A Multicenter, Observational, 6-Month Follow-up Study of Patients With COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study
Conditions: COVID-19, Long COVID
Sponsor: Hoffmann-La Roche

 
Official Title: 
A Multicenter, Observational, 6-Month Follow-up Study of Patients 
With COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study 
NCT Number: 
NCT05059080 
Document Date: 
Protocol Version 1: 03-March-2021 
 
 
 

 
 
CONFIDENTIAL 
This clinical study is being sponsored globally by F. Hoffmann-La Roche Ltd of Basel, Switzerland (as 
sponsor in countries outside the United States) and Atea Pharmaceuticals, Inc. (as sponsor in the 
United States).  However, it may be implemented in individual countries by Roche's local affiliates, 
including Genentech, Inc. in the United States.  The information contained in this document, especially 
any unpublished data, is the property of F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc. (or 
under their control) and therefore is provided to you in confidence as an investigator, potential 
investigator, or consultant, for review by you, your staff, and an applicable Ethics Committee or 
Institutional Review Board.  It is understood that this information will not be disclosed to others without 
written authorization from Roche or Atea except to the extent necessary to obtain informed consent 
from persons to whom the drug may be administered. 
 
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc. 
Protocol CV43140, Version 1 
PROTOCOL 
TITLE: 
A MULTICENTER, OBSERVATIONAL, 6-MONTH 
FOLLOW-UP STUDY OF PATIENTS WITH 
COVID-19 PREVIOUSLY ENROLLED IN A 
RO7496998 (AT-527) STUDY 
PROTOCOL NUMBER: CV43140 
VERSION NUMBER: 
1 
EUDRACT NUMBER: 
2021-000627-12 
IND NUMBER: 
149508 
NCT NUMBER: 
To be determined 
TEST PRODUCT: 
Not applicable 
MEDICAL MONITOR: 
, M.D., Ph.D. 
SPONSORS: 
F. Hoffmann-La Roche Ltd (Ex-United States) 
Atea Pharmaceuticals, Inc. (United States) 
DATE FINAL: 
See electronic date stamp below. 
 
 
FINAL PROTOCOL APPROVAL 
 
Date 
Title 
Approver’s Name 
Signature 
 
, 
Atea Pharmaceuticals, Inc. 
, M.D. 
MAR 3 2021
 
03-Mar-2021 18:49:39
Title
Approver's Name
Company Signatory
Date and Time (UTC)

F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
2/Protocol CV43140, Version 1
TABLE OF CONTENTS
PROTOCOL ACCEPTANCE FORM .................................................................... 7
PROTOCOL SYNOPSIS ...................................................................................... 8
1.
BACKGROUND .......................................................................................... 13
1.1
Background on COVID-19..................................................... 13
1.2
Study Rationale and Benefit-Risk Assessment...................... 15
2.
OBJECTIVES AND ENDPOINTS ............................................................... 16
3.
STUDY DESIGN......................................................................................... 17
3.1
Description of the Study......................................................... 17
3.2
End of Study and Length of Study......................................... 18
3.3
Rationale for Study Design.................................................... 18
3.3.1
Rationale for Non-Standard Clinical Outcome 
Assessments ......................................................................... 18
3.3.2
Rationale for Biomarker Assessments................................... 19
4.
MATERIALS AND METHODS .................................................................... 19
4.1
Patients.................................................................................. 19
4.1.1
Inclusion Criteria.................................................................... 19
4.1.2
Exclusion Criteria................................................................... 20
4.2
Method of Treatment Assignment and Blinding..................... 20
4.3
Study Treatment and Other Treatments Relevant 
to the Study Design ............................................................... 20
4.4
Concomitant Therapy and Additional Restrictions................. 20
4.5
Study Assessments ............................................................... 20
4.5.1
Informed Consent Forms and Screening Log........................ 21
4.5.2
Medical History, Baseline Conditions, 
Concomitant Medication, and Demographic Data ................. 21
4.5.3
Wearable Device ................................................................... 22
4.5.4
Laboratory, Biomarker, and Other Biological 
Samples................................................................................. 22
4.5.5
Clinical Outcome Assessments ............................................. 23
4.5.5.1
Data Collection Methods for Clinical Outcome 
Assessments ......................................................................... 23

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4.5.5.2
Description of Clinical Outcome Assessment 
Instruments............................................................................ 24
4.5.5.3
Additional COVID-19Related Assessments......................... 25
4.5.6
Optional Blood Samples for Whole Genome 
Sequencing or Whole Exome Sequencing 
(Patients at Participating Sites).............................................. 26
4.6
Patient, Study, and Site Discontinuation................................ 27
4.6.1
Patient Discontinuation from the Study.................................. 27
4.6.2
Study Discontinuation............................................................ 27
4.6.3
Site Discontinuation............................................................... 28
5.
ASSESSMENT OF SAFETY....................................................................... 28
5.1
Safety Plan ............................................................................ 28
5.2
Safety Parameters and Definitions ........................................ 28
5.2.1
Adverse Events ..................................................................... 28
5.2.2
Serious Adverse Events (Immediately Reportable 
to the Sponsor)...................................................................... 29
5.3
Methods and Timing for Capturing and 
Assessing Safety Parameters................................................ 30
5.3.1
Adverse Event Reporting Period ........................................... 30
5.3.2
Eliciting Adverse Event Information....................................... 30
5.3.3
Assessment of Severity of Adverse Events ........................... 30
5.3.4
Assessment of Causality of Adverse Events ......................... 31
5.3.5
Procedures for Recording Adverse Events............................ 32
5.3.5.1
Diagnosis versus Signs and Symptoms................................. 32
5.3.5.2
Adverse Events That Are Secondary to Other 
Events.................................................................................... 32
5.3.5.3
Persistent or Recurrent Adverse Events................................ 32
5.3.5.4
Deaths ................................................................................... 33
5.3.5.5
Preexisting Medical Conditions.............................................. 33
5.3.5.6
Lack of Efficacy or Worsening of COVID-19.......................... 34
5.3.5.7
Hospitalization or Prolonged Hospitalization.......................... 34
5.3.5.8
Patient-Reported Outcome Data ........................................... 34
5.4
Immediate Reporting Requirements from 
Investigator to Sponsor.......................................................... 34

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5.4.1
Medical Monitors and Emergency Medical 
Contacts ................................................................................ 35
5.4.2
Reporting Requirements for Serious Adverse 
Events.................................................................................... 35
5.4.3
Reporting Requirements for Pregnancies.............................. 36
5.4.3.1
Pregnancies in Female Patients............................................ 36
5.4.3.2
Abortions ............................................................................... 36
5.4.3.3
Congenital Anomalies/Birth Defects ...................................... 36
5.4.4
Reporting Requirements for Medical Device 
Complaints............................................................................. 37
5.5
Follow-Up of Patients after Adverse Events .......................... 37
5.5.1
Investigator Follow-Up........................................................... 37
5.5.2
Sponsor Follow-Up ................................................................ 37
5.6
Expedited Reporting to Health Authorities, 
Investigators, Institutional Review Boards, 
and Ethics Committees.......................................................... 37
6.
STATISTICAL CONSIDERATIONS AND ANALYSIS PLAN....................... 38
6.1
Determination of Sample Size ............................................... 38
6.2
Summaries of Conduct of Study............................................ 38
6.3
Summaries of Demographic and Baseline 
Characteristics....................................................................... 38
6.4
Statistical Analyses................................................................ 39
6.4.1
Primary Endpoint................................................................... 39
6.4.2
Secondary Endpoints ............................................................ 39
6.4.3
Exploratory Endpoints............................................................ 40
6.5
Safety Analyses..................................................................... 41
6.6
Biomarker Analyses............................................................... 41
6.7
Interim Analysis ..................................................................... 41
6.8
Subgroup Analyses ............................................................... 41
7.
DATA COLLECTION AND MANAGEMENT ............................................... 41
7.1
Data Quality Assurance......................................................... 41
7.2
Electronic Case Report Forms............................................... 42
7.3
Electronic Patient-Reported Outcome Data........................... 42
7.4
Source Data Documentation.................................................. 43

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7.5
Use of Computerized Systems .............................................. 44
7.6
Retention of Records............................................................. 44
8.
ETHICAL CONSIDERATIONS.................................................................... 44
8.1
Compliance with Laws and Regulations ................................ 44
8.2
Informed Consent.................................................................. 44
8.3
Institutional Review Board or Ethics Committee.................... 46
8.4
Confidentiality........................................................................ 46
8.5
Financial Disclosure .............................................................. 47
9.
STUDY DOCUMENTATION, MONITORING, AND 
ADMINISTRATION ..................................................................................... 47
9.1
Study Documentation ............................................................ 47
9.2
Protocol Deviations................................................................ 47
9.3
Management of Study Quality ............................................... 47
9.4
Site Inspections ..................................................................... 48
9.5
Administrative Structure......................................................... 48
9.6
Dissemination of Data and Protection of Trade 
Secrets .................................................................................. 48
9.7
Protocol Amendments ........................................................... 49
10. REFERENCES ........................................................................................... 50
LIST OF TABLES
Table 1
Objectives and Corresponding Endpoints................................... 16
Table 2
Adverse Event Severity Grading Scale for Events Not 
Specifically Listed in NCI CTCAE ............................................... 31
Table 3
Causal Attribution Guidance ....................................................... 31
LIST OF APPENDICES
Appendix 1
Schedule of Activities.................................................................. 53
Appendix 2
COVID-19 Symptom Diary.......................................................... 56
Appendix 3
Patient Global Impression of Severity......................................... 58
Appendix 4
Patient Reported Outcomes Measurement Information 
System (PROMIS)-Dyspnea Questionnaire................................ 59
Appendix 5
St. George’s Respiratory Questionnaire ..................................... 60
Appendix 6
EuroQol 5-Dimension, 5-Level Questionnaire............................. 66

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Appendix 7
Work Productivity and Activity Impairment Questionnaire 
plus Classroom Impairment Questions:  Specific Health 
Problems..................................................................................... 69

F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
7/Protocol CV43140, Version 1
PROTOCOL ACCEPTANCE FORM
TITLE:
A MULTICENTER, OBSERVATIONAL, 6-MONTH 
FOLLOW-UP STUDY OF PATIENTS WITH 
COVID-19 PREVIOUSLY ENROLLED IN A 
RO7496998 (AT-527) STUDY
PROTOCOL NUMBER:
CV43140
VERSION NUMBER:
1
EUDRACT NUMBER:
2021-000627-12
IND NUMBER:
149508
NCT NUMBER:
To be determined
TEST PRODUCT:
Not applicable
MEDICAL MONITOR:
, M.D., Ph.D.
SPONSORS:
F. Hoffmann-La Roche Ltd (Ex-United States)
Atea Pharmaceuticals, Inc. (United States)
I agree to conduct the study in accordance with the current protocol.
Principal Investigator's Name  (print)
Principal Investigator's Signature
Date
Please retain the signed original of this form for your study files.  Please return a copy of 
the signed form as instructed by your local study monitor. 

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8/Protocol CV43140, Version 1
PROTOCOL SYNOPSIS
TITLE:
A MULTICENTER, OBSERVATIONAL, 6-MONTH FOLLOW-UP 
STUDY OF PATIENTS WITH COVID-19 PREVIOUSLY ENROLLED 
IN A RO7496998 (AT-527) STUDY 
PROTOCOL NUMBER:
CV43140
VERSION NUMBER:
1
EUDRACT NUMBER:
2021-000627-12
IND NUMBER:
149508
NCT NUMBER:
To be determined 
TEST PRODUCT:
Not applicable
PHASE:
Phase III 
INDICATION:
COVID-19
SPONSORS:
F. Hoffmann-La Roche Ltd (Ex-United States)
Atea Pharmaceuticals, Inc. (United States)
Objectives and Endpoints
The purpose of this study is to evaluate the long-term sequelae of coronavirus disease 2019
(COVID-19) in patients diagnosed with COVID-19 who previously enrolled in a RO7496998 
(AT-527) study (i.e., parent study), for approximately 6 months after the end of the parent study.  
Specific objectives and corresponding endpoints for the study are outlined below.
Primary Objective
Corresponding Endpoint
To evaluate the long-term 
symptoms of patients diagnosed 
with COVID-19 
Descriptive summaries, over time, of COVID-19 
symptoms, as assessed through the COVID-19 
Symptom Diary (Items 114)
Secondary Objectives
Corresponding Endpoints
To evaluate HRQoL of patients 
diagnosed with COVID-19 
Impact of dyspnea symptoms on specific activities, as 
assessed through use of PROMIS-Dyspnea 
Questionnaire at Day 1 and Months 1, 2, 3, 4, 5, and 6
Respiratory-specific HRQoL, as assessed through use 
of SGRQ at Day 1 and Months 1, 2, 3, 4, 5, and 6
To evaluate medical resource 
utilization for patients diagnosed 
with COVID-19 
Proportion of patients with COVID-19related 
medically-attended visits through to study end (defined 
as hospitalization, emergency room visit, urgent care 
visit, physician’s office visit, or telemedicine visit with 
the primary reason for the visit being COVID-19 or 
COVID-19related symptoms)

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9/Protocol CV43140, Version 1
Secondary Objectives (cont.)
Corresponding Endpoints (cont.)
To evaluate the long-term 
outcomes of COVID-19 in patients 
diagnosed with COVID-19 
Proportion of patients with all-cause mortality
Proportion of patients with death attributable to 
progression of COVID-19
Proportion of patients re-infected with SARS-CoV-2
Proportion of patients with any post-treatment infection 
including but not limited to bacterial, viral, or fungal 
pneumonia or sepsis
Frequency of COVID-19related complications 
(e.g., death, hospitalization, radiologically-confirmed 
pneumonia, acute respiratory failure, sepsis, 
coagulopathy, pericarditis, myocarditis, cardiac failure)
To evaluate adverse events in 
patients diagnosed with COVID-19 
who previously enrolled in a 
RO7496998 (AT-527) study
Incidence and severity of adverse events and serious 
adverse events, with severity determined according to 
NCI CTCAE v5.0
Exploratory Objectives
Corresponding Endpoints
To evaluate symptom severity of 
patients diagnosed with COVID-19 
Self-reported symptom severity, as assessed weekly 
through use of PGIS
To evaluate health status and 
utility scores of patients diagnosed 
with COVID-19 
Health status utility, as assessed by EQ-5D-5L at 
Day 1 and Months 1, 2, 3, 4, 5, and 6
Work or school utility, as assessed through 
WPAI+CIQ:  SHP at Day 1, Months 3 and 6
To identify and/or evaluate 
biomarkers that can increase the 
knowledge and understanding of 
disease biology
Prevalence of neutralizing SARS-CoV-2 antibodies 
over time
Levels of biomarkers in blood and urine samples and 
their relationship with long-term outcomes or other 
biomarker endpoints
To evaluate the effectiveness of a 
consumer-grade wearable to track
changes in physiological and 
behavioral patterns following 
COVID-19 infection, as countries 
permit
Change in heart rate over time
Change in SpO2 over time 
Change in activity over time
Change in sleep patterns over time 
COVID-19coronavirus disease 2019; EQ-5D-5LEuroQol 5-Dimension, 5-Level Questionnaire; 
HRQoLhealth-related quality of life; NCI CTCAE v5.0 National Cancer Institute Common 
Terminology Criteria for Adverse Events, Version 5.0; PGISPatient Global Impression of 
Severity; PROMISPatient Reported Outcomes Measurement Information System;
SARS-CoV-2severe acute respiratory syndrome coronavirus-2; SGRQSt. George's 
Respiratory Questionnaire; SpO2 peripheral capillary oxygen saturation; 
WPAI+CIQ:  SHPWork Productivity and Activity Impairment Questionnaire plus Classroom 
Impairment Questions:  Specific Health Problems.
Study Design
Description of Study
This is a Phase III, non-treatment, observational, multicenter, follow-up study to assess 
long-term outcomes for approximately 6 months in patients diagnosed with COVID-19 who 
previously enrolled a RO7496998 (AT-527) study, also referred to as the parent study.  

