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
- Registration Number
- NCT04292730
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1113
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: Remdesivir (RDV), 5 Days Standard of Care 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. Part A: Remdesivir, 10 Days Standard of Care 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. Part A: SOC Therapy Standard of Care Participants will receive continued standard of care therapy. Part B: Extension Treatment, Remdesivir 10 Days Standard of Care 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. Part A: Remdesivir (RDV), 5 Days Remdesivir 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. Part A: Remdesivir, 10 Days Remdesivir 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. Part B: Extension Treatment, Remdesivir 10 Days Remdesivir 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.
- Primary Outcome Measures
Name Time Method Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 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
Name Time Method Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) First dose date up to last dose date (maximum: 10 days) plus 30 days 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.
Trial Locations
- Locations (183)
Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.
🇺🇸Los Angeles, California, United States
Robert Wood Johnson University Hospital Somerset, 1 RWJ Place
🇺🇸New Brunswick, New Jersey, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue
🇺🇸Anaheim, California, United States
Mills-Peninsula Medical Center
🇺🇸Burlingame, California, United States
Alta Bates Summit Medical Center
🇺🇸Berkeley, California, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway
🇺🇸Downey, California, United States
Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.
🇺🇸Harbor City, California, United States
Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave
🇺🇸Fontana, California, United States
St Joseph Hospital Eureka
🇺🇸Fortuna, California, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue
🇺🇸Los Angeles, California, United States
Mission Hospital Regional Medical Center
🇺🇸Mission Viejo, California, United States
Kaiser Permanente Los Angeles Medical Center,27300 Iris Avenue
🇺🇸Moreno Valley, California, United States
El Camino Hospital
🇺🇸Mountain View, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue
🇺🇸Ontario, California, United States
Kaiser Permanente Oakland Medical Center
🇺🇸Oakland, California, United States
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
🇺🇸Orange, California, United States
Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue
🇺🇸Riverside, California, United States
Kaiser Permanente Los Angeles Medical Center,13651 Willard Street
🇺🇸Panorama City, California, United States
Sutter Medical Center Sacramento, One Medical Plaza
🇺🇸Roseville, California, United States
Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850
🇺🇸San Jose, California, United States
Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway
🇺🇸Santa Clara, California, United States
Providence St. Johns Medical Center
🇺🇸Santa Monica, California, United States
Sutter Santa Rosa Regional Hospital
🇺🇸Santa Rosa, California, United States
Stanford Hospital
🇺🇸Stanford, California, United States
SCL Health St. Joseph Hospital, 200 Exempla Circle.
🇺🇸Lafayette, Colorado, United States
IU Health Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Cook County General Hospital
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Holy Cross Hospital
🇺🇸Silver Spring, Maryland, United States
Brigham & Women's Hospital and Harvard Medical School
🇺🇸Boston, Massachusetts, United States
Darmouth-Hitchhock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue
🇺🇸Newark, New Jersey, United States
St. Joseph's University Medical Center
🇺🇸Paterson, New Jersey, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Danbury Hospital
🇺🇸Lagrangeville, New York, United States
Jamaica Hospital Medical Center
🇺🇸Jamaica, New York, United States
Icahn School of Medicine at Mount Sinai, 1000 10th Avenue
🇺🇸New York, New York, United States
North Shore University Hospital, 270-05 76th Ave
🇺🇸New Hyde Park, New York, United States
Icahn School of Medicine at Mount Sinai, 350 East 17th Street
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai, 440 West 114th St.
🇺🇸New York, New York, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Weill Cornell Medical College/NYU Presbyterian Hospital
🇺🇸New York, New York, United States
Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave
🇺🇸Hillsboro, Oregon, United States
Hospital of the University of Pennsylvania, 51 N. 31st Street
🇺🇸Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Prisma Health Richland Hospital
🇺🇸Columbia, South Carolina, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Prisma Health Richland Hospital, 701 Grove Road
🇺🇸Greenville, South Carolina, United States
The Liver Institute of Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center Amelia Court, HIV Research Clinic
🇺🇸Dallas, Texas, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Baylor University Medical Center, 1400 8th Ave
🇺🇸Fort Worth, Texas, United States
UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd
🇺🇸Dallas, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Baylor University Medical Center, 2401 S. 31st St.
