Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
- Registration Number
- NCT04292899
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4891
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥ 18), or willing and able to provide assent (age ≥ 12 to < 18, where locally and nationally approved) prior to performing study procedures
- 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))
- Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
- Currently hospitalized
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening
Key
- Participation in any other clinical trial of an experimental treatment for COVID-19
- Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
- Evidence of multiorgan failure
- Mechanically ventilated [including veno-venous (V-V) extracorporeal membrane oxygenation (ECMO)] ≥ 5 days, or any duration of veno-arterial (V-A) ECMO.
- 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, 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 B: Remdesivir 10 days (Mechanically Ventilated) Standard of Care Participants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10 Part A: Remdesivir (RDV), 5 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, and 5. Part B: Remdesivir, 10 Days (Extension) Standard of Care Part B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10. Part A: Remdesivir (RDV), 5 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, 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: Remdesivir, 10 Days (Extension) Remdesivir Part B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10. Part B: Remdesivir 10 days (Mechanically Ventilated) Remdesivir Participants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10
- 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 14 Day 14 Clinical status was derived from death, hospital discharge, and the 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 assessment carried forward for any missing values.The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or 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 (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 the Remdesivir for 10 days group vs the Remdesivir for 5 days 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 Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study treatment start date and no later than 30 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatment.
Trial Locations
- Locations (182)
UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.
🇺🇸Dallas, Texas, United States
Prisma Health Richland Hospital
🇺🇸Columbia, South Carolina, United States
Alta Bates Summit Medical Center
🇺🇸Berkeley, California, United States
Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue
🇺🇸Los Angeles, California, United States
Hospital of the University of Pennsylvania, 51 N. 31st Street
🇺🇸Philadelphia, Pennsylvania, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
El Camino Hospital
🇺🇸Mountain View, California, United States
UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd
🇺🇸Dallas, Texas, United States
John H. Stroger Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
IU Health Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd
🇺🇸San Diego, California, United States
Kaiser Permanente Oakland Medical Center, 2500 Merced St
🇺🇸San Leandro, California, United States
Hennepin Healthcare
🇺🇸Minneapolis, Minnesota, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Providence St Patrick Hospital and International Heart Institute of MT Foundation
🇺🇸Missoula, Montana, United States
Erasmus Medical Centre
🇳🇱Rotterdam, Netherlands
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Amsterdam University Medical Centre - Location AMC
🇳🇱Amsterdam, Netherlands
National Centre for Infectious Diseases, Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Universitätsspital Zürich
🇨🇭Zürich, Switzerland
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
St. Joseph's University Medical Center
🇺🇸Paterson, New Jersey, United States
Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave
🇺🇸Hillsboro, Oregon, United States
Hopitaux Universitaires de Genève
🇨🇭Genève 14, Switzerland
Ospedale Regionale di Locarno La Carità
🇨🇭Lugano, Switzerland
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
UOC Malattie Infettive, IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
UOC Medicina Di Laboratorio, Azienda Ospedaliera di Padova
🇮🇹Padova PD, Italy
Azienda Ospedaliero Universitaria di Parma
🇮🇹Parma, Italy
UOC Malattie Infettive I, Fondazione IRCCS Policlinio San Matteo
🇮🇹Pavia, Italy
Ospedale Guglielmo da Saliceto AUSL di Piacenza
🇮🇹Piacenza, Italy
Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia
🇮🇹Torino, Italy
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave
🇺🇸Fontana, California, United States
Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue
🇺🇸Anaheim, California, United States
Kaiser Permanente Los Angeles Medical Center, 27300 Iris Avenue
🇺🇸Moreno Valley, California, United States
Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.
🇺🇸Los Angeles, California, United States
Providence St. Johns Medical Center
🇺🇸Santa Monica, 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
Brigham & Women's Hospital and Harvard Medical School
🇺🇸Boston, Massachusetts, United States
SCL Health St. Joseph Hospital, 200 Exempla Circle.
🇺🇸Lafayette, Colorado, United States
University of Chicago
🇺🇸Chicago, Illinois, 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
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Stanford Hospital
🇺🇸Stanford, California, United States
Robert Wood Johnson University Hospital Somerset
🇺🇸Hillsborough, New Jersey, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Robert Wood Johnson University Hospital Somerset, 1 RWJ Place
🇺🇸New Brunswick, New Jersey, United States
North Shore University Hospital, 270-05 76th Ave
🇺🇸New Hyde Park, New York, United States
Darmouth-Hitchhock Medical Center
🇺🇸Lebanon, New Hampshire, United States
The University of Michigan Hospitals and Health Systems
🇺🇸Ann Arbor, Michigan, United States
Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue
🇺🇸Newark, New Jersey, United States
Icahn School of Medicine at Mount Sinai, 1000 10th Avenue
🇺🇸New York, New York, United States
Baylor University Medical Center, 2401 S. 31st St.
🇺🇸Temple, Texas, United States
MultiCare Deaconess Hospital
🇺🇸Spokane, Washington, United States
Icahn School of Medicine at Mount Sinai, 440 West 114th St.
🇺🇸New York, New York, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
The Liver Institute of Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie
🇩🇪Berlin, Germany
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States
Baylor University Medical Center, 1400 8th Ave
🇺🇸Fort Worth, Texas, United States
Prisma Health Richland Hospital, 701 Grove Road
🇺🇸Greenville, South Carolina, United States
UT Southwestern Medical Center Amelia Court, HIV Research Clinic
🇺🇸Dallas, Texas, United States
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Tokyo Metropolitan Bokutoh Hospital
🇯🇵Tokyo, Japan
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
🇮🇹Roma, Italy
CHU de Montpellier-Hopital Gui de Chauliac
🇫🇷Montpelier Cedex 5, France
Hospital Universitario Cruces
🇪🇸Bizkaia, Spain
Hospital Principe de Asturias
🇪🇸Alcalá De Henares, Madrid, Spain
MultiCare Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Inova Fairfax Medical Campus
🇺🇸Falls Church, Virginia, United States
Kadlec Regional Medical Center
🇺🇸Kennewick, Washington, United States
Swedish Center for Comprehensive Care
🇺🇸Seattle, Washington, United States
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
CHU Pellegrin
🇫🇷Bordeaux, France
Providence St. Peter Hospital
🇺🇸Olympia, Washington, United States
ASST di Cremona - Azienda Socio Sanitaria Territor
🇮🇹Cremona, Italy
Hopital Saint Antoine
🇫🇷Paris, France
ASST degli Spedali Civili di Brescia
🇮🇹Brescia, Italy
Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2
🇩🇪Munich, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
🇩🇪Kiel, Germany
UOC Malattie Infettive, ASST Papa Giovanni XXIII
🇮🇹Bergamo, Italy
China Medical University Hospital
🇨🇳Taichung, Taiwan
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
National Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Nagoya City East Medical Center
🇯🇵Nagoya, Japan
Singapore General Hospital
🇸🇬Singapore, Singapore
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Yokohama Municipal Citizen's Hospital
🇯🇵Kanagawa, Japan
National University Hospital
🇸🇬Singapore, Singapore
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Liverpool University Hospital
🇬🇧Liverpool, United Kingdom
University College London
🇬🇧London, United Kingdom
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Pennine Acute Hospitals NHS Trust
🇬🇧Manchester, United Kingdom
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Northwick Park Hospital
🇬🇧London, United Kingdom
Hospital Regional Universitario de Málaga
🇪🇸Málaga, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
King's College Hospital NHS Trust
🇬🇧London, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Royal Lancaster Hospital
🇬🇧Lancaster, United Kingdom
Sheffield Teaching Hospitals
🇬🇧Sheffield, United Kingdom
CHU de Nantes-Hotel Dieu
🇫🇷Nantes, France
Hopital Saint-Louis
🇫🇷Paris, France
Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie
🇩🇪Düsseldorf, Germany
Universitatsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie
🇩🇪Leipzig, Germany
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
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Rose Medical Center
🇺🇸Denver, Colorado, 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
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Mills-Peninsula Medical Center
🇺🇸Burlingame, California, United States
Mission Hospital Regional Medical Center
🇺🇸Mission Viejo, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
🇺🇸Orange, California, United States
Kaiser Permanente Oakland Medical Center
🇺🇸Oakland, California, United States
Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue
🇺🇸Riverside, California, United States
Sutter Medical Center Sacramento
🇺🇸Sacramento, California, United States
Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue
🇺🇸San Diego, California, United States
Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd
🇺🇸San Francisco, California, United States
Sutter Santa Rosa Regional Hospital
🇺🇸Santa Rosa, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
VCU Health Medical Center
🇺🇸Richmond, Virginia, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
James J. Peters Veterans Administration Medical Center
🇺🇸Bronx, New York, United States
Icahn School of Medicine at Mount Sinai, 350 East 17th Street
🇺🇸New York, New York, United States
Columbia University Medical Center-New York Presbyterian Hospital
🇺🇸New York, New York, United States
New York Presbyterian Hospital/Weill Cornell Medical Center
🇺🇸New York, New York, United States
St Joseph Hospital Eureka
🇺🇸Fortuna, California, United States
Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.
🇺🇸Harbor City, California, United States
Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway
🇺🇸Downey, California, United States
Kaiser Permanente Los Angeles Medical Center, 13651 Willard Street
🇺🇸Panorama City, California, United States
Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue
🇺🇸Ontario, California, United States
Holy Cross Hospital
🇺🇸Silver Spring, Maryland, United States
Danbury Hospital
🇺🇸Lagrangeville, New York, United States
Jamaica Hospital Medical Center
🇺🇸Jamaica, New York, United States
Providence Regional Medical Center Everett
🇺🇸Everett, Washington, United States
St Joseph Medical Center
🇺🇸Tacoma, Washington, United States
Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP)
🇩🇪Stuttgart, Germany
Dipartimento di Malattie Infettive, Malattie Infettive I- Malattie Infettive III, AssT Fatebenefratelli Sacco Ospedale Luigi Sacco
🇮🇹Milano, Italy
Klinik für Hämatologie, Onkologie, Immunologie
🇩🇪München, Germany
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
SUS (Skanes University Hospital)
🇸🇪Malmo, Sweden
Sahlgrenska University Hospital, Ostra
🇸🇪Gothenburg, Sweden
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Imperial College Healthcare NHS Trust
🇬🇧London, Greater London, United Kingdom
Kaiser Permanente Hawaii Moanalua Medical Center
🇺🇸Honolulu, Hawaii, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway
🇺🇸Santa Clara, California, United States
Virginia Hospital Center
🇺🇸Arlington, Virginia, United States
Manchester University NHS Foundation Trust
🇬🇧Manchester, United Kingdom
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
Princess Margaret Hospital
🇭🇰Hong Kong, Hong Kong
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong