Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
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-New Haven Hospital
- Kaiser Permanente Hawaii Moanalua Medical Center
- John H. Stroger Jr. Hospital of Cook County
- 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
- 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 University 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 Medical Center-New York Presbyterian Hospital
- New York Presbyterian Hospital/Weill Cornell Medical Center
- 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 Medical Campus
- VCU Health Medical Center
- Providence Regional Medical Center Everett
- 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
- Dipartimento di Malattie Infettive, Malattie Infettive I- Malattie Infettive III, AssT Fatebenefratelli Sacco Ospedale Luigi Sacco
- UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- UOC Medicina Di Laboratorio, Azienda Ospedaliera di Padova
- Azienda Ospedaliero Universitaria di Parma
- UOC Malattie Infettive I, Fondazione IRCCS Policlinio 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 Universitari 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
- 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 Healthcare NHS Trust
- Royal Infirmary 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
Experimental
Experimental
Experimental
Experimental
Part A: Remdesivir (RDV), 5 Days
Part A: Remdesivir, 10 Days
Part B: Remdesivir, 10 Days (Extension)
Part B: Remdesivir 10 days (Mechanically Ventilated)
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.
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) 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.
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