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 moderate 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 was randomized and open-label (patients know what medication they are getting and for how long, doctors and study staff also know):
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, receiving RDV for 10 days or for not receiving RDV at all. In all treatment arms, participants still received standard of care treatment.
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 randomized to one of the following treatment groups:
1. Standard of care treatment together with RDV 200mg on Day 1 and then RDV 100mg on Days 2, 3, 4 and 5
2. Standard of care treatment together with RDV 200mg on Day 1 and then RDV 100mg on Days 2, 3, 4, 5, 6, 7, 8, 9 and 10
3. Standard of care treatment and no RDV
Part B Extension Treatment Group – For participants enrolled when Part A is completed, they received standard of care treatment together with RDV 200mg on Day 1 and then RDV 100mg on Days 2, 3, 4, 5, 6, 7, 8, 9, 10. The treatment may have been reduced to a total of 5 days based on the results from Part A.
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 133 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
2020-000842-32
ClinicalTrials.gov number
NCT04292730
Protocol/serial number
GS-US-540-5774, IRAS 282026, CPMS 45459
Study information
Scientific title
A phase 3 randomized study to evaluate the safety and antiviral activity of remdesivir (GS-5734™) in participants with moderate COVID-19 compared to standard of care treatment
Acronym
Study hypothesis
The odds of improvement for the RDV 5-day treatment group (Treatment Group 1) or 10-day treatment group (Treatment Group 2) is different from the odds of improvement for SOC treatment group (Treatment Group 3) with respect to clinical status assessed by a 7-point ordinal scale on Day 11.
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/0105
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 600 participants who met all eligibility criteria were randomized via an interactive web response system (IWRS) in 1:1:1 ratio into one of the following treatment groups:
Treatment Group 1: continued SOC therapy together with intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2, 3, 4, and 5
Treatment Group 2: continued SOC 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
Treatment Group 3: continued SOC therapy
Part B began enrollment after enrollment to Part A is complete. In Part B, an additional approximately 1,000 participants who met all of the eligibility criteria received:
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
Based on the results from Part A, or if treatment for 5 days is selected in a study of more severe disease, 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
(The ordinal scale is an assessment of the clinical status on a given day. Each day, the worst score from the previous day will be recorded. 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.)
The ordinal scale was recorded each day from Baseline until discharge or Day14, any change in category from Day 14 to discharge (or Day28) was also recorded.
Secondary outcome measures
Adverse Events were 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
26/06/2020
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 and requiring medical care for COVID-19
5. SpO2 >94% on room air 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
Mixed
Gender
Both
Target number of participants
1,600
Total final enrolment
1113
Participant exclusion criteria
1. Participation in any other clinical trial of an experimental treatment for COVID-19
2. Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2
3. Requiring mechanical ventilation at screening
4. ALT or AST >5 x ULN
Note: if per local practice only ALT is routinely measured, exclusion criteria will be evaluated on ALT alone
5. 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
6. Positive pregnancy test
7. Breastfeeding woman
8. Known hypersensitivity to the study drug, the metabolites, or formulation excipient
Recruitment start date
15/03/2020
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
Princess Margaret Hospital
2-10 Princess Margaret Hospital Road,
Kowloon
N.T.
Hong Kong
Trial participating centre
Nagoya City East Medical Center
1-2-23 Wakamizu,Chikusa-ku,
Nagoya, Aichi,
464-8547
Japan
Trial participating centre
Yokohama Municipal Citizen’s Hospital
1-1, Mitsuzawanishimachi, Kanagawa-ku,
Yokohama-shi, Kanagawa
221-0855
Japan
Trial participating centre
Seoul Medical Center
156 Sinnae-ro, Jungnang-gu,
Seoul
2053
Korea, South
Trial participating centre
National Medical Center,
245, Euljiro, Jung-gu,
Seoul
4564
Korea, South
Trial participating centre
National University Hospital
1E Kent Ridge Road,
NUHS Tower Block
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
Hôpital Saint-André
1 Rue Jean Burguet,
Service des maladies infectieuses et tropicales,
Bordeaux
33075
France
Trial participating centre
Hôpital Saint Louis
1 Avenue Claude Vellefaux,
Service des Maladies Infectieuses et Tropicales,
Paris
75010
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
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,
Milano, Lombardia
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
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,
Pabellon A, 2ª planta,
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 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 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
Hospital Clinic de Barcelona
C/ Villarroel 170,
Badalona, Barcelona
8036
Spain
Trial participating centre
Karolinska University Hospital
Hälsovägen, Stockholm
SE-141 86
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, Zürich (de)
8091
Switzerland
Trial participating centre
Royal Free London NHS Foundation Trust
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
St Mary's Hospital
Praed Street
London
W2 1NY
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
Royal Infirmary of Edinburgh – PPDS
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Trial participating centre
Queen Elizabeth University Hospital – PPDS
1345 Govan Road
Glasgow
G51 4TF
United Kingdom
Trial participating centre
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom
Trial participating centre
King's College Hospital
King's College Hospital NHS Foundation Trust
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
Delaunays Road
Crumpsall
Manchester
M8 5RB
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 West
1000 10th Avenue, Suite 2T, New York, NY
10019
United States of America
Trial participating centre
Mount Sinai Beth Israel
350 East 17th Street, 3rd floor, New York, NY
1003
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
45 Goethals Drive,
Suite 300,
Richland, Washington
99352
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
MultiCare Institute for Research and Innovation
910 West 5th Ave.,
Suite 1001, Spokane,
Washington
99204
United States of America
Trial participating centre
Temple University Hospital
1801 N. Broad Street,
Philadelphia, Pennsylvania
19122
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
1330 Rockefeller Avenue,
Suite 440, Everett,
Washington
98201
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
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
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 Iowa Hospitals And Clinics
200 Hawkins Drive,
Iowa City, Iowa
52242
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
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
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
Northwell Health
300 Community Drive,
Manhasset, New York
11030
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
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
Weill Cornell Medicine
1300 York Avenue,
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
2205
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
University of Chicago
5801 S. Ellia Avenue,
Chicago, Illinois
60637
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
Danbury Hospital
24 Hospital Avenue,
Danbury, Connecticut
6810
United States of America
Trial participating centre
Columbia University Medical Center
177 Fort Washington Avenue,
Milstein Hospital,
Fourth Floor, 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
Rush University Medical Center
600 South Paulina,
Suite 143, Chicago, Illinois
60612
United States of America
Trial participating centre
El Camino Hospital
2500 Grant Road,
Mountain View, California
94040
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 Santa Clara
700 Lawrence Expressway, Santa Clara, CA
95051
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 South San Francisco Medical Center
1200 El Camino Real, San Francisco, CA
94080
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
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
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.
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/NCT04292730)
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