🇺🇸Temple, Texas, United States
Providence Medical Research Center
🇺🇸Everett, Washington, United States
Kadlec Regional Medical Center
🇺🇸Kennewick, Washington, United States
Virginia Hospital Center
🇺🇸Arlington, Virginia, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Providence St. Peter Hospital
🇺🇸Olympia, Washington, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
MultiCare Deaconess Hospital
🇺🇸Spokane, Washington, United States
Swedish Center for Comprehensive Care
🇺🇸Seattle, Washington, United States
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
MultiCare Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie
🇩🇪Berlin, Germany
Hopital Saint Antoine
🇫🇷Paris, France
CHU de Nantes-Hotel Dieu
🇫🇷Nantes, France
Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie
🇩🇪Düsseldorf, Germany
Hopital Saint-Louis
🇫🇷Paris, France
CHU de Montpellier-Hopital Gui de Chauliac
🇫🇷Montpelier Cedex 5, France
Universitätsklinikum Schleswig-Holstein Campus Kiel
🇩🇪Kiel, Germany
Universitatsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie
🇩🇪Leipzig, Germany
Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2
🇩🇪Munich, Germany
Klinik für Hämatologie, Onkologie, Immunologie
🇩🇪München, Germany
Princess Margaret Hospital
🇭🇰Hong Kong, Hong Kong
Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP)
🇩🇪Stuttgart, Germany
UOC Malattie Infettive, ASST Papa Giovanni XXIII
🇮🇹Bergamo, Italy
ASST degli Spedali Civili di Brescia
🇮🇹Brescia, Italy
UOC Malattie Infettive e Tropicali, Azienda Ospedaliera di Padova
🇮🇹Padova PD, Italy
ASST di Cremona - Azienda Socio Sanitaria Territor
🇮🇹Cremona, Italy
UOC Malattie Infettive, IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
ASST Fatebenefratelli Sacco
🇮🇹Milano, Italy
Azienda Ospedaliero Universitaria di Parma
🇮🇹Parma, Italy
Malattie Infettive I, Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Ospedale Guglielmo da Saliceto AUSL di Piacenza
🇮🇹Piacenza, Italy
UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
🇮🇹Roma, Italy
Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia
🇮🇹Torino, Italy
Yokohama Municipal Citizen's Hospital
🇯🇵Kanagawa, Japan
Nagoya City East Medical Center
🇯🇵Nagoya, Japan
National Medical Center
🇰🇷Seoul, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Tokyo Metropolitan Bokutoh Hospital
🇯🇵Tokyo, Japan
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Amsterdam University Medical Centre - Location AMC
🇳🇱Amsterdam, Netherlands
Singapore General Hospital
🇸🇬Singapore, Singapore
Hospital Principe de Asturias
🇪🇸Alcalá De Henares, Madrid, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Cruces
🇪🇸Bizkaia, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Regional Universitario de Málaga
🇪🇸Málaga, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Sahlgrenska University Hospital, Ostra
🇸🇪Gothenburg, Sweden
SUS (Skanes University Hospital)
🇸🇪Malmo, Sweden
Ospedale Regionale di Locarno La Carità
🇨🇭Lugano, Switzerland
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Universitätsspital Zürich
🇨🇭Zürich, Switzerland
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Imperial College NHS Trust
🇬🇧London, Greater London, United Kingdom
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
NHS Lothian, Royal lnfirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Liverpool University Hospital
🇬🇧Liverpool, United Kingdom
Royal Lancaster Hospital
🇬🇧Lancaster, United Kingdom
Northwick Park Hospital
🇬🇧London, United Kingdom
King's College Hospital NHS Trust
🇬🇧London, United Kingdom
University College London
🇬🇧London, United Kingdom
Manchester University NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Pennine Acute Hospitals NHS Trust
🇬🇧Manchester, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Sheffield Teaching Hospitals
🇬🇧Sheffield, United Kingdom
Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue
🇺🇸San Diego, California, United States
Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd
🇺🇸San Diego, California, United States
Hennepin Healthcare
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Kaiser Permanente Oakland Medical Center, 1200 El Camino Real
🇺🇸San Francisco, California, United States
California Pacific Medical Center-Infectious Disease Associates Medical Group
🇺🇸San Francisco, California, United States
Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd
🇺🇸San Francisco, California, United States
Kaiser Permanente Oakland Medical Center, 2500 Merced St
🇺🇸San Leandro, California, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
CHU Pellegrin
🇫🇷Bordeaux, France
Erasmus Medical Centre
🇳🇱Rotterdam, Netherlands
Hopitaux Universitaires de Genève
🇨🇭Genève 14, Switzerland
National University Hospital
🇸🇬Singapore, Singapore
National Centre for Infectious Diseases, Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Providence St Patrick Hospital and International Heart Institute of MT Foundation
🇺🇸Missoula, Montana, United States
Hackensack Medical Center
🇺🇸Hackensack, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
🇺🇸Hillsborough, New Jersey, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Colorado Denver, University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
SCL Health St. Joseph Hospital, 1375 East 19th Ave
🇺🇸Denver, Colorado, United States
SCL Health St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Kaiser Sunnyside Medical Center
🇺🇸Portland, Oregon, United States
Sutter Medical Center Sacramento
🇺🇸Sacramento, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Kaiser Permanente Hawaii Moanalua Medical Center
🇺🇸Honolulu, Hawaii, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
The University of Michigan Hospitals and Health Systems
🇺🇸Ann Arbor, Michigan, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
James J. Peters Veterans Administration Medical Center
🇺🇸Bronx, New York, United States
VCU Health Medical Center
🇺🇸Richmond, Virginia, United States
St Joseph Medical Center
🇺🇸Tacoma, Washington, United States
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom
Hull University Teaching Hospitals NHS Trust
🇬🇧Hull, United Kingdom
Seoul Medical Center
🇰🇷Seoul, Korea, Republic of
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong