Condition category
Infections and Infestations
Date applied
29/10/2020
Date assigned
03/11/2020
Last edited
02/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
The purpose of this study is to test a new medicine, remdesivir (RDV) for people with COVID-19.
There are no approved medications to treat COVID-19, a new disease caused by a virus called SARS-CoV-2 that was just identified in late 2019. COVID-19 can cause many symptoms. The symptoms can range from mild to very severe and sometimes can lead to death. The purpose of this study is to see if RDV can improve the health of people with severe COVID-19.

Who can participate?
Persons 12 years of age or older who have SARS-CoV-2 infection less than 4 days before joining the study, and are in hospital

What does the study involve?
Part A of this study included approximately 400 participants with severe COVID-19 infection. Part B of this study included approximately 5,600 participants also with severe COVID-19 infection. The treatment assignment for participants in Part B was based on whether or not they were on mechanical ventilation. The study doctor conducted a screening visit to make sure they could join the study.
Part A
Randomized study: The researchers used a computer program to randomly choose the treatment each participant took. This helped make sure the treatments were chosen fairly. Participants had an equal chance of receiving RDV for 5 days or RDV for 10 days. In both treatment arms, participants still received standard of care treatment.
Open label study: Each participant knew which treatment length they would get and the doctors and study staff also knew.

Part B was also open-label.
Participants who qualified for the study and decided to join received RDV by injections directly into the vein

Participants were followed up for 10 days.

What are the possible benefits and risks of participating?
Possible benefits: Participants may not get any benefit from taking part in this study. Studies are a way for doctors to see if a drug is useful in treating a disease. Taking part in this study may help us know more about how to treat people with COVID-19 in the future.
Possible risks: All medicines could potentially cause side effects in some people. Increases in levels of liver enzymes have been seen in some people who have taken RDV, which may be a sign of inflammation or damage to the cells in the liver.

Where is the study run from?
The study was run from Gilead Sciences, Inc. (USA) and took place at 173 centres globally.

When is the study starting and how long is it expected to run for?
February 2020 to June 2020

Who is funding the study?
Gilead Sciences, Inc. (USA)

Who is the main contact?
GileadClinicalTrials@gilead.com

Trial website

Contact information

Type

Scientific

Primary contact

Ms Devi Sengupta

ORCID ID

Contact details

333 Lakeside Drive
Foster City
California
94404
United States of America
+1 646-351-9642
Devi.SenGupta@gilead.com

Additional identifiers

EudraCT number

2020-000841-15

ClinicalTrials.gov number

NCT04292899

Protocol/serial number

GS-US-540-5773, IRAS 282007, CPMS 45460

Study information

Scientific title

A phase 3 randomized study to evaluate the safety and antiviral activity of Remdesivir (GS-5734™) in participants with severe COVID-19

Acronym

Study hypothesis

The odds of improvement for the 5-day treatment group (Treatment Group 1) is different from the odds of improvement for the 10-day treatment group (Treatment Group 2) with respect to clinical status assessed by a 7-point ordinal scale on Day 14

Ethics approval

Approved 25/03/2020, North East - Tyne & Wear South Research Ethics Committee (HRA Jarrow, Room 001, Jarrow Business Centre, Rolling Mill Road, Jarrow, NE32 3DT, UK; +44 (0)207 1048084; nrescommittee.northeast-tyneandwearsouth@nhs.net), ref: 20/NE/0104

Study design

Phase 3 randomized open-label multi-center study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

The study was conducted in two parts.

In Part A, approximately 400 participants who met all eligibility criteria and who were not mechanically ventilated were randomized via an interactive web response system (IWRS) in a 1:1 ratio into one of the following treatment groups:
Treatment Group 1: continued standard of care therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2, 3, 4, and 5
Treatment Group 2: continued standard of care therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10

After Part A completed enrollment, Part B enrolled up to 5600 additional participants, including some who were on mechanical ventilation. In Part B, participants who met all of the eligibility criteria were enrolled to receive the following (based on whether they were mechanically ventilated at enrollment):
Mechanically Ventilated Treatment Group: continued standard of care therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10
Extension Treatment Group: continued standard of care therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10
If the 5-day dosing regimen used in Treatment Group 1 of Part A is selected for Part B, all participants in the Extension Treatment Group and all new participants will be reassigned to receive treatment for a total of 5 days. National and local regulatory authorities will be informed.

All participants were followed-up for 28 days.

Intervention type

Drug

Phase

Phase III

Drug names

Remdesivir (RDV)

Primary outcome measure

The odds of ratio for improvement on a 7-point ordinal scale on day 14, calculated from daily scores taken each day from baseline to day 14. (The ordinal scale is an assessment of the clinical status at a given day. The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol Remdesivir administration 7. Not hospitalized)

Secondary outcome measures

Adverse Events recorded from patient medical records from the time of consent up to Day 28 (+/-5 days). Serious adverse events were reported up to 30 days of last dose and after the protocol defined follow-up period if deemed relevant to the use of study drug.

Overall trial start date

11/02/2020

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under ICH E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 18 years of age), or willing and able to provide assent (participants ≥12 and <18 years of age, where locally and nationally approved) prior to performing study procedures. For participants ≥12 and <18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures
2. Aged ≥ 18 years (at all sites), or aged ≥12 and <18 years of age weighing ≥40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board [IRB] or independent ethics committee [IEC])
3. SARS-CoV-2 infection confirmed by PCR test ≤4 days before randomization
4. Currently hospitalized
5. SpO2 ≤94% on room air or requiring supplemental oxygen at screening
6. Radiographic evidence of pulmonary infiltrates
7. Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

6,000

Total final enrolment

4891

Participant exclusion criteria

1. Participation in any other clinical trial of an experimental treatment for COVID-19
2. Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 <24 hours prior to study drug dosing
3. Evidence of multiorgan failure
4. Mechanically ventilated (including V-V ECMO) ≥5 days, or any duration of V-A ECMO
5. ALT or AST >5 ULN
6. Creatinine clearance <50 mL/min using the Cockcroft-Gault formula for participants ≥18 years of age and Schwartz Formula for participants <18 years of age
7. Positive pregnancy test
8. Breastfeeding woman
9. Known hypersensitivity to the study drug, the metabolites, or formulation excipient

Recruitment start date

06/03/2020

Recruitment end date

29/05/2020

Locations

Countries of recruitment

France, Germany, Hong Kong, Italy, Japan, Korea, South, Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States of America

Trial participating centre

Prince of Wales Hospital
Room G05, Ground Floor 30-32 Ngan Shing Street Sha Tin
Hong Kong
-
Hong Kong

Trial participating centre

Queen Mary Hospital
102 Pokfulam Road 2-10 Princess Margaret Hospital Road Kowloon
Hong Kong
-
Hong Kong

Trial participating centre

Tokyo Metropolitan Bokutoh Hospital
4-23-15 Kotobashi, Sumida-ku
Toyko
130-8575
Japan

Trial participating centre

Yokohama Municipal Citizen’s Hospital
1-1, Mitsuzawanishimachi, Kanagawa-ku, Yokohama-shi, Kanagawa 221-0855
221-0855
Japan

Trial participating centre

Seoul Medical Center
156 Sinnae-ro, Jungnang-gu Seoul, 2053
2053
Korea, South

Trial participating centre

National Medical Center
245, Euljiro, Jung-gu Seoul, 4564
4564
Korea, South

Trial participating centre

National University Hospital
1E Kent Ridge Road, NUHS Tower Block 119228
119228
Singapore

Trial participating centre

Singapore General Hospital (SGH)
20 College Road
169856
Singapore

Trial participating centre

National Centre for Infectious Diseases
16 Jalan Tan Tock Seng
308442
Singapore

Trial participating centre

National Taiwan University Hospital
No.25, Lane 442, Sec.1, Jingguo Road, Hsinchu City, Hsinchu
30059
Taiwan

Trial participating centre

Kaohsiung Veterans General Hospital
No. 386, Ta Chung 1st. Road, Kaohsiung City
81362
Taiwan

Trial participating centre

Hôpital Saint Antoine
184 rue du Faubourg Saint Antoine, Paris,
75571
France

Trial participating centre

Hôpital Saint-André
1 Rue Jean Burguet, Service des maladies infectieuses et tropicales, Bordeaux
3075
France

Trial participating centre

Hôpital Saint Louis
1 Avenue Claude Vellefaux, Paris,
75010
France

Trial participating centre

Hôtel Dieu – Nantes
1 Place Alexis Ricordeau, Service des Maladies Infectieuses et Tropicales Nantes, Loire-Atlantique
44093
France

Trial participating centre

CHU Gui De Chauliac
80, avenue Augustin Fliche, Montpellier,
34295
France

Trial participating centre

Universitatsklinikum
Dusseldorf, Moorenstraße 5, Düsseldorf
40225
Germany

Trial participating centre

Klinikum St. Georg gGmbH
Delitzscher Strasse 141, Leipzig Sachsen
4129
Germany

Trial participating centre

Universitätsklinikum Hamburg Eppendorf
Martinistraße 52, I. Medizinische Klinik und Poliklinik,Hamburg
20246
Germany

Trial participating centre

Universitatsklinikum Schleswig-Holstein
Arnold Heller Straße 3, Klinik für Innere Medizin I, Kiel
24105
Germany

Trial participating centre

Charité - Universitätsmedizin Berlin
Augustenburger Platz 1 Berlin
13353
Germany

Trial participating centre

Robert Bosch Krankenhaus
Auerbachstrasse 112, Stuttgart
70376
Germany

Trial participating centre

Klinikum rechts der Isar der Technischen Universität München
Ismaninger Str. 22, II. Medizinische Klinik und Poliklinik der TU München,München, Bayern
81675
Germany

Trial participating centre

Klinikum Schwabing
Kölner Platz 1, München Bayern
80804
Germany

Trial participating centre

Fondazione IRCCS
Policlinico San Matteo di Pavia, Viale Golgi 19, UOC malattie Infettive I Pavia
27100
Italy

Trial participating centre

Ospedale San Raffaele S.r.l. – PPDS
Via Olgettina 60, Isituto Scientifico Universitario San Raffaele,Milano
20132
Italy

Trial participating centre

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Pazzale Spedali Civili 1,U.O. di Malattie Infettive, Brescia
25123
Italy

Trial participating centre

Azienda Ospedaliera Di Padova
Via Giustiniani 2, Unità Operativa Malattie Infettive E Tropicali, Padova,Veneto
35128
Italy

Trial participating centre

Ospedale Guglielmo Da Saliceto
Via Taverna, 49 Piacenza, Emilia-Romagna
29100
Italy

Trial participating centre

Comprensorio Amedeo Di Savoia Birago Di Vische
Corso Svizzera 164, Torino,Piemonte
10149
Italy

Trial participating centre

ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Via Giovanni Battista Grassi, 74, Dipartimento di Scienze Biomediche e Cliniche L. Sacco,MilanoLombardia
20157
Italy

Trial participating centre

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Via Francesco Sforza 35, Milano,Lombardia
20122
Italy

Trial participating centre

Azienda Ospedaliero Universitaria di Parma
Via Gramsci 14, Parma
43100
Italy

Trial participating centre

Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
Via Portuense 292 Roma
00149
Italy

Trial participating centre

ASST di Cremona - Azienda Socio Sanitaria
Territoriale di Cremona, Viale Concordia 1, Cremona,Lombardia
26100
Italy

Trial participating centre

ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa
Giovanni XXIII,Piazza OMS 1,Bergamo
24127
Italy

Trial participating centre

Academisch Medisch Centrum Amsterdam
Meibergdreef 9, Amsterdam, Noord-Holland
1105 AZ
Netherlands

Trial participating centre

Erasmus MC
Dr. Molewaterplein 230, Rotterdam
3015GD
Netherlands

Trial participating centre

Leids Universitair Medisch Centrum
Albinusdreef 2, Leiden
2333 ZA
Netherlands

Trial participating centre

Hospital Universitario A Coruña
As Xubias, 84, A Coruña
15006
Spain

Trial participating centre

Hospital Universitario La Paz – PPDS
Paseo de la Castellana 261, Madrid
28046
Spain

Trial participating centre

Hospital Universitario de Bellvitge
Feixa Llarga s/n, L'Hospitalet de Llobregat, Barcelona
8907
Spain

Trial participating centre

Hospital Regional Universitario de Malaga – Hospital General
Avda. Carlos Haya, s/n, Servicio de Enfermedades Infecciosas,Malaga
29010
Spain

Trial participating centre

Hospital Universitari i Politecnic La Fe de Valencia
Avenida Fernado Abril Martorell, 106, Valencia
46026
Spain

Trial participating centre

Hospital Universitario Virgen del Rocio – PPDS
Avenida Manuel Siurot s/n, Sevilla
41013
Spain

Trial participating centre

Hospital Universitario Vall d'Hebrón – PPDS
Passeig de la Vall d'Hebron, 119, Barcelona
8035
Spain

Trial participating centre

Hospital Universitario de Cruces
Cruces Plaza, S/N, Unidad enfermedades infecciosas,Barakaldo
48903
Spain

Trial participating centre

Hospital Universitario Fundacion Jimenez Diaz
Av. Reyes Católicos 2, Madrid
28040
Spain

Trial participating centre

Hospital Universitario 12 de Octubre
Avenida de Andalucía s/n, Madrid
28041
Spain

Trial participating centre

Hospital Clinic de Barcelona
C/ Villarroel 170 Barcelona
08036
Spain

Trial participating centre

Hospital Universitario Ramon y Cajal
Ctra. de Colmenar, Km. 9,100, Madrid
28034
Spain

Trial participating centre

Hospital Universitario Principe de Asturias
Carretera de Alcala Meco s/n, Madrid
28805
Spain

Trial participating centre

Karolinska University Hospital
Hälsovägen, Stockholm
SE-141 86
Sweden

Trial participating centre

Sahlgrenska Universitetssjukhuset
SE-41685, Göteborg, Vastra Gotalands lan
41685
Sweden

Trial participating centre

Skånes Universitetssjukhus Malmö
Ruth Lundskogs gata 3, Infektionskliniken, Malmö
SE-20502
Sweden

Trial participating centre

Ospedale Regionale Lugano Civico
Via Tesserete 46, Lugano, Ticino (it),
6900
Switzerland

Trial participating centre

Hopitaux Universitaires de Geneve (HUG),
4 Rue Gabrielle Perret-Gentil, Geneve
1205
Switzerland

Trial participating centre

Universitätsspital Zürich
Rämistrasse 100, Klinik für Infektiologie und Spitalhygiene, Zürich
8091
Switzerland

Trial participating centre

Manchester Royal Infirmary – PPDS
Oxford Road Campus Manchester Foundation Trust Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Royal Free London NHS Foundation Trust
17 Lyndhurst Gardens, Hampstead
London
NW3 5NU
United Kingdom

Trial participating centre

University College London Hospitals (UCLH)
235 Euston Road
London
NW1 2BU
United Kingdom

Trial participating centre

Derriford Hospital
Derriford Road Crownhill
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Royal Hallamshire Hospital
Glossop Road,
Sheffield
S10 2JF
United Kingdom

Trial participating centre

St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom

Trial participating centre

Queen Elizabeth University Hospital – PPDS
1345 Govan Road,
Glasgow
G51 4TF
United Kingdom

Trial participating centre

Royal Lancaster Infirmary
-
Lancaster
LA1 4RP
United Kingdom

Trial participating centre

Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom

Trial participating centre

King's College Hospital NHS Foundation Trust
King's College Hospital Denmark Hill
London
SE5 9RS
United Kingdom

Trial participating centre

Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom

Trial participating centre

North Manchester General Hospital – PPDS
Delaunays Road, Crumpsall
Manchester
M8 5RB
United Kingdom

Trial participating centre

Royal Infirmary of Edinburgh – PPDS
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

Northwick Park Hospital
Watford Road Harrow
London
HA1 3UJ
United Kingdom

Trial participating centre

Icahn School of Medicine at Mount Sinai
17 East 102nd Street, 8th Floor, New York
10029
United States of America

Trial participating centre

Mount Sinai Beth Israel
350 East 17th Street, 3rd floor, New York
1003
United States of America

Trial participating centre

Mount Sinai West
1000 10th Avenue, Suite 2T, New York, NY
10019
United States of America

Trial participating centre

Mount Sinai Morningside
440 West 114th Street, 6th floor, New York, NY
10025
United States of America

Trial participating centre

St Joseph Hospital – Eureka
2700 Dolbeer Street,Eureka, California
95501
United States of America

Trial participating centre

Kadlec Regional Medical Center
888 Swift Boulevard, Richland, Washington
99352
United States of America

Trial participating centre

Jamaica Hospital Medical Center
800 Van Wyck Expressway,Jamaica, New York
11418
United States of America

Trial participating centre

Mission Hospital
27700 Medical Center Road, Mission Viejo, California
92691
United States of America

Trial participating centre

Hennepin Healthcare Research Institute
701 Park Avenue, Minneapolis, Minnesota
55415
United States of America

Trial participating centre

Hackensack University Medical Center
30 Prospect Avenue, Hackensack, New Jersey
7601
United States of America

Trial participating centre

Henry Ford Hospital
2799 West Grand Blvd, Detroit, Michigan
48202
United States of America

Trial participating centre

James J Peters Veterans Administration Medical Center – NAVREF
130 West Kingsbridge Road, Bronx, New York
10468
United States of America

Trial participating centre

St.Joseph Hospital – Orange
1100 West Stewart Drive, Orange,California
92868
United States of America

Trial participating centre

University of Colorado
4200 East 9th Avenue, Denver, Colorado
80262
United States of America

Trial participating centre

Providence Saint Patrick Hospital
500 West Broadway, Missoula, Montana
59802
United States of America

Trial participating centre

Inland Northwest Research
910 West 5th Avenue, Suite500,Spokane,Washington
99204
United States of America

Trial participating centre

Temple University Hospital
3401 North Broad Street ,Philadelphia, Pennsylvania
19140
United States of America

Trial participating centre

Hospital of the University of Pennsylvania
3400 Spruce Street Philadelphia, PA
19104
United States of America

Trial participating centre

Hospital of the University of Pennsylvania
3400 Spruce Street, Philadelphia, Pennsylvania
19104
United States of America

Trial participating centre

Providence Regional Medical Center Everett
1321, Colby Avenue, Office B3-018, Everett, Washington,
98122
United States of America

Trial participating centre

Long Island Jewish Medical Center
270-05 76th Aven New Hyde Park, NY
11040
United States of America

Trial participating centre

Northwell Health,
300 Community Drive, Manhasset, New York
11030
United States of America

Trial participating centre

Mills Peninsula Medical Center
1501 Trousdale Drive, Burlingame, California
94010
United States of America

Trial participating centre

Tulane University School of Medicine
1415 Tulane Avenue, New Orleans, Louisiana
70112
United States of America

Trial participating centre

Swedish Medical Center
747 Broadway, Seattle, Washington,
98122
United States of America

Trial participating centre

Baylor University Medical Center
3500 Gaston Ave, Dallas, Texas
75246
United States of America

Trial participating centre

Baylor Scott & White All Saints Medical Center
1400 8th Ave Fort Worth, TX
76104
United States of America

Trial participating centre

Baylor Scott & White Medical Center -Temple
2401 S 31st St Temple, TX
76508
United States of America

Trial participating centre

Sutter Santa Rosa Regional Hospital
30 Mark West Springs Rd, Santa Rosa, California
95403
United States of America

Trial participating centre

Houston Methodist Hospital
6565 Fannin Street, TX Medical Flagship, Houston, Texas
77030
United States of America

Trial participating centre

Indiana University School of Medicine-Indianapolis
545 Barnhill Drive, Emerson Hall, Suite 421, Indianapolis, Indiana
46077
United States of America

Trial participating centre

Rose Medical Center
4567 East 9th Avenue, Denver, Colorado
80220
United States of America

Trial participating centre

Providence St. John’s Health Center
2121 Santa Monica Blvd, 1st Floor, Santa Monica, California
90404
United States of America

Trial participating centre

Prisma Health–Midlands
5 Richland Medical Park Drive, Columbia, South Carolina
29203
United States of America

Trial participating centre

Prisma Health-Greenville Memorial Hospital
701 Grove Rd Greenville, SC
29605
United States of America

Trial participating centre

University Hospitals Cleveland Medical Center
11100 Euclid Ave, Cleveland, Ohio
44106
United States of America

Trial participating centre

John H. Stroger, Jr. Hospital of Cook County
1901 West Harrison Street, Chicago, Illinois
60612
United States of America

Trial participating centre

University of Utah – PPDS
50 N Medical Drive, Salt Lake City, Utah
84132
United States of America

Trial participating centre

University Of Iowa Hospitals And Clinics
200 Hawkins Drive, Iowa City, Iowa
52242
United States of America

Trial participating centre

UT Southwestern Medical Center–ID Clinical Research
1936 Amelia Court 2nd Floor Dallas, TX
75235
United States of America

Trial participating centre

UT Southwestern Medical Center–ID Clinical Reseach
1936 Amelia Court 2nd Floor Dallas, TX
75235
United States of America

Trial participating centre

Holy Cross Hospital
1500 Forest Glen Road, Silver Spring, Maryland
20910
United States of America

Trial participating centre

Franciscan Health System Research Center
1708 South Yakima Avenue, Suite 300, Tacoma, Washington
98405
United States of America

