search
Back to results

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Remdesivir
Standard of Care
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Willing and able to provide written informed consent prior to performing study procedures (participants ≥ 18 years of age) or assent (participants ≥ 12 and < 18 years of age) 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
  • Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
  • Currently hospitalized and requiring medical care for COVID-19
  • Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
  • Radiographic evidence of pulmonary infiltrates

Key Exclusion Criteria:

  • Participation in any other clinical trial of an experimental treatment for COVID-19
  • Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2
  • Requiring mechanical ventilation at screening
  • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
  • Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of age

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue
  • Alta Bates Summit Medical Center
  • Mills-Peninsula Medical Center
  • Eden Medical Center
  • Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway
  • Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave
  • St Joseph Hospital Eureka
  • Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.
  • Kaiser Permanente Los Angeles Medical Center
  • Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.
  • Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue
  • Mission Hospital Regional Medical Center
  • Kaiser Permanente Los Angeles Medical Center,27300 Iris Avenue
  • El Camino Hospital
  • Hoag Memorial Hospital Presbyterian
  • Kaiser Permanente Oakland Medical Center
  • Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue
  • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
  • Kaiser Permanente Los Angeles Medical Center,13651 Willard Street
  • Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue
  • Sutter Medical Center Sacramento, One Medical Plaza
  • Sutter Medical Center Sacramento
  • Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue
  • Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd
  • Kaiser Permanente Oakland Medical Center, 1200 El Camino Real
  • California Pacific Medical Center-Infectious Disease Associates Medical Group
  • Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd
  • Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850
  • Kaiser Permanente Oakland Medical Center, 2500 Merced St
  • Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway
  • Providence St. Johns Medical Center
  • Sutter Santa Rosa Regional Hospital
  • Stanford Hospital
  • University of Colorado Denver, University of Colorado Hospital
  • SCL Health St. Joseph Hospital, 1375 East 19th Ave
  • SCL Health St. Joseph Hospital
  • Rose Medical Center
  • SCL Health St. Joseph Hospital, 200 Exempla Circle.
  • Yale University
  • Kaiser Permanente Hawaii Moanalua Medical Center
  • Cook County General Hospital
  • Rush University Medical Center
  • University of Chicago
  • IU Health Methodist Hospital
  • University of Iowa Hospitals & Clinics
  • Tulane University
  • Maine Medical Center
  • Holy Cross Hospital
  • Tufts Medical Center
  • Brigham & Women's Hospital and Harvard Medical School
  • Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center
  • The University of Michigan Hospitals and Health Systems
  • Henry Ford Health System
  • Hennepin Healthcare
  • Mayo Clinic
  • Providence St Patrick Hospital and International Heart Institute of MT Foundation
  • Darmouth-Hitchhock Medical Center
  • Hackensack Medical Center
  • Robert Wood Johnson University Hospital Somerset
  • Robert Wood Johnson University Hospital Somerset, 1 RWJ Place
  • Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue
  • St. Joseph's University Medical Center
  • Jacobi Medical Center
  • James J. Peters Veterans Administration Medical Center
  • Jamaica Hospital Medical Center
  • Danbury Hospital
  • North Shore University Hospital
  • North Shore University Hospital, 270-05 76th Ave
  • Icahn School of Medicine at Mount Sinai, 350 East 17th Street
  • Icahn School of Medicine at Mount Sinai, 1000 10th Avenue
  • Icahn School of Medicine at Mount Sinai, 440 West 114th St.
  • Icahn School of Medicine at Mount Sinai
  • Columbia University Irving Medical Center
  • Weill Cornell Medical College/NYU Presbyterian Hospital
  • Duke University Medical Center
  • University Hospitals Cleveland Medical Center
  • Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center
  • Kaiser Sunnyside Medical Center
  • Hospital of the University of Pennsylvania, 51 N. 31st Street
  • Hospital of the University of Pennsylvania
  • Temple University Hospital
  • The Miriam Hospital
  • Prisma Health Richland Hospital
  • Prisma Health Richland Hospital, 701 Grove Road
  • The Liver Institute of Methodist Dallas Medical Center
  • UT Southwestern Medical Center Amelia Court, HIV Research Clinic
  • Baylor University Medical Center
  • UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.
  • UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd
  • Baylor University Medical Center, 1400 8th Ave
  • Houston Methodist Hospital
  • Baylor University Medical Center, 2401 S. 31st St.
  • University of Utah Health
  • Virginia Hospital Center
  • Inova Fairfax Hospital
  • VCU Health Medical Center
  • Providence Medical Research Center
  • Kadlec Regional Medical Center
  • Providence St. Peter Hospital
  • Virginia Mason Medical Center
  • Swedish Center for Comprehensive Care
  • MultiCare Deaconess Hospital
  • MultiCare Tacoma General Hospital
  • St Joseph Medical Center
  • The First Affiliated Hospital of Guangzhou Medical University
  • CHU Pellegrin
  • CHU de Montpellier-Hopital Gui de Chauliac
  • CHU de Nantes-Hotel Dieu
  • Hopital Saint-Louis
  • Hopital Saint Antoine
  • Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie
  • Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie
  • Universitatsklinikum Hamburg-Eppendorf
  • Universitätsklinikum Schleswig-Holstein Campus Kiel
  • Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie
  • Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2
  • Klinik für Hämatologie, Onkologie, Immunologie
  • Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP)
  • Prince of Wales Hospital
  • Princess Margaret Hospital
  • Queen Mary Hospital
  • UOC Malattie Infettive, ASST Papa Giovanni XXIII
  • ASST degli Spedali Civili di Brescia
  • ASST di Cremona - Azienda Socio Sanitaria Territor
  • UOC Malattie Infettive, IRCCS Ospedale San Raffaele
  • ASST Fatebenefratelli Sacco
  • UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • UOC Malattie Infettive e Tropicali, Azienda Ospedaliera di Padova
  • Azienda Ospedaliero Universitaria di Parma
  • Malattie Infettive I, Fondazione IRCCS Policlinico San Matteo
  • Ospedale Guglielmo da Saliceto AUSL di Piacenza
  • UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
  • Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia
  • Yokohama Municipal Citizen's Hospital
  • Nagoya City East Medical Center
  • Tokyo Metropolitan Bokutoh Hospital
  • Kyungpook National University Hospital
  • Seoul Medical Center
  • National Medical Center
  • Amsterdam University Medical Centre - Location AMC
  • Leiden University Medical Center
  • Erasmus Medical Centre
  • National University Hospital
  • Singapore General Hospital
  • National Centre for Infectious Diseases, Tan Tock Seng Hospital
  • Hospital Principe de Asturias
  • Complejo Hospitalario Universitario A Coruña
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitari de Bellvitge
  • Hospital Clinic de Barcelona
  • Hospital Universitario Cruces
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario Fundación Jiménez Díaz
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Regional Universitario de Málaga
  • Hospital Universitario Virgen del Rocio
  • Hospital Universitari i Politecnic La Fe
  • Sahlgrenska University Hospital, Ostra
  • SUS (Skanes University Hospital)
  • Karolinska University Hospital
  • Hopitaux Universitaires de Genève
  • Ospedale Regionale di Locarno La Carità
  • Universitätsspital Zürich
  • Kaohsiung Veterans General Hospital
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Imperial College NHS Trust
  • NHS Lothian, Royal lnfirmary of Edinburgh
  • Queen Elizabeth University Hospital
  • Hull University Teaching Hospitals NHS Trust
  • Royal Lancaster Hospital
  • Liverpool University Hospital
  • Northwick Park Hospital
  • Royal Free London NHS Foundation Trust
  • King's College Hospital NHS Trust
  • University College London
  • Manchester University NHS Foundation Trust
  • Manchester University NHS Foundation Trust
  • Pennine Acute Hospitals NHS Trust
  • Derriford Hospital
  • Sheffield Teaching Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

Part A: Remdesivir (RDV), 5 Days

Part A: Remdesivir, 10 Days

Part A: SOC Therapy

Part B: Extension Treatment, Remdesivir 10 Days

Arm Description

Participants will receive continued standard of care (SOC) therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.

Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Participants will receive continued standard of care therapy.

Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Outcomes

Primary Outcome Measures

Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11
Clinical status was derived from death, hospital discharge, and ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last available assessment for missing value. 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 odds ratio represents the odds of improvement in the ordinal scale for a RDV group relative to the SOC group.

Secondary Outcome Measures

Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
TEAEs were defined as the following: any AE with an onset date on or after the study treatment start date and no later than 30 days after permanent discontinuation of study treatment and/or any AE leading to premature discontinuation of study treatment. For participants randomized to the SOC group, all AEs reported on or after the protocol-specified Day 1 visit were considered as treatment emergent.

Full Information

First Posted
February 28, 2020
Last Updated
January 21, 2021
Sponsor
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04292730
Brief Title
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
April 29, 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study was to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Remdesivir (RDV), 5 Days
Arm Type
Experimental
Arm Description
Participants will receive continued standard of care (SOC) therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.
Arm Title
Part A: Remdesivir, 10 Days
Arm Type
Experimental
Arm Description
Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.
Arm Title
Part A: SOC Therapy
Arm Type
Active Comparator
Arm Description
Participants will receive continued standard of care therapy.
Arm Title
Part B: Extension Treatment, Remdesivir 10 Days
Arm Type
Experimental
Arm Description
Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.
Intervention Type
Drug
Intervention Name(s)
Remdesivir
Other Intervention Name(s)
GS-5734™, Veklury®
Intervention Description
Administered as an intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care Treatment for COVID-19 Infection
Primary Outcome Measure Information:
Title
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11
Description
Clinical status was derived from death, hospital discharge, and ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last available assessment for missing value. 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 odds ratio represents the odds of improvement in the ordinal scale for a RDV group relative to the SOC group.
Time Frame
Day 11
Secondary Outcome Measure Information:
Title
Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Description
TEAEs were defined as the following: any AE with an onset date on or after the study treatment start date and no later than 30 days after permanent discontinuation of study treatment and/or any AE leading to premature discontinuation of study treatment. For participants randomized to the SOC group, all AEs reported on or after the protocol-specified Day 1 visit were considered as treatment emergent.
Time Frame
First dose date up to last dose date (maximum: 10 days) plus 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Willing and able to provide written informed consent prior to performing study procedures (participants ≥ 18 years of age) or assent (participants ≥ 12 and < 18 years of age) 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 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization Currently hospitalized and requiring medical care for COVID-19 Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening Radiographic evidence of pulmonary infiltrates Key Exclusion Criteria: Participation in any other clinical trial of an experimental treatment for COVID-19 Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 Requiring mechanical ventilation at screening Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of age Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue
City
Anaheim
State/Province
California
ZIP/Postal Code
92806
Country
United States
Facility Name
Alta Bates Summit Medical Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Mills-Peninsula Medical Center
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
Eden Medical Center
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave
City
Fontana
State/Province
California
ZIP/Postal Code
92335
Country
United States
Facility Name
St Joseph Hospital Eureka
City
Fortuna
State/Province
California
ZIP/Postal Code
95540
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90034
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue
City
Los Angeles
State/Province
California
ZIP/Postal Code
91365
Country
United States
Facility Name
Mission Hospital Regional Medical Center
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center,27300 Iris Avenue
City
Moreno Valley
State/Province
California
ZIP/Postal Code
92555
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Kaiser Permanente Oakland Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue
City
Ontario
State/Province
California
ZIP/Postal Code
91761
Country
United States
Facility Name
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center,13651 Willard Street
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Sutter Medical Center Sacramento, One Medical Plaza
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sutter Medical Center Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue
City
San Diego
State/Province
California
ZIP/Postal Code
92120-2507
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permanente Oakland Medical Center, 1200 El Camino Real
City
San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
California Pacific Medical Center-Infectious Disease Associates Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente Oakland Medical Center, 2500 Merced St
City
San Leandro
State/Province
California
ZIP/Postal Code
94577
Country
United States
Facility Name
Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Providence St. Johns Medical Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Sutter Santa Rosa Regional Hospital
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Stanford Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Denver, University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
SCL Health St. Joseph Hospital, 1375 East 19th Ave
City
Denver
State/Province
Colorado
ZIP/Postal Code
80208
Country
United States
Facility Name
SCL Health St. Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
SCL Health St. Joseph Hospital, 200 Exempla Circle.
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Kaiser Permanente Hawaii Moanalua Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Cook County General Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
IU Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46077
Country
United States
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brigham & Women's Hospital and Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
The University of Michigan Hospitals and Health Systems
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5378
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Hennepin Healthcare
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Providence St Patrick Hospital and International Heart Institute of MT Foundation
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Darmouth-Hitchhock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Hackensack Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Robert Wood Johnson University Hospital Somerset
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Robert Wood Johnson University Hospital Somerset, 1 RWJ Place
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
St. Joseph's University Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
James J. Peters Veterans Administration Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Jamaica Hospital Medical Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Facility Name
Danbury Hospital
City
Lagrangeville
State/Province
New York
ZIP/Postal Code
12540
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
North Shore University Hospital, 270-05 76th Ave
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai, 350 East 17th Street
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai, 1000 10th Avenue
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai, 440 West 114th St.
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Weill Cornell Medical College/NYU Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave
City
Hillsboro
State/Province
Oregon
ZIP/Postal Code
97124
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Kaiser Sunnyside Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Hospital of the University of Pennsylvania, 51 N. 31st Street
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Prisma Health Richland Hospital
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Prisma Health Richland Hospital, 701 Grove Road
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
The Liver Institute of Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
UT Southwestern Medical Center Amelia Court, HIV Research Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor University Medical Center, 1400 8th Ave
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor University Medical Center, 2401 S. 31st St.
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Hospital Center
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
VCU Health Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Providence Medical Research Center
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Kadlec Regional Medical Center
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Providence St. Peter Hospital
City
Olympia
State/Province
Washington
ZIP/Postal Code
98506
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Center for Comprehensive Care
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
MultiCare Deaconess Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
MultiCare Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
St Joseph Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
Country
China
Facility Name
CHU Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU de Montpellier-Hopital Gui de Chauliac
City
Montpelier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nantes-Hotel Dieu
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitatsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie
City
Leipzig
ZIP/Postal Code
4129
Country
Germany
Facility Name
Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinik für Hämatologie, Onkologie, Immunologie
City
München
ZIP/Postal Code
80804
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP)
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
UOC Malattie Infettive, ASST Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
ASST degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
ASST di Cremona - Azienda Socio Sanitaria Territor
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
UOC Malattie Infettive, IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
ASST Fatebenefratelli Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
UOC Malattie Infettive e Tropicali, Azienda Ospedaliera di Padova
City
Padova PD
ZIP/Postal Code
35121
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Malattie Infettive I, Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale Guglielmo da Saliceto AUSL di Piacenza
City
Piacenza
Country
Italy
Facility Name
UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia
City
Torino
ZIP/Postal Code
10149
Country
Italy
Facility Name
Yokohama Municipal Citizen's Hospital
City
Kanagawa
ZIP/Postal Code
240-8555
Country
Japan
Facility Name
Nagoya City East Medical Center
City
Nagoya
ZIP/Postal Code
464-8547
Country
Japan
Facility Name
Tokyo Metropolitan Bokutoh Hospital
City
Tokyo
ZIP/Postal Code
130-8575
Country
Japan
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Seoul Medical Center
City
Seoul
ZIP/Postal Code
02053
Country
Korea, Republic of
Facility Name
National Medical Center
City
Seoul
ZIP/Postal Code
04564
Country
Korea, Republic of
Facility Name
Amsterdam University Medical Centre - Location AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Erasmus Medical Centre
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169856
Country
Singapore
Facility Name
National Centre for Infectious Diseases, Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308442
Country
Singapore
Facility Name
Hospital Principe de Asturias
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Universitario Cruces
City
Bizkaia
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Sahlgrenska University Hospital, Ostra
City
Gothenburg
ZIP/Postal Code
41685
Country
Sweden
Facility Name
SUS (Skanes University Hospital)
City
Malmo
ZIP/Postal Code
20502
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
Hopitaux Universitaires de Genève
City
Genève 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Ospedale Regionale di Locarno La Carità
City
Lugano
ZIP/Postal Code
CH- 6900
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Imperial College NHS Trust
City
London
State/Province
Greater London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
NHS Lothian, Royal lnfirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Hull University Teaching Hospitals NHS Trust
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Royal Lancaster Hospital
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Northwick Park Hospital
City
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
King's College Hospital NHS Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
University College London
City
London
ZIP/Postal Code
WC1E 6JF
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Pennine Acute Hospitals NHS Trust
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8BG
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Citations:
PubMed Identifier
32821939
Citation
Spinner CD, Gottlieb RL, Criner GJ, Arribas Lopez JR, Cattelan AM, Soriano Viladomiu A, Ogbuagu O, Malhotra P, Mullane KM, Castagna A, Chai LYA, Roestenberg M, Tsang OTY, Bernasconi E, Le Turnier P, Chang SC, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wang H, Gaggar A, Brainard DM, McPhail MJ, Bhagani S, Ahn MY, Sanyal AJ, Huhn G, Marty FM; GS-US-540-5774 Investigators. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2020 Sep 15;324(11):1048-1057. doi: 10.1001/jama.2020.16349.
Results Reference
result
PubMed Identifier
34350582
Citation
Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD014962. doi: 10.1002/14651858.CD014962.
Results Reference
derived

Learn more about this trial

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment

We'll reach out to this number within 24 hrs