Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe COVID-19

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Remdesivir; Drug: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 4891
• Phase: Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • The First Affiliated Hospital of Guangzhou Medical University
• France
  • Bordeaux, France, 33076
    • CHU Pellegrin
  • Montpelier Cedex 5, France, 34295
    • CHU de Montpellier-Hopital Gui de Chauliac
  • Nantes, France, 44035
    • CHU de Nantes-Hotel Dieu
  • Paris, France, 75012
    • Hôpital Saint Antoine
  • Paris, France, 75010
    • Hopital Saint-Louis
• Germany
  • Berlin, Germany, 13353
    • Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie
  • Düsseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie
  • Hamburg, Germany, 20246
    • Universitatsklinikum Hamburg-Eppendorf
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein Campus Kiel
  • Leipzig, Germany, 4129
    • Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie
  • Munich, Germany, 81675
    • Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2
  • München, Germany, 80804
    • Klinik für Hämatologie, Onkologie, Immunologie
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP)
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
  • Hong Kong, Hong Kong
    • Princess Margaret Hospital
• Italy
  • Bergamo, Italy, 24127
    • UOC Malattie Infettive, ASST Papa Giovanni XXIII
  • Brescia, Italy, 25123
    • Asst Degli Spedali Civili Di Brescia
  • Cremona, Italy, 26100
    • ASST di Cremona - Azienda Socio Sanitaria Territor
  • Milan, Italy, 20122
    • UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Milano, Italy, 20127
    • UOC Malattie Infettive, IRCCS Ospedale San Raffaele
  • Milano, Italy, 20157
    • Dipartimento di Malattie Infettive, Malattie Infettive I- Malattie Infettive III, AssT Fatebenefratelli Sacco Ospedale Luigi Sacco
  • Padova PD, Italy, 35121
    • UOC Medicina Di Laboratorio, Azienda Ospedaliera di Padova
  • Parma, Italy, 43126
    • Azienda Ospedaliero Universitaria di Parma
  • Pavia, Italy, 27100
    • UOC Malattie Infettive I, Fondazione IRCCS Policlinio San Matteo
  • Piacenza, Italy
    • Ospedale Guglielmo da Saliceto AUSL di Piacenza
  • Roma, Italy, 00149
    • UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
  • Torino, Italy, 10149
    • Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia
• Japan
  • Kanagawa, Japan, 240-8555
    • Yokohama Municipal Citizen's Hospital
  • Nagoya, Japan, 464-8547
    • Nagoya City East Medical Center
  • Tokyo, Japan, 130-8575
    • Tokyo Metropolitan Bokutoh Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Seoul, Korea, Republic of, 02053
    • Seoul Medical Center
  • Seoul, Korea, Republic of, 04564
    • National medical center
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam University Medical Centre - Location AMC
  • Leiden, Netherlands, 2300 RC
    • Leiden University Medical Center
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus Medical Centre
• Singapore
  • Singapore, Singapore, 119228
    • National University Hospital
  • Singapore, Singapore, 169856
    • Singapore General Hospital
  • Singapore, Singapore, 308442
    • National Centre for Infectious Diseases, Tan Tock Seng Hospital
• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 8036
    • Hospital Clínic de Barcelona
  • Barcelona, Spain, 08907
    • Hospital Universitari de Bellvitge
  • Bizkaia, Spain, 48903
    • Hospital Universitario Cruces
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Díaz
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28805
      • Hospital Príncipe de Asturias
• Sweden
  • Gothenburg, Sweden, 41685
    • Sahlgrenska University hospital, Östra
  • Malmo, Sweden, 20502
    • SUS (Skanes University Hospital)
  • Stockholm, Sweden, SE-141 86
    • Karolinska University Hospital
• Switzerland
  • Genève 14, Switzerland, 1211
    • Hôpitaux Universitaires de Genève
  • Lugano, Switzerland, CH- 6900
    • Ospedale Regionale di Locarno La Carità
  • Zürich, Switzerland, 8091
    • UniversitätsSpital Zürich
• Taiwan
  • Kaohsiung, Taiwan, 81362
    • Kaohsiung Veterans General Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taipei City, Taiwan, 10002
    • National Taiwan University Hospital
• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • Royal Infirmary of Edinburgh
  • Glasgow, United Kingdom, G51 4TF
    • Queen Elizabeth University Hospital
  • Hull, United Kingdom, HU16 5JQ
    • Hull University Teaching Hospitals NHS Trust
  • Lancaster, United Kingdom, LA1 4RP
    • Royal Lancaster Hospital
  • Liverpool, United Kingdom, L7 8XP
    • Liverpool University Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free London NHS Foundation Trust
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Trust
  • London, United Kingdom, HA1 3UJ
    • Northwick Park Hospital
  • London, United Kingdom, WC1E 6JF
    • University College London
  • Manchester, United Kingdom, M13 9WL
    • Manchester University NHS Foundation Trust
  • Manchester, United Kingdom, M23 9LT
    • Manchester University NHS Foundation Trust
  • Manchester, United Kingdom, M8 5RB
    • Pennine Acute Hospitals NHS Trust
  • Plymouth, United Kingdom, PL6 8BG
    • Derriford Hospital
  • Sheffield, United Kingdom, S10 2JF
    • Sheffield Teaching Hospitals
  • Greater London
    • London, Greater London, United Kingdom, W2 1NY
      • Imperial College Healthcare NHS Trust
• United States
  • California
    • Anaheim, California, United States, 92806
      • Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue
    • Berkeley, California, United States, 94609
      • Alta Bates Summit Medical Center
    • Burlingame, California, United States, 94010
      • Mills-Peninsula Medical Center
    • Castro Valley, California, United States, 94546
      • Eden Medical Center
    • Downey, California, United States, 90241
      • Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway
    • Fontana, California, United States, 92335
      • Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave
    • Fortuna, California, United States, 95540
      • St Joseph Hospital Eureka
    • Harbor City, California, United States, 90710
      • Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Los Angeles, California, United States, 90034
      • Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.
    • Los Angeles, California, United States, 91365
      • Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue
    • Mission Viejo, California, United States, 92691
      • Mission Hospital Regional Medical Center
    • Moreno Valley, California, United States, 92555
      • Kaiser Permanente