Trial participating centre

University of Michigan
1500 East Medical Center Drive, Ann Arbor, Michigan
48109
United States of America

Trial participating centre

Inova Fairfax Hospital
3300 Gallows Road, Falls Church, Virginia
22042
United States of America

Trial participating centre

Sutter Medical Center Sacramento
2825 Capitol Avenue, Sacramento, California
95816
United States of America

Trial participating centre

Sutter Roseville Medical Center
One Medical Plaza Roseville, CA
95661
United States of America

Trial participating centre

Jacobi Medical Center
1400 Pelham Parkway South, Bronx, New York
10461
United States of America

Trial participating centre

California Pacific Medical Center
1101 Van Ness Avenue, San Francisco, California
94109
United States of America

Trial participating centre

Virginia Mason Medical Center
1100 9th Avenue, Seattle, Washington
98101
United States of America

Trial participating centre

Tacoma General Hospital
315 Martin Luther King Jr Way ,Tacoma, Washington
98405
United States of America

Trial participating centre

Liver Institute at Methodist Dallas
1411 North Beckley Avenue, Pavillion III, Suite 268, Dallas, Texas
75203
United States of America

Trial participating centre

New York Presbyterian Hospital - Weill-Cornell
525 East 68th Street, New York
10065
United States of America

Trial participating centre

Brigham and Womens Hospital
75 Francis Street, Division of Infectious Disease, Brigham and Women's Hospital, Boston, Massachusetts
2115
United States of America

Trial participating centre

Alta Bates Summit Medical Center
2450 Ashby Avenue, Berkeley, California
94705
United States of America

Trial participating centre

Virginia Hospital Center
1701 North George Mason Drive, Arlington, Virginia
22205
United States of America

Trial participating centre

Kaiser Permanente
Skyline Medical Office 1375 East 20th Avenue Denver, CO
80204
United States of America

Trial participating centre

Kaiser Permanente Center For Health Research
3800 North Interstate Avenue, Portland, Oregon
97227
United States of America

Trial participating centre

Kiaser Westside Medical Center
2875 NW Stucki Ave., Hillsboro, OR
97124
United States of America

Trial participating centre

University of Chicago
5841 S. Maryland Ave., Chicago, Illinois
60637
United States of America

Trial participating centre

Somerset Medical Center
110 Rehill Avenue, Somerville, New Jersey
8876
United States of America

Trial participating centre

Robert Wood Johnson University Hospital New Brunswick
1 RWJ Place New Brunswick, NJ
08901
United States of America

Trial participating centre

Newark Beth Isreael Medical Center
201 Lyons Avenue Newark, NJ
07112
United States of America

Trial participating centre

Danbury Hospital
24 Hospital Avenue, Danbury, Connecticut
6810
Uruguay

Trial participating centre

Columbia University Medical Center
622 W 168th St, PH E101, New York
10032
United States of America

Trial participating centre

Yale-New Haven Hospital
20 York St, New Haven, Connecticut
06510-3220
United States of America

Trial participating centre

Tufts Medical Center – PPDS
800 Washington Street, Boston, Massachusetts
2111
United States of America

Trial participating centre

Providence Saint Vincent's Medical Center
9205 Southwest Barnes Road, Portland, Oregon
97225
United States of America

Trial participating centre

St Joseph's Regional Medical Center
703 Main Street, Paterson, New Jersey
7503
United States of America

Trial participating centre

Mayo Clinic – PPDS
200 First Street Southwest, Rochester, Minnesota
55905
United States of America

Trial participating centre

Hoag Memorial Hospital Presbyterian
One Hoag Drive, Newport Beach, California,
92663
United States of America

Trial participating centre

Virginia Commonwealth University
1250 East Marshall Street, Richmond, Virginia
23298
United States of America

Trial participating centre

Maine Medical Center
22 Bramhall Street, Portland, Maine
4102
United States of America

Trial participating centre

Eden Medical Center
20103 Lake Chabot Road, Castro Valley, California
94546
United States of America

Trial participating centre

Rush University Medical Center
1653 W. Congress Parkway, Chicago, Illinois
60612
United States of America

Trial participating centre

Kaiser Permanente Oakland Medical Center
3600 Broadway, Oakland, California
94611
United States of America

Trial participating centre

Kaiser Permanente San Francisco Medical Center
2425 Geary Blvd. San Francisco, CA
94115
United States of America

Trial participating centre

Kaiser Permanente South San Francisco Medical Center
1200 El Camino Real, San Francisco, CA
94080
United States of America

Trial participating centre

Kaiser Permanente San Jose Medical Center
250 Hospital Parkway, San Jose, CA
95119
United States of America

Trial participating centre

Kaiser Permanente San Leandro Medical Center
2500 Merced Street San Leandro, CA
94577
United States of America

Trial participating centre

Kaiser Permanente Santa Clara
700 Lawrence Expressway, Santa Clara, CA
95051
United States of America

Trial participating centre

Providence St Peter Hospital
, 413 Lilly Road Northeast, Olympia, Washington
98506
United States of America

Trial participating centre

Beth Israel Deaconess Medical Center
330 Brookline Avenue, Boston, Massachusetts
2215
United States of America

Trial participating centre

Stanford University School of Medicine
300 Pasteur Drive, Stanford, California
94305
United States of America

Trial participating centre

Miriam Hospital
164 Summitt Avenue, Providence, Rhode Island
2906
United States of America

Trial participating centre

Woodland Hills Medical Center
5601 De Soto Avenue, Woodland Hills, CA
91365
United States of America

Trial participating centre

Ontario Medical Center
2295 S. Vineyard Avenue Ontario, CA
91761
United States of America

Trial participating centre

San Diego Medical Center
9455 Clairemont Mesa Blvd San Diego, CA
92123
United States of America

Trial participating centre

Zion Medical Center
4647 Zion Avenue, San Diego, CA
92120
United States of America

Trial participating centre

Downey Medical Center
9333 Imperial Highway Downey, CA
90241
United States of America

Trial participating centre

Riverside Medical Center
10800 Magnolia Avenue Riverside, CA
92505
United States of America

Trial participating centre

Kaiser Permanente Los Angeles Medical Center
4867 West Sunset Boulevard, Los Angeles, California
90027
United States of America

Trial participating centre

Orange County Anaheim Medical Center
3440 E. La. Palma Avenue Anaheim, CA
92806
United States of America

Trial participating centre

West Los Angeles Medical Center
6041 Cadillac Avenue, Los Angeles, CA
90034
United States of America

Trial participating centre

Moreno Valley Medical Center
27300 Iris Avenue Moreno Valley, CA
92555
United States of America

Trial participating centre

Fontana Medical Center
9961 Sierra Avenue Fontana, CA
92335
United States of America

Trial participating centre

Panorama City Medical Center
13651 Willard Street Panorama City, CA
91402
United States of America

Trial participating centre

South Bay Medical Center
25825 S. Vermont Avenue Harbor City, CA
90710
United States of America

Trial participating centre

Duke University Medical Center
2301 Erwin Road, Durham, North Carolina
27710
United States of America

Trial participating centre

Dartmouth-Hitchcock Medical Center
1 Medical Center Drive, Lebanon, New Hampshire
3766
United States of America

Sponsor information

Organisation

Gilead Sciences (United States)

Sponsor details

333 Lakeside Drive
Foster City
California
94404
United States of America
+1-833-445-3230
GileadClinicalTrials@gilead.com

Sponsor type

Industry

Website

http://www.gilead.com/

Funders

Funder type

Industry

Funder name

Gilead Sciences

Alternative name(s)

Gilead, Gilead Sciences, Inc., Gilead Sciences Inc

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

The Protocol is available at the following address within the supplemental materials:
https://www.nejm.org/doi/full/10.1056/NEJMoa2015301

A redacted version of the latest protocol and statistical analysis plan, will be available on ClinicalTrials.gov when results are submitted: https://clinicaltrials.gov/ct2/show/NCT04292899

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Gilead Sciences shares anonymized individual patient data upon request or as required by law or regulation with qualified external researchers based on submitted curriculum vitae and reflecting non conflict of interest. The request proposal must also include a statistician. Approval of such requests is at Gilead Science’s discretion and is dependent on the nature of the request, the merit of the research proposed, the availability of the data, and the intended use of the data. Data requests should be sent to datarequest@gilead.com . Data will become available 18 months after study completion and will be accessible in a secured external environment. More information on Gilead’s data sharing policy can be found here: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

Intention to publish date

01/06/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

2020 results in https:doi.org/10.1056/NEJMoa2015301 (added 29/10/2020)

Publication citations

Additional files

Editorial Notes

02/11/2020: Trial’s existence confirmed by North East - Tyne & Wear South Research Ethics Committee.