandular tissue: areola follows the skin contours of the chest
Tanner II
Breast bud forms, with small area of surrounding glandular tissue; areola begins to widen
Tanner III
Breast begins to become more elevated, and extends beyond the borders of the areola, which 
continues to widen but remains in contour with surrounding breast
Tanner IV
Increased breast size and elevation; areola and papilla form a secondary mound projecting from the 
contour of the surrounding breast
Tanner V
Breast reaches final adult size; areola returns to contour of the surrounding breast, with a projecting 
central papilla


GS-5245
Protocol GS-US-611-6464
Final
Gilead Sciences, Inc.
Amendment 0.1 EU
CONFIDENTIAL
Page 80
15 November 2023
11.6.
Blood Volume Tables for Clinical Laboratory Studies
The smallest possible blood vials, such as microtainer tubes, must be used for participants 
weighing < 15 kg.
Table 5.
Cohorts 1 and 2 - Blood Volume
Assessment
Screening/Day 1
Day 3
Day 5
Day 35/EOS
Total (mL)a,b
Hematology
1.2
1.2
1.2
1.2
4.8
Chemistry
1.1
1.1
1.1
1.1
4.4
Coagulation
1.8
1.8
3.6
PK
1
5
6
Additional PK (for hospitalized 
participants)
1
1
Total
4.1
3.3
9.1
2.3
18.8
Total (for hospitalized participants)
4.1
3.3
10.1
2.3
19.8
EOS = end of study; PK = pharmacokinetic(s); 
a.
Cohort 1 blood volume limits (≥ 40 kg participant): 80 mL for 24 hour maximum and 160 mL for 30 day maximum.
b.
Cohort 2 blood volume limits (≥ 20 kg to < 40 kg participant): 40 mL to ≤ 80 mL for 24 hour maximum and 80 mL to 
≤ 160 mL for 30 day maximum.
Blood volume tables for Cohort 3 onwards will be provided in a protocol amendment.


GS-5245
Protocol GS-US-611-6464
Final
Gilead Sciences, Inc.
Amendment 0.1 EU
CONFIDENTIAL
Page 81
15 November 2023
11.7.
Amendment History
A high-level summary of this amendment is provided in tabular form in the subsection below, 
with changes listed in order of importance. Minor changes such as the correction of typographic 
errors, grammar, or formatting are not detailed.
A separate tracked change (red-lined) document comparing the original protocol to this 
amendment will be made available upon the publication of this protocol.
11.7.1.
Amendment 0.1 (15 November 2023)
Rationale for Key Changes Included in Amendment 0.1
Affected Sections
In response to EU CTR comment, reference to relevant European Union 
regulation was added
Section 9.3.1


protocol GS-US-611-6464 amd 0.1 EU
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Clinical Development
eSigned
16-Nov-2023
09:19:26
PPD

SAP_001.pdf: 
S T A TI S TI C A L A N A L Y SI S P L A N
St u d y Title:
A P hase 2/ 3 Si n gle- Ar m, O pe n-la bel St u d y t o E val uate t he 
Safet y, P har mac o ki netics a n d Efficac y of O bel desi vir i n 
Pe diatric Partici pa nts Wit h C O VI D- 1 9
N a me of Test Dr u g:  
O bel desi vir ( O D V; G S- 5 2 4 5 ™) 
St u d y N u m ber:
G S- U S- 6 1 1- 6 4 6 4
Pr ot oc ol Versi o n ( D ate):  
Ori gi nal ( 0 9 Ma y 2 0 2 3);
A d mi nistrati ve A me n d me nt 1 ( 2 2 J u ne 2 0 2 3);
A me n d me nt 0. 1 E U ( 1 5 N o ve m ber 2 0 2 3)
A n al ysis T y pe:
Fi nal A nal ysis 
A n al ysis Pl a n Versi o n:  
Versi o n 1. 0
A n al ysis Pl a n D ate:  
1 7 J u ne 2 0 2 4
A n al ysis Pl a n A ut h or(s):
C O N FI D E N TI A L A N D P R O P RI E T A R Y I N F O R M A TI O N
P P D
GI L  E  A  U 


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 2 of 3 8
T A B L E O F C O N T E N T S
T A B L E O F C O N T E N T S................................................................................................................................................ 2
LI S T O F I N- T E X T T A B L E S......................................................................................................................................... 3
LI S T O F A B B R E VI A TI O N S......................................................................................................................................... 4
P H A R M A C O KI N E TI C A B B R E VI A TI O N S................................................................................................................. 6
1.  
I N T R O D U C TI O N.................................................................................................................................................. 7
1. 1.   
St u d y O bjecti ves a n d E n d p oi nts................................................................................................................ 7
1. 2.   
St u d y Desi g n ............................................................................................................................................. 8
1. 3.   
Sa m ple Size a n d P o wer........................................................................................................................... 1 0
2.   
T Y P E O F P L A N N E D A N A L Y SI S...................................................................................................................... 1 1
2. 1.   
I nteri m A nal yses...................................................................................................................................... 1 1
2. 1. 1.    
D ose Selecti o n A nal ysis........................................................................................................ 1 1
2. 1. 2.    
Data M o nit ori n g C o m mittee A nal yses.................................................................................. 1 1
2. 2.   
Fi nal A nal ysis.......................................................................................................................................... 1 1
2. 3.   
C ha n ges fr o m Pr ot oc ol- S pecifie d A nal yses............................................................................................ 1 1
3.    
G E N E R A L C O N SI D E R A TI O N S F O R D A T A A N A L Y S E S............................................................................. 1 2
3. 1.    
A nal ysis Sets ........................................................................................................................................... 1 2
3. 1. 1.    
All E nr olle d A nal ysis Set...................................................................................................... 1 2
3. 1. 2.   
F ull A nal ysis Set.................................................................................................................... 1 2
3. 1. 3.   
Safet y A nal ysis Set................................................................................................................ 1 2
3. 1. 4.   
P har mac o ki netic A nal ysis Set............................................................................................... 1 2
3. 1. 5.    
Vir ol o g y A nal ysis Set............................................................................................................ 1 2
3. 2.   
Partici pa nt Gr o u pi n g ............................................................................................................................... 1 3
3. 3.   
Strata a n d C o variates............................................................................................................................... 1 3
3. 4.   
E xa mi nati o n of Partici pa nt S u b gr o u ps.................................................................................................... 1 3
3. 5.    
M ulti ple C o m paris o ns............................................................................................................................. 1 3
3. 6.    
Missi n g Data a n d O utliers....................................................................................................................... 1 3
3. 6. 1.    
Missi n g Data.......................................................................................................................... 1 3
3. 6. 2.    
O utliers.................................................................................................................................. 1 3
3. 7.    
Data Ha n dli n g C o n ve nti o ns a n d Tra nsf or mati o ns.................................................................................. 1 3
3. 8.    
A nal ysis Visit Wi n d o ws.......................................................................................................................... 1 5
3. 8. 1.    
Defi niti o n of St u d y Da y ........................................................................................................ 1 5
3. 8. 2.    
A nal ysis Visit Wi n d o ws........................................................................................................ 1 5
3. 8. 3.   
Selecti o n of Data i n t he E ve nt of M ulti ple Rec or ds i n a n A nal ysis Visit 
Wi n d o w................................................................................................................................. 1 7
4.   P A R TI CI P A N T DI S P O SI TI O N .......................................................................................................................... 1 9
4. 1.   
Partici pa nt E nr oll me nt a n d Dis p ositi o n................................................................................................... 1 9
4. 2.   
E xte nt of St u d y Dr u g E x p os ure a n d A d here nce...................................................................................... 1 9
4. 3.   
Pr ot oc ol De viati o ns................................................................................................................................. 1 9
4. 4.    
Assess me nt of Disaster or P u blic Healt h E mer ge nc y I m pact................................................................. 1 9
5.   
B A S E LI N E C H A R A C T E RI S TI C S..................................................................................................................... 2 0
5. 1.    
De m o gra p hics a n d Baseli ne C haracteristics ........................................................................................... 2 0
5. 2.    
Ot her Baseli ne C haracteristics ................................................................................................................ 2 0
5. 3.    
Me dical Hist or y....................................................................................................................................... 2 1
6.   
E F FI C A C Y A N A L Y S E S..................................................................................................................................... 2 2


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 3 of 3 8
6. 1.   
Pri mar y Efficac y E n d p oi nt...................................................................................................................... 2 2
6. 2.   
Sec o n dar y Efficac y E n d p oi nts ................................................................................................................ 2 2
6. 4.   
C ha n ges Fr o m Pr ot oc ol- S pecifie d Efficac y A nal yses ............................................................................ 2 2
7.   S A F E T Y A N A L Y S E S......................................................................................................................................... 2 3
7. 1.    
A d verse E ve nts a n d Deat hs..................................................................................................................... 2 3
7. 1. 1.    
A d verse E ve nt Dicti o nar y ..................................................................................................... 2 3
7. 1. 2.    
A d verse E ve nt Se verit y......................................................................................................... 2 3
7. 1. 3.   
Relati o ns hi p of A d verse E ve nts t o St u d y Dr u g..................................................................... 2 3
7. 1. 4.   
Seri o us A d verse E ve nts......................................................................................................... 2 3
7. 1. 5.   
Treat me nt- E mer ge nt A d verse E ve nts.................................................................................... 2 3
7. 1. 5. 1.    
Defi niti o n of Treat me nt- E mer ge nt A d verse E ve nts........................................ 2 3
7. 1. 5. 2.   
I nc o m plete Dates............................................................................................. 2 4
7. 1. 6.   
S u m maries of A d verse E ve nts a n d Deat hs............................................................................ 2 4
7. 1. 6. 1.   
S u m maries of A E i nci de nce i n C o m bi ne d Se verit y Gra de 
S u bsets............................................................................................................. 2 4
7. 2.   
La b orat or y E val uati o ns ........................................................................................................................... 2 4
7. 2. 1.    
Gra de d La b orat or y Val ues .................................................................................................... 2 5
7. 2. 1. 1.   
Treat me nt- E mer ge nt La b orat or y A b n or malities ............................................. 2 5
7. 2. 1. 2.   
S u m maries of La b orat or y A b n or malities ........................................................ 2 5
7. 2. 2.   
Li ver-relate d La b orat or y E val uati o ns.................................................................................... 2 5
7. 3.   
B o d y Wei g ht a n d Vital Si g ns.................................................................................................................. 2 6
7. 4.   
Pri or a n d C o nc o mita nt Me dicati o ns........................................................................................................ 2 6
7. 5.   
Ta n ner Sta ge Assess me nt........................................................................................................................ 2 6
7. 6.   
Palata bilit y a n d Acce pta bilit y Assess me nt.............................................................................................. 2 6
7. 7.    
Ot her Safet y Meas ures ............................................................................................................................ 2 6
7. 8.   
C ha n ges Fr o m Pr ot oc ol- S pecifie d Safet y A nal yses................................................................................ 2 6
8.   P H A R M A C O KI N E TI C ( P K) A N A L Y S E S......................................................................................................... 2 7
8. 1.   
P K Sa m ple C ollecti o n ............................................................................................................................. 2 7
8. 2.   
P K A nal yses Relate d t o S parse P K Sa m pli n g......................................................................................... 2 7
8. 3.   
C ha n ges Fr o m Pr ot oc ol- S pecifie d P K A nal yses..................................................................................... 2 7
9.   
R E F E R E N C E S..................................................................................................................................................... 2 8
1 0. 
S O F T W A R E......................................................................................................................................................... 2 9
1 1. 
S A P R E VI SI O N................................................................................................................................................... 3 0
1 2.  
A P P E N DI C E S...................................................................................................................................................... 3 1
LI S T O F I N- T E X T T A B L E S
Ta ble 1- 1.   
St u d y Desi g n.............................................................................................................................. 9
Ta ble 3- 1.    
A nal ysis Visit Wi n d o ws f or C he mistr y La b orat or y Tests, He mat ol o g y La b orat or y 
Tests, a n d Vital Si g ns.............................................................................................................. 1 6
Ta ble 3- 2.    
A nal ysis Visit Wi n d o ws f or C oa g ulati o n La b orat or y Tests.................................................... 1 6
Ta ble 3- 3.    
A nal ysis Visit Wi n d o ws f or Uri nal ysis La b orat or y Tests....................................................... 1 6
Ta ble 3- 4.    
A nal ysis Visit Wi n d o ws f or S A R S- C o V- 2 Mi dt ur bi nate Nasal S wa b a n d 
Micr o bi ol o g y La b orat or y Tests............................................................................................... 1 7
C CI


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 4 of 3 8
LI S T O F A B B R E VI A TI O N S
A E
a d verse e ve nt
A L P
al kali ne p h os p hatase
A L T
ala ni ne a mi n otra nsferase
a P T T  
acti vate d partial t hr o m b o plasti n ti me
A S T
as partate a mi n otra nsferase
B L Q
bel o w t he li mit of q ua ntitati o n
B MI
b o d y mass i n de x
C B C
c o m plete bl o o d c o u nt
C S R
cli nical st u d y re p ort
D AI D S  
Di visi o n of AI D S
D M C  
data m o nit ori n g c o m mittee
D O B
date of birt h
e C R F  
electr o nic case re p ort f or m
e G F R  
esti mate d gl o mer ular filtrati o n rate
F A S
F ull A nal ysis Set
G A
gestati o nal a ge
H L G T  
hi g h-le vel gr o u p ter m
H L T
hi g h-le vel ter m
I D
i de ntifier
I N R
i nter nati o nal n or malise d rati o
L L O Q  
l o wer li mit of q ua ntificati o n
L T T
l o wer-le vel ter m
L O D
li mit of detecti o n
L O Q
li mit of q ua ntitati o n
M A P
mea n arterial press ure
Me d D R A  
Me dical Dicti o nar y f or Re g ulat or y Acti vities
O D V
o bel desi vir
P K
p har mac o ki netics
P o p P K  
p o p ulati o n p har mac o ki netics
P T
pr ot hr o m bi n ti me
Q 1, Q 3  
first q uartile, t hir d q uartile
R B C
re d bl o o d cell
R D V
re m desi vir
R S V
res pirat or y s y nc ytial vir us
S A E
seri o us a d verse e ve nt
S A P
statistical a nal ysis pla n
R D V
re m desi vir
S D
sta n dar d de viati o n


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 5 of 3 8
S O C
s yste m or ga n class
T E A E  
treat me nt-e mer ge nt a d verse e ve nt
T F Ls  
ta bles, fi g ures, a n d listi n gs
U L N
u p per li mit of n or mal
W H O
W orl d Healt h Or ga nizati o n
S D
sta n dar d de viati o n
S O C
s yste m or ga n class
T E A E  
treat me nt-e mer ge nt a d verse e ve nt
T F Ls  
ta bles, fi g ures, a n d listi n gs
U L N
u p per li mit of n or mal
W H O
W orl d Healt h Or ga nizati o n


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 6 of 3 8
P H A R M A C O KI N E TI C A B B R E VI A TI O N S
A U C  
area u n der t he c o nce ntrati o n vers us ti me c ur ve
A U C 0 1 2
partial area u n der t he c o nce ntrati o n vers us ti me c ur ve fr o m ti me “ x” t o ti me “ x x”
C ma x
ma xi m u m o bser ve d c o nce ntrati o n of dr u g 
C tr o u g h
c o nce ntrati o n at t he e n d of t he d osi n g i nter val 


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 7 of 3 8
1.   
I N T R O D U C TI O N
T his statistical a nal ysis pla n ( S A P) descri bes t he statistical a nal ysis met h o ds a n d data 
prese ntati o ns t o be use d i n ta bles, fi g ures, a n d listi n gs ( T F Ls) i n t he cli nical st u d y re p ort ( C S R) 
f or St u d y G S- U S- 6 1 1- 6 4 6 4. T his S A P is base d o n t he st u d y pr ot oc ol ori gi nal date d 
0 9 Ma y 2 0 2 3, st u d y pr ot oc ol a d mi nistrati ve a me n d me nt 1 date d 2 2 J u ne 2 0 2 3, st u d y pr ot oc ol 
a me n d me nt 0. 1 E U date d 1 5 N o ve m ber 2 0 2 3  a n d t he electr o nic case re p ort f or m (e C R F). T he 
S A P will be fi nalize d bef ore data base fi nalizati o n. A n y c ha n ges ma de after t he fi nalizati o n of t he 
S A P will be d oc u me nte d i n t he C S R.
T his st u d y was ter mi nate d earl y; he nce o nl y t he a nal yses o utli ne d i n t his S A P will be perf or me d.
1. 1.   
St u d y O bjecti ves a n d E n d p oi nts
Pri m ar y O bjecti ve(s)
Pri m ar y E n d p oi nt(s)
•  
T o e val uate t he plas ma p har mac o ki netics 
( P K) of O D V i n pe diatric partici pa nts wit h 
C O VI D- 1 9
•  
P K para meters ( A U C 0- 1 2, Cma x , a n d Ctr o u g h) f or 
O D V meta b olite, G S- 4 4 1 5 2 4
•  
T o e val uate t he safet y a n d t olera bilit y of O D V 
i n pe diatric partici pa nts wit h C O VI D- 1 9
•  
I nci de nce of treat me nt-e mer ge nt a d verse 
e ve nts ( A Es) b y Da y 3 5
•  
I nci de nce of treat me nt-e mer ge nt la b orat or y 
a b n or malities b y Da y 3 5
Sec o n d ar y O bjecti ve(s)
Sec o n d ar y E n d p oi nt(s)
•  
T o assess t he i m pact of O D V o n ti me t o 
s ustai ne d alle viati o n of tar gete d C O VI D- 1 9 
s y m pt o ms i n pe diatric partici pa nts wit h 
C O VI D- 1 9
•  
Ti me t o s ustai ne d alle viati o n of tar gete d 
C O VI D- 1 9 s y m pt o ms b y Da y 3 5
•  
T o e val uate t he a nti viral acti vit y of O D V o n 
S A R S- C o V- 2 nasal s wa b viral l oa d i n 
pe diatric partici pa nts wit h C O VI D- 1 9
•  
C ha n ge fr o m baseli ne i n S A R S- C o V- 2 nasal 
s wa b viral l oa d at Da y 5
•  
T o assess t he i m pact of O D V o n t he 
re q uire me nt f or s u p ple me ntal o x y ge n i n 
pe diatric partici pa nts wit h C O VI D 1 9
•  
Pr o p orti o n of partici pa nts w h o re q uire 
s u p ple me ntal o x y ge n s u p p ort (l o w fl o w 
o x y ge n, hi g h fl o w o x y ge n, n o ni n vasi ve 
ve ntilati o n, mec ha nical ve ntilati o n, or 
e xtrac or p oreal me m bra ne o x y ge nati o n) b y 
Da y 3 5
•  
T o e val uate palata bilit y a n d acce pta bilit y of 
O D V i n pe diatric partici pa nts wit h C O VI D- 1 9
•  
Assess me nt of palata bilit y a n d acce pta bilit y 
sc ores of eac h f or m ulati o n at Da y 5


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 8 of 3 8
•  
T o pr o vi de data o n t he use of me dicati o ns 
ot her t ha n re m desi vir ( R D V) a n d O D V f or 
treat me nt of C O VI D- 1 9 i n pe diatric 
partici pa nts wit h C O VI D- 1 9
•  
Pr o p orti o n of partici pa nts wit h c o nc o mita nt 
use of me dicati o ns ot her t ha n R D V a n d O D V 
f or treat me nt of C O VI D- 1 9 b y Da y 3 5
•  
T o assess t he i m pact of O D V o n C O VI D- 1 9-
relate d h os pitalizati o ns or all-ca use deat h i n 
pe diatric partici pa nts wit h C O VI D- 1 9
•  
Pr o p orti o n of partici pa nts wit h C O VI D- 1 9-
relate d h os pitalizati o n or all-ca use deat h b y 
Da y 3 5
1. 2.   
St u d y Desi g n
T his is a P hase 2/ 3, si n gle-ar m, m ulti-c o h ort, o pe n-la bel st u d y t o e val uate t he safet y, P K, a n d 
efficac y of O D V i n pe diatric partici pa nts wit h C O VI D- 1 9 w h o are at ris k of pr o gressi o n t o 
se vere disease. 
C CI


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 9 of 3 8
At least 5 2 partici pa nts a ge d 0 da ys t o < 1 8 years were pla n ne d t o be e nr olle d as descri be d i n 
Ta ble 1- 1 . Partici pa nts were e nr olle d i n a sta g gere d ma n ner a n d recei ve d treat me nt wit h O D V. 
C o h orts were o pe ne d f or e nr oll me nt base d u p o n a vaila bilit y of a s uita ble pe diatric f or m ulati o n 
a n d a vaila bilit y of preli mi nar y safet y a n d P K data.
T a ble 1- 1.   
St u d y Desi g n
C o h ort
Descri pti o n
D ose
N u m ber of 
p artici p a nts
Pe diatric partici pa nts ≥ 2 8 da ys t o < 1 8 years ol d
1  
≥ 6 years t o < 1 8 years a n d wei g ht ≥ 4 0 k g  
O D V    
 a d mi nistere d orall y 
BI D f or 5 da ys
1 2
2  
≥ 6 years t o < 1 8 years a n d wei g ht ≥ 2 0 k g t o 
< 4 0 k g
O D V    
 a d mi nistere d orall y 
BI D f or 5 da ys
1 2
3  
≥ 2 years t o < 1 8 years a n d wei g ht ≥ 1 2 k g t o 
< 2 0 k g
T B C
1 2
4  
≥ 2 8 da ys t o < 1 8 years a n d wei g ht ≥ 3 k g t o 
< 1 2 k g
T B C
1 2
Ter m ne o natal partici pa nts 0 da ys t o < 2 8 da ys ol d
5
≥ 1 4 da ys t o < 2 8 da ys of a ge, G A ≥ 3 7 
wee ks a n d wei g ht ≥ 2. 5 k g
T B C
≥ 4
6  
0 da ys t o < 1 4 da ys of a ge, G A ≥ 3 7 wee ks 
a n d birt h wei g ht ≥ 2. 5 k g
T B C
All a vaila ble
Preter m ne o nates a n d i nfa nts 0 da ys t o < 5 6 da ys ol d
7  
0 da ys t o < 5 6 da ys of a ge, G A < 3 7 wee ks 
a n d birt h wei g ht ≥ 1. 5 k g
T B C
All a vaila ble
G A = gestati o nal a ge; T B C = T o be c o nfir me d.
Partici pa nts ha d t o ha ve:
•
S A R S- C o V- 2 i nfecti o n c o nfir me d b y p ol y merase c hai n reacti o n or a n alter nati ve m olec ular 
dia g n ostic assa y
•
I nitial o nset of C O VI D- 1 9 si g ns/s y m pt o ms ≤ 5 da ys bef ore scree ni n g wit h ≥ 1 si g n/s y m pt o m
•
Prese nce of ≥ 1 c haracteristic or u n derl yi n g me dical c o n diti o n ass ociate d wit h a n i ncrease d 
ris k of de vel o pi n g se vere ill ness d ue t o C O VI D- 1 9
Ra n d o mizati o n a n d treat me nt c o des were n ot a p plica ble i n t his st u d y. Bli n di n g of treat me nt 
assi g n me nts or data was n ot a p plica ble i n t his st u d y.
T he st u d y treat me nt peri o d was 5 da ys wit h a p osttreat me nt f oll o w- u p peri o d of 3 0 da ys after t he 
last d ose of st u d y dr u g.
T he sc he d ule of st u d y pr oce d ures is prese nte d i n A p pe n di x 1 .
C CI
C CI--


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 1 0 of 3 8
1. 3.   
S a m ple Size a n d P o wer
T he t otal sa m ple size was pla n ne d t o be at least 5 2 partici pa nts.
A mi ni m u m of 1 2 e val ua ble partici pa nts fr o m eac h c o h ort ( C o h orts 1- 4) pr o vi des > 9 0 % p o wer 
t o reject t he n ull h y p ot hesis t hat t here is at least a 3 0 % differe nce i n G S- 4 4 1 5 2 4 A U C 0- 1 2 a n d 
C ma x , res pecti vel y, bet wee n pe diatric a n d a d ult partici pa nts, usi n g 2 o ne-si de d tests wit h eac h 
perf or me d at a n al p ha le vel of 0. 0 5. T his p o wer a nal ysis ass u mes t hat t he e x pecte d ge o metric 
mea n rati o bet wee n t he pe diatric partici pa nts vers us t he a d ult gr o u p is 1, t he e q ui vale nc y 
b o u n dar y is 7 0 % t o 1 4 3 %, a n d t he i nter partici pa nt sta n dar d de viati o n ( S D) of A U C 0- 1 2 a n d C ma x  
are 0. 1 9 h• n g/ m L a n d 0. 1 8 n g/ m L res pecti vel y ( nat ural l o g scale, preli mi nar y res ults fr o m St u d y 
G S- U S- 6 1 1- 6 2 4 8).
T he sa m ple size calc ulati o n was perf or me d usi n g S A S ®  S oft ware Versi o n 9. 4.
T his st u d y was ter mi nate d earl y; he nce t he n u m ber of partici pa nts ori gi nall y pla n ne d t o be 
e nr olle d as o utli ne d a b o ve was n ot ac hie ve d.


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 1 1 of 3 8
2.   
T Y P E O F P L A N N E D A N A L Y SI S
2. 1.   
I nteri m A n al yses
As t he st u d y has bee n ter mi nate d earl y, i nteri m a nal yses are n o l o n ger re q uire d.
2. 1. 1.    
D ose Selecti o n A n al ysis
As t he st u d y has bee n ter mi nate d earl y, d ose selecti o n a nal yses f or a d diti o nal c o h orts are n o 
l o n ger re q uire d. 
2. 1. 2.    
D at a M o nit ori n g C o m mittee A n al yses
As t he st u d y has bee n ter mi nate d earl y, data m o nit ori n g c o m mittee ( D M C) a nal yses are n o 
l o n ger re q uire d. 
2. 2.   
Fi n al A n al ysis
T he fi nal a nal ysis will be perf or me d after all partici pa nts e nr olle d at t he ti me of st u d y 
ter mi nati o n ha ve c o m plete d t he st u d y, o utsta n di n g data q ueries ha ve bee n res ol ve d or 
a dj u dicate d as u nres ol va ble, a n d t he data ha ve bee n clea ne d a n d fi nalize d. 
2. 3.    
C h a n ges fr o m Pr ot oc ol- S pecifie d A n al yses
T his st u d y was ter mi nate d earl y; he nce o nl y t he a nal yses o utli ne d i n t he s u bse q ue nt secti o ns will 
be perf or me d.


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 1 2 of 3 8
3.    
G E N E R A L C O N SI D E R A TI O N S F O R D A T A A N A L Y S E S
D ue t o t he l o w n u m ber of partici pa nt i n t he st u d y at t he ti me of earl y ter mi nati o n, n o ta bles or 
fi g ures will be pr o vi de d f or t his st u d y. 
B y- partici pa nt listi n gs will be prese nte d f or all partici pa nts i n t he All E nr olle d A nal ysis Set a n d 
s orte d b y c o h ort, partici pa nt i de ntitifier (I D) n u m ber i n asce n di n g or der, visit date, a n d ti me 
(if a p plica ble), u nless ot her wise s pecifie d. Data c ollecte d o n l o g f or ms, s uc h as A Es, will be 
prese nte d i n c hr o n ol o gical or der wit hi n t he partici pa nt. T he c o h ort t o w hic h partici pa nts were 
e nr olle d will be use d i n t he listi n gs. A ge, se x at birt h, race, a n d et h nicit y will be i ncl u de d i n t he 
listi n gs, as s pace per mits.
3. 1.    
A n al ysis Sets
A nal ysis sets defi ne t he partici pa nts t o be i ncl u de d i n a n a nal ysis. A nal ysis sets a n d t heir 
defi niti o ns are pr o vi de d i n t his secti o n. T he a nal ysis set will be i de ntifie d a n d i ncl u de d as a 
s u btitle of eac h T F L.
3. 1. 1.    
All E nr olle d A n al ysis Set
All E nr olle d A nal ysis Set i ncl u des all partici pa nts w h o recei ve d a st u d y partici pa nt I D n u m ber i n 
t he st u d y after scree ni n g.
3. 1. 2.   
F ull A n al ysis Set
T he F ull A nal ysis Set ( F A S)  i ncl u des all e nr olle d partici pa nts w h o t o o k at least 1 d ose of st u d y 
dr u g. T his is t he pri mar y a nal ysis set f or efficac y a nal yses.
3. 1. 3.   
S afet y A n al ysis Set
T he Safet y A nal ysis Set i ncl u des all partici pa nts w h o t o o k at least 1 d ose of st u d y dr u g. T his is 
t he pri mar y a nal ysis set f or safet y a nal yses.
3. 1. 4.   
P h ar m ac o ki netic A n al ysis Set
T he P K  A nal ysis Set will i ncl u de all e nr olle d partici pa nts w h o t o o k at least 1 d ose of st u d y dr u g 
a n d ha ve at least 1 n o n missi n g c o nce ntrati o n val ue re p orte d b y t he P K la b orat or y f or 
G S- 4 4 1 5 2 4. T his is t he pri mar y a nal ysis set  f or all P K a nal yses. Wit hi n t he P K A nal ysis Set, 
t h ose partici pa nts wit h P K e x p os ure data s uccessf ull y deri ve d fr o m t he p o p ulati o n P K ( P o p P K) 
m o deli n g will be i ncl u de d i n t he a nal yses relate d t o P K e x p os ure.
3. 1. 5.    
Vir ol o g y A n al ysis Set
T he Vir ol o g y A nal ysis Set will i ncl u de all e nr olle d partici pa nts w h o t o o k at least 1 d ose of st u d y 
dr u g a n d ha ve a baseli ne S A R S- C o V- 2 viral l oa d ≥ l o wer li mit of q ua ntificati o n ( L L O Q). Refer 
t o Secti o n 3. 7  f or t he defi niti o n of L L O Q.


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
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Pa ge 1 3 of 3 8
3. 2.   
P artici p a nt Gr o u pi n g
F or a nal yses, partici pa nts will be gr o u pe d acc or di n g t o t he c o h ort t o w hic h partici pa nts were 
e nr olle d.
3. 3.   
Str at a a n d C o v ari ates
T his st u d y is n ot ra n d o mize d. It t heref ore di d n ot use a stratifie d ra n d o mizati o n sc he d ule w he n 
e nr olli n g partici pa nts. N o c o variates will be i ncl u de d i n efficac y a n d safet y a nal yses.
3. 4.   
E x a mi n ati o n of P artici p a nt S u b gr o u ps
T here are n o pres pecifie d partici pa nt s u b gr o u pi n gs f or efficac y a n d safet y a nal yses.
3. 5.    
M ulti ple C o m p aris o ns
A dj ust me nts f or m ulti plicit y will n ot be ma de, beca use n o f or mal statistical testi n g will be 
perf or me d i n t his st u d y.
3. 6.    
Missi n g D at a a n d O utliers
3. 6. 1.    
Missi n g D at a
I n ge neral, missi n g data will n ot be i m p ute d u nless met h o ds f or ha n dli n g missi n g data are 
s pecifie d. E xce pti o ns are prese nte d i n t his d oc u me nt.
F or missi n g last d osi n g date of st u d y dr u g, i m p utati o n r ules are descri be d i n Secti o n 4. 2 . T he 
ha n dli n g of missi n g or i nc o m plete dates f or A E o nset is descri be d i n Secti o n 7. 1. 5. 2 , a n d f or 
pri or a n d c o nc o mita nt me dicati o ns i n Secti o n 7. 3 .
3. 6. 2.    
O utliers
O utliers of n o n- P K data will be i de ntifie d d uri n g t he data ma na ge me nt a n d data a nal ysis pr ocess, 
b ut n o se nsiti vit y a nal yses will be c o n d ucte d. All data will be i ncl u de d i n t he data a nal ysis.
3. 7.    
D at a H a n dli n g C o n ve nti o ns a n d Tr a nsf or m ati o ns
T he f oll o wi n g c o n ve nti o ns will be use d f or t he i m p utati o n of date of birt h w he n it is partiall y 
missi n g or n ot c ollecte d:
•
If o nl y m o nt h a n d year of birt h is c ollecte d, t he n “ 1 5” will be i m p ute d as t he da y of birt h
•
If o nl y year of birt h is c ollecte d, t he n “ 0 1 J ul y” will be i m p ute d as t he da y a n d m o nt h of birt h
•
If year of birt h is missi n g, t he n date of birt h will n ot be i m p ute d.


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 1 4 of 3 8
I n ge neral, a ge c ollecte d at Da y 1 will be use d f or a nal yses a n d prese nte d i n listi n gs. If a ge at 
Da y 1 is n ot a vaila ble f or a partici pa nt, t he n a ge deri ve d base d o n date of birt h a n d t he Da y 1 
visit date will be use d i nstea d. If a n e nr olle d partici pa nt was n ot d ose d wit h a n y st u d y dr u g, t he 
e nr oll me nt date will be use d i nstea d of t he Da y 1 visit date. F or scree n fail ures, t he date t he first 
i nf or me d c o nse nt was si g ne d will be use d f or t he a ge deri vati o n. A ge re q uire d f or l o n git u di nal 
a n d te m p oral calc ulati o ns a n d a nal yses (f or e g, esti mates of creati ni ne cleara nce, a ge at date of 
A E) will be base d o n a ge deri ve d fr o m date of birt h a n d t he date of t he meas ure me nt or e ve nt, 
u nless ot her wise s pecifie d.
N o n- P K data t hat are c o nti n u o us i n nat ure b ut are less t ha n t he L L O Q or a b o ve t he u p per li mit of 
q ua ntitati o n ( L O Q) will be i m p ute d as f oll o ws:
•
A val ue t hat is 1 u nit less t ha n t he L L O Q at t he sa me precisi o n le vel of t he ori gi nall y 
re p orte d val ue will be use d t o calc ulate descri pti ve statistics if t he dat u m is re p orte d i n t he 
f or m of “ x” ( w here x is c o nsi dere d t he L L O Q). F or e g, if t he val ues are re p orte d as 
< 5 0 a n d < 5. 0, val ues of 4 9 a n d 4. 9, res pecti vel y, will be use d t o calc ulate s u m mar y 
statistics. A n e xce pti o n t o t his r ule is a n y val ue re p orte d as < 1 or < 0. 1, etc. F or val ues 
re p orte d as < 1 or < 0. 1, a val ue of 0. 9 or 0. 0 9, res pecti vel y, will be use d t o calc ulate 
s u m mar y statistics.
•
A val ue t hat is 1 u nit a b o ve t he u p per L O Q will be use d t o calc ulate descri pti ve statistics if 
t he dat u m is re p orte d i n t he f or m of “ > x” ( w here x is c o nsi dere d t he u p per L O Q). Val ues 
wit h deci mal p oi nts will f oll o w t he sa me l o gic as a b o ve.
•
T he l o wer or u p per L O Q will be use d t o calc ulate descri pti ve statistics if t he dat u m is 
re p orte d i n t he f or m of “ ≤ x” or “ ≥ x” ( w here x is c o nsi dere d t he l o wer or u p per L O Q, 
res pecti vel y).
S A R S- C o V- 2 viral l oa d res ults t hat are bel o w L L O Q b ut ha ve a p ositi ve si g nal will be re p orte d 
as “ < 2 2 2 8 c p/ m L S A R S- C o V- 2 detecte d” a n d t h ose t hat are bel o w t he l o wer li mit of detecti o n 
( L O D) a n d ne gati ve will be re p orte d as “ N o S A R S- C o V- 2 detecte d”. T he data will be i m p ute d 
as f oll o ws:
•
A val ue of 1 1 1 4 c o pies/ m L ( half of t he L O Q 2 2 2 8 c o pies/ m L) will be use d t o calc ulate 
descri pti ve statistics if t he dat u m is re p orte d as “ < 2 2 2 8c p/ m L S A R S- C o V- 2 detecte d”.
•
A val ue of 7 4 6. 5 c o pies/ m L ( half of t he L O D 1 4 9 3 c o pies/ m L) will be use d t o calc ulate 
descri pti ve statistics if t he dat u m is re p orte d as “ N o S A R S- C o V- 2 detecte d”.
Base 1 0 l o garit h m tra nsf or mati o n will be use d f or a nal yzi n g S A R S- C o V- 2 viral l oa d.
S parse P K c o nce ntrati o n val ues t hat are bel o w t he li mit of q ua ntitati o n ( B L Q) will be prese nte d 
as “ B L Q” i n t he data listi n g.


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
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Pa ge 1 5 of 3 8
3. 8.    
A n al ysis Visit Wi n d o ws
3. 8. 1.    
Defi niti o n of St u d y D a y
St u d y da y will be calc ulate d fr o m t he first d osi n g date of st u d y dr u g  a n d deri ve d as f oll o ws:
•
F or p ost d ose st u d y da ys: Assess me nt Date – First D osi n g Date + 1
•
F or da ys pri or t o t he first d ose: Assess me nt Date – First D osi n g Date
T heref ore, St u d y Da y 1 is t he da y of first d ose of st u d y dr u g a d mi nistrati o n.
Last D ose Date is defi ne d as t he ma xi m u m, n o n missi n g, n o nzer o d ose e n d date of treat me nt 
rec or de d o n t he St u d y Dr u g A d mi nistrati o n e C R F wit h “ C hec k b o x if st u d y dr u g was 
per ma ne ntl y wit h dra w n” c hec ke d f or partici pa nts w h o pre mat urel y disc o nti n ue d or c o m plete d 
st u d y dr u g acc or di n g t o t he St u d y Dr u g C o m pleti o n e C R F. Refer t o Secti o n 4. 2  f or missi n g date 
i m p utati o n, if necessar y.
Last St u d y Date is t he latest of t he st u d y dr u g start dates a n d e n d dates, t he i n- pers o n or virt ual 
visit dates, t he vital si g n c ollecti o n dates, t he partici pa nt a n d/ or care gi ver C O VI D- 1 9 s y m pt o m 
assess me nt q uesti o n naire dates, t he la b orat or y c ollecti o n dates, a n d t he deat h date (if a p plica ble, 
f or partici pa nts w h o die d d uri n g t he st u d y, t he deat h date will be t he Last St u d y Date. F or 
partici pa nts w h o die d after c o m pleti n g t he st u d y or after pre mat urel y disc o nti n ui n g t he st u d y, t he 
deat h date will n ot be c o nsi dere d f or t he Last St u d y Date).
Baseli ne val ue is defi ne d as t he last val ue o btai ne d o n or pri or t o t he first d ose of st u d y dr u g 
a d mi nistrati o n date u nless ot her wise s pecifie d (see Secti o n 3. 8. 3 ).
3. 8. 2.    
A n al ysis Visit Wi n d o ws
Partici pa nt visits mi g ht n ot occ ur o n pr ot oc ol-s pecifie d da ys. T heref ore, f or t he p ur p ose of 
a nal ysis, o bser vati o ns will be assi g ne d t o a nal ysis wi n d o ws.
T he a nal ysis wi n d o ws f or c he mistr y la b orat or y tests, he mat ol o g y la b orat or y tests, a n d vital si g ns 
are pr o vi de d i n Ta ble 3- 1 .


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 1 6 of 3 8
T a ble 3- 1.    
A n al ysis Visit Wi n d o ws f or C he mistr y L a b or at or y Tests, He m at ol o g y 
L a b or at or y Tests, a n d Vit al Si g ns
Visit Wi n d o w St u d y D a y
Visit
St u d y D a y
L o wer Li mit
U p per Li mit
Baseli ne
1
( n o ne)
1
Da y 3
3
2
4
Da y 5
5
5
2 0
Da y 3 5
3 5
2 1
≥ 3 5
He mat ol o g y la b orat or y tests i ncl u de c o m plete bl o o d c o u nt ( C B C) wit h differe ntial.
C he mistr y la b orat or y tests i ncl u de al b u mi n, ala ni ne a mi n otra nsferase ( A L T), al kali ne p h os p hatase ( A L P), as partate 
a mi n otra nsferase ( A S T), t otal bilir u bi n, bl o o d urea nitr o ge n, creati ni ne, esti mate d gl o mer ular filtrati o n rate (e G F R) usi n g be dsi de 
Sc h wartz f or m ula, i o nize d calci u m, car b o n di o xi de, c hl ori de, t otal ser u m pr otei n, p otassi u m, a n d s o di u m.
Vitals si g ns i ncl u de heart rate, te m perat ure, bl o o d press ure ( mea n arterial press ure [ M A P] if a vaila ble, s yst olic a n d diast olic), 
res pirat or y rate, a n d o x y ge n sat urati o n.
T he a nal ysis wi n d o ws f or c oa g ulati o n la b orat or y tests are pr o vi de d i n Ta ble 3- 2 .
T a ble 3- 2.    
A n al ysis Visit Wi n d o ws f or C o a g ul ati o n L a b or at or y Tests
Visit Wi n d o w St u d y D a y
Visit
St u d y D a y
L o wer Li mit
U p per Li mit
Baseli ne
1
( n o ne)
1
Da y 5
5
2
≥ 5
C oa g ulati o n la b orat or y tests i ncl u de pr ot hr o m bi n ti me ( P T), acti vate d partial t hr o m b o plasti n ti me (a P T T) wit h calc ulate d 
i nter nati o nal n or malise d rati o (I N R).
T he a nal ysis wi n d o ws f or uri nal ysis la b orat or y tests are pr o vi de d i n Ta ble 3- 3 .
T a ble 3- 3.    
A n al ysis Visit Wi n d o ws f or Uri n al ysis L a b or at or y Tests
Visit Wi n d o w St u d y D a y
Visit
St u d y D a y
L o wer Li mit
U p per Li mit
Baseli ne
1
( n o ne)
1
Uri nal ysis la b orat or y tests i ncl u de bilir u bi n, gl uc ose, er yt hr oc ytes, a n d le u k oc ytes.
T he a nal ysis wi n d o ws f or S A R S- C o V- 2 mi dt ur bi nate nasal s wa b a n d micr o bi ol o g y la b orat or y 
tests are pr o vi de d i n Ta ble 3- 4 .


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 1 7 of 3 8
T a ble 3- 4.    
A n al ysis Visit Wi n d o ws f or S A R S- C o V- 2 Mi dt ur bi n ate N as al S w a b a n d 
Micr o bi ol o g y L a b or at or y Tests
Visit Wi n d o w St u d y D a y
Visit
St u d y D a y
L o wer Li mit
U p per Li mit
Baseli ne
1
( n o ne)
1
Da y 3
3
2
4
Da y 5
5
5
6
Da y 8
8
7
1 1
Da y 1 4
1 4
1 2
2 5
Da y 3 5
3 5
2 6
≥ 3 5
Micr o bi ol o g y la b orat or y tests i ncl u de I nfl ue nza A Vir us, I nfl ue nza B Vir us, Res pirat or y S y nc ytial Vir us ( R S V), a n d 
S A R S- C o V- 2.
3. 8. 3.   
Selecti o n of D at a i n t he E ve nt of M ulti ple Rec or ds i n a n A n al ysis Visit 
Wi n d o w
De pe n di n g o n t he statistical a nal ysis met h o d, si n gle val ues ma y be re q uire d f or eac h a nal ysis 
wi n d o w. F or e xa m ple, c ha n ge fr o m baseli ne b y visit us uall y re q uires a si n gle val ue, w hereas a 
ti me-t o-e ve nt a nal ysis w o ul d n ot re q uire 1 val ue per a nal ysis wi n d o w.
If m ulti ple vali d, n o n missi n g meas ure me nts e xist i n a n a nal ysis wi n d o w, rec or ds will be c h ose n 
base d o n t he f oll o wi n g r ules if a si n gle val ue is nee de d:
•
F or baseli ne data, t he last n o n missi n g val ue o n or pri or t o t he first d ose of st u d y dr u g 
a d mi nistrati o n date will be selecte d, u nless s pecifie d differe ntl y. If t here are m ulti ple rec or ds 
o n t he sa me da y, t he baseli ne val ue will be selecte d as f oll o ws:

F or c o nti n u o us data:
▪
F or S A R S- C o V- 2 viral l oa d data, t he ge o metric mea n (c o pies/ m L) will be ta ke n.
▪
F or ot her c o nti n u o us data, t he a vera ge of t he meas ure me nts will be ta ke n.

F or cate g orical data:
▪
F or S A R S- C o V- 2 i nfecti o n stat us, t he hi g hest se verit y (ie, a p ositi ve P C R res ult) will 
be selecte d.
▪
F or ot her cate g orical data, t he l o west se verit y will be selecte d.


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 1 8 of 3 8
•
F or p ost baseli ne val ues:

T he rec or d cl osest t o t he n o mi nal da y f or t hat visit will be selecte d wit h t he e xce pti o n of 
S A R S- C o V- 2 viral l oa d data i n w hic h t he latest rec or d will be selecte d.

If t here are 2 rec or ds t hat are e q ui dista nt fr o m t he n o mi nal da y, t he later rec or d will be 
selecte d.

If t here is m ore t ha n 1 rec or d o n t he selecte d da y, val ues will be selecte d as f oll o ws:
▪
F or S A R S- C o V- 2 viral l oa d, if t here are m ulti ple rec or ds wit h t he sa me ti me or n o 
ti me rec or de d o n t he sa me da y, t he ge o metric mea n val ue (c o pies/ m L) will be ta ke n.
▪
F or re d bl o o d cell ( R B C) M or p h ol o g y res ult, if t here is m ore t ha n 1 rec or d o n t he 
selecte d da y, all res ults will be selecte d.
▪
F or ot her para meters, if t here is m ore t ha n 1 rec or d o n t he selecte d da y, t he a vera ge 
will be ta ke n f or c o nti n u o us data a n d t he w orst se verit y will be ta ke n f or cate g orical 
data, u nless ot her wise s pecifie d.


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 1 9 of 3 8
4.   
P A R TI CI P A N T DI S P O SI TI O N
4. 1.   
P artici p a nt E nr oll me nt a n d Dis p ositi o n
B y- partici pa nt listi n gs s orte d b y partici pa nt I D n u m ber (i n asce n di n g or der) will be pr o vi de d f or 
t he f oll o wi n g:
•
E nr oll me nt
•
Partici pa nt dis p ositi o n, i ncl u di n g c o h ort, date of e nr oll me nt, first d ose date, last d ose date, 
e n d of st u d y date, st u d y dr u g disc o nti n uati o n, st u d y disc o nti n uati o n, a n d reas o ns f or st u d y 
dr u g or st u d y disc o nti n uati o n
4. 2.   
E xte nt of St u d y Dr u g E x p os ure a n d A d here nce
T otal d urati o n of e x p os ure t o st u d y dr u g will be defi ne d as last d osi n g date mi n us first d osi n g 
date pl us 1, re gar dless of a n y te m p orar y i nterr u pti o ns i n st u d y dr u g a d mi nistrati o n, a n d will be 
e x presse d i n da ys. If t he last st u d y dr u g d osi n g date is missi n g, t he last d osi n g date is i m p ute d as 
t he earliest date fr o m t he f oll o wi n g:
•
Da y 5 if t he partici pa nt t o o k 2 ta blets o n Da y 1
•
Da y 6 if t he partici pa nt t o o k 1 ta blet o n Da y 1
•
Last st u d y visit date
St u d y da y f or t he i m p ute d last d osi n g date will n ot e xcee d St u d y Da y 6.
A b y- partici pa nt listi n g of st u d y dr u g a d mi nistrati o n will be pr o vi de d se paratel y b y partici pa nt 
I D n u m ber (i n asce n di n g or der).
4. 3.   
Pr ot oc ol De vi ati o ns 
Partici pa nts w h o di d n ot meet t he eli gi bilit y criteria f or st u d y e ntr y b ut e nr olle d i n t he st u d y, will 
be s u m marize d re gar dless of w het her t he y were e xe m pte d b y t he s p o ns or or n ot. A 
b y- partici pa nt listi n g will be pr o vi de d f or t h ose partici pa nts w h o di d n ot meet at 
least 1 eli gi bilit y (i ncl usi o n or e xcl usi o n) criteri o n. T he listi n g will prese nt t he eli gi bilit y 
criteri o n ( or criteria if m ore t ha n 1 de viati o n) t hat partici pa nts di d n ot meet a n d relate d 
c o m me nts, if c ollecte d.
Pr ot oc ol de viati o ns occ urri n g after partici pa nts e ntere d t he st u d y are d oc u me nte d d uri n g r o uti ne 
m o nit ori n g. A b y- partici pa nt listi n g will be pr o vi de d f or t h ose partici pa nts wit h pr ot oc ol 
de viati o ns, i ncl u de d a c ol u m n s pecif yi n g w het her t he pr ot oc ol de viati o n is i m p orta nt.
4. 4.    
Assess me nt of Dis aster or P u blic He alt h E mer ge nc y I m p act
T he st u d y is i n partici pa nts wit h C O VI D- 1 9 t h us n o a d diti o nal assess me nt of C O VI D- 1 9 i m pact 
will be i ncl u de d.


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 2 0 of 3 8
5.   
B A S E LI N E C H A R A C T E RI S TI C S
5. 1.    
De m o gr a p hics a n d B aseli ne C h ar acteristics
De m o gra p hics a n d baseli ne c haracteristics i ncl u de:
•
A ge [i n years]
•
A ge gr o u p ( < 2 8 da ys; 2 8 da ys t o < 2 years; 2 t o < 1 2 years; 1 2 t o < 1 8 years)
•
Se x at birt h ( Male; Fe male)
•
Race ( A merica n I n dia n or Alas ka Nati ve; Asia n; Blac k; Nati ve Ha waiia n or Pacific Isla n der; 
W hite; N ot Per mitte d; Ot her)
•
Et h nicit y ( His pa nic or Lati n o; N ot His pa nic or Lati n o; N ot Per mitte d) 
•
Baseli ne b o d y wei g ht [i n k g]
•
Baseli ne b o d y mass i n de x ( B MI) [i n k g/ m²]
•
B MI-f or-a ge Z-sc ores
•
B MI-f or-a ge perce ntile cate g or y ( < 5t h Perce ntile; 5t h t o < 8 5t h Perce ntile; 8 5t h t o 
< 9 5 t h Perce ntile; ≥ 9 5t h Perce ntile)

Details o n B MI-f or-a ge perce ntiles are a vaila ble i n A p pe n di x 2 .
A b y- partici pa nt de m o gra p hic listi n g, i ncl u di n g t he i nf or me d c o nse nt date, will be pr o vi de d b y 
partici pa nt I D n u m ber (i n asce n di n g or der). N ote: If i nf or mati o n o n A p gar sc ore f or partici pa nts 
< 2 4 h o urs, hea d circ u mfere nce (i n c m) f or partici pa nts < 2 8 da ys, birt h wei g ht (i n k g) f or 
partici pa nts < 5 6 da ys of a ge a n d/ or gestati o nal a ge (i n wee ks) f or partici pa nts < 1 year has bee n 
c ollecte d t his i nf or mati o n will be liste d.
5. 2.    
Ot her B aseli ne C h ar acteristics
Ot her baseli ne c haracteristics i ncl u de:
•
D urati o n of C O VI D- 1 9 s y m pt o ms pri or t o first d osi n g date ( da ys)

Defi ne d as: First D osi n g Date – O nset Date of First/ Earliest C O VI D- 1 9 S y m pt o m
•
D urati o n fr o m first p ositi ve S A R S- C o V- 2 dia g n ostic test t o first d osi n g date ( da ys)

Defi ne d as: First D osi n g Date – Date of C O VI D- 1 9 Dia g n osis
•
Ris k fact ors li n ke d t o me dical hist or y:

 
C CI


O b el  d e si v ir (  OD  V;   G S  -5 2 4 5  ™) 
G S-  U S- 6 1 1 -6 4 6 4 
St ati sti c al  A n al ysis   Pl a n  -  Fi n a l A n a  lysis 
•     Tot a l n u  m b er of ri s k f a ct ors 
•     Bas eli n e  C  O  V I  D- 1 9 v a c c i nati o n  st at us: ( a) Y e s  ; ( b) N o 
V er si o n   1. 0 
•     Bas eli n e  res pir at o 1y  vir a l c oi nf e cti o ns:  ( a) N o n e;   ( b) Y e s   su b d i vi d e d i nto: (i) I nfl ue n z a  A; 
(ii) I nfl u e n za   B;  (iii)   RS  V 
•     Bas eli n e  S  A  R S -C o  V - 2  vir al lo a d  ( as a  c o nt i n u o us v ar i a ble,  a n d  a  c at e g o ric al v a ria b le: 
( a)  <  6 l o g 1 0 c o pi e s/m  L : ( b)   6 l o g 10 c o pi es /m  L ) 
•     Bas eli n e e  GF  R u si n g t h e b e d si d e  S c h w aii z   f o 1  m ul a  (m L  /mi n/ 1. 7 3 m 2) 
•     Bas eli n e  A L T   (  U/ L) 
A   b y- p aiii ci p a nt  listi n g of oth er  b as eli n e  ch ai·a c t eristi cs  wi  ll b e  pr o vi d e d  b y  p aiii ci p a nt  I  D 
n u  m b er  (i n a s c e n di n g  or d e r). 
5. 3.   
M e di c al   Hi st o r y 
M e di c al   hi st o1y  wi  ll b e  c o ll ect e d  at  s cr e e ni ng  f or g e n er a l c o n diti o ns  (i e, c o n diti o n s  n ot s p e cific 
t o th e  dis e as e  b ei n g  st u di e d).  M e di c al   hi st o1y  wi  ll b e  c o d e d u s i ng t h e  cm T e nt M e di c al   Di  cti o n ai y 
f or R e  g ul at o 1y  A c  ti viti es (  M e d  D  R  A) di cti o n ai y. 
G e n er al   m  e di c a l hi st o1y   d at a  w  ill b e  c o lle ct e d  at  s cr e eni n g  a n d  list e d  o nl y. 
1 7 J u n e 2 0 2 4 
GI L E  A  D   C  O  N FI  D E  N TI  A L   I  N F  O  R  M  A TI  O  N 
P a g e 2 1 of 3 8 


O b e l desi vir  (  OD  V;   G S  -5 2 4 5  ™) 
G S-  U S- 6 1 1 -6 4 6 4 
St ati sti c al  A n al ysis   Pl a n  -  Fi n a l A n a  lysis 
6. 
E F F I  C  A  C  Y  A  N  A  L  Y S  E S 
6. 1.   
P ri  m a r y  Effi c a c y  E n d p oi nt 
T h e r e i s n o  pri  m ai y  effi c a c y  e n d p oi nt  i n t his st u dy. 
6. 2. 
S e c o n d a r y  Effi c a c y  E n d p oi nt s 
V er si o n   1. 0 
B y  - p aiii ci p a nt listi n gs s o1i e d  b y  p a 1ii ci p a nt  I  D n u  m b er  (i n as c e n di n g  or d e r)  wi  ll b e  pr o vi d e d  f or 
t h e f oll o  wi n g: 
•   C  O  VI  D- 1  9  s ym pt  o  m s  a s s e s s e d  b y  t h e p aiii ci p a nt  a n d/ or  c ai·e gi v e r C  O  V I  D- 1 9 s y  m pt o  m 
a s s e s s m e n  t q u esti o n n air e  d at a 
•   S  A  R S -C o  V- 2   n a s a l s  w a b  v ir al lo a d 
•   O x y g e n   s u p pl e  m e nt ati o n 
•     Ho s pit ali z atio n 
6. 4.   
C h a n g e s   F r o  m  P r ot o c ol- S p e cifi e d  Effi c a c y  A n al y s e s 
T h e  d efi niti o n of th e  Vir o  lo g y  A n al y si s   S et  w a s   m  o di fie d s o t h at p a 1ii ci p an ts wit h  a   b a s e li n e 
S  A  R S -C o  V- 2   vir al  lo a d  <  L L  O  Q  wi  ll n ot  b e  i n cl u d e d i n t h e Vir ol o g y   A n  al y s i s S et. 
T hi s  st u dy  w a s   t e n ni n at e d e ai·l y; h e n c e t he  pr o t o c ol-s p e cifi e d effi c a c y  a n al ys es  w  ill n ot b e 
pr o vi d e d . O nl y   b y- p aiii ci p a nt  listi n g s wi  ll b e  pr e s e nt e d . 
1 7 J u n e 2 0 2 4 
GI L E  A  D   C  O  N FI  D E  N TI  A L   I  N F  O  R  M  A TI  O  N 
P a g e  2 2 of 3 8 


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 2 3 of 3 8
7.   
S A F E T Y A N A L Y S E S
7. 1.    
A d verse E ve nts a n d De at hs
7. 1. 1.    
A d verse E ve nt Dicti o n ar y
Cli nical a n d la b orat or y A Es will be c o de d usi n g t he c urre nt versi o n of Me d D R A. S yste m or ga n 
class, hi g h-le vel gr o u p ter m ( H L G T), hi g h-le vel ter m ( H L T), preferre d ter m, a n d l o west-le vel 
ter m ( L L T) will be pr o vi de d i n t he A E dataset.
7. 1. 2.    
A d verse E ve nt Se verit y
T he se verit y of A Es will be gra de d usi n g t he Di visi o n of AI D S ( D AI D S) Ta ble f or Gra di n g t he 
Se verit y of A d ult a n d Pe diatric A d verse E ve nts, Versi o n 2. 1 date d J ul y 2 0 1 7. F or eac h e pis o de, 
t he hi g hest gra de attai ne d s h o ul d be re p orte d as defi ne d i n t he gra di n g scale. T he D AI D S scale is 
a vaila ble at t he f oll o wi n g l ocati o n:
htt ps://rsc. niai d. ni h. g o v/sites/ defa ult/files/ dai ds gra di n gc orrecte d v 2 1. p df
A d verse e ve nts are gra de d b y t he i n vesti gat or as Gra de 1, 2, 3, 4, or 5 (fatal) acc or di n g t o 
t o xicit y criteria s pecifie d i n t he pr ot oc ol. T he se verit y gra de of e ve nts f or w hic h t he i n vesti gat or 
di d n ot rec or d se verit y will be cate g orize d as “ missi n g” f or ta b ular s u m maries a n d data listi n gs. 
T he missi n g cate g or y will be liste d last i n s u m mar y prese ntati o n.
7. 1. 3.    
Rel ati o ns hi p of A d verse E ve nts t o St u d y Dr u g
Relate d A Es are t h ose f or w hic h t he i n vesti gat or selecte d “ Relate d” o n t he A E e C R F t o t he 
q uesti o n of “ Relate d t o St u d y Treat me nt.” Relate d ness will al wa ys defa ult t o t he i n vesti gat or’s 
c h oice, n ot t hat of t he me dical m o nit or. E ve nts f or w hic h t he i n vesti gat or di d n ot rec or d 
relati o ns hi p t o st u d y dr u g will be c o nsi dere d relate d t o st u d y dr u g f or s u m mar y p ur p oses. 
H o we ver, b y- partici pa nt data listi n gs will s h o w t he relati o ns hi p as missi n g.
7. 1. 4.   
Seri o us A d verse E ve nts
Seri o us a d verse e ve nts ( S A Es) will be i de ntifie d a n d ca pt ure d as S A Es if t he A Es met t he 
defi niti o ns of S A Es t hat were s pecifie d i n t he st u d y pr ot oc ol. S A Es ca pt ure d a n d st ore d i n t he 
cli nical data base will be rec o ncile d wit h t he S A E data base fr o m t he Gilea d Gl o bal Patie nt Safet y 
De part me nt bef ore data fi nalizati o n.
7. 1. 5.   
Tre at me nt- E mer ge nt A d verse E ve nts 
7. 1. 5. 1.    
Defi niti o n of Treat me nt- E mer ge nt A d verse E ve nts
Treat me nt-e mer ge nt a d verse e ve nts ( T E A Es) are defi ne d as 1 or b ot h of t he f oll o wi n g:


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 2 4 of 3 8
•
A n y A Es wit h a n o nset date o n or after t he st u d y dr u g start date a n d n o later t ha n 3 0 da ys 
after per ma ne nt disc o nti n uati o n of st u d y dr u g
•
A n y A Es lea di n g t o pre mat ure disc o nti n uati o n of st u d y dr u g.
7. 1. 5. 2.   
I nc o m plete Dates
If t he o nset date of t he A E is i nc o m plete a n d t he A E st o p date is n ot pri or t o t he first d osi n g date 
of st u d y dr u g, t he n t he m o nt h a n d year ( or year al o ne if m o nt h is n ot rec or de d) of o nset 
deter mi ne w het her a n A E is treat me nt e mer ge nt. T he e ve nt is c o nsi dere d treat me nt e mer ge nt if 
b ot h of t he f oll o wi n g 2 criteria are met:
•
T he A E o nset is t he sa me as or after t he m o nt h a n d year ( or year) of t he first d osi n g date of 
st u d y dr u g, a n d
•
T he A E o nset date is t he sa me as or bef ore t he m o nt h a n d year ( or year) of t he date 
c orres p o n di n g t o 3 0 da ys after t he date of t he last d ose of st u d y dr u g 
A n A E wit h c o m pletel y missi n g o nset a n d st o p dates, or wit h t he o nset date missi n g a n d a st o p 
date later t ha n t he first d osi n g date of st u d y dr u g, will be c o nsi dere d t o be treat me nt e mer ge nt. I n 
a d diti o n, a n A E wit h t he o nset date missi n g a n d i nc o m plete st o p date wit h t he sa me or later 
m o nt h a n d year ( or year al o ne if m o nt h is n ot rec or de d) as t he first d osi n g date of st u d y dr u g will 
be c o nsi dere d treat me nt e mer ge nt.
7. 1. 6.   
S u m m aries of A d verse E ve nts a n d De at hs
7. 1. 6. 1.   
S u m maries of A E i nci de nce i n C o m bi ne d Se verit y Gra de S u bsets 
B y- partici pa nt listi n gs will be pr o vi de d f or t he f oll o wi n g:
•
All A Es, i n dicati n g w het her t he e ve nt is treat me nt e mer ge nt
•
All Deat hs
7. 2.   
L a b or at or y E v al u ati o ns
La b orat or y data c ollecte d d uri n g t he st u d y will be a nal yze d usi n g b ot h q ua ntitati ve a n d 
q ualitati ve met h o ds. T he a nal ysis will be base d o n val ues re p orte d i n c o n ve nti o nal u nits. W he n 
val ues are bel o w t he L O Q, t he y will be liste d as s uc h, a n d t he cl osest i m p ute d val ue will be use d 
f or t he p ur p ose of calc ulati n g s u m mar y statistics as s pecifie d i n Secti o n 3. 7 . 
A b y- partici pa nt listi n g f or la b orat or y test res ults will be pr o vi de d b y partici pa nt I D n u m ber a n d 
visit i n c hr o n ol o gical or der f or he mat ol o g y, ser u m c he mistr y, a n d c oa g ulati o n se paratel y. Val ues 
falli n g o utsi de of t he rele va nt refere nce ra n ge a n d/ or ha vi n g a se verit y gra de of 1 or hi g her will 
be fla g ge d i n t he data listi n gs, as a p pr o priate.


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 2 5 of 3 8
7. 2. 1.    
Gr a de d L a b or at or y V al ues
T he D AI D S Ta ble f or Gra di n g t he Se verit y of A d ult a n d Pe diatric A d verse E ve nt, Versi o n 2. 1 
(J ul y 2 0 1 7) will be use d t o assi g n t o xicit y gra des ( 0 t o 4) t o la b orat or y res ults f or a nal ysis. Gra de 
0 i ncl u des all val ues t hat d o n ot meet t he criteria f or a n a b n or malit y of at least Gra de 1.
7. 2. 1. 1.   
Treat me nt- E mer ge nt La b orat or y A b n or malities
Treat me nt-e mer ge nt la b orat or y a b n or malities are defi ne d as val ues t hat i ncrease at least 
1 t o xicit y gra de fr o m baseli ne at a n y p ost baseli ne ti me p oi nt, u p t o a n d i ncl u di n g t he date of last 
d ose of st u d y dr u g pl us 3 0 da ys partici pa nts w h o per ma ne ntl y disc o nti n ue d st u d y dr u g, or t he 
last a vaila ble date i n t he data base s na ps h ot f or partici pa nts w h o were still o n treat me nt at t he 
ti me of a n i nteri m a nal ysis. If t he rele va nt baseli ne la b orat or y val ue is missi n g, a n y a b n or malit y 
of at least Gra de 1 o bser ve d wit hi n t he ti me fra me s pecifie d a b o ve will be c o nsi dere d treat me nt 
e mer ge nt.
7. 2. 1. 2.   
S u m maries of La b orat or y A b n or malities
A b y- partici pa nt listi n g of treat me nt-e mer ge nt la b orat or y a b n or malities will be pr o vi de d b y 
partici pa nt I D n u m ber a n d visit i n c hr o n ol o gical or der. T his listi n g will i ncl u de all test res ults 
t hat were c ollecte d t hr o u g h o ut t he st u d y f or t he la b test of i nterest, wit h all a p plica ble se verit y 
gra des a n d a b n or mal fla gs  dis pla ye d.
F or I N R a n d a P T T, pr ot oc ol s pecifie d t o xicit y gra di n g scale de pe n ds o n t he u p per li mit of 
n or mal ra n ge ( U L N). W hile t he U L N of I N R a n d a P T T de pe n ds o n w het her t he partici pa nt is 
ta ki n g a ntic oa g ula nt me dicati o n or n ot (ie, N ot ta ki n g oral a ntic oa g ula nt: 0. 8 – 1. 2; Ta ki n g oral 
a ntic oa g ula nt: 2. 0 – 3. 0), t his i nf or mati o n is n ot c ollecte d b y t he refere nce la b orat or y. As a 
res ult, I N R a n d a P T T will be gra de d b y ass u mi n g partici pa nt is n ot ta ki n g a n oral a ntic oa g ula nt, 
w hic h is a c o nser vati ve a p pr oac h t hat ma y lea d t o o ver-re p orti n g of a b n or malities f or I N R a n d 
a P T T.
7. 2. 2.   
Li ver-rel ate d L a b or at or y E v al u ati o ns
Li ver-relate d a b n or malities after i nitial st u d y dr u g d osi n g will be e xa mi ne d usi n g t he partici pa nts 
w h o were re p orte d t o ha ve t he f oll o wi n g la b orat or y test val ues f or p ost baseli ne meas ure me nts:
•
A S T: (a) > 3 ti mes of t he u p per li mit of refere nce ra n ge ( U L N); ( b) > 5 x U L N; 
(c) > 1 0 x U L N; ( d) > 2 0 x U L N
•
A L T: (a) > 3 x U L N; ( b) > 5 x U L N; (c) > 1 0 x U L N; ( d) > 2 0 x U L N
•
A S T or A L T: (a) > 3 x U L N; ( b) > 5 x U L N; (c) > 1 0 x U L N; ( d) > 2 0 x U L N
•
T otal bilir u bi n > 2 x U L N
•
A L P > 1. 5 x U L N
•
A S T or A L T > 3 x U L N a n d t otal bilir u bi n: (a) > 1. 5 x U L N; ( b) > 2 x U L N 
A listi n g of partici pa nts w h o met at least 1 of t he a b o ve criteria will be pr o vi de d.


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 2 6 of 3 8
7. 3.   
B o d y Wei g ht a n d Vit al Si g ns
A b y- partici pa nt listi n g of vital si g ns will be pr o vi de d b y partici pa nt I D n u m ber a n d visit i n 
c hr o n ol o gical or der. B o d y wei g ht, hei g ht, a n d B MI  will be i ncl u de d i n t he vital si g ns listi n g, if 
s pace per mits. If n ot, t he y will be pr o vi de d se paratel y.
7. 4.   
Pri or a n d C o nc o mit a nt Me dic ati o ns
Me dicati o ns c ollecte d at scree ni n g a n d d uri n g t he st u d y will be c o de d usi n g t he c urre nt versi o n 
of t he Gilea d- m o difie d  W orl d Healt h Or ga nizati o n ( W H O) Dr u g dicti o nar y.
Pri or me dicati o ns are defi ne d as a n y me dicati o ns wit h a start date pri or t o t he first d osi n g date of 
st u d y dr u g, re gar dless of w he n t he st o p date is. If a partial start date is e ntere d, t he me dicati o n 
will be c o nsi dere d pri or u nless t he m o nt h a n d year (if da y is missi n g) or year (if da y a n d m o nt h 
are missi n g) of t he start date are after t he first d osi n g date. Me dicati o ns wit h a c o m pletel y 
missi n g start date will be c o nsi dere d as pri or me dicati o ns.
C o nc o mita nt me dicati o ns are defi ne d as me dicati o ns ta ke n w hile a partici pa nt t o o k st u d y dr u g.
All pri or a n d c o nc o mita nt me dicati o ns ( ot her t ha n per- pr ot oc ol st u d y dr u gs) will be pr o vi de d i n a 
b y- partici pa nt listi n g s orte d b y partici pa nt I D n u m ber a n d a d mi nistrati o n date i n c hr o n ol o gical 
or der. T his listi n g will i ncl u de A nat o mical T hera pe utic C he mical ( A T C) dr u g class Le vel 2.
7. 5.   
T a n ner St a ge Assess me nt
Ta n ner Sta ge res ults at Da y 1 a n d d uri n g t he st u d y, if a vaila ble, will be liste d.
7. 6.   
P al at a bilit y a n d Acce pt a bilit y Assess me nt
Palata bilit y a n d acce pta bilit y assess me nts will be liste d.
7. 7.    
Ot her S afet y Me as ures
A b y- partici pa nt listi n g of partici pa nt pre g na ncies d uri n g t he st u d y will be pr o vi de d b y 
partici pa nt I D n u m ber (i n asce n di n g or der). 
7. 8.    
C h a n ges Fr o m Pr ot oc ol- S pecifie d S afet y A n al yses
T his st u d y was ter mi nate d earl y; he nce t he pr ot oc ol-s pecifie d safet y a nal yses will n ot be 
pr o vi de d. O nl y b y- partici pa nt listi n gs will be prese nte d.


O b el d esi vir   (  OD  V;   G S  -5 2 4 5  ™) 
G S-  U S- 6 1 1- 6 4 6 4 
St ati sti c al  A n al ysis   Pl a n  -  Fi n a l A n a  lysis 
8. 
P  H  A  R  M  A  C  O  K I  N  E  T I  C   ( P  K) A  N  A  L  Y S  E S 
8. 1. 
P  K S a  m pl e  C oll e cti o n 
V er si o n   1. 0 
A s  i ngl e  P  K  bl o o d  s a  mpl e  w a s   pl a n n e d  t o b e  c oll e ct e d  at t h e f oll o  wi n g ti  m es  a n d vi s its: 
•   C o h o 1i s  1 a n d 2: 
-    Da ys 3: 1  s a  mpl e  b et  w e e n 
-
p o st d o s e 
-  
D a y 5: 
p ost d os e f or  hos p ita li z e d p a 1ii ci p a nt s  onl y 
As   m a n  y of t h e a b o v e  s p e c ifie d P  K s a  mpl e s s h oul d  h a v e  b e e n  o bt ai n e d fro  m  e a c h p aiii ci p a nt  as 
w a s f eas i bl e. 
8. 2. 
P  K A n al y s e s   R el at e d   t o S p a r s e P  K S a  m pli n g 
T h e  f oll o  wi n g  listi n gs wi  ll b e  pr o vi d e d: 
• 
P  K s am pli n  g  d et ails  b y  p aiii ci p a nt , i n cl u di ng  pr o c e d ur e s, diff er e n c es  i n s ch e d ul e d  a n d a ct u al 
dr a w   ti  m es, a n d  s am pl  e  a g e  fr o  m t h e P  K s am pl e  s as  w e  ll as  c o n c entr ati o n  d at a. 
8. 3. 
C h a n g e s   F r o  m  P r ot o c ol- S p e cifi e d P  K A n al y s e s 
T his  st u dy  w a s   t e n ni n at e d e ai·ly;  h e n c e  t he  pr ot o c o l-s p e cifi e d P  K a n al ys es  wi  ll n ot  b e  pr o vi d e d. 
O nl y   b y- p aiii ci p a nt  listi n gs wi  ll b e  pr es e nt e d. 
1 7 J u n e 2 0 2 4 
GI L E  A  D   C  O  N FI  D E  N TI  A L   I  N F  O  R  M  A TI  O  N 
P a g e  2 7 of 3 8 


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 2 8 of 3 8
9.    
R E F E R E N C E S
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. Defi ni n g B MI cate g ories. A vaila ble at: 
htt ps:// w w w.c dc. g o v/ o besit y/ basics/c hil d h o o d- defi ni n g. ht ml Accesse d: 
1 8 A pril 2 0 2 4; Last Re vie we d: 2 1 Marc h 2 0 2 3.
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. Gr o wt h C hart Trai ni n g. A vaila ble at: 
htt ps:// w w w.c dc. g o v/ ncc d p h p/ d n pa o/ gr o wt hc harts/res o urces/sas. ht m Accesse d: 
1 8 A pril 2 0 2 4; Last Re vie we d: 1 5 A u g ust 2 0 2 3.
W orl d Healt h Or ga nizati o n. C hil d gr o wt h sta n dar ds. A vaila ble at: 
htt ps:// w w w. w h o.i nt/t o ol kits/c hil d- gr o wt h-sta n dar ds/s oft ware Accesse d: 
1 8 A pril 2 0 2 4.


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 2 9 of 3 8
1 0.   
S O F T W A R E
S A S ®  S oft ware Versi o n 9. 4. S A S I nstit ute I nc., Car y, N C, U S A.


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 3 0 of 3 8
1 1.   
S A P R E VI SI O N
Re visi o n D ate
( D D M M M Y Y Y Y)  
Secti o n  
S u m m ar y of Re visi o n
Re as o n f or Re visi o n


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4 
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 3 1 of 3 8
1 2.    
A P P E N DI C E S
A p pe n di x 1.   
Sc he d ule of Assess me nts......................................................................................................... 3 2
A p pe n di x 2.   
Pr o gra m mi n g S pecificati o ns.................................................................................................... 3 4


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4 
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 3 2 of 3 8
A p pe n di x 1.   
Sc he d ule of Assess me nts
Scree ni n g/ 
( D −1)a
B aseli ne/ 
D 1 a
D 3  
D 5  
D 8  
D 1 4  
D 2 1  
D 2 8
E O S/ D 
3 5
–
–
–
–  
± 1 d  
± 2 d  
± 2 d  
± 2 d  
± 5 d
I n pers o n
I n pers o n 
or re m ote b
I n 
pers o n
I n pers o n or 
re m ote b
Virt u al c
I n pers o n
Partici pa nt a n d/ or pare nt or le gal g uar dia n c o nse nt/asse nt
Me dical hist or y
d
D oc u me nt S A R S- C o V- 2 i nfecti o n
C o m plete p h ysical e xa mi nati o n e
S y m pt o m- directe d p h ysical e xa mi nati o n e
B o d y wei g ht
Hei g ht/le n gt h f
Last rec or de d A p gar sc ore if < 2 4 h o urs of a ge
Birt h wei g ht if < 5 6 da ys of a ge
Gestati o nal a ge if < 1 years of a ge
Vital si g ns g
Ta n ner sta ge assess me nt if ≥ 6 years of a ge
He mat ol o g y, c he mistr y
Uri nal ysis
R o uti ne c oa g ulati o n test ( P T/a P T T wit h calc ulate d I N R)
Ne o natal bilir u bi n pa nel f or all ne o nates < 1 4 da ys, a n d a n y ne o nate prese nti n g wit h 
ja u n dice
Uri ne pre g na nc y test h
Mi dt ur bi nate nasal s wa b
i
Re vie w i ncl usi o n/e xcl usi o n criteria
Partici pa nt a n d/ or care gi ver s y m pt o m assess me nt j
P K sa m ple k
St u d y dr u g dis pe nsati o n
St u d y dr u g a d mi nistrati o n l
St u d y dr u g ret ur n m
C o nc o mita nt me dicati o ns
H os pitalizati o n details n
O x y ge n s u p ple me ntati o n re q uire me nt o
C CI


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4 
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 3 3 of 3 8
Scree ni n g/ 
( D −1)a
B aseli ne/ 
D 1 a
D 3  
D 5  
D 8  
D 1 4  
D 2 1  
D 2 8
E O S/ D 
3 5
–
–
–
–  
± 1 d  
± 2 d  
± 2 d  
± 2 d  
± 5 d
I n pers o n
I n pers o n 
or re m ote b
I n 
pers o n
I n pers o n or 
re m ote b
Virt u al c
In pers o n
A d verse e ve nts p
Acce pta bilit y/ palata bilit y assess me nt
a P T T = acti vate d partial t hr o m b o plasti n ti me; C O VI D- 1 9 = c or o na vir us disease 2 0 1 9; D/ d = da y; E O S = e n d of st u d y; I g = i m m u n o gl o b uli n; I N R = i nter nati o nal n or malize d rati o; M A P = mea n arterial 
press ure; P T = pr ot hr o m bi n ti me; P K = p har mac o ki netic(s); R T- q P C R = re verse tra nscri pti o n- q ua ntitati ve p ol y merase c hai n reacti o n; S A R S- C o V- 2 = se vere ac ute res pirat or y s y n dr o me c or o na vir us 2
a   
Scree ni n g wi n d o w is wit hi n 4 8 h o urs of t he baseli ne visit. Baseli ne visit ma y occ ur o n t he sa me da y as scree ni n g. If t he Da y 1 a n d Scree ni n g visits occ ur wit hi n t he sa me cale n dar da y, d o n ot 
re peat assess me nts c o m m o n t o Scree ni n g a n d Da y 1 visits.
b    
A n i n- pers o n visit will occ ur eit her at a me dical facilit y or as a re m ote visit at h o me b y a healt h care pr ofessi o nal ( w here per mitte d).
c    
Virt ual visit is defi ne d as a n i nteracti o n wit h a healt h care pr ofessi o nal usi n g tele p h o ne or o nli ne base d i nteracti o n (e g, tele healt h, we bcast, vi de oc o nfere nci n g).
d    
Me dical hist or y will i ncl u de t he date of first C O VI D- 1 9 s y m pt o ms, o verall C O VI D- 1 9 s y m pt o ms, all C O VI D- 1 9 vacci nati o ns pri or t o scree ni n g, de m o gra p hics, baseli ne c haracteristics, 
aller gies, a n d all ot her me dical hist or y.
e    
A c o m plete p h ysical e xa mi nati o n i ncl u des s o urce d oc u me ntati o n of ge neral a p peara nce a n d t he f oll o wi n g b o d y s yste ms: hea d, nec k, a n d t h yr oi d; e yes, ears, n ose, t hr oat, m o ut h, a n d t o n g ue; 
c hest (e xcl u di n g breasts); res pirat or y; car di o vasc ular; l y m p h n o des, a b d o me n; s ki n, hair, nails; m usc ul os keletal; a n d ne ur ol o gical. Ur o ge nital a n d re pr o d ucti ve e xa mi nati o n s h o ul d o nl y be 
c o m plete d if cli nicall y i n dicate d. A p h ysical e xa mi nati o n will o nl y be c o n d ucte d d uri n g a n i n- pers o n visit b y a q ualifie d healt h care pr ofessi o nal.
f   
Rec or d le n gt h a n d hea d circ u mfere nce if < 2 8 da ys at e nr oll me nt.
g    
Vitals si g ns i ncl u de heart rate, te m perat ure, bl o o d press ure ( M A P if a vaila ble, s yst olic a n d diast olic), res pirat or y rate, a n d o x y ge n sat urati o n. Vital si g ns will be c ollecte d at i n- pers o n visits 
o nl y.
h   
F or fe male partici pa nts of c hil d beari n g p ote ntial o nl y.
i   
T he nasal s wa b sa m ple will be use d f or S A R S- C o V- 2 R T- q P C R, p ote ntial i nfecti o us viral titer assess me nt, p ote ntial resista nce testi n g, a n d viral c oi nfecti o n.
j   
Partici pa nt a n d/ or care gi ver s y m pt o m assess me nt will be c o m plete d o n sti p ulate d da ys via a q uesti o n naire ( Pr ot oc ol Secti o n 6. 3. 7).
k   
Refer t o Pr ot oc ol Secti o n 6. 3. 5  f or P K sa m ples c ollecti o n ti me p oi nts. P K sa m ples will be c ollecte d o n 
 f or C o h orts 1 a n d 2.
l   
St u d y dr u g a d mi nistrati o n ti me will be rec or de d b y i n vesti gati o nal site pers o n nel or b y partici pa nt/ pare nt/care gi ver via a diar y. Partici pa nt t o wit h h ol d t heir d ose pri or t o arri vi n g t o t he site o n 
Da y 5, as t he d ose will be a d mi nistere d at t he site.
m   
St u d y dr u g b ottle s h o ul d be ret ur ne d b y t he partici pa nt o n Da y 5, if t he partici pa nt has alrea d y c o m plete d b ot h d oses of st u d y dr u g. If t he partici pa nt has t he last d ose of st u d y dr u g re mai ni n g 
b y t he c o ncl usi o n of t he Da y 5 i n- pers o n visit, t he partici pa nt ma y ret ur n t he st u d y dr u g b ottle if a n i n- pers o n visit is c o n d ucte d o n a n y s u bse q ue nt visits (i ncl u di n g E o S visit). Alter nati vel y, 
t he partici pa nt ma y c o urier t he st u d y dr u g b ottle t o t he site.
n   
T o be c ollecte d f or h os pitalize d partici pa nts. I nf or mati o n t o be c ollecte d: h os pitalizati o n date, reas o n f or h os pitalizati o n, disc har ge date, a n d disc har ge o utc o me.
o   
T o be c ollecte d f or h os pitalize d partici pa nts. Refer t o Pr ot oc ol Secti o n 6. 3. 4  f or i nf or mati o n c ollecti o n o n o x y ge n s u p ple me ntati o n or o x y ge nati o n.
p    
All partici pa nts prese nti n g wit h m ultis yste m i nfla m mat or y s y n dr o me i n c hil dre n ( MI S- C; htt ps://e mer ge nc y.c dc. g o v/ ha n/ 2 0 2 0/ ha n 0 0 4 3 2.as p) s h o ul d be m o nit ore d a n d treate d as cli nicall y 
i n dicate d.
q   
T o be c ollecte d f or h os pitalizati o n partici pa nts.
C CI
C CI


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4 
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 3 4 of 3 8
A p pe n di x 2.   
Pr o gr a m mi n g S pecific ati o ns
1) If “ A ge at Da y 1” o n t he De m o gra p hics e C R F is n ot a vaila ble, a ge [i n years] will be 
calc ulate d as f oll o ws:
a)
O nl y year is pr o vi de d f or t he date of birt h ( D O B). Use J ul y 1 f or t he m o nt h a n d da y.
i) 
A G E [i n years] is calc ulate d fr o m t he n u m ber of da ys bet wee n t he D O B a n d St u d y 
Da y 1,
ii)
Use t he S A S I N T C K f u ncti o n t o deter mi ne t he n u m ber of “ 1st- of- m o nt h da ys” (f or 
e g, Ja n uar y 1st, Fe br uar y 1st, Marc h 1st) bet wee n D O B a n d Da y 1 (i ncl usi ve),
iii) Di vi de t he res ult i n (ii) b y 1 2,
A G E = t he i nte ger of t he res ult i n (iii).
A ge f or la b orat or y test refere nce ra n ge will be base d o n t he a ge at t he sa m ple c ollecti o n date.
2)
All scree ne d partici pa nts refer t o all partici pa nts w h o are scree ne d (ie, wit h n o n missi n g 
scree ni n g date) a n d ha ve a scree ni n g n u m ber. F or s u m maries t he sa me partici pa nt is c o u nte d 
o nl y o nce.
3)
Scree n fail ure partici pa nts are t he partici pa nts w h o eit her:

were scree ne d a n d a ns were d “ N o” f or a n y i ncl usi o n criteria or “ Yes” f or a n y e xcl usi o n 
criteria re gar dless of w hic h versi o n of pr ot oc ol t he partici pa nt was c o nse nte d 

met all i ncl usi o n a n d e xcl usi o n criteria b ut were n ot e nr olle d.
4)
Partici pa nts i n t he All E nr olle d A nal ysis Set are defi ne d as partici pa nts e nr olle d i nt o t he 
st u d y. I X R S R A N D is t he s o urce t o deter mi ne w het her t he partici pa nt is e nr olle d (ie, 
partici pa nt wit h n o n missi n g E N R D T N i n t he I X R S R A N D dataset), a n d c o nfir me d b y 
i nf or mati o n rec or de d o n t he E N R O L L e C R F (ie, E N R O L L Y N = “ Yes” i n E N R O L L dataset).
5)
E nr olle d treat me nt (ie, T R T 0 1 P i n A D S L) is deri ve d fr o m I X R S R A N D, w hile act ual 
treat me nt recei ve d (ie, T R T 0 1 A i n A D S L) is assi g ne d as t he e nr olle d treat me nt if a 
partici pa nt t o o k at least 1 d ose of st u d y dr u g. T R T 0 1 A is assi g ne d as bla n k if t he partici pa nt 
was ne ver d ose d.
6)
B o d y mass i n de x ( B MI) will be calc ulate d o nl y at baseli ne as f oll o ws:

B MI = ( wei g ht [ k g]) / ( hei g ht [ meters] 2)
Baseli ne hei g ht a n d wei g ht will be use d f or t his calc ulati o n if a vaila ble.


O b e  ld esi v ir (O  D  V  ; G S  -5 2 4 5  ™) 
G S-  U S- 6 1 1 -6 4 6 4 
St at istic al  A n al ysis   Pl a n  -  Fi n a l A n a  lysis 
7)   B  MI-f or-  a g e  p er c e ntil e: 
V er si o n   1. 0 
a)   P aiii c i p a nts <  2 4  m o  nt h s: B  MI- f or-a g e  p er c e ntil e  wi  ll b e  c o m p ut e d   us i ng  W  H  O   S  A S 
p a c k a g e : w  w  w.  w  h o. i nt/t o ol kits/ c hil d- gr o  wt h- s t a nd ai·ds /s oft  w ai·e 
b)   P aiii c i p a nts   2  y e ars  t o <  2 0  y e ars  wi  ll b e  c o  m p ut e d b a s e d o n   C  D C: 
w  w  w. c d c. g o v  /n c c d p h p / d n p a o / gr o  wt h c h aii s/r es o ur c e s/ s as . ht  m 
8) Ri  s k f a ct ors d efi n e d  i n t h e i n cl us i o n cr it eri a: 
-  
I nf o 1  m atio n  o n  f oll o  wi ng  ris k f a ct ors is c o ll ect e d  o n  t h e M e di c al   Hi  st o 1y  e  C R F  : 
• 
• 
• 
• 
• 
• 
9)   T E  A E 
E v e nt s  wit h   Missi n g   O n s et   D a y   a n d /o r  M o nt h 
A n   e v e nt  is c o n si d ere d T E if a ll of  t he  f oll o  wi ng  3  c rit eria  ar e  m  et: 
a)   T h e  m  o nt h  a n d y e ai· ( or y e ai-) of o n s et d at e  is t h e s a  m e  as  or  aft er  t h e m o  nt h  a n d y e ai· ( or 
y e ai-) of  t he  first  d o s e of s t u d y d  m g  a d  mi ni str ati o n, a n d 
b) T h e   m o nt h  a n d y e a r ( or y e ai-) of  t h e o n s et d a t e is t h e s a  m e as  or  b ef or e  t h e m o  nt h  a n d 
y e a r  ( or y e a r) of t h e 3 0t h  d a y  a ft er t h e d at e  of  t he l as t  dos e of st u dy d  m g  a d  mi ni str atio n, 
a n d 
c)   E n d  d at e  is  as f oll o  ws : 
i)   T h e  ( c om pl et e) e n d  d at e i s  o n  or  aft er  t h e first d os e  d at e ,  or 
ii) T h e   m o nt h  a n d y e a r ( or y e ai-) of e n d  d at e  is t h e s am e   as  or  aft e r t h e m o  nt h  a n d y e a r 
( or  y e a r)  of t h e first  d o s e of s t u d y d  m g,  or 
iii)  E n d  d at e  is c o  m pl et el y  mi  ssi n g 
1 7 Ju n e  2 0 2 4 
GI L E  A  D   C  O  N FI  D E  N TI  A L   I  N F  O  R  M  A TI  O  N 
P a g e  3 5 of 3 8 


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4 
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 3 6 of 3 8
E ve nts wit h C o m pletel y Missi n g O nset D ate
A n A E wit h a c o m pletel y missi n g o nset date is defi ne d as T E A E if e n d date meets a n y of t he 3 
criteria s pecifie d a b o ve.
1 0)   
T he precisi o n i n re p orti n g n u merical val ues s h o ul d be as f oll o ws:
a)
Ra w meas ure me nts will be re p orte d t he sa me as t he data ca pt ure d electr o nicall y or o n t he 
e C R F f or all b ut he mat ol o g y a n d c he mistr y val ues.
b)
S D a n d S E will be re p orte d t o o ne m ore si g nifica nt deci mal place t ha n t he ra w 
meas ure me nt.
c) 
Mea n, me dia n, mi ni m u m, Q 1, Q 3, a n d ma xi m u m will be re p orte d t o t he sa me n u m ber of 
deci mal places of t he ra w meas ure me nts.
E xce pti o ns ma y be c o nsi dere d; f or e g, if m ore t ha n 4 si g nifica nt di gits are pr o vi de d f or t he 
meas ure me nt.
Precisi o n f or deri ve d para meters as f oll o ws:
P ar a meters
Deci m al Pl aces
B MI
2
P K c o nce ntrati o n
2
1 1)  
I nc o m plete deat h dates will be i m p ute d as t he ma xi m u m of t he st u d y dr u g start dates, 
st u d y dr u g e n d dates, cli nic or virt ual visit dates ( L S T S V D T), la b orat or y visit dates 
( L S T L B D T), C O VI D- 1 9 s y m pt o m assess me nt q uesti o n naire dates pl us 1.
1 2)    
Gra de d La b orat or y A b n or malities S u m mar y
T he f oll o wi n g la bels will be use d f or la b orat or y a b n or malities listi n gs:


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4 
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 3 7 of 3 8
C ate g or y
L a b Test L a bel Use d i n 
l-l bt o x Listi n g
T o xicit y 
Directi o n
L a b Test L a bel Use d i n 
t-l bt o x T a ble
He m o gl o bi n
Decrease
He m o gl o bi n ( Decrease d)
L y m p h oc ytes
Decrease
L y m p h oc ytes ( Decrease d)
Ne utr o p hils
Decrease
Ne utr o p hils ( Decrease d)
Platelets
Decrease
Platelets ( Decrease d)
He mat ol o g y
W B C
Decrease
W B C ( Decrease d)
Al b u mi n
Decrease
Al b u mi n ( Decrease d)
Al kali ne P h os p hatase  
I ncrease
Al kali ne P h os p hatase (I ncrease d)
A L T
I ncrease
A L T (I ncrease d)
A S T
I ncrease
A S T (I ncrease d)
Bicar b o nate
Decrease
Bicar b o nate ( Decrease d)
C orrecte d Calci u m  
I ncrease
C orrecte d Calci u m ( H y percalce mia)
C orrecte d Calci u m  
Decrease
C orrecte d Calci u m ( H y p ocalce mia)
Creati ne Ki nase ( C K)  
I ncrease
Creati ne Ki nase (I ncrease d)
Creati ni ne
I ncrease
Creati ni ne (I ncrease d)
Creati ni ne Cleara nce  
Decrease
Creati ni ne Cleara nce b y C oc kcr oft- Ga ult, 
Gilea d Calc ulate d ( Decrease d)
Li pase
I ncrease
Li pase (I ncrease d)
Ma g nesi u m
Decrease
Ma g nesi u m ( H y p o ma g nese mia)
P h os p hate
Decrease
P h os p hate ( H y p o p h os p hate mia)
Ser u m Gl uc ose
I ncrease
Ser u m Gl uc ose ( H y per gl yce mia)
Ser u m Gl uc ose
Decrease
Ser u m Gl uc ose ( H y p o gl yce mia)
Ser u m P otassi u m
I ncrease
Ser u m P otassi u m ( H y per kale mia)
Ser u m P otassi u m
Decrease
Ser u m P otassi u m ( H y p o kale mia)
Ser u m S o di u m
I ncrease
Ser u m S o di u m ( H y per natre mia)
Ser u m S o di u m
Decrease
Ser u m S o di u m ( H y p o natre mia)
T otal Bilir u bi n
I ncrease
T otal Bilir u bi n ( H y per bilir u bi ne mia)
C he mistr y
Uric Aci d
I ncrease
Uric Aci d ( H y per urice mia)
Acti vate d partial 
t hr o m b o plasti n ti me (a P T T)
I ncrease
Acti vate d Partial T hr o m b o plasti n Ti me 
(I ncrease d)
Pr ot hr o m bi n I ntl. 
N or malize d Rati o (I N R)
I ncrease  
Pr ot hr o m bi n I ntl. N or malize d Rati o (I ncrease d)
C oa g ulati o n
Pr ot hr o m bi n Ti me  
I ncrease
N ot A p plica ble


O bel desi vir ( O D V; G S- 5 2 4 5 ™)
G S- U S- 6 1 1- 6 4 6 4
Statistical A nal ysis Pla n – Fi nal A nal ysis
Versi o n 1. 0
1 7 J u ne 2 0 2 4 
GI L E A D C O N FI D E N TI A L I N F O R M A TI O N
Pa ge 3 8 of 3 8
Refer t o ite m 1 3 bel o w f or m ore i nf or mati o n o n gl uc ose.
1 3)    
Gl uc ose
Fasti n g is n ot re q uire d per pr ot oc ol f or c ollecti n g gl uc ose sa m ple. Mi xe d fasti n g gl uc ose a n d 
n o nfasti n g gl uc ose res ults are prese nte d i n t he dataset. Fasti n g gl uc ose or n o nfasti n g Gl uc ose is 
gra de d per D AI D S gra di n g scale. T he treat me nt-e mer ge nt gl uc ose a b n or malit y will be 
deter mi ne d per Secti o n 7. 2. 1  wit h o ut re gar d t o fasti n g stat us ( h y per gl yce mia or h y p o gl yce mia).


G S- U S- 6 1 1- 6 4 6 4- Fi n al- A n al y si s- S A P- v 1. 0
E L E C T R O NI C SI G N A T U R E S
Si g n e d b y
M e a ni n g of Si g n at ur e  
S er v er D at e
( d d- M M M-
y y y y h h: m m: s s)
Bi o st ati sti c s e Si g n e d
Cli ni c al P h ar m a c ol o g y
e Si g n e d
Gl o b al D e v el o p m e nt
L e a d ( G D L) e Si g n e d
P P D
P P D
P P D
P P D