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There is no study drug or other treatment required in this follow-up study.  Throughout this 
protocol, “study drug” refers to treatment administered in the parent study prior to this study 
(CV43140).  
Any patients previously enrolled in a Phase III RO7496998 (AT-527) study will be informed of 
the opportunity to participate in this study (CV43140).  An attempt will be made, where possible, 
to consent patients to this study at the same time patients are consented to the parent study.  At 
the latest, patients must provide consent at the Day 1 visit (baseline) of this study (CV43140), 
prior to the first assessment.  
The Day 1 visit (baseline) can coincide with the final visit of the parent study, or as soon as 
possible after the final visit and within 7 days.  Study outcomes will be assessed by measuring 
specific endpoints in patients at either daily (i.e., continuous measurements via consumer-grade 
wearable devices), weekly, or monthly time intervals for approximately 6 months.  Patients will 
complete the COVID-19 Symptom Diary and Patient Global Impression of Severity every week; 
Patient Reported Outcomes Measurement Information System-Dyspnea Questionnaire, 
St. George's Respiratory Questionnaire, and EuroQol 5-Dimension, 5-Level Questionnaire
every month; Work Productivity and Activity Impairment Questionnaire plus Classroom 
Impairment Questions:  Specific Health Problems at the Day 1 visit, Months 3 and 6. 
Patients will be assessed through concomitant medication, nasopharyngeal swabs (as clinically 
indicated), blood samples, and urine samples.  Patients will be closely monitored for COVID-19 
signs and symptoms and adverse events; adverse events will be graded according to National 
Cancer Institute Common Terminology Criteria for Adverse Events v5.0.  Patients will be 
assessed monthly for COVID-19related medically-attended visits.
In addition, depending on local and country regulations and allowances, patients will use a 
consumer-grade wearable device (e.g., Apple Watch), provided by the Sponsor, on a 
continuous basis to capture heart rate, peripheral capillary oxygen saturation, activity, and sleep 
patterns for the duration of the study.  Data stored in the wearable device will be uploaded via a 
smart device.  At the end of this study, patients will be required to return the smart device and 
the wearable device. 
Number of Patients
Approximately 1040 patients diagnosed with COVID-19 who previously enrolled in a Phase III 
RO7496998 (AT-527) study are expected to enroll in this study.
Target Population
Inclusion Criteria
Patients must meet the following criteria for study entry:

Signed Informed Consent Form (signed by patient’s legally authorized representative for 
patients who have not attained the age of majority) 

Signed Assent Form when appropriate, as determined by patient’s age, individual site, and 
country standards

Age 18 years (regardless of weight) at the time of signing Informed Consent Form or age 
12 to 18 years (weight 40 kg) at the time of signing Informed Consent Form (and 
Assent Form)

Ability, judged by the investigator, to comply with the study protocol

Patient was diagnosed with COVID-19 and enrolled in a Phase III RO7496998 (AT-527) 
COVID-19 study. 
Note:  Patients who completed all study assessments in the parent study are eligible, 
regardless of whether patients completed or discontinued early from the study drug.
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from study entry:

Participation in an interventional study at the time of enrollment or plans to enroll in an 
interventional study during this study

Any serious medical condition or abnormality of clinical laboratory tests that, in the 
investigator’s judgment, precludes the patient’s safe participation in and completion of the
study

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End of Study
The end of this study is defined as the date when the last patient, last visit occurs or the date at 
which the last data point required for statistical analysis is received from the last patient on the 
study, whichever occurs later.  The end of the study is expected to occur approximately 
6 months after the last patient is enrolled.
In addition, the Sponsor may decide to terminate the study at any time.
Length of Study
The total length of the study, from enrollment of the first patient into this follow-up study to the 
end of the study, is expected to be approximately 10 months.  The total length of the study may 
be extended if patients from additional Phase III RO7496998 (AT-527) studies roll over into this 
study. 
Investigational Medicinal Products
This is an observational study and there is no investigational medicinal product in the study.  
Statistical Methods
Primary Analysis
The primary objective of this study is to evaluate the long-term symptoms of patients diagnosed 
with COVID-19 who previously enrolled in a RO7496998 (AT-527) study (i.e., parent study), for 
approximately 6 months after the end of the parent study. 
This will be assessed by the following endpoint:

Descriptive summaries, over time, of COVID-19 symptoms, as assessed through the 
COVID-19 Symptom Diary (Items 114)
This endpoint will be explored using descriptive summary statistics over time and will be 
specified in the Statistical Analysis Plan (SAP).  Because the primary analysis is descriptive in 
nature, there will be no formal hypothesis testing in the analysis of the primary endpoint.  The 
analysis population will consist of all patients enrolled in the study.
Details of the statistical analysis methods and endpoints will be described in the study SAP
which will be finalized prior to study completion.
Determination of Sample Size  
This study is observational in nature and designed for estimation and hypothesis-generating 
purposes.  The sample size of approximately 1040 patients is based on site feasibility 
assessment rather than statistical considerations.
Interim Analysis
While no interim analysis is planned for this study, if necessary, in support of a marketing 
application to health authorities, interim safety analyses may be conducted.

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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
Abbreviation
Definition
CDC
Centers for Disease Control
COPD
chronic obstructive pulmonary disease
COVID-19
coronavirus disease 2019
EC
Ethics Committee
ER
emergency room
eCRF
electronic Case Report Form
EDC
electronic data capture
EQ-5D-5L
EuroQol 5-Dimension, 5-Level Questionnaire
FDA
(U.S.) Food and Drug Administration
HIPAA
Health Insurance Portability and Accountability Act
ICH
International Council for Harmonisation
IMP
investigational medicinal product
IND
Investigational New Drug (Application)
IRB
Institutional Review Board
MN
mobile nursing
NCI CTCAE
National Cancer Institute Common Terminology Criteria for 
Adverse Events
NGS
next-generation sequencing
NP
nasopharyngeal
PGIS
Patient Global Impression of Severity
PRO
patient-reported outcome
PROMIS
Patient Reported Outcomes Measurement Information System
RT-PCR
reverse transcriptase-polymerase chain reaction
SAP
Statistical Analysis Plan
SARS-CoV-2
Severe Acute Respiratory Syndrome coronavirus-2
SDV
source data verification
SGRQ
St. George's Respiratory Questionnaire
SOC
standard of care
SpO2
peripheral capillary oxygen saturation
WPAICIQ:  SHP
Work Productivity and Activity Impairment Questionnaire plus 
Classroom Impairment Questions:  Specific Health Problems
WES
whole exome sequencing
WGS
whole genome sequencing

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1.
BACKGROUND
1.1
BACKGROUND ON COVID-19
While most patients who have an acute infection with Severe Acute Respiratory 
Syndrome coronavirus-2 (SARS-CoV-2) and develop coronavirus disease 2019
(COVID-19) recover to their previous health status, some may have persistent or late 
symptoms.  These persistent symptoms are often referred to as “long COVID” and the 
group of those patients experiencing them are often called “long haulers”.  This 
persistence of symptoms appears to occur often in non-hospitalized patients who 
experience mild COVID-19 illness (Centers for Disease Control [CDC] 2020) but has 
presented in more severe patients as well.  The most commonly reported long-term 
symptoms include fatigue, shortness of breath, cough, joint pain, and chest pain 
(CDC 2020).  Two to three weeks after testing positive in the outpatient setting, 35% of 
persons had not returned to their previous state of health, including 47% of those aged
50 years or older (Tenforde et al. 2020).  An increased hazard for psychiatric diagnoses 
in the three months after the diagnosis of COVID-19 has also been described 
(Taquet et al. 2020).
Few studies have quantified the frequency or duration of persistent symptoms in this 
now recognized chronic phase of COVID-19, especially in non-hospitalized patients.  
Reports to date have revealed mixed findings with regards to frequency, type, and 
severity of persistent symptoms, possibly as a consequence of presenting self-reported 
outcomes versus outcomes measured by tests or confirmed diagnoses; measuring 
outcomes at different time points during the course of the disease; and defining 
outcomes using different degrees of severity (such as mild fatigue vs. severe fatigue), 
among other reasons. 
Among 143 patients who were hospitalized for COVID-19 in Italy and recovered from the 
acute phase (mean age, 57 years; 63% men), 87% presented with at least one 
COVID-19related symptom in the follow-up visit that took place at a mean of 60 days 
after onset of first symptom of COVID-19; 32% of 143 patients had 1 or 2 symptoms and 
55% had three or more (Carfi et al. 2020).  Worsened quality of life was noted in 44% of 
patients.  The most common persistent symptoms were fatigue (53%), dyspnea (43%), 
joint pain (27%), and chest pain (22%).  Some symptoms that were common in the acute 
phase were not as common at the follow-up visit, such as cough, headache, myalgia, 
dysgeusia, lack of appetite, and anosmia.
A U.S.-based project followed 357 patients who tested positive for SARS-CoV-2 and 
reported on their health via online surveys (age and sex of this group not reported; 
3% hospitalized) (Cirulli et al. 2020). Of the 216 patients who tested positive and 
provided information after 30 days, 36% reported at least one symptom, whereas the 
corresponding proportion was 12% among patients who tested negative, and 8% in 
those who did not undergo tests.  Patients reported these predominant symptoms lasting 

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longer than 30 days associated with COVID-19 as follows:  dry cough, difficulty 
breathing, anosmia, difficulty concentrating, and headache.  
In the United Kingdom, United States, and Sweden, 4182 patients reported their 
symptoms prospectively after testing positive for a SARS-CoV-2 PCR using a mobile 
application (mean age, 43 years; 29% men; 14% visited a hospital) (Sudre et al. 2020).  
Of the 4182 patients, the following were reported:  13% with symptoms lasting longer 
than 4 weeks, 5% with symptoms lasting longer than 8 weeks; and 2% with symptoms 
lasting longer than 12 weeks.  Frequent persistent symptoms were fatigue (98% of 
patients who had symptoms 28 days after testing positive), headache (91%), dyspnea, 
and anosmia.
Additionally, a 6-month follow-up study following a cohort of discharged hospitalized 
patients in China reported that COVID-19 survivors were mainly troubled with fatigue or 
muscle weakness, sleep difficulties, and anxiety or depression (Huang et al. 2021).
The U.K. National Health Service, in March 2020, predicted that 45% of COVID-19 
patients who had been hospitalized will need ongoing medical care, 4% will require 
inpatient rehabilitation, and 1% may permanently require acute care.
It has been reported that outpatient multidisciplinary follow-up research studies will help 
to improve our understanding of the natural history of COVID-19 sequelae together with 
factors and mediators involved (Cortinovis et al. 2021).  
The widespread utilization of consumer-grade wearable devices has enabled new ways 
to study disease through continuous patient monitoring and passive collection of data. 
Physiological and behavioral data from these devices provide rich information to deepen 
the understanding of the disease itself. Prospective, continuous data collection using 
consumer-grade wearable devices may provide valuable insight on physiological and 
behavioral patterns following COVID-19 infection that have been difficult to understand 
and describe thus far.
Data from consumer-grade wearable devices have been studied previously to develop 
preliminary digital measures of cognitive impairment (Chen et al. 2019), characterize the 
impact of chronic pain on daily activities (Tran et al. 2019), and describe population-level 
response to influenza-like illness using passively collected, daily behavioral data (heart 
rate, activity, sleep) (Bradshaw et al. 2019). Ongoing studies are examining the extent 
to which these data relate to real world clinical outcomes and patient-reported outcomes 
(PROs) in influenza (Study WV42005).  Within the COVID-19 indication, a new study 
recently demonstrated that consumer-grade wearable devices can predict a positive 
COVID-19 diagnosis up to a week before current PCR-based nasal swab tests
(Hirten et al. 2021).  In COVID-19 long-term follow-up, however, there is currently a 
paucity of data from wearable devices, leaving opportunity to examine the physiological 
and behavioral patterns in patients after the acute phase of their disease.

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There is limited evidence on the long-term effects of COVID-19 infection, particularly for 
non-hospitalized patients with mild or moderate COVID-19.  Therefore, additional 
evaluation of COVID-19 long-term symptoms, including frequency and time to resolution, 
is warranted in patients with mild to moderate COVID-19, utilizing clinical follow-up, 
PROs, and consumer-grade wearable devices.
1.2
STUDY RATIONALE AND BENEFIT-RISK ASSESSMENT
The main benefit of this study will be an improved understanding of the long-term 
sequelae of COVID-19 by following patients diagnosed with COVID-19 who previously 
enrolled in a RO7496998 (AT-527) study (i.e., parent study). Close monitoring of these 
long-term COVID-19related symptoms will be beneficial in determining recovery 
post-infection in these patients. For the individual patient, there is a potential benefit of 
additional medical oversight.
Potential risks of a patient’s involvement in this study include risks common to clinical 
trials, such as the inconvenience of clinical assessments, blood draws, and urine 
samples.  Nasopharyngeal (NP) swabs may be collected if clinically indicated, such as 
by worsening of symptoms.  Collection of blood and urine samples from patients will 
provide vital information on the clinical manifestation or cessation of biomarkers related 
to viral infection and immune response mounted by patients over time.  Blood and urine 
sampling is routine with biomarker surveillance studies in the clinical trial setting.  
The risk to patients regarding the blood sampling venipuncture procedure will be low, no 
greater than blood collected as part of standard of care (SOC), and the procedure will be 
conducted by a trained professional.  The volume of blood collected during the study will 
be minimized to mitigate unnecessary blood sampling and visits scheduled for the 
patient.  Symptom driven NP swabs during this study will help to confirm infection as 
clinically indicated and correlate virology with study biomarkers also being followed.  NP
swabs are synonymous with virology studies and the swab procedure will be conducted 
by site personnel well versed in the procedure.  
Based on the wide number and differing clinical observations reported by authors for 
convalescent COVID-19 patients, this follow-up study will employ a multi-faceted
approach for collecting clinical measures to observe the patient cohort over an 
approximately 6-month period, including PROs and activity and physiological data from 
wearable devices. This will enable future clinical studies to have a clinically meaningful 
suite of tools at their disposal to assess the long-term COVID-19 sequelae, particularly in 
those patients diagnosed with mild to moderate COVID-19.   
Although the use of PROs and wearable devices are not considered to be part of the 
SOC in the treatment or follow-up of COVID-19 patients, associated risks with the use of
these devices by patients are considered to be minimal.  A potential risk of the wearable 
device is a rash from the armband due to sensitivities or allergies.  The use of a 
consumer-grade wearable device will be purely exploratory in this study but the 
technology may provide data (e.g., heart rate, pulse oximetry, activity, and sleep) about 

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the long-term recovery in patients with COVID-19 through employing a less invasive and 
less burdensome approach to patient follow-up. 
Considering the above, the benefit-risk balance for this study is considered favorable.
2.
OBJECTIVES AND ENDPOINTS
The purpose of this study is to evaluate the long-term sequelae of COVID-19 in patients 
diagnosed with COVID-19 who previously enrolled in a RO7496998 (AT-527) study 
(i.e., parent study), for approximately 6 months after the end of the parent study.  
Specific objectives and corresponding endpoints for the study are outlined in Table 1.
Table 1
Objectives and Corresponding Endpoints
Primary Objective
Corresponding Endpoint
To evaluate the long-term 
symptoms of patients diagnosed 
with COVID-19 
Descriptive summaries, over time, of COVID-19 
symptoms, as assessed through the COVID-19 
Symptom Diary (Items 114)
Secondary Objectives
Corresponding Endpoints
To evaluate HRQoL of patients 
diagnosed with COVID-19 
Impact of dyspnea symptoms on specific activities, as 
assessed through use of PROMIS-Dyspnea 
Questionnaire at Day 1 and Months 1, 2, 3, 4, 5, and 6
Respiratory-specific HRQoL, as assessed through use 
of SGRQ at Day 1 and Months 1, 2, 3, 4, 5, and 6
To evaluate medical resource 
utilization for patients diagnosed 
with COVID-19 
Proportion of patients with COVID-19related 
medically-attended visits through to study end (defined 
as hospitalization, emergency room visit, urgent care 
visit, physician’s office visit, or telemedicine visit with 
the primary reason for the visit being COVID-19 or 
COVID-19related symptoms)
To evaluate the long-term 
outcomes of COVID-19 in patients 
diagnosed with COVID-19 
Proportion of patients with all-cause mortality
Proportion of patients with death attributable to 
progression of COVID-19
Proportion of patients re-infected with SARS-CoV-2
Proportion of patients with any post-treatment infection 
including but not limited to bacterial, viral, or fungal 
pneumonia or sepsis
Frequency of COVID-19related complications 
(e.g., death, hospitalization, radiologically-confirmed 
pneumonia, acute respiratory failure, sepsis, 
coagulopathy, pericarditis, myocarditis, cardiac failure)
To evaluate adverse events in 
patients diagnosed with COVID-19 
who previously enrolled in a 
RO7496998 (AT-527) study
Incidence and severity of adverse events and serious 
adverse events, with severity determined according to 
NCI CTCAE v5.0

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Table 1
Objectives and Corresponding Endpoints (cont.)
Exploratory Objectives
Corresponding Endpoints
To evaluate symptom severity of 
patients diagnosed with COVID-19 
Self-reported symptom severity, as assessed weekly 
through use of PGIS
To evaluate health status and 
utility scores of patients diagnosed 
with COVID-19 
Health status utility, as assessed by EQ-5D-5L at 
Day 1 and Months 1, 2, 3, 4, 5, and 6
Work or school utility, as assessed through 
WPAI+CIQ:  SHP at Day 1, Months 3 and 6
To identify and/or evaluate 
biomarkers that can increase the 
knowledge and understanding of 
disease biology
Prevalence of neutralizing SARS-CoV-2 antibodies 
over time
Levels of biomarkers in blood and urine samples and 
their relationship with long-term outcomes or other 
biomarker endpoints
To evaluate the effectiveness of a 
consumer-grade wearable to track
changes in physiological and 
behavioral patterns following 
COVID-19 infection, as countries 
permit
Change in heart rate over time
Change in SpO2 over time 
Change in activity over time
Change in sleep patterns over time 
COVID-19coronavirus disease 2019; EQ-5D-5LEuroQol 5-Dimension, 5-Level Questionnaire; 
HRQoLhealth-related quality of life; NCI CTCAE v5.0 National Cancer Institute Common 
Terminology Criteria for Adverse Events, Version 5.0; PGISPatient Global Impression of 
Severity; PROMISPatient Reported Outcomes Measurement Information System;
SARS-CoV-2severe acute respiratory syndrome coronavirus-2; SGRQSt. George's 
Respiratory Questionnaire; SpO2 peripheral capillary oxygen saturation; 
WPAI+CIQ:  SHPWork Productivity and Activity Impairment Questionnaire plus Classroom 
Impairment Questions:  Specific Health Problems.
3.
STUDY DESIGN
3.1
DESCRIPTION OF THE STUDY
This is a Phase III, non-treatment, observational, multicenter, follow-up study to assess 
long-term outcomes for approximately 6 months in patients diagnosed with COVID-19 
who previously enrolled a RO7496998 (AT-527) study, also referred to as the parent 
study.  
There is no study drug or other treatment required in this follow-up study.  Throughout 
this protocol, “study drug” refers to treatment administered in the parent study prior to 
this study (CV43140). 
Any patients previously enrolled in a Phase III RO7496998 (AT-527) study will be 
informed of the opportunity to participate in this study (CV43140).  An attempt will be 
made, where possible, to consent patients to this study at the same time patients are 
consented to the parent study.  At the latest, patients must provide consent at the Day 1 
visit (baseline) of this study (CV43140), prior to the first assessment.  

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The Day 1 visit (baseline) can coincide with the final visit of the parent study, or as soon 
as possible after the final visit and within 7 days. Study outcomes will be assessed by 
measuring specific endpoints in patients at either daily (i.e., continuous measurements 
via consumer-grade wearable devices), weekly, or monthly time intervals for 
approximately 6 months. Patients will complete the COVID-19 Symptom Diary and 
Patient Global Impression of Severity (PGIS) every week; Patient Reported Outcomes
Measurement Information System (PROMIS)-Dyspnea Questionnaire, St. George's 
Respiratory Questionnaire (SGRQ), and EuroQol 5-Dimension, 5-Level Questionnaire
(EQ-5D-5L) every month; Work Productivity and Activity Impairment Questionnaire plus 
Classroom Impairment Questions:  Specific Health Problems (WPAI+CIQ:  SHP) at the 
Day 1 visit, Months 3 and 6. 
Patients will be assessed through concomitant medication, NP swabs (as clinically 
indicated), blood samples, and urine samples (see Appendix 1 for details regarding the 
timing of these assessments).  Patients will be closely monitored for COVID-19 signs 
and symptoms and adverse events; adverse events will be graded according to National 
Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Patients will be assessed monthly for COVID-19related medically-attended visits.
In addition, depending on local and country regulations and allowances, patients will use 
a consumer-grade wearable device (e.g., Apple Watch), provided by the Sponsor, on a 
continuous basis to capture heart rate, peripheral capillary oxygen saturation (SpO2),
activity, and sleep patterns for the duration of the study (see Section 4.5.3).  Data stored
in the wearable device will be uploaded via a smart device.  At the end of this study, 
patients will be required to return the smart device and the wearable device.
3.2
END OF STUDY AND LENGTH OF STUDY
The end of this study is defined as the date when the last patient, last visit occurs or the 
date at which the last data point required for statistical analysis is received from the last 
patient on the study, whichever occurs later.  The end of the study is expected to occur 
approximately 6 months after the last patient is enrolled.
In addition, the Sponsor may decide to terminate the study at any time.
The total length of the study, from enrollment of the first patient into this follow-up study 
to the end of the study, is expected to be approximately 10 months.  The total length of 
the study may be extended if patients from additional Phase III RO7496998 (AT-527)
studies roll over into this study. 
3.3
RATIONALE FOR STUDY DESIGN
3.3.1
Rationale for Non-Standard Clinical Outcome Assessments
At the onset of the global emergency, there was limited understanding of what 
constituted disease progression in COVID-19 and how the symptoms experienced by 
patients manifested themselves and affected their lives.  Given the heterogeneous 

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nature of COVID-19related symptoms in outpatients, key COVID-19related symptoms 
should be assessed systematically to provide an accurate evaluation.  For this reason, 
the example U.S. FDA COVID-19 PRO instrument has been used as a basis for the 
COVID-19 Symptom Diary assessing 14 key symptoms and will be used for this study.  
The symptom items used in this PRO are derived from information provided by the 
Centers for Disease Control and Prevention as of 28 August 2020.
3.3.2
Rationale for Biomarker Assessments
COVID-19 is a heterogeneous disease, and expression of certain biomarkers has been 
shown to vary with disease severity (Arunachalam et al. 2020; Su et al. 2020).  
Exploratory biomarkers during the long-term observational study may allow for 
identification of patients at higher risk of sustained or worse outcomes to COVID-19. 
Blood biomarkers will include, but are not limited to, markers of inflammation and those 
with known associations to tissue damage and repair (e.g., wound healing/fibrotic 
remodeling of the lung) to explore their associations to persistent lung anomalies 
induced by COVID-19 (Dressen et al. 2018; Neighbors et al. 2018). Biomarkers for 
nonlung-related outcomes may also be measured to understand the progression of 
COVID-19. The changes in biomarkers and their relationship to long-term clinical and 
other biomarker endpoints will be assessed to further the understanding of disease 
biology of COVID-19. 
4.
MATERIALS AND METHODS
4.1
PATIENTS
Approximately 1040 patients diagnosed with COVID-19 who previously enrolled in a 
Phase III RO7496998 (AT-527) study are expected to enroll in this study.
4.1.1
Inclusion Criteria
Patients must meet the following criteria for study entry:

Signed Informed Consent Form (signed by patient’s legally authorized 
representative for patients who have not attained the age of majority)

Signed Assent Form when appropriate, as determined by patient’s age, individual 
site, and country standards

Age 18 years (regardless of weight) at the time of signing Informed Consent Form 
or age 12 to 18 years (weight 40 kg) at the time of signing Informed Consent 
Form (and Assent Form)

Ability, judged by the investigator, to comply with the study protocol

Patient was diagnosed with COVID-19 and enrolled in a Phase III RO7496998 
(AT-527) COVID-19 study.
Note: Patients who completed all study assessments in the parent study are
eligible, regardless of whether patients completed or discontinued early from 
the study drug.

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4.1.2
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from study entry:

Participation in an interventional study at the time of enrollment or plans to enroll in 
an interventional study during this study

Any serious medical condition or abnormality of clinical laboratory tests that, in the 
investigator’s judgment, precludes the patient’s safe participation in and completion 
of the study
4.2
METHOD OF TREATMENT ASSIGNMENT AND BLINDING
This is a non-randomized, observational, and non-treatment study.  After initial written 
informed consent has been obtained, all screening procedures and assessments have 
been completed, and eligibility has been established for a patient, the study site will set
up the patient in the electronic data capture (EDC) system with the same patient 
identification number as from the parent study.
The treatment arm to which patients were assigned in the parent study will not be 
disclosed until the final analysis of the parent study is reported, which may occur during 
this study (CV43140).  
4.3
STUDY TREATMENT AND OTHER TREATMENTS RELEVANT 
TO THE STUDY DESIGN
This is an observational study.  No study drug will be administered.
4.4
CONCOMITANT THERAPY AND ADDITIONAL RESTRICTIONS
Concomitant therapy consists of any medication (e.g., prescription drugs, 
over-the-counter drugs, vaccines, herbal or homeopathic remedies, nutritional 
supplements) and supplemental oxygen used by a patient from the Day 1 visit of this 
study to the end of this study (CV43140). Concomitant therapy data may be transferred
from the parent study. There are no food, alcohol, herbal therapy, or smoking 
restrictions during this study.
Although there are no restrictions on concomitant therapies in this study, all such 
medications should be reported to the investigator and recorded on the Concomitant 
Medications electronic Case Report Form (eCRF).  
4.5
STUDY ASSESSMENTS 
The schedule of activities to be performed during the study is provided in Appendix 1.  
All activities should be performed and documented for each patient.  
At applicable sites, certain study assessments and visits may be performed by a mobile 
nursing (MN) professional at the patient's home or another suitable location, to improve 
access and convenience for patients participating in the study.  The Sponsor will select a 
healthcare company that will be responsible for providing MN services for participating 

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sites (the MN vendor).  The MN vendor is responsible for ensuring that all MN
professionals are licensed, qualified, and in good standing, as per applicable regulations, 
and that appropriate background checks have been performed.  If the investigator at a 
participating site determines that MN services are appropriate for a patient and the 
patient gives written informed consent to participate in MN visits, the MN network will 
communicate with the patient and the patient's site.  MN visits will be scheduled on 
specified visit days, to allow for relevant assessments to be performed by the MN
professional.  The schedule of activities (see Appendix 1) will specify the assessments 
that may be performed by an MN professional.
Assessments at Unscheduled Visits 
Assessments listed in Appendix 1, as deemed necessary by the investigator and/or the
Sponsor (e.g., for evaluation of an adverse event), may be performed at unscheduled 
visits.  
4.5.1
Informed Consent Forms and Screening Log
Written informed consent and assent (where appropriate) for participation in the study 
must be obtained before performing any study-related procedures (including screening 
evaluations).  Informed Consent Forms (and Assent Forms where appropriate) for 
enrolled patients and for patients who are not subsequently enrolled will be maintained 
at the study site.
All screening evaluations must be completed and reviewed to confirm that patients 
meet all eligibility criteria before enrollment.  The investigator will maintain a screening 
log to record details of all patients screened and to confirm eligibility or record reasons 
for screening failure, as applicable.
4.5.2
Medical History, Baseline Conditions, Concomitant Medication,
and Demographic Data
Medical history, demographic data, concomitant medications, and resolved adverse 
events may be transferred from the parent study. Ongoing adverse events at the end of 
the parent study will be reopened in this study (CV43140) (see Section 5.1). 
In addition, all concomitant medications (e.g., prescription drugs, over-the-counter drugs, 
vaccines, herbal or homeopathic remedies, nutritional supplements) and supplemental 
oxygen used by the patient during the study will be recorded. At each visit, changes in 
concomitant medication and allergies will be recorded. 
Any COVID-19 vaccination that has occurred before the patient enrolls into the study or 
during the study will be recorded on the Concomitant Medications eCRF, including the 
report product or brand/trade or company manufacturer, if available (examples: Pfizer 
COVID-19 vaccine, Moderna COVID-19 vaccine), and date(s) administered if 
known. If not available, report as COVID-19 vaccine.

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4.5.3
Wearable Device
At the Day 1 visit, depending on local and country regulations and allowances, patients 
will be provided with a consumer-grade wearable device (e.g., Apple Watch) where 
possible and detailed instructions on the correct use of the device to track their health 
data continuously (e.g., heart rate, SpO2, activity, and sleep pattern).  Data stored in the 
consumer-grade wearable device will be uploaded through a smart device, preferably on 
a daily basis.  Data are not available to the Sponsor in real-time; therefore, are not 
medically actionable.  Data captured from this consumer-grade wearable device are not 
considered medical-grade and are for exploratory analysis only.
At the end of this study, patients will be required to return the consumer-grade wearable 
device and the smart device. All patient identifiers and personal information will be 
removed from these devices at the end of the study. 
4.5.4
Laboratory, Biomarker, and Other Biological Samples
Samples for the following laboratory tests will be sent to designated central laboratories 
or the Sponsor or a designee for analysis:

Symptom-guided NP swab for SARS-CoV-2 reverse-transcriptase (RT)-PCR, 
genotypic analysis, and respiratory pathogen co-infections panel (multiplex BioFire
assay) (see Appendix 2 for example symptoms)

Serum samples for exploratory biomarker research and SARS-CoV-2 antibodies

Symptom guided serum samples for exploratory biomarker research and 
SARS-CoV-2 antibodies (see Appendix 2 for example symptoms)

Blood PAXgeneRNA for RNA sequencing or quantitative PCR

Blood sample for hemoglobin A1c

Urine sample for exploratory biomarker research
NP swabs (symptom-guided; as clinically indicated), blood, and urine sample collection 
may be performed by an MN professional.
Exploratory biomarker research and virology tests may include, but will not be limited to, 
analysis of SARS-CoV-2 antibody titer, inflammatory mediators and/or cytokines, 
immune cells, viral load, viral titer, virus drug susceptibility and virus genotypic analysis
(e.g., next-generation sequencing [NGS]). Research may involve extraction of DNA, 
cell-free DNA, or RNA; analysis of mutations, single nucleotide polymorphisms, and 
other genomic variants; and genomic profiling through use of NGS of a comprehensive 
panel of genes.  Genomic research will be aimed at exploring inherited characteristics.
For sampling procedures, storage conditions, and shipment instructions, see the 
laboratory manual.

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Biological samples will be destroyed no later than the time of completion of the final 
Clinical Study Report, with the following exception:

NP swabs, serum, blood PAXgeneRNA, blood, and urine samples collected for 
virology and biomarker research will be destroyed no later than 15 years after the 
final Clinical Study Report has been completed.  However, the storage period will be 
in accordance with the Institutional Review Board/ Ethics Committee 
(IRB/EC)approved Informed Consent Form and applicable laws (e.g., health 
authority requirements).
When a patient withdraws from the study, samples collected prior to the date of 
withdrawal may still be analyzed, unless the patient specifically requests that the 
samples be destroyed or local laws require destruction of the samples.  However, if 
samples have been tested prior to withdrawal, results from those tests will remain as 
part of the overall research data.
Data arising from sample analysis, including data on genomic variants, will be subject to 
the confidentiality standards described in Section 8.4.
Given the complexity and exploratory nature of exploratory biomarker analyses, data 
derived from these analyses will generally not be provided to study investigators or 
patients unless required by law.  The aggregate results of any conducted research will 
be available in accordance with the effective Sponsor policy on study data publication.
4.5.5
Clinical Outcome Assessments
Clinical outcome assessments in this study will be completed by patients via PROs to
evaluate long-term outcomes of patients with COVID-19 who previously enrolled in a 
RO7496998 (AT-527) study.  In addition, PRO instruments will enable the capture of 
each patient's direct experience with any long-term symptoms of COVID-19.
PRO data will be collected through use of the following instruments:  COVID-19 
Symptom Diary, PGIS, PROMIS-Dyspnea Questionnaire, SGRQ, EQ-5D-5L, and 
WPAI+CIQ:  SHP.
4.5.5.1
Data Collection Methods for Clinical Outcome Assessments
PRO instruments will be self-administered at home at specified timepoints during the 
study (see schedule of activities in Appendix 1).
PRO instruments, translated into the local language as appropriate, will be completed 
through use of an electronic device provided by the Sponsor.  The device will be 
pre-programmed to enable the instrument to be administered at each specified 
timepoint.  The electronic device and instructions for completing the instruments 
electronically will be provided by the site staff.  The data will be transmitted to a 
centralized database maintained by the electronic device vendor.  The data will be 
available for access by appropriate study personnel.

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Patients should be given the following instructions for completing PRO instruments at 
home:

Patients should complete the instruments in a quiet area with minimal distractions 
and disruptions.

Patients should answer questions to the best of their ability; there are no right or 
wrong answers.

Patients should not obtain advice or help from others (e.g., family members or 
friends) when completing the instruments.
4.5.5.2
Description of Clinical Outcome Assessment Instruments
COVID-19 Symptom Diary
The COVID-19 Symptom Diary (see Appendix 2) will be used to characterize key 
symptoms recognized as part of COVID-19 illness per FDA guidance (FDA 2020).  
The COVID-19 Symptom Diary is composed of 14 individual symptom questions, each 
with a 3- or 4-point Likert response option. The content of the COVID-19 Symptom 
Diary remains unchanged from the parent study (Study CV43043), but the recall period 
and administration schedule are modified for the long-term study design. 
The COVID-19 Symptom Diary will be completed in its entirety by the patient once a 
week (see Appendix 1).  To ensure that data standards meet health authority 
requirements, the COVID-19 Symptom Diary will be completed as per schedule of 
assessment for the duration of the study.
Patient Global Impression of Severity
The PGIS (see Appendix 3) is a single item assessment of a patient’s impression of the 
severity of his or her COVID-19 symptoms during the course of the study.  Change in 
COVID-19 symptoms are rated on a 4-point Likert scale from “none” (0) to “severe” (3).  
The PGIS will be completed by the patient once a week for the duration of the study.
PROMIS-Dyspnea Questionnaire
The PROMIS Short Form Dyspnea Severity Questionnaire is a 10-item questionnaire 
selected from the PROMIS Item Bank v1.0Dyspnea Severity (Choi et al. 2011). The 
item bank assesses the severity of shortness of breath and difficulty of breathing in 
response to specific activities. Patients will be asked to self-report their severity of 
shortness of breath over the past seven days (see Appendix 4). The PROMIS Short 
Form Dyspnea Severity instrument is scored on a 4-point Likert scale, with an option to 
indicate that an activity had not been performed. A higher score indicates a higher 
symptom severity of dyspnea. 
St. George’s Respiratory Questionnaire
The SGRQ is a 50-item respiratory-specific quality-of-life questionnaire initially 
developed and validated for use in chronic obstructive pulmonary disease (COPD)
(Jones et al. 1992) (see Appendix 5). It includes questions that assess the impact of 
disease on symptoms, activity, and functionality. Each scale is scored from 0 to 100, 

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and a total score represents the weighted average of these three subscores. Items are 
assessed on various response scales, including a 5-point Likert scale and a true/false 
scale. The SGRQ has a recall period of the past 4 weeks. Recently, the SGRQ has 
been applied more broadly to assess patients with airflow limitation due to causes other 
than COPD, including asthma (Ortega et al. 2014). The SGRQ will be administered 
once a month.
EuroQol-5D-5L
The EQ-5D-5L, is a validated self-report health status questionnaire that is used to 
calculate a health status utility score for use in health economic analyses 
(EuroQol Group 1990; Brooks 1996; Herdman et al. 2011; Janssen et al. 2013)
(see Appendix 6).  There are two components to the EQ-5D-5L:  a five-item health state 
profile that assesses mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression, as well as a Visual Analog Scale that measures health state.  The 
EQ-5D-5L is designed to capture the patient's current health status.  Published weighting 
systems allow for creation of a single composite score of the patient's health status.  
The EQ-5D-5L takes approximately 3 minutes to complete.  It will be used in this study 
for informing pharmacoeconomic evaluations.
Work Productivity and Activity Impairment Questionnaire plus Classroom 
Impairment Questions:  Specific Health Problems 
The WPAI+CIQ:  SHP is a 10-item scale (see Appendix 7) adapted from the 
WPAI:  General Health v2 (Reilly et al. 1993) to assess both work and classroom 
environments.  Patients will be asked to estimate the amount of time that their work, 
school work and daily activities were affected by their COVID-19 symptoms over the 
previous 7 days (Reilly et al. 1996).  The WPAICIQ:  SHP assesses absenteeism as 
well as “presenteeism,” which accounts for the time when patients were present for work 
or school, but believed their health had a negative effect on their ability to perform at the 
usual level.  A higher score represents greater impairment in productivity.
4.5.5.3
Additional COVID-19Related Assessments
COVID-19Related Medically-Attended Visit(s) Assessment
A COVID-19related medically-attended visit will be defined as follows:  hospitalization, 
emergency room (ER) visit, urgent care visit, physician’s office visit, or telemedicine visit, 
with the primary reason for the visit being COVID-19 or COVID-19related symptoms. 
Only medically-attended visits related to COVID-19, as determined by the investigator, 
will be recorded in the eCRF.  Details will include at minimum:

Type of visit (hospitalization, ER visit, urgent care visit, physician’s office visit, or 
telemedicine visit)

Date of visit

Primary reason for COVID-19related medically-attended visit 

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
Treatments given for COVID-19 (including, but not limited to, concomitant 
medications and supplemental oxygen) 

If hospitalization due to COVID-19 was required, include length of visit, whether 
intensive care unit care was given, or whether mechanical ventilation was required
Any adverse events or concomitant therapies reported to the investigator should be
recorded on the respective Adverse Events eCRF or Concomitant Medications eCRF.
4.5.6
Optional Blood Samples for Whole Genome Sequencing or 
Whole Exome Sequencing (Patients at Participating Sites)
At participating sites, optional blood samples will be collected from consenting patients 
for DNA extraction to enable Whole Genome Sequencing (WGS) or whole exome 
sequencing (WES) to identify variants that are predictive of response to study drug, are 
associated with progression to a more severe disease state, are associated with 
susceptibility to developing adverse events, can lead to improved adverse event 
monitoring or investigation, or can increase the knowledge and understanding of disease 
biology and drug safety.  Of note, at participating sites, blood samples will only be 
collected from consenting patients who have not previously provided a WGS sample in 
the parent study. Research will be aimed at exploring inherited characteristics.  The 
samples may be sent to one or more laboratories for analysis.
Collection and submission of blood samples for WGS or WES is contingent upon the 
review and approval of the exploratory research by each site's IRB/EC and, if applicable, 
an appropriate regulatory body.  If a site has not been granted approval for WGS or 
WES, this section of the protocol (Section 4.5.6) will not be applicable at that site.
The Informed Consent Form will contain a separate section that addresses optional 
blood samples for WGS or WES.  A separate, specific signature will be required to 
document a patient's agreement to provide optional blood samples.  The investigator 
should document whether or not the patient has given consent to participate and (if 
applicable) the date(s) of consent, by completing the Optional Whole Genome 
Sequencing or Whole Exome Sequencing Informed Consent/Withdrawal eCRF. 
Genomics is increasingly informing researcher's understanding of disease pathobiology.  
WGS and WES provide a comprehensive characterization of the genome and exome, 
respectively, and, along with clinical data collected in this study, may increase the 
opportunity for developing new therapeutic approaches or new methods for monitoring 
efficacy and safety or predicting which patients are more likely to respond to a drug or 
develop adverse events.  Data will be analyzed in the context of this study but may also 
be explored in aggregate with data from other studies.  The availability of a larger 
dataset will assist in identification and characterization of important biomarkers and 
pathways to support future drug development.

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For sampling procedures, storage conditions, and shipment instructions, see the 
laboratory manual.  
Blood samples collected for WGS or WES are to be stored for up to 15 years after the 
final Clinical Study Report has been completed.  However, the storage period will be in 
accordance with the IRB/ECapproved Informed Consent Form and applicable laws 
(e.g., health authority requirements).
Refer to Section 4.5.4 for details on use of samples after patient withdrawal, 
confidentiality standards for data, and availability of data from biomarker analyses.
4.6
PATIENT, STUDY, AND SITE DISCONTINUATION
4.6.1
Patient Discontinuation from the Study
Patients are required to complete an early termination visit as soon as possible after 
they decide to withdraw from the study or the investigator withdraws the patient from the 
study.  This visit can be performed remotely. 
Patients have the right to voluntarily withdraw from the study at any time for any reason.  
In addition, the investigator has the right to withdraw a patient from the study at any time.
Reasons for patient discontinuation from the study may include, but are not limited to, 
the following:

Patient withdrawal of consent

Study termination or site closure

Adverse event

Loss to follow-up

Patient non-compliance, defined as failure to comply with protocol requirements as 
determined by the investigator or Sponsor
Every effort should be made to obtain a reason for patient discontinuation from the 
study.  The primary reason for discontinuation from the study should be documented on 
the appropriate eCRF.  If a patient requests to be withdrawn from the study, this request 
must be documented in the source documents and signed by the investigator.  Patients 
who withdraw from the study will not be replaced.
If a patient withdraws from the study, the study staff may use a public information source 
(e.g., county records) to obtain information about survival status.
4.6.2
Study Discontinuation
The Sponsor has the right to terminate this study at any time.  Reasons for terminating 
the study may include, but are not limited to, the following:

Patient enrollment is unsatisfactory

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The Sponsor will notify the investigator if the Sponsor decides to discontinue the study.  
4.6.3
Site Discontinuation
The Sponsor has the right to close a site at any time.  Reasons for closing a site may 
include, but are not limited to, the following:

Excessively slow recruitment

Poor protocol adherence

Inaccurate or incomplete data recording

Non-compliance with the International Council for Harmonisation (ICH) guideline for 
Good Clinical Practice

No study activity (i.e., all patients have completed the study and all obligations have 
been fulfilled)
5.
ASSESSMENT OF SAFETY
5.1
SAFETY PLAN
Any adverse events that occur during this study should be reported as outlined below.  
For ongoing adverse events starting in the parent study, any follow-up of the adverse 
event will be reported in this study (Study CV43140). The adverse event severity, 
according to NCI CTCAE v5.0 (Table 2), should be evaluated by the investigator at the 
Day 1 visit of this study and recorded in the "adverse event initial NCI CTCAE grade" 
field of the Adverse Event eCRF for Study CV43140. The most extreme NCI CTCAE 
grade for the adverse event should also be recorded, taking into account the severity of 
the event since it was first reported during the parent study.  
Please note that “study drug” refers to the treatment administered in the parent study 
prior to this follow-up study.
5.2
SAFETY PARAMETERS AND DEFINITIONS
Safety assessments will consist of monitoring and recording adverse events, including 
serious adverse events that are deemed critical to the safety evaluation of the study.
Certain types of events require immediate reporting to the Sponsor, as outlined in 
Section 5.4.
5.2.1
Adverse Events
According to the ICH guideline for Good Clinical Practice, an adverse event is any 
untoward medical occurrence in a clinical investigation subject administered a 

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pharmaceutical product, regardless of causal attribution.  An adverse event can 
therefore be any of the following:

Any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease temporally associated with the use of a medicinal product, 
whether or not considered related to the medicinal product

Any new disease or exacerbation of an existing disease (a worsening in the 
character, frequency, or severity of a known condition) (see Sections 5.3.5.5
and 5.3.5.6 for more information)

Recurrence of an intermittent medical condition (e.g., headache) not present at 
baseline

Adverse events that are related to a protocol-mandated intervention
5.2.2
Serious Adverse Events (Immediately Reportable to the 
Sponsor)
A serious adverse event is any adverse event that meets any of the following criteria:

Is fatal (i.e., the adverse event actually causes or leads to death)

Is life threatening (i.e., the adverse event, in the view of the investigator, places the 
patient at immediate risk of death)
This does not include any adverse event that, had it occurred in a more severe 
form or was allowed to continue, might have caused death.

Requires or prolongs inpatient hospitalization (see Section 5.3.5.7)

Results in persistent or significant disability/incapacity (i.e., the adverse event 
results in substantial disruption of the patient's ability to conduct normal life 
functions)

Is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to 
study drug

Is a significant medical event in the investigator's judgment (e.g., may jeopardize the 
patient or may require medical/surgical intervention to prevent one of the outcomes 
listed above)
The terms "severe" and "serious" are not synonymous.  Severity refers to the intensity of 
an adverse event (e.g., rated as mild, moderate, or severe, or according to NCI CTCAE; 
see Section 5.3.3); the event itself may be of relatively minor medical significance (such 
as severe headache without any further findings).
Severity and seriousness need to be independently assessed for each adverse event 
recorded on the eCRF.
Serious adverse events are required to be reported by the investigator to the Sponsor 
immediately (i.e., no more than 24 hours after learning of the event; see Section 5.4.2 for 
reporting instructions).

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5.3
METHODS AND TIMING FOR CAPTURING AND ASSESSING 
SAFETY PARAMETERS
The investigator is responsible for ensuring that all adverse events (see Section 5.2.1 for 
definition) are recorded on the Adverse Event eCRF and reported to the Sponsor in 
accordance with instructions provided in this section and in Sections 5.45.6.  
The investigator is also responsible for reporting medical device complaints 
(see Section 5.4.4).
For each adverse event recorded on the Adverse Event eCRF, the investigator will make 
an assessment of seriousness (see Section 5.2.2 for seriousness criteria), severity 
(see Section 5.3.3), and causality (see Section 5.3.4).  
5.3.1
Adverse Event Reporting Period
Investigators will seek information on adverse events at each patient contact.  
All adverse events, whether reported by the patient or noted by study personnel, will be 
recorded in the patient's medical record and on the Adverse Event eCRF.
After informed consent has been obtained, all adverse events should be reported from 
Day 1 visit of this study until the end of the study.  For ongoing adverse events which 
occurred before the Day 1 visit of this study, the adverse event will be reported as 
outlined in Section 5.1.
Instructions for reporting adverse events that occur after the adverse event reporting 
period are provided in Section 5.6.
5.3.2
Eliciting Adverse Event Information
A consistent methodology of non-directive questioning should be adopted for eliciting 
adverse event information at all patient evaluation timepoints.  Examples of non-directive 
questions include the following:
"How have you felt since your last clinic visit?"
"Have you had any new or changed health problems since you were last here?" 
5.3.3
Assessment of Severity of Adverse Events
The adverse event severity grading scale for the NCI CTCAE (v5.0) will be used for 
assessing adverse event severity.  Table 2 will be used for assessing severity for 
adverse events that are not specifically listed in the NCI CTCAE.

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Table 2
Adverse Event Severity Grading Scale for Events Not Specifically 
Listed in NCI CTCAE
Grade
Severity
1
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
or intervention not indicated
2
Moderate; minimal, local, or non-invasive intervention indicated; or limiting 
age-appropriate instrumental activities of daily living a
3
Severe or medically significant, but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; or 
limiting self-care activities of daily living b, c
4
Life-threatening consequences or urgent intervention indicated d
5
Death related to adverse event d
NCI CTCAENational Cancer Institute Common Terminology Criteria for Adverse Events.
Note:  Based on the most recent version of NCI CTCAE (v5.0), which can be found at:  
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm
a Instrumental activities of daily living refer to preparing meals, shopping for groceries or 
clothes, using the telephone, managing money, etc.
b Examples of self-care activities of daily living include bathing, dressing and undressing, 
feeding oneself, using the toilet, and taking medications, as performed by patients who are 
not bedridden.
c If an event is assessed as a "significant medical event," it must be reported as a serious 
adverse event (see Section 5.4.2 for reporting instructions), per the definition of serious 
adverse event in Section 5.2.2.
d Grade 4 and 5 events must be reported as serious adverse events (see Section 5.4.2 for 
reporting instructions), per the definition of serious adverse event in Section 5.2.2.
5.3.4
Assessment of Causality of Adverse Events
Investigators should use their knowledge of the patient, the circumstances surrounding 
the event, and an evaluation of any potential alternative causes to determine whether an 
adverse event is considered to be related to the study drug administered in the parent 
study, indicating "yes" or "no" accordingly.  The following guidance should be taken into 
consideration (Table 3):
Table 3
Causal Attribution Guidance
Is the adverse event suspected to be caused by the study drug administered in the parent 
study on the basis of facts, evidence, science-based rationales, and clinical judgment?
YES
There is a plausible temporal relationship between the onset of the adverse event and 
administration of the study drug, and the adverse event cannot be readily explained by 
the patient's clinical state, intercurrent illness, or concomitant therapies.
NO
An adverse event will be considered related, unless it fulfills the criteria specified below.  
Evidence exists that the adverse event has an etiology other than the procedure
(e.g., preexisting medical condition, underlying disease, intercurrent illness, 
or concomitant medication); and/or the adverse event has no plausible temporal 
relationship to the initiation of a study procedure.

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5.3.5
Procedures for Recording Adverse Events
Investigators should use correct medical terminology/concepts when recording adverse 
events on the Adverse Event eCRF.  Avoid colloquialisms and abbreviations.
Only one adverse event term should be recorded in the event field on the Adverse Event 
eCRF.
5.3.5.1
Diagnosis versus Signs and Symptoms
A diagnosis (if known) should be recorded on the Adverse Event eCRF rather than 
individual signs and symptoms (e.g., record only liver failure or hepatitis rather than 
jaundice, asterixis, and elevated transaminases).  However, if a constellation of signs 
and/or symptoms cannot be medically characterized as a single diagnosis or syndrome 
at the time of reporting, each individual event should be recorded on the Adverse Event 
eCRF.  If a diagnosis is subsequently established, all previously reported adverse events 
based on signs and symptoms should be nullified and replaced by one adverse event 
report based on the single diagnosis, with a starting date that corresponds to the starting 
date of the first symptom of the eventual diagnosis.
5.3.5.2
Adverse Events That Are Secondary to Other Events
In general, adverse events that are secondary to other events (e.g., cascade events or 
clinical sequelae) should be identified by their primary cause, with the exception of 
severe or serious secondary events.  A medically significant secondary adverse event 
that is separated in time from the initiating event should be recorded as an independent 
event on the Adverse Event eCRF.  For example:

If vomiting results in mild dehydration with no additional treatment in a healthy adult, 
only vomiting should be reported on the eCRF.

If vomiting results in severe dehydration, both events should be reported separately 
on the eCRF.

If a severe gastrointestinal hemorrhage leads to renal failure, both events should be 
reported separately on the eCRF.

If dizziness leads to a fall and consequent fracture, all three events should be 
reported separately on the eCRF.

If neutropenia is accompanied by an infection, both events should be reported 
separately on the eCRF.
All adverse events should be recorded separately on the Adverse Event eCRF if it is 
unclear as to whether the events are associated.
5.3.5.3
Persistent or Recurrent Adverse Events
A persistent adverse event is one that extends continuously, without resolution, between 
patient evaluation timepoints.  Such events should only be recorded once on the 
Adverse Event eCRF.  The initial severity (intensity or grade) of the event will be 
recorded at the time the event is first reported.  If a persistent adverse event becomes 

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more severe, the most extreme severity should also be recorded on the Adverse Event 
eCRF.  If the event becomes serious, it should be reported to the Sponsor immediately 
(i.e., no more than 24 hours after learning that the event became serious; 
see Section 5.4.2 for reporting instructions).  The Adverse Event eCRF should be 
updated by changing the event from "non-serious" to "serious," providing the date that 
the event became serious, and completing all data fields related to serious adverse 
events.
A recurrent adverse event is one that resolves between patient evaluation timepoints 
and subsequently recurs.  Each recurrence of an adverse event should be recorded as a 
separate event on the Adverse Event eCRF.
5.3.5.4
Deaths
All deaths that occur during the protocol-specified adverse event reporting period 
(see Section 5.3.1), regardless of relationship to study drug, must be recorded on the 
Adverse Event eCRF and immediately reported to the Sponsor (see Section 5.4.2).  
This includes death attributed to progression of COVID-19.
Death should be considered an outcome and not a distinct event.  The event or condition 
that caused or contributed to the fatal outcome should be recorded as the single medical 
concept on the Adverse Event eCRF.  Generally, only one such event should be 
reported.  If the cause of death is unknown and cannot be ascertained at the time of 
reporting, "unexplained death" should be recorded on the Adverse Event eCRF.  If the 
cause of death later becomes available (e.g., after autopsy), "unexplained death" should
be replaced by the established cause of death.  The term "sudden death" should not be 
used unless combined with the presumed cause of death (e.g., "sudden cardiac death").
If the death is attributed solely to progression of COVID-19, “COVID-19 progression”
should be recorded on the Adverse Event eCRF.
Deaths that occur after the adverse event reporting period should be reported as 
described in Section 5.6.
5.3.5.5
Preexisting Medical Conditions
A preexisting medical condition is one that is present at the screening visit for the parent 
study.  Such conditions should be recorded on the General Medical History and Baseline 
Conditions eCRF and where possible, will be transferred from the parent study.
A preexisting medical condition should be recorded as an adverse event only if the 
frequency, severity, or character of the condition worsens during the study.  When 
recording such events on the Adverse Event eCRF, it is important to convey the concept 
that the preexisting condition has changed by including applicable descriptors 
(e.g., "more frequent headaches").

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5.3.5.6
Lack of Efficacy or Worsening of COVID-19 
Medical occurrences or symptoms of deterioration that are anticipated as part of 
COVID-19, such as fluctuations in symptoms should not be recorded as adverse events. 
However, deterioration that is judged by the investigator to have unexpectedly worsened 
in severity or frequency or changed in nature at any time during the study should be 
recorded as an adverse event.  When recording an unanticipated worsening of 
COVID-19 on the Adverse Event eCRF, it is important to convey the concept that the 
condition has changed by including applicable descriptors (e.g., "accelerated worsening 
of COVID-19").
5.3.5.7
Hospitalization or Prolonged Hospitalization
Any adverse event that results in hospitalization (i.e., inpatient admission to a hospital)
or prolonged hospitalization should be documented and reported as a serious adverse 
event (per the definition of serious adverse event in Section 5.2.2), except as outlined 
below.  
An event that leads to hospitalization under the following circumstances should not be 
reported as an adverse event or a serious adverse event:

Hospitalization for a preexisting condition, provided that all of the following criteria 
are met:
The hospitalization was planned prior to the study or was scheduled during the 
study when elective surgery became necessary because of the expected 
normal progression of the disease
The patient has not experienced an adverse event
5.3.5.8
Patient-Reported Outcome Data
Adverse event reports will not be derived from PRO data by the Sponsor.  Sites are not 
expected to review the PRO data for adverse events.
5.4
IMMEDIATE REPORTING REQUIREMENTS FROM 
INVESTIGATOR TO SPONSOR
Certain events require immediate reporting to allow the Sponsor to take appropriate 
measures to address potential new risks in a clinical trial.  The investigator must report 
such events to the Sponsor immediately; under no circumstances should reporting take 
place more than 24 hours after the investigator learns of the event.  The following is a list 
of events that the investigator must report to the Sponsor within 24 hours after learning 
of the event, regardless of relationship to study drug:

Serious adverse events (defined in Section 5.2.2; see Section 5.4.2 for details on 
reporting requirements)

Pregnancies (see Section 5.4.3 for details on reporting requirements)

Medical device complaints (see Section 5.4.4 for details on reporting requirements)

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For serious adverse events, the investigator must report new significant follow-up 
information to the Sponsor immediately (i.e., no more than 24 hours after becoming 
aware of the information).  New significant information includes the following:

New signs or symptoms or a change in the diagnosis

Significant new diagnostic test results

Change in causality based on new information

Change in the event's outcome, including recovery

Additional narrative information on the clinical course of the event
Investigators must also comply with local requirements for reporting serious adverse 
events to the local health authority and IRB/EC.
5.4.1
Medical Monitors and Emergency Medical Contacts
PPD 24-Hour Safety Hotline:

North America:
1 (888) 483-7729

EMEA/APAC:
44 (0) 1223 374 240

Latin America:
55 11 4504 4801
Roche Medical Monitor/ Medical Responsible:
, M.D., Ph.D.
Mobile Telephone No.:
To ensure the safety of study patients, an Emergency Medical Call Center will be 
available 24 hours per day, 7 days per week, in case the above-listed contacts cannot 
be reached.  The Emergency Medical Call Center will connect the investigator with an 
Emergency Medical Contact, provide medical translation service if necessary, and track 
all calls.  Contact information, including toll-free numbers for the Emergency Medical Call 
Center, will be distributed to investigators. 
5.4.2
Reporting Requirements for Serious Adverse Events
After informed consent has been obtained, serious adverse events will be reported from 
Day 1 visit of this study.  For ongoing serious adverse events since the parent study, the 
adverse event will be reported as outlined in Section 5.1.  Investigators should record all 
case details that can be gathered immediately (i.e., within 24 hours after learning of the 
event) on the Adverse Event eCRF and submit the report via the EDC system.  A report 
will be generated and sent to Roche Safety Risk Management by the EDC system.
In the event that the EDC system is unavailable, the paper Clinical Trial Serious Adverse 
Event/Adverse Event of Special Interest Reporting Form provided to investigators should 
be completed and submitted to the Sponsor or its designee immediately (i.e., no more 
than 24 hours after learning of the event), either by faxing or by scanning and emailing 
the form using the fax number or email address provided to investigators.  Once the 

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EDC system is available, all information will need to be entered and submitted via the 
EDC system.  
5.4.3
Reporting Requirements for Pregnancies
5.4.3.1
Pregnancies in Female Patients
Female patients of childbearing potential will be instructed through the Informed Consent 
Form to immediately inform the investigator if they become pregnant during the study. 
A paper Clinical Trial Pregnancy Reporting Form should be completed and submitted to 
the Sponsor or its designee immediately (i.e., no more than 24 hours after learning of the 
pregnancy), either by faxing or by scanning and emailing the form using the fax number 
or email address provided to investigators.  Pregnancy should not be recorded on the 
Adverse Event eCRF.  The investigator should counsel the patient, discussing the risks 
of the pregnancy and the possible effects on the fetus.  Monitoring of the patient should 
continue until conclusion of the pregnancy.  Any serious adverse events associated with 
the pregnancy (e.g., an event in the fetus, an event in the mother during or after the 
pregnancy, or a congenital anomaly/birth defect in the child) should be reported on the 
Adverse Event eCRF.  In addition, the investigator will submit a Clinical Trial Pregnancy 
Reporting Form when updated information on the course and outcome of the pregnancy 
becomes available.  
5.4.3.2
Abortions
A spontaneous abortion should be classified as a serious adverse event (as the Sponsor 
considers abortions to be medically significant), recorded on the Adverse Event eCRF, 
and reported to the Sponsor immediately (i.e., no more than 24 hours after learning of 
the event; see Section 5.4.2).
If a therapeutic or elective abortion was performed because of an underlying maternal or 
embryofetal toxicity, the toxicity should be classified as a serious adverse event, 
recorded on the Adverse Event eCRF, and reported to the Sponsor immediately (i.e., no 
more than 24 hours after learning of the event; see Section 5.4.2).  A therapeutic or 
elective abortion performed for reasons other than an underlying maternal or 
embryofetal toxicity is not considered an adverse event.
All abortions should be reported as pregnancy outcomes on the paper Clinical Trial 
Pregnancy Reporting Form.
5.4.3.3
Congenital Anomalies/Birth Defects
Any congenital anomaly/birth defect in a child born to a female patient exposed to study 
drug should be classified as a serious adverse event, recorded on the Adverse Event 
eCRF, and reported to the Sponsor immediately (i.e., no more than 24 hours after 
learning of the event; see Section 5.4.2).

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5.4.4
Reporting Requirements for Medical Device Complaints
In this study, the wearable monitor (e.g., Apple Watch) is considered a medical device.  
The investigator must report all medical device complaints to the Sponsor.  
The investigator should document as much information as possible and forward the 
complaints to the Sponsor immediately (i.e., no more than 24 hours after learning of the 
event).  If the medical device results in an adverse event to the study patient, the event
must be reported on the Adverse Event eCRF and submitted through the EDC system.  
If the event is serious, the Adverse Event eCRF must be completed immediately (i.e., no 
more than 24 hours after learning of the event), as outlined in Section 5.4.2.
For complaints and adverse events associated with the wearable monitor (e.g., Apple 
Watch), the Sponsor will forward the complaint to the manufacturer.  The manufacturer 
will report all adverse events according to the regulatory requirements for reporting of 
medical device-related adverse events (21 CFR 803).
5.5
FOLLOW-UP OF PATIENTS AFTER ADVERSE EVENTS
5.5.1
Investigator Follow-Up
The investigator should follow each adverse event until the event has resolved to baseline 
grade or better, the event is assessed as stable by the investigator, the patient is lost to 
follow-up, or the patient withdraws consent.  Every effort should be made to follow all 
serious adverse events considered to be related to study treatment or trial-related 
procedures until a final outcome can be reported.
During the adverse event reporting period (defined in Section 5.3.1), resolution of adverse 
events (with dates) should be documented on the Adverse Event eCRF and in the patient's 
medical record to facilitate source data verification.
All pregnancies reported during the study should be followed until pregnancy outcome.
5.5.2
Sponsor Follow-Up
For serious adverse events and pregnancies, the Sponsor or a designee may follow up 
by telephone, fax, email, and/or a monitoring visit to obtain additional case details and 
outcome information (e.g., from hospital discharge summaries, consultant reports, 
autopsy reports) in order to perform an independent medical assessment of the 
reported case.
5.6
EXPEDITED REPORTING TO HEALTH AUTHORITIES, 
INVESTIGATORS, INSTITUTIONAL REVIEW BOARDS, 
AND ETHICS COMMITTEES
The Sponsor will promptly evaluate all serious adverse events against cumulative 
product experience to identify and expeditiously communicate possible new safety 
findings to investigators, IRBs, ECs, and applicable health authorities based on 
applicable legislation.

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To determine reporting requirements for single adverse event cases, the Sponsor will 
assess the expectedness of these events through use of the reference safety 
information in the document listed below:
Drug
Document
AT-527
AT-527 Investigator's Brochure
The Sponsor will compare the severity of each event and the cumulative event 
frequency reported for the study with the severity and frequency reported in the 
applicable reference document.
Reporting requirements will also be based on the investigator's assessment of causality 
and seriousness, with allowance for upgrading by the Sponsor as needed.
An aggregate report of any clinically relevant imbalances that do not favor the test 
product will be submitted to health authorities.
6.
STATISTICAL CONSIDERATIONS AND ANALYSIS PLAN
The final analysis of the study will occur at the end of the study (see Section 3.2).
Differential loss to follow-up may introduce bias into the study.  Patients may be lost to 
follow-up because they are fully recovered or they experience an adverse outcome.  
Details of the statistical analysis methods and endpoints will be described in the study 
Statistical Analysis Plan (SAP) which will be finalized prior to study completion.
6.1
DETERMINATION OF SAMPLE SIZE
This study is observational in nature and designed for estimation and 
hypothesis-generating purposes.  The sample size of approximately 1040 patients is 
based on site feasibility assessment rather than statistical considerations.
6.2
SUMMARIES OF CONDUCT OF STUDY
Patient disposition (i.e., the number of patients who enroll, discontinue, or complete the 
study) will be summarized descriptively.  Reasons for premature study discontinuation 
will also be summarized and may be listed if appropriate.  Enrollment and major protocol 
deviations will be listed and evaluated for their potential effects on the interpretation of 
study results.
A patient disposition figure will show the flow of patients starting with the parent study 
and finishing with the number of patients contributing data to this study.
6.3
SUMMARIES OF DEMOGRAPHIC AND BASELINE 
CHARACTERISTICS
Demographic and baseline characteristics (including age, sex, race/ethnicity, region, 
treatment group in the parent study, RT-PCR status, seropositive status, presence of 

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risk factors, preexisting symptoms and other patient characteristics of interest) will be 
summarized using descriptive statistics including means, standard deviations, medians, 
and ranges for continuous variables and proportions for categorical variables, as 
appropriate.  Summaries will be presented overall. Demographic and baseline 
characteristics may be obtained from data collected in the parent study.
Patient characteristics will be displayed in a tabular format (number and percentage), 
including demographics, medical history before COVID-19, and treatments received for 
COVID-19.
To evaluate the potential for selection bias, patient characteristics will be compared 
between the parent study and the follow-up study to examine for systematic differences.
6.4
STATISTICAL ANALYSES
The analysis population will consist of all patients enrolled in the study.  Long-term 
clinical and PROs will be summarized descriptively and trends over time will be 
explored.  Outcomes may also be explored by patient characteristics (e.g., treatment 
received in the parent study), as appropriate. 
6.4.1
Primary Endpoint
The primary objective of this study is to evaluate the long-term symptoms of patients 
diagnosed with COVID-19 who previously enrolled in a RO7496998 (AT-527) study 
(i.e., parent study), for approximately 6 months after the end of the parent study. 
This will be assessed by the following endpoint:

Descriptive summaries, over time, of COVID-19 symptoms, as assessed through 
the COVID-19 Symptom Diary (Items 114)
This endpoint will be explored using descriptive summary statistics over time and will be 
specified in the SAP. Because the primary analysis is descriptive in nature, there will be 
no formal hypothesis testing in the analysis of the primary endpoint.
6.4.2
Secondary Endpoints
The secondary endpoints are as follows:

Impact of dyspnea symptoms on specific activities, as assessed through use of 
PROMIS-Dyspnea Questionnaire at Day 1 and Months 1, 2, 3, 4, 5, and 6

Respiratory-specific health-related quality of life, as assessed through use of SGRQ
at Day 1 and Months 1, 2, 3, 4, 5, and 6

Proportion of patients with COVID-19related medically-attended visits through to 
study end (defined as hospitalization, ER visit, urgent care visit, physician’s office 
visit, or telemedicine visit with the primary reason for the visit being COVID-19 or 
COVID-19related symptoms)

Proportion of patients with all-cause mortality

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
Proportion of patients with death attributable to progression of COVID-19

Proportion of patients re-infected with SARS-CoV-2

Proportion of patients with any post-treatment infection including but not limited to 
bacterial, viral, or fungal pneumonia or sepsis

Frequency of COVID-19related complications (e.g., death, hospitalization, 
radiologically-confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, 
pericarditis, myocarditis, cardiac failure)

Incidence and severity of adverse events and serious adverse events, with severity 
determined according to NCI CTCAE v5.0
Observed absolute values will be summarized by means, standard deviations, medians, 
and ranges for continuous endpoints, as appropriate, while count and percentages will 
be tabulated for categorical endpoints by study timepoints.  Longitudinal modeling of 
endpoints may also be explored, as appropriate.
All endpoints will be summarized descriptively and no p-values will be presented.
6.4.3
Exploratory Endpoints 
The exploratory endpoints are as follows:

Self-reported symptom severity, as assessed weekly through use of PGIS

Health status utility, as assessed by EQ-5D-5L at Day 1 and Months 1, 2, 3, 4, 5, 
and 6

Work or school utility, as assessed through WPAI+CIQ:  SHP at Day 1, Months 3 
and 6

Prevalence of neutralizing SARS-CoV-2 antibodies over time

Levels of biomarkers in blood and urine samples and their relationship with 
long-term outcomes or other biomarker endpoints

Changes in physiological and behavioral patterns, as measured by consumer-grade 
wearables outputs, such as:
–
Change in heart rate over time
–
Change in SpO2 over time 
–
Change in activity over time
–
Change in sleep patterns over time 
Observed absolute values will be summarized by means, standard deviations, medians, 
and ranges for continuous endpoints, as appropriate, while count and percentages will 
be tabulated for categorical endpoints by study timepoints.  Longitudinal modeling of 
endpoints may also be explored, as appropriate.
All endpoints will be summarized descriptively and no p-values will be presented.

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6.5
SAFETY ANALYSES
The safety analyses will include all enrolled patients in the study. 
Safety will be assessed through descriptive summaries of serious adverse events 
(nature, frequency, and severity) and vital signs.  Serious adverse events will also be 
listed.  Safety may be explored by study treatment received in the parent study, as 
appropriate.
All verbatim adverse event terms will be mapped to Medical Dictionary for Regulatory 
Activities thesaurus terms, and adverse event severity will be graded according to 
NCI CTCAE v5.0.  All adverse events, including serious adverse events that are 
continuing/persisting from the parent study (regardless of causal association with the 
study drug administered in the parent study) or any new adverse event with an onset 
date on or after the first day of enrollment and during this follow-up study, will be 
summarized by mapped term, appropriate thesaurus level, and severity grade.  
For events of varying severity, the highest grade will be used in the summaries.  
Deaths and cause of death will be summarized.
6.6
BIOMARKER ANALYSES
Although no formal statistical analysis of exploratory biomarkers will be performed, data 
may be analyzed in the context of this study and in aggregate with data from other 
studies.  
6.7
INTERIM ANALYSIS
While no interim analysis is planned for this study, if necessary, in support of a 
marketing application to health authorities, interim safety analyses may be conducted.
6.8
SUBGROUP ANALYSES
The main analyses may be performed for groups of patients with certain characteristics. 
Some characteristics that may denote groups with different results will be identified 
during the course of the parent study.  At this point, it is anticipated that such 
characteristics may be related to age, sex, morbidity before COVID-19 (e.g., obesity, 
diabetes, asthma), severity of acute COVID-19 before receiving treatment in the parent 
study and/or having completed the treatment of RO7496998 (AT-527) during the parent 
study. Subgroup analyses will be specified in the SAP.
7.
DATA COLLECTION AND MANAGEMENT
7.1
DATA QUALITY ASSURANCE
The Sponsor will be responsible for data management of this study, including quality 
checking of the data.  Data entered manually will be collected via EDC through use of 
eCRFs.  Sites will be responsible for data entry into the EDC system.  In the event of 
discrepant data, the Sponsor will request data clarification from the sites, which the sites 
will resolve electronically in the EDC system.

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The Sponsor will produce an EDC Study Specification document that describes the 
quality checking to be performed on the data.  Central laboratory data and electronic 
PRO will be sent directly to the Sponsor, using the Sponsor's standard procedures to 
handle and process the electronic transfer of these data.
eCRFs and correction documentation will be maintained in the EDC system's audit trail.  
System backups for data stored by the Sponsor and records retention for the study data
will be consistent with the Sponsor's standard procedures.
PRO data will be collected through the use of an electronic device provided by a vendor
(see Section 7.3 for details).
7.2
ELECTRONIC CASE REPORT FORMS 
eCRFs are to be completed through use of a Sponsor-designated EDC system.  
Sites will receive training and have access to a manual for appropriate eCRF 
completion.  eCRFs will be submitted electronically to the Sponsor and should be 
handled in accordance with instructions from the Sponsor.
All eCRFs should be completed by designated, trained site staff.  eCRFs should be 
reviewed and electronically signed and dated by the investigator or a designee.
At the end of the study, the investigator will receive patient data for his or her site in a 
readable format that must be kept with the study records.  Acknowledgement of receipt 
of the data is required.
7.3
ELECTRONIC PATIENT-REPORTED OUTCOME DATA
An electronic device or application installed on the patient’s personal device will be used 
to capture PRO data.  The device is designed for entry of data in a way that is 
attributable, secure, and accurate, in compliance with U.S. FDA regulations for electronic 
records (21 CFR Part 11).  The data will be transmitted to a centralized database 
maintained by the electronic device vendor.
The electronic data will be available for view access only, via a secure web server.  
Only identified and trained users may view the data, and their actions will become part of 
the audit trail.  The Sponsor will have view access only.  System backups for data stored 
by the Sponsor and records retention for the study data will be consistent with the 
Sponsor's standard procedures.
Once the study is complete, the data, audit trail, and trial and system documentation will 
be archived.  The investigator will receive patient data for the site in both human- and 
machine-readable formats that must be kept with the study records as source data.  
Acknowledgement of receipt of the data is required.  In addition, the Sponsor will receive 
all data in a machine-readable format.

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7.4
SOURCE DATA DOCUMENTATION
Where permitted, study monitors will perform targeted source data verification and 
review to confirm that critical protocol data as defined in the Monitoring Plan and entered 
into the eCRFs by authorized site personnel are accurate, complete, and verifiable from
source documents. 
Due to the COVID-19 pandemic, access to clinical trial sites may be restricted.  In such 
cases, remote source data verification (SDV) (if permitted by the site and by local law) 
and remote data review will be performed.  Study monitors will perform ongoing remote 
data review to confirm that critical protocol data (i.e., source data) entered on the eCRFs 
by authorized site personnel are accurate and complete. 
Source documents (paper or electronic) are those in which patient data are recorded 
and documented for the first time.  They include, but are not limited to, hospital records, 
clinical and office charts, laboratory notes, memoranda, PROs, evaluation checklists, 
pharmacy dispensing records, recorded data from automated instruments, copies of 
transcriptions that are certified after verification as being accurate and complete, 
microfiche, photographic negatives, microfilm or magnetic media, X-rays, patient files, 
and records kept at pharmacies, laboratories, and medico-technical departments 
involved in a clinical trial.
Before study initiation, the types of source documents that are to be generated will be 
clearly defined in the Trial Monitoring Plan.  This includes any protocol data to be 
entered directly into the eCRFs (i.e., no prior written or electronic record of the data) and 
considered source data.
Source documents that are required to verify the validity and completeness of data 
entered into the eCRFs must not be obliterated or destroyed and must be retained per 
the policy for retention of records described in Section 7.6.
To facilitate source data verification and review, the investigators and institutions must 
provide the Sponsor direct access to applicable source documents and reports for 
trial-related monitoring, Sponsor audits, and IRB/EC review.  The study site must also 
allow inspection by applicable health authorities.
In addition to SDV or remote SDV on targeted critical data, ongoing remote data 
monitoring will be performed for this study.  Study monitors will perform ongoing remote 
data review (defined in the Monitoring Plan and Centralized Monitoring Plan) to confirm 
that critical protocol data are entered into the eCRF by authorized site personnel are 
accurate and complete.  Centralized monitoring tools will be implemented in order to 
support the remote data monitoring activity.

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7.5
USE OF COMPUTERIZED SYSTEMS
When clinical observations are entered directly into a study site's computerized medical 
record system (i.e., in lieu of original hardcopy records), the electronic record can serve 
as the source document if the system has been validated in accordance with health 
authority requirements pertaining to computerized systems used in clinical research.  
An acceptable computerized data collection system allows preservation of the original 
entry of data.  If original data are modified, the system should maintain a viewable audit 
trail that shows the original data as well as the reason for the change, name of the 
person making the change, and date of the change.
7.6
RETENTION OF RECORDS
Records and documents pertaining to the conduct of this study, including eCRFs, 
electronic or paper PRO data (if applicable), Informed Consent Forms, laboratory test 
results, and medication inventory records, and images, must be retained by the Principal 
Investigator for 15 years after completion or discontinuation of the study or for the length 
of time required by relevant national or local health authorities, whichever is longer.  
After that period of time, the documents may be destroyed, subject to local regulations.  
No records may be disposed of without the written approval of the Sponsor.  
Written notification should be provided to the Sponsor prior to transferring any records to 
another party or moving them to another location.
The Sponsor will retain study data for 25 years after the final study results have been 
reported or for the length of time required by relevant national or local health authorities, 
whichever is longer.
8.
ETHICAL CONSIDERATIONS
8.1
COMPLIANCE WITH LAWS AND REGULATIONS
This study will be conducted in full conformance with the ICH E6 guideline for Good 
Clinical Practice and the principles of the Declaration of Helsinki, or the applicable laws 
and regulations of the country in which the research is conducted, whichever affords the 
greater protection to the individual.  The study will comply with the requirements of the 
ICH E2A guideline (Clinical Safety Data Management:  Definitions and Standards for 
Expedited Reporting).  Studies conducted in the United States or under a U.S. 
Investigational New Drug (IND) Application will comply with U.S. FDA regulations and 
applicable local, state, and federal laws.  Studies conducted in the European Union or 
European Economic Area will comply with the E.U. Clinical Trial Directive (2001/20/EC)
and applicable local, regional, and national laws.
8.2
INFORMED CONSENT
The Sponsor's sample Informed Consent Form (and ancillary sample Informed Consent 
Forms such as an Assent Form or MN Informed Consent Form, if applicable) will be 
provided to each site.  If applicable, it will be provided in a certified translation of the 

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local language.  The Sponsor or its designee must review and approve any proposed 
deviations from the Sponsor's sample Informed Consent Forms or any alternate consent 
forms proposed by the site (collectively, the "Consent Forms") before IRB/EC 
submission.  The final IRB/ECapproved Consent Forms must be provided to the 
Sponsor for health authority submission purposes according to local requirements.
If applicable, the Informed Consent Form will contain separate sections for any optional 
procedures.  The investigator or authorized designee will explain to each patient the 
objectives, methods, and potential risks associated with each optional procedure.  
Patients will be told that they are free to refuse to participate and may withdraw their 
consent at any time for any reason.  A separate, specific signature will be required to 
document a patient's agreement to participate in optional procedures.  Patients who 
decline to participate will not provide a separate signature.
The Consent Forms must be signed and dated by the patient or the patient's legally 
authorized representative before his or her participation in the study.  The case history or 
clinical records for each patient shall document the informed consent process and that 
written informed consent was obtained prior to participation in the study.
The Consent Forms should be revised whenever there are changes to study procedures 
or when new information becomes available that may affect the willingness of the patient 
to participate.  The final revised IRB/ECapproved Consent Forms must be provided to 
the Sponsor for health authority submission purposes.
If the Consent Forms are revised (through an amendment or an addendum) to 
communicate information that might affect a patient's willingness to continue in the 
study, the patient or a legally authorized representative must re-consent by signing the 
most current version of the Consent Forms or the addendum, in accordance with 
applicable laws and IRB/EC policy.  For any updated or revised Consent Forms, the 
case history or clinical records for each patient shall document the informed consent 
process and that written informed consent was obtained using the updated/revised 
Consent Forms for continued participation in the study.
A copy of each signed Consent Form must be provided to the patient or the patient's
legally authorized representative.  All signed and dated Consent Forms must remain in 
each patient's study file or in the site file and must be available for verification by study 
monitors at any time.
For sites in the United States, each Consent Form may also include patient authorization 
to allow use and disclosure of personal health information in compliance with the U.S. 
Health Insurance Portability and Accountability Act (HIPAA) of 1996.  If the site utilizes a 
separate Authorization Form for patient authorization for use and disclosure of personal 
health information under the HIPAA regulations, the review, approval, and other 

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processes outlined above apply except that IRB review and approval may not be 
required per study site policies.
8.3
INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE
This protocol, the Informed Consent Forms, any information to be given to the patient, 
and relevant supporting information must be submitted to the IRB/EC by the Principal 
Investigator and reviewed and approved by the IRB/EC before the study is initiated.  
In addition, any patient recruitment materials must be approved by the IRB/EC. 
The Principal Investigator is responsible for providing written summaries of the status of 
the study to the IRB/EC annually or more frequently in accordance with the 
requirements, policies, and procedures established by the IRB/EC.  Investigators are 
also responsible for promptly informing the IRB/EC of any protocol amendments (see 
Section 9.6).
In addition to the requirements for reporting all adverse events to the Sponsor, 
investigators must comply with requirements for reporting serious adverse events to the 
local health authority and IRB/EC.  Investigators may receive written IND safety reports 
or other safety-related communications from the Sponsor.  Investigators are responsible 
for ensuring that such reports are reviewed and processed in accordance with health 
authority requirements and the policies and procedures established by their IRB/EC, and 
archived in the site's study file. 
8.4
CONFIDENTIALITY
The Sponsor maintains confidentiality standards by coding each patient enrolled in the 
study through assignment of a unique patient identification number.  This means that 
patient names are not included in data sets that are transmitted to any Sponsor location.
Patient medical information obtained by this study is confidential and may be disclosed 
to third parties only as permitted by the Informed Consent Form (or separate 
authorization for use and disclosure of personal health information) signed by the 
patient, unless permitted or required by law.
Medical information may be given to a patient's personal physician or other appropriate 
medical personnel responsible for the patient's welfare, for treatment purposes.
Given the complexity and exploratory nature of exploratory biomarker analyses, data 
derived from these analyses will generally not be provided to study investigators or 
patients unless required by law.  The aggregate results of any conducted research will 
be available in accordance with the effective Sponsor policy on study data publication 
(see Section 9.6).

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Data generated by this study must be available for inspection upon request by 
representatives of national and local health authorities, Sponsor monitors, 
representatives, and collaborators, and the IRB/EC for each study site, as appropriate.
Study data, which may include data on genomic variants may be submitted to 
government or other health research databases or shared with researchers, government 
agencies, companies, or other groups that are not participating in this study.  These data 
may be combined with or linked to other data and used for research purposes, to 
advance science and public health, or for analysis, development, and commercialization 
of products to treat and diagnose disease.  In addition, redacted Clinical Study Reports
and other summary reports will be provided upon request (see Section 9.6).
8.5
FINANCIAL DISCLOSURE
Investigators will provide the Sponsor with sufficient, accurate financial information in 
accordance with local regulations to allow the Sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate health authorities.  
Investigators are responsible for providing information on financial interests during the 
course of the study and for 1 year after completion of the study (see definition of end of 
study in Section 3.2).
9.
STUDY DOCUMENTATION, MONITORING, AND 
ADMINISTRATION
9.1
STUDY DOCUMENTATION
The investigator must maintain adequate and accurate records to enable the conduct of 
the study to be fully documented, including, but not limited to, the protocol, protocol 
amendments, Informed Consent Forms, and documentation of IRB/EC and 
governmental approval.  In addition, at the end of the study, the investigator will receive 
the patient data, including an audit trail containing a complete record of all changes to 
data.
9.2
PROTOCOL DEVIATIONS
The investigator should document and explain any protocol deviations. The investigator 
should promptly report any deviations that might have an impact on patient safety and 
data integrity to the Sponsor and to the IRB/EC in accordance with established IRB/EC 
policies and procedures.  The Sponsor will review all protocol deviations and assess 
whether any represent a serious breach of Good Clinical Practice guidelines and require 
reporting to health authorities.  As per the Sponsor's standard operating procedures, 
prospective requests to deviate from the protocol, including requests to waive protocol 
eligibility criteria, are not allowed.
9.3
MANAGEMENT OF STUDY QUALITY
The Sponsor has implemented a system to manage the quality of the study, focusing on 
processes and data that are essential to ensuring patient safety and data integrity. 

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Prior to study initiation, the Sponsor identified potential risks associated with critical trial 
processes and data and implemented plans for evaluating and controlling these risks. 
Risk evaluation and control included the selection of risk-based parameters 
(e.g., adverse event rate, protocol deviation rate) and the establishment of quality 
tolerance limits for these parameters prior to study initiation. Detection of deviations 
from quality tolerance limits will trigger an evaluation to determine if action is needed. 
Details on the establishment and monitoring of quality tolerance limits are provided in a 
Quality Tolerance Limit Management Plan and a Centralized Monitoring Plan.
9.4
SITE INSPECTIONS
Site visits will be conducted by the Sponsor or an authorized representative for 
inspection of study data, patients' medical records, and eCRFs.  The investigator will 
permit national and local health authorities; Sponsor monitors, representatives, and 
collaborators; and the IRBs/ECs to inspect facilities and records relevant to this study.
9.5
ADMINISTRATIVE STRUCTURE
This trial will be sponsored by F. Hoffmann-La Roche Ltd (outside the United States) and 
Atea Pharmaceuticals, Inc. (in the United States).  F. Hoffmann-La Roche Ltd will 
provide clinical operations management and data management, and both, 
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc. will provide medical 
monitoring.
Approximately 180 sites globally will participate to enroll approximately 1040 patients.  
A contract research organization will be used for site management and monitoring, 
medical monitoring, and select regulatory submissions.  
An MN vendor will be used to facilitate study visits being performed within the patient’s 
home.
Central facilities will be used for certain study assessments throughout the study 
(e.g., specified laboratory tests, virology, biomarker analyses), as specified in 
Section 4.5.  Accredited local laboratories will be used for routine monitoring; local 
laboratory ranges will be collected.
9.6
DISSEMINATION OF DATA AND PROTECTION OF TRADE 
SECRETS
Regardless of the outcome of a trial, the Sponsor is dedicated to openly providing 
information on the trial to healthcare professionals and to the public, at scientific 
congresses, in clinical trial registries, and in peer-reviewed journals. The Sponsor will 
comply with all requirements for publication of study results.  Study data may be shared 
with others who are not participating in this study (see Section 8.4 for details), and 
redacted Clinical Study Reports and other summary reports will be made available upon 

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request.  For more information, refer to the Roche Global Policy on Sharing of Clinical
Study Information at the following website:
www.roche.com/roche_global_policy_on_sharing_of_clinical_study_information.pdf
The results of this study may be published or presented at scientific congresses.  For all 
clinical trials in patients involving an investigational medicinal product (IMP) for which a 
marketing authorization application has been filed or approved in any country, the 
Sponsor aims to submit a journal manuscript reporting primary clinical trial results within 
6 months after the availability of the respective Clinical Study Report.  In addition, for all 
clinical trials in patients involving an IMP for which a marketing authorization application 
has been filed or approved in any country, the Sponsor aims to publish results from 
analyses of additional endpoints and exploratory data that are clinically meaningful and 
statistically sound.
The investigator must agree to submit all manuscripts or abstracts to the Sponsor prior 
to submission for publication or presentation.  This allows the Sponsor to protect 
proprietary information and to provide comments based on information from other 
studies that may not yet be available to the investigator.
In accordance with standard editorial and ethical practice, the Sponsor will generally 
support publication of multicenter trials only in their entirety and not as individual center 
data.  In this case, a coordinating investigator will be designated by mutual agreement.
Authorship will be determined by mutual agreement and in line with International 
Committee of Medical Journal Editors authorship requirements.  Any formal publication 
of the study in which contribution of Sponsor personnel exceeded that of conventional 
monitoring will be considered as a joint publication by the investigator and the 
appropriate Sponsor personnel.
Any inventions and resulting patents, improvements, and/or know-how originating from 
the use of data from this study will become and remain the exclusive and unburdened 
property of the Sponsor, except where agreed otherwise.
9.7
PROTOCOL AMENDMENTS
Any protocol amendments will be prepared by the Sponsor.  Protocol amendments will 
be submitted to the IRB/EC and to regulatory authorities in accordance with local 
regulatory requirements.
Approval must be obtained from the IRB/EC and regulatory authorities (as locally 
required) before implementation of any changes, except for changes necessary to 
eliminate an immediate hazard to patients or changes that involve logistical or 
administrative aspects only (e.g., change in Medical Monitor or contact information).

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10.
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biomarkers for patients with idiopathic pulmonary fibrosis treated with pirfenidone: 
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eosinophilic asthma. N Engl J Med 2014;371:1198207.
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Tran JL, Kumar S,  Eulogio R, et al. Pain management strategies and activity tracker 
utilization in a large-scale chronic pain study, Value in Health 2019;22: S378.

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Appendix 1
Schedule of Activities
Month
Day 1 a
Month 1
Month 2
Month 3
Month 4
Month 5
Month 6
ET/UV b
(Visit Window)
7 days
7 days
7 days
7 days
7 days
7 days
Informed consent a
x
PROs c
COVID-19 Symptom Diary d
To be collected weekly
x
PGIS d
To be collected weekly
x
PROMIS-Dyspnea 
Questionnaire
x
x
x
x
x
x
x
x
St. George’s Respiratory 
Questionnaire
x
x
x
x
x
x
x
x
EQ-5D-5L
x
x
x
x
x
x
x
x
WPAI+CIQ:  SHP
x
x
x
x
Medically-attended visit(s) 
assessment e
x
x
x
x
x
x
x
x
NP swab for
SARS-CoV-2 RT-PCR, genetic 
analysis, and BioFireassay 
(symptom-guided) f, g
As clinically indicated
Serum sample for biomarkers 
and SARS-CoV-2 antibodies 
x
x
x
x
Serum sample for biomarkers 
and SARS-CoV-2 antibodies
(symptom-guided) h
As clinically indicated 

Appendix 1: Schedule of Activities (cont.)
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
54/Protocol CV43140, Version 1
Month
Day 1 a
Month 1
Month 2
Month 3
Month 4
Month 5
Month 6
ET/UV b
(Visit Window)
7 days
7 days
7 days
7 days
7 days
7 days
Blood sample for RNA
x
x
x
x
Blood sample for HbA1c
x
Urine sample for exploratory 
biomarker research
x
x
x
Blood sample for WGS or WES
(optional) i
x
Collection of heart rate, SpO2, 
activity, and sleep pattern–
wearable device j
Continuous
Concomitant medications k
Adverse Events l
COVID-19coronavirus disease 2019; EQ-5D-5LEuro-QoL-5D-5-L; ET early termination; HbA1chemoglobin A1c; NPnasopharyngeal;
PGISPatient Global Impression of Severity; PROpatient-reported outcome; PROMISPatient Reported Outcomes Measurement Information 
System; RT-PCRreverse-transcriptase polymerase chain reaction; SpO2peripheral capillary oxygen saturation; UVunscheduled visit; 
WESwhole exome sequencing; WGSwhole genome sequencing; WPAI+CIQ:  SHPWork Productivity and Activity Impairment Questionnaire 
plus Classroom Impairment Questions:  Specific Health Problems. 
Note:  All assessments at each visit, except sample collections, can be conducted remotely (e.g., via telephone or computer).  For patients at 
participating sites who have provided written informed consent to participate in mobile nursing visits, select assessments or procedures
(e.g., sample collection) may be performed by a trained nursing professional at the patient's home or another suitable location.
a The Day 1 visit (baseline) can coincide with the final visit of the parent study, or as soon as possible after the final visit and within 7 days  
Informed consent must be documented before any study assessment is performed. An attempt will be made, where possible, to consent 
patients to this study at the same time patients are consented to the parent study.  
b An UV represents a visit that is not specified by the protocol but is determined to be necessary by the investigator or Sponsor (e.g., for 
evaluation of an adverse event).  Assessments should be performed as clinically indicated.  
c PRO questionnaires are to be completed by the patient before the patient receives any information on disease status, prior to the performance of 
non-PRO assessments.  The assessments are to be conducted in the order listed in the schedule above.  

Appendix 1: Schedule of Activities (cont.)
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
55/Protocol CV43140, Version 1
d The COVID-19 Symptom Diary will be completed by the patient every week, with a 7-day recall of symptoms at worst.  This questionnaire should 
be completed within 48 hours when the window for completion opens every 7 days. The PGIS will be completed every week at the same time as 
the COVID-19 Symptom Diary for the duration of the study.
e All details to be recorded in the eCRF at all visits.  For details of the assessment, see Section 4.5.5.3.
f
The symptom-guided NP swab for COVID-19 RT-PCR, genetic analysis, and BioFireassay is to be conducted at any visit or UV, when the 
investigator determines it is warranted.  Symptom-guided defined as patient with any “COVID-19 like” symptom(s) (see Appendix 2 for example 
symptoms). Patients should immediately contact the site upon onset of any “COVID-19 like” symptom(s) to ensure timely collection of 
appropriate samples.
g At least two NP swabs, one from each nostril, will be taken and sent to a central laboratory, as clinically indicated.  Results from NP swabs will 
not be available during the study. Therefore, if a COVID-19 re-infection is suspected, it is under investigator’s discretion to perform a local 
diagnostic test.
h The symptom-guided serum sample for biomarkers and SARS-CoV-2 antibodies is to be conducted at any visit or UV, when the investigator 
determines it is warranted. Symptom-guided defined as patient with any “COVID-19 like” symptom(s) (see Appendix 2 for example symptoms).
Patients should immediately contact the site upon onset of any “COVID-19 like” symptom(s) to ensure timely collection of appropriate samples.  
i Not applicable for a site that has not been granted approval for WGS or WES. Performed only for patients at participating sites who have 
provided written informed consent to participate and have not previously provided a blood sample for WGS in the parent study. If the sample is 
not collected at the Day 1 visit for any reason, it may be collected at any later timepoint.
j
Depending on local and country regulations and allowances, patients will be provided with a consumer-grade wearable device (e.g., Apple 
Watch) where possible at the Day 1 visit to use on a continuous basis.  Patients will be provided information regarding the use of the device 
(e.g., charging, waterproof properties, and support).  Data stored in the wearable device will be uploaded through a smart device preferably on a 
daily basis.
k Medications (e.g., prescription drugs, over-the-counter drugs, vaccines, herbal or homeopathic remedies, nutritional supplements) and 
supplemental oxygen used by a patient during the study will be recorded.  Any COVID-19 vaccination which has occurred before the patient 
enrolls into the study or during the study will be recorded in the concomitant medications eCRF, including the report product or brand/trade or 
company manufacturer, if available (examples: Pfizer COVID-19 vaccine, Moderna COVID-19 vaccine), and date(s) administered if known. If 
not available, report as COVID-19 vaccine.
l
After informed consent has been obtained, all adverse events should be collected from the Day 1 visit of this study through the end of the study .  
For ongoing adverse events which occurred before the Day 1 visit of this study, the adverse event will be reported as outlined in Section 5.1.

F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
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Appendix 2
COVID-19 Symptom Diary
Do not reproduce or distribute.  The Sponsor will provide 
sites with all instruments to be completed in this study.
Note that the following is a sample.  Sites will be provided with separate versions of the 
diary for in-clinic assessment and patient at-home assessment.
COVID-19 Symptom Diary 
This diary will keep track of your COVID-19 symptoms during the study. Please 
complete one time each week. 
Please rate the severity of each symptom at its worst over the past 7 days.
None
0
Mild
1
Moderate
2
Severe
3
1. Nasal Congestion or runny nose
2. Sore Throat
3. Cough
4. Shortness of breath (difficulty 
breathing)
5. Muscle or body aches
6. Fatigue (tiredness)
7. Headache
8. Chills/Sweats 
9. Feeling hot or feverish
10. Nausea (wanting to throw up)
11. Vomiting (thrown up)
12. Diarrhea (mostly or completely 
liquid bowel movements)

Appendix 2: COVID-19 Symptom Diary (cont.)
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
57/Protocol CV43140, Version 1
Same as usual
0
Less than usual
1
No sense 
2
13. Rate your sense of 
smell over the past 7 
days.
14. Rate your sense of 
taste over the past 7 
days.

F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
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Appendix 3
Patient Global Impression of Severity
Do not reproduce or distribute.  The Sponsor will provide 
sites with all instruments to be completed in this study.
Patient Global Impression of Severity
Please rate your overall COVID-19 symptoms at their worst over the past 7 days.
☐None
☐Mild
☐Moderate 
☐Severe 

F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
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Appendix 4
Patient Reported Outcomes Measurement Information System 
(PROMIS)-Dyspnea Questionnaire
Do not reproduce or distribute.  The Sponsor will provide 
sites with all instruments to be completed in this study.

F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
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Appendix 5
St. George’s Respiratory Questionnaire
Do not reproduce or distribute.  The Sponsor will provide 
sites with all instruments to be completed in this study.

Appendix 5: St. George’s Respiratory Questionnaire (cont.)
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
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Appendix 5: St. George’s Respiratory Questionnaire (cont.)
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
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Appendix 5: St. George’s Respiratory Questionnaire (cont.)
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
63/Protocol CV43140, Version 1

Appendix 5: St. George’s Respiratory Questionnaire (cont.)
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
64/Protocol CV43140, Version 1

Appendix 5: St. George’s Respiratory Questionnaire (cont.)
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
65/Protocol CV43140, Version 1

F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
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Appendix 6
EuroQol 5-Dimension, 5-Level Questionnaire
Do not reproduce or distribute.  The Sponsor will provide 
sites with all instruments to be completed in this study.

Appendix 6: EuroQol 5-Dimension, 5-Level Questionnaire (cont.)
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
67/Protocol CV43140, Version 1

Appendix 6: EuroQol 5-Dimension, 5-Level Questionnaire (cont.)
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
68/Protocol CV43140, Version 1

F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
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Appendix 7
Work Productivity and Activity Impairment Questionnaire plus 
Classroom Impairment Questions:  Specific Health Problems
Do not reproduce or distribute.  The Sponsor will provide 
sites with all instruments to be completed in this study.

Appendix 7: Work Productivity and Activity Impairment Questionnaire plus Classroom 
Impairment Questions:  Specific Health Problems (cont.)
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
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Appendix 7: Work Productivity and Activity Impairment Questionnaire plus Classroom 
Impairment Questions:  Specific Health Problems (cont.)
F. Hoffmann-La Roche Ltd and Atea Pharmaceuticals, Inc.
71/Protocol CV43140, Version 1