Supplementary Appendix

This appendix has been provided by the authors to give readers additional information about their work.

Supplement to: Dougan M, Nirula A, Azizad M, et al. Bamlanivimab plus etesevimab in mild or moderate Covid-19.
N Engl J Med. DOI: 10.1056/NEJMoa2102685
 Supplementary Appendix

Table of contents

BLAZE-1 Investigators pg 2

Support staff pg 3

Supplementary Methods pg 12

Supplementary Figures and Tables pg 20

Symptom Questionnaire pg 30

1
BLAZE-1 Investigators
Faisal Amin - Central Valley Research, Modesto, CA

Masoud Azizad - Valley Clinical Trials Northridge, Northridge, CA

Katherine Belden - Jefferson Hospital, Philadelphia, PA

Joseph Boscia - VitaLink, Union, SC

Yevgeniy Bukhman – Great Lakes Clinical Trialsm Chicago, IL

Jose Cardona - Indago Research and Health Center, Miami, FL

Peter Chen – Cedars-Sinai Medical Center, LA, CA

Paul Cook - Brody School of Medicine, East Carolina Greenville, NC

Chad Crystal – Eastside Research Associates, Redmond, WA

Mike Dougan - Mass General Hospital, Boston, MA

William Fischer - University of North Carolina, Chapel Hill, NC

Jeffrey Glassberg - Mt. Sinai, New York

Robert L Gottlieb - Baylor University Medical Center, Dallas, TX, Baylor Scott and White Medical
Center – Irving, Irving, TX, Baylor Scott and White All Saints Medical Center, Fort Worth, TX, and
Baylor Scott and White Medical Center – Round Rock, Round Rock, TX

Corey Herbert - NOLA Research Works, New Orleans, LA

Howard Huang - Houston Methodist, Houston, TX

Gregory Huhn – John Stroger Jr. Hospital of Cook County, Chicago, IL

Jeffery Kingsley - iACT Health, Columbus, GA

Princy Kumar – Georgetown, Washington

Anuj Malik - St. Johns Ascension, Tulsa, OK

Carlos Malvestutto - Ohio State University Wexner Medical Center, Columbus, OH

Patrick Milligan - Community Hospital South, Indianapolis, IN

Bharat Mocherla - Las Vegas Medical Research, Las Vegas, NV

Ramesh Mohseni – Catalina Research Institute, Montclair, CA

Jason Morris – Clinical Trials of SWLA, Lake Charles, LA

Ramesh Nathan – Healix, Thousand Oaks, CA

David Pitrak - University of Chicago Medical, Chicago, IL

Joshua Purow - Holy Cross, Ft. Lauderdale, FL

Mayur Ramesh - Henry Ford Hospital, Detroit, MI

Yessica Sachdeva - Arizona Clinical Trials-Mesa, Mesa, AZ

2
Adam Schwartz - Kaiser Permanente, San Diego, CA

Imad Shawa - Franciscan St Francis Indy, Indianapolis, IN

Nader Sobh – Smart Cares, Anaheim, CA

Valentina Stosor - Northwestern University Feinberg School of Medicine, Chicago, IL

Charles Thompson – VitaLink, Anderson, SC

Omesh Verma - Crossroads Clinical Research, Victoria, TX

Erica Kaufman West - Franciscan St Francis Hammond, Hammond, IN

David Wheeler - Care ID, Fairfax, VA

Michael Winnie - Coastal Bend Clinical Research, Corpus Christie, TX

Brian Zeno – Remington Davis, Columbus, OH

Support Staff

Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114 (Dr. Dougan)

Keri Sullivan

Kathryn Hall

Valley Clinical Trials Northridge, Northridge, CA, USA (Dr. Azizad)

Sub Investigators

Lisa Nakatani FNP

Fahed Bitar M.D.

Julie Toven CCRP

Lisa Nakatani FNP

Haydee Gutierrez MPH, CCRP

Monica Brown

Thomas Johnson

Tayler Flores RN

Justin Palarca RN

Evelyn Flores LVN

Chase Miller

Leslie Silva LVN

3
Las Vegas Medical Research Center, 8530 W Sunset Rd Ste 300, Las Vegas, NV, USA (Dr. Bharat
Mocherla)

Sub investigators

Dana Forte

Del Gardner

Beth Moreno

CRCs

Erlie Lopez

Nicole Martini

Kelly Beck

Jesse Hawkins

Valarie Maldonado

Lorna Duff

Tina Martinez

Joanna Bachowska

Sandra Barcena

RA

Damon Murray

Pharmacy

Jane Filus

James Fajardo

Theresa Reyes

Joanna Salvador

Baylor University Medical Center and Baylor Scott and White Research Institute, 3410 Worth St, Suite
250, Dallas, TX, USA (Dr. Gottlieb)

John S. Garrett, MD, MRA, FACEP

Marcus Holmes, DO

Cedric Spak, MD, MPH

Sarah Burris, MHA

Rebecca Baker, MSN, RN

Solomon Bassett

4
Emily Brock

Giselle Carino

Laura Clariday

Tanqunisha Coleman

Allyson Davis

Mariana Hurutado‐Rodriguez, RN, BSN

Allyson Fowlks

Nazia Iram

Janet Jerrow, PhD

Felecia Jones

Tina Jones

Kiara Leonard

Erica Lusk, CCRP

Katalin Martits‐Chalangari, MD

Chintal Patel, RN, BSN

Shannon Perez

Noelia Ramirez

Raven Robert, MPH

Dianna Robinson, LVN

Madison Ryan

Samantha Villa

Samantha Wang, RN, BSN

Aaron D. Killian, PharmD, BCPS

Adriana Soliz Palacios, MS, PharmD

Edilia J. Solia, BS, CPhT

Baylor Scott and White All Saints Medical Center, Fort Worth, TX, USA (Dr. Gottlieb)

Bryan Youree, MD

Nathan Albright, DO

Asifa Ashraf, MD

Abhishek Avirineni, MD

5
Dipesh Bista, MD

Andrew Darwin, DO

Sathishkumar Seeliyur Duraiswamy, MD

Shovendra Gautam, MD

Ezmina Lalani, DO

Sherly Mathew, MD

Cheryl McDonald, MD

Diana Moise, MD

Jack Ni, DO

Whitney Nwagbara, MD

Ijeoma Nwelue, MD

Aaron Oubre, MD

Huma Paika, MD

Vivek Ramarathnam, MD

Nida Rasheed, MD

Jacelyn Baldridge

Sharon Brown

Theresa Cheyne

Sandra Garcia

Kristina Perez

Felicity Vaughan

Decolia Washington

Natalia Wiemann

Elizabeth Berihun, PharmD

Sierra Mullen, PharmD

Sunaina Rao, PharmD

Theresa Yarger, PharmD, BCPS

Baylor Scott and White Medical Center – Irving, Irving, TX, USA (Dr. Gottlieb)

Steven Davis, MD

Robert Engle, AG-ACNP

6
Blake Johnson, MD

Alyssa Boudreau

Robin Buckner, LVN, CCRC

Krizia Duque

Brittany Garcia

Jon Thammavong

Mary Wallace

Julia Cullen, PharmD

Susan Ferdosian, PharmD

Hemangini Joshi, PharmD

Chad Samuelson, PharmD

Alice Stacey, RPh

Amy C. Thomas, PharmD

Baylor Scott and White Medical Center – Round Rock, Round Rock, TX, USA (Dr. Gottlieb) and Baylor
Scott and White Research Institute, Dallas, TX, USA (Dr. Gottlieb)

MaryAnn Tran MD

William Tobleman MD

Nordelle Bent MPH, RN, CPH

Theresa Quezada

Carmen Sutton

Emily Zoelle, PharmD

Department of Medicine, Women’s Guild Lung Institute, Cedars-Sinai Medical Center, 8700 Beverly
Blvd, Los Angeles, CA (Dr. Chen)

Anders Berg, MD

Emad Bayoumi, MD

Antonina Caudill

Gregg Clapham

Jeremy Falk, MD

David Frishberg, MD

Billy Gellepis

7
Lisa Herrera

Niree Hindoyan

Carissa Huynh

Susan Jackman, RN, MS

Harneet Jawanda

Elizabeth Kissell

Yuri Matusov, MD

Shaunt Mehdikhani

Tanyalak Parimon, MD

Ethan Pascual

Victor Tapson, MD

Sam Torbati, MD

Tanzira Zaman, MD

Timothy Wynter

Gadolin Research, Beaumont, TX, USA (Dr. Perry)

Sub-Investigators

Joel Ebuh, MD

Dennisse Galdamez

CRCs

Britney Greer

Deisy Espinoza

Patient Advocate

Herman Davis

Vitalink Research, Union, SC, USA (Dr. Boscia)

Meredith Benfield

Tara Shetley

Carita Barefoot

Polly Turner

8
Clinical Trials of SWLA, Lake Charles, LA (Dr. Morris)

Janet Bourque

Melissa Comeaux

David Guillory

Brandi Ingalls

Codie Lee

Sam Liprie

Summer Moss

Page Prather

Kira Rice

Eastside Research Associates, Redmond, WA, USA (Dr. Crystal)

Kevin Hanson MD

Javier Nazar MD

Ema Burcheci, RN

Pavel Codreanu, MSCR

Sherry Alboucq, CRCP

Sophia Bixler, RN

Mitchell Kennedy

Bryan McKay

Jack O’Donnell

Hillary Thoreson, RN

Hilda Yousefi

Gregory Lang, R.Ph, B.S. Pharm

Anhaita Jamula, CCRC

Jenay Hanson, MBA

Kinsey Grey, MPH

Monroe Biomedical Research, NC, USA (Dr. Igbinadolor)

Krista Gross

Jennifer Norton

9
Suvi Gross

Maria Carrillo

Shalynn Fields

Benjamin Karsai

Syed Mehdi

Chioma B Ejiogu, NP

Cook County Health, 2020 W Harrison St, Chicago, IL (Dr. Huhn)

Coty Coffee

Stephen Epner

Tracy Everett

Kimberly Forbes

Sybil Hosek

Matthew Itterra

Kody Keckler

Karen Kroc

Mark Mycyk

Robert Needleman

Heather Prescaro

Monina Quindipan

Indago Research and Health Center, FL, USA (Dr. Cardona)

Daniel Pineda

Karel Reyes

Franciscan St Francis Indy, Indianapolis, IN (Dr. Shawa)

Kristin Mounce, NP

Tara Simon, NP

Stepahanie Alford, RN

Kathleen Kioussopoulos, RN

Tricia Kunz, RN

10
Kelly Underwood, RN

Chanda Beckner

11
Supplementary Methods

Inclusion Criteria

Participants were eligible to be included in the study only if all of the following criteria

apply:

Age

- ≥12 years of age at the time of screening

Disease Characteristics

- Not hospitalized

- Have one or more mild or moderate COVID-19 symptoms (FDA May 2020, Available

at: https://www.fda.gov/regulatory-information/search-fda-guidance-

documents/covid-19-developing-drugs-and-biological-products-treatment-or-

prevention)

i. Fever

ii. Cough

iii. Sore throat

iv. Malaise

v. Headache

vi. Muscle pain

vii. Gastrointestinal symptoms, or

12
 viii. Shortness of breath with exertion

- Must have sample collection for first positive SARS-CoV-2 viral infection

determination ≤3 days prior to start of the infusion

Sex

- Are males or females, including pregnant females. Reproductive and Contraceptive

agreements and guidance is provided in Section 10.4, Appendix 4, PYAB Protocol (k).

Contraceptive use by males or females should be consistent with local regulations

for those participating in clinical studies.

Study Procedures

- Understand and agree to comply with planned study procedures

- Agree to the collection of nasopharyngeal swabs and venous blood

Informed Consent

- The participant or legally authorized representative give signed informed consent

and/or assent as described in Section 10.1.3 of PYAB Protocol (k) which includes

compliance with the requirements and restrictions listed in the informed consent

form (ICF) and in this protocol.

For this portion of the BLAZE-1 trial;

- Are ≥18 years of age and satisfy at least one of the following at the time of screening

• Are ≥ 65 years of age

• Have a BMI ≥ 35

• Have chronic kidney disease

13
 • Have type 1 or type 2 diabetes

• Have immunosuppressive disease

• Are currently receiving immunosuppressive treatment, or

• Are ≥ 55 years of age AND have

o cardiovascular disease, OR

o hypertension, OR

o chronic obstructive pulmonary disease or other

chronic respiratory disease

Note: BMI is rounded to the nearest whole number, for example, 34.5 is rounded to 35.

- Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the

time of screening

• Have a BMI ≥85th percentile for their age and gender based on CDC

growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm

• Have sickle cell disease

• Have congenital or acquired heart disease

• Have neurodevelopmental disorders, for example, cerebral palsy

• Have a medical-related technological dependence, for example,

tracheostomy, gastrostomy, or positive pressure ventilation (not related

to COVID-19)

• Have asthma or reactive airway or other chronic respiratory disease that

requires daily medication for control

• Have type 1 or type 2 diabetes

14
 • Have chronic kidney disease

• Have immunosuppressive disease, or

• Are currently receiving immunosuppressive treatment.

Exclusion Criteria

Participants were excluded from the study if any of the following criteria apply:

Medical Conditions

- SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per

minute, heart rate ≥125 per minute (FDA May 2020)

- Require mechanical ventilation or anticipated impending need for mechanical

ventilation

- Have known allergies to any of the components used in the formulation of the

interventions

- Have hemodynamic instability requiring use of pressors within 24 hours of

randomization

- Suspected or proven serious, active bacterial, fungal, viral, or other infection

(besides COVID-19) that in the opinion of the investigator could constitute a risk

when taking intervention

- Have any co-morbidity requiring surgery within <7 days, or that is considered life

threatening within 29 days

- Have any serious concomitant systemic disease, condition or disorder that, in the

opinion of the investigator, should preclude participation in this study.

Other Exclusions

15
 - Have a history of a positive SARS-CoV-2 serology test

- Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for

this study

- Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30

days before dosing

- Have received treatment with a SARS-CoV-2 specific monoclonal antibody

- Have received convalescent COVID-19 plasma treatment

- Have participated, within the last 30 days, in a clinical study involving an

investigational intervention. If the previous investigational intervention has a long

half-life, 5 half-lives or 30 days, whichever is longer, should have passed.

- Are concurrently enrolled in any other type of medical research judged not to be

scientifically or medically compatible with this study

- Are breast feeding

- Are investigator site personnel directly affiliated with this study, and

- Have body weight <40 kg.

Randomization and Blinding

All participants were centrally randomized to study intervention using an interactive web

response system and stratified by duration since symptom onset to randomization (≤8 days

versus >8 days), and age at the time of screening (<18 years of age versus ≥18 years of age).

Eligible participants were randomized using a 1:1 allocation ratio. In this double-blind study,

neither participants, investigators, nor the sponsor study team were aware of treatment

assignments prior to the final data base lock at the conclusion of the study arm. If an

16
investigator, site personnel performing assessments, or participant is unblinded while the

infusion is ongoing, the participant was discontinued from the study intervention and the

infusion stopped.

RT-PCR for SARS-CoV-2

SARS-CoV-2 was detected from nasopharyngeal swabs collected in sterile, viral transport

media using the materials, extraction method, and RT-PCR protocol described in the “Lilly

SARS-CoV-2 Assay EUA Summary” published on the US Food and Drug Administration website

( https://www.fda.gov/media/140543/download). The SARS-CoV-2 specific primers “N1” and

“N2” target different sequences of the SARS-CoV-2 nucleocapsid N gene and are co-amplified

with a human internal control target, RNase P, for 45 cycles of PCR. Primer and probe

sequences are available in the “Lilly SARS-CoV-2 Assay EUA Summary” and were obtained

from Integrated DNA Technologies (IDT, San Jose, CA).

RT-PCR results were interpreted as follows; a clinical sample was “positive” for detection of

SARS-CoV-2 if either or both SARS-CoV-2 specific N1 and N2 targets showed clear and

unambiguous amplification and a cycle threshold (Ct) determined. A clinical sample was

“negative” for detection of SARS-CoV-2 if neither the N1 nor N2 target showed amplification,

and the internal human control, RNase P, showed clear and unambiguous amplification. A

clinical sample was “invalid” if all three targets showed no amplification. Viral presence or

absence and any quantitative determination was not scored for “invalid” samples. All

amplification curves were reviewed by a board-certified pathologist blinded to the treatment

assignment.

17
Determination of Viral Clearance and Time to Viral Clearance

For qualitative endpoints in the trial (viral clearance yes/no, time to viral clearance) the

qualitative determination of “positive”/”negative” was used, as described above. SARS-CoV-

2 clearance was defined as 2 consecutive negative RT-PCR tests for the SARS-CoV-2 virus as

previously described. The date of viral clearance was defined as the earliest date of the 2

consecutive negative tests. Additionally, a normalization step was included for any sample

with a “positive” SARS-CoV-2 test result.

Quantitation of RT-PCR Results

For quantitative endpoints in the trial (change from baseline, area under the response viral

load curve [AUC]), the viral load will be derived based on cycle threshold (Ct) values with the

following considerations; (i) two Ct values will be provided on 2 different genes: N1 and N2.

N1 will be used as the primary measure, N2 will only be used when the Ct value for N1 is not

available (ii) Ct values range between 0 and 45 (iii) Negative CoV-2 tests will be associated

with a Ct value of 45 (iv) The (log base 10) viral load will be calculated from the Ct value (45-

Ct)/log 2 10, or (45-Ct)/3.321928.

Hierarchical Testing

A hierarchical multiple comparisons procedure, to control type I error in the primary endpoint

analysis, was implemented. All primary and key secondary endpoints within a dose were

tested in a sequential manner at a 1-sided 0.025 significance level. The following is a list of

the primary and key secondary outcomes tested for each dose:

18
• Primary (Test 1) - proportion of participants who experience COVID-19 related

hospitalization (defined as ≥24 hours of acute care) or death from any cause by Day

29 (primary objective)

• Key Secondary (Test 2) – change from baseline to Day 7 (±2 days) in viral load

• Key Secondary (Test 3) – proportion of participants with SARS-CoV-2 viral load greater

than 5.27 on Day 7 (+2 days)

• Key Secondary (Test 4) – proportion of participants who experience these events by

Day 29:

o COVID-19 related hospitalization (defined as ≥24 hours of acute care)

o COVID-19 related emergency room visit, or

o Death from any cause

• Key Secondary (Test 5) - time to sustained symptom resolution (defined as 2

consecutive assessments a score of 0 in all of the following symptoms: shortness of

breath, feeling feverish, body aches and pain, sore throat, chills, and headache; and a

score of 0 or 1 in both cough and fatigue symptoms).

19
Supplementary Figures and Tables

Figure S1: Kaplan-Meier analysis of time to SARS-CoV-2 clearance among high-risk patients treated
with bamlanivimab + etesevimab versus placebo.

Data for patients at risk are displayed in the associated table and represent the number of patients at
risk (number of events) per treatment group.

20
Figure S2: Kaplan-Meier analysis of time to symptom improvement up to Day 11 among high-risk
patients treated with bamlanivimab + etesevimab versus placebo.

Data for patients at risk are displayed in the associated table and represent the number of patients at
risk (number of events) per treatment group.

21
Figure S3: Kaplan-Meier analysis of time to symptom resolution up to Day 11 among high-risk patients
treated with bamlanivimab + etesevimab versus placebo.

Data for patients at risk are displayed in the associated table and represent the number of patients at
risk (number of events) per treatment group.

22
Figure S4: Kaplan-Meier analysis of time to sustained symptom resolution up to Day 29 among high-
risk patients treated with bamlanivimab + etesevimab versus placebo.

Data for patients at risk are displayed in the associated table and represent the number of patients at
risk (number of events) per treatment group.

23
Figure S5: Kaplan-Meier analysis of time to sustained complete symptom resolution up to Day 29
among high-risk patients treated with bamlanivimab + etesevimab versus placebo.

Data for patients at risk are displayed in the associated table and represent the number of patients at
risk (number of events) per treatment group.

24
Table S1: Patient mortality reported over the course of the trial.

Days from
Study Day (since
Patient Treatment Age BMI Sex Comorbidity Symptom Onset (to
Randomization)
Randomization)
1 Placebo 39 49 M Hypertension 1 day Day 20
2 Placebo 73 29 M Hyperlipidaemia 4 days Day 13
3 Placebo 54 40 F Anxiety 4 days Day 36
4 Placebo 77 34 F Dementia 3 days Day 16
Cardiac pacemaker
5 Placebo 75 22 M 7 days Day 24
insertion
Cardiac failure
6 Placebo 62 32 M 2 days Day 24
congestive
7 Placebo 62 23 M Hypertension 4 days Day 25
8 Placebo 65 40 M Hypertension 4 days Day 36
Coronary artery
9 Placebo 59 61 M 7 days Day 3
disease
10 Placebo 62 39 M Oedema 3 days Day 19

All deaths (except one) were determined to be COVID-19-related.

25
Table S2: Symptom resolution at Days 2-11 among high-risk patients treated with bamlanivimab +
etesevimab versus placebo.

Bamlanivimab
+ Etesevimab
(N=518)
Symptom resolution at Day 2 vs Placebo,
-0.7 (-5.5, 4.0)
Δ (95% CI)
Symptom resolution at Day 3 vs Placebo,
5.9 (0.6, 11.3)
Δ (95% CI)
Symptom resolution at Day 4 vs Placebo,
5.8 (0.0, 11.7)
Δ (95% CI)
Symptom resolution at Day 5 vs Placebo,
8.7 (2.5, 14.8)
Δ (95% CI)
Symptom resolution at Day 6 vs Placebo,
9.4 (3.1, 15.7)
Δ (95% CI)
Symptom resolution at Day 7 vs Placebo,
8.6 (2.6, 14.6)
Δ (95% CI)
Symptom resolution at Day 8 vs Placebo,
12.2 (5.5, 18.9)
Δ (95% CI)
Symptom resolution at Day 9 vs Placebo,
7.3 (0.7, 13.9)
Δ (95% CI)
Symptom resolution at Day 10 vs Placebo,
10.7 (4.2, 17.2)
Δ (95% CI)
Symptom resolution at Day 11 vs Placebo,
9.1 (3.0, 15.2)
Δ (95% CI)
N, number of subjects; CI, confidence interval

26
Table S3: Patient demographics and baseline clinical characteristics.

(next page)

27
 Bamlanivimab
Placebo + Etesevimab Total
(N=517) (N=518) (N=1035)
Age (median years) 56 57 56
Age Group 517 518 1035
>=12 and <18 7 (1.4) 4 (0.8) 11 (1.1)
>=18 and <35 69 (13.3) 73 (14.1) 142 (13.7)
>=35 and <45 77 (14.9) 83 (16.0) 160 (15.5)
>=45 and <55 94 (18.2) 66 (12.7) 160 (15.5)
>=55 and <65 115 (22.2) 124 (23.9) 239 (23.1)
>=65 155 (30.0) 168 (32.4) 323 (31.2)
Race ‡, n*a 513 512 1025
n (%)*a
American Indian or Alaska Native 1 (0.2) 2 (0.4) 3 (0.3)
Asian 22 (4.3) 16 (3.1) 38 (3.7)
Black or African American 39 (7.6) 44 (8.6) 83 (8.1)
Native Hawaiian or Other Pacific 2 (0.4) 0 2 (0.2)
Islander
White 447 (87.1) 449 (87.7) 896 (87.4)
Of multiple race decent 2 (0.4) 1 (0.2) 3 (0.3)
Missing 4 6 10
Ethnicity ‡, n 516 517 1033
Hispanic or LatinX, n (%)*a 155 (30.0) 149 (28.8) 304 (29.4)
Height (median, cm) 170.0 169.0 169.5
Weight (median, kg) 95.40 95.63 95.40
Body-mass index § (median) 33.90 34.14 34.09
Days since COVID-19 symptom
onset to randomization;

≤8 485 (93.8) 494 (95.4) 979 (94.6)

>8 32 (6.2) 24 (4.6) 56 (5.4)
SpO2 category, n*a 514 516 1030

<96%, n (%) 106 (20.6) 90 (17.4) 196 (19.0)

≥96%, n (%) 408 (79.4) 426 (82.6) 834 (81.0)
Number of High-risk criteria met
(Adults only) n (%)*a 510 514 1024

0 24 (4.7) 25 (4.9) 49 (4.8)

1 274 (53.7) 273 (53.1) 547 (53.4)
2 116 (22.7) 105 (20.4) 221 (21.6)
3 70 (13.7) 64 (12.5) 134 (13.1)
4 20 (3.9) 34 (6.6) 54 (5.3)
5 4 (0.8) 11 (2.1) 15 (1.5)
6 1 (0.2) 2 (0.4) 3 (0.3)
7 1 (0.2) 0 1 (0.1)

Number of High-risk criteria met

(Adolescents only) n (%)*a 7 4 11

28
 0 3 (42.9) 0 3 (27.3)
1 3 (42.9) 4 (100.0) 7 (63.6)
2 1 (14.3) 0 1 (9.1)

High-risk status for severe

COVID-19† illness, n 517 518 1035

High, n (%) 490 (94.8) 493 (95.2) 983 (95.0)

Low, n (%) 27 (5.2) 25 (4.8) 52 (5.0)
Mild COVID-19, n (%) 403 (77.9) 397 (76.6) 800 (77.3)
Moderate COVID-19, n (%) 114 (22.1) 121 (23.4) 235 (22.7)
Medical history and pre-existing
condition, n 517 518 1035

Chronic Kidney Disease 24 (4.6) 12 (2.3) 36 (3.5)

Diabetes 134 (25.9) 151 (29.2) 285 (27.5)
Immunosuppressive Disease 9 (1.7) 7 (1.4) 16 (1.5)
Immunosuppressive Treatment 30 (5.8) 21 (4.1) 51 (4.9)
Age>=55 with Cardiovascular
Disease (Adults Only), n*a 510 514 1024
n (%) 38 (7.5) 38 (7.4) 76 (7.4)
Age>=55 with Hypertension
(Adults only), n*a 510 514 1024
n (%) 164 (32.2) 183 (35.6) 347 (33.9)
Age>=55 with Chronic
Obstructive Pulmonary
Disease (Adults only), n*a 510 514 1024
n (%) 30 (5.9) 54 (10.5) 84 (8.2)

Duration of symptoms, median

no. days from symptom onset to
4.00(0,13) 4.00 (0,29) 4.00 (0,29)
randomization (min, max)

Viral load (mean Ct ¶ value) 23.97 23.98 23.97

*a number of participants with non-missing data

† COVID-19 denotes coronavirus disease 2019.
‡ Race or ethnic group was reported by the participants, who could choose more than one category.
§ The body-mass index is the weight in kilograms divided by the square of the height in meters.
N Denotes number of subjects in analysis population.
SpO2 denotes saturation of peripheral oxygen
¶ Ct denotes the cycle threshold of the reverse-transcriptase–polymerase-chain-reaction assay.

29
Questionnaire obtained by: Study ID Subject Number Visit/Cycle Number Signature of Individual Completing Form
J2W-MC-PYAB

Investigator Number Page 1 of 2 Date Signed by Individual Completing Form

1. Assessment Date:
(DD/MMM/YYYY)

2. Cough ○ Yes
○ Mild
○ Moderate
○ Severe
○ No (Absent)

3. Shortness of breath ○ Yes

○ Mild
○ Moderate
○ Severe
○ No (Absent)

4. Feeling feverish ○ Yes

○ Mild
○ Moderate
○ Severe
○ No (Absent)

5. Fatigue ○ Yes
○ Mild
○ Moderate
○ Severe
○ No (Absent)

6. Body aches and pain ○ Yes

○ Mild
○ Moderate
○ Severe
○ No (Absent)

7. Sore throat ○ Yes

○ Mild
○ Moderate
○ Severe
○ No (Absent)

200528001-Symptom_Assessment-1-English-US-Source #EI253352
Study ID Subject Number Visit/Cycle Number Page 2 of 2
J2W-MC-PYAB

8. Chills ○ Yes
○ Mild
○ Moderate
○ Severe
○ No (Absent)

9. Loss of appetite ○ Yes

○ Mild
○ Moderate
○ Severe
○ No (Absent)

10. Headache ○ Yes

○ Mild
○ Moderate
○ Severe
○ No (Absent)

11. Loss of taste ○ Yes

○ No

12. Loss of smell ○ Yes

○ No

13. Overall, how bad are your symptoms TODAY (check one)? ○ No symptoms
○ Mild
○ Moderate
○ Severe
○ Very severe

14. Overall, how is your general physical health TODAY (check one)? ○ Poor
○ Fair
○ Good
○ Very good
○ Excellent

15. Have you returned to your usual (pre-COVID) health today (check one)? ○ Yes
○ No

200528001-Symptom_Assessment-1-English-US-Source #EI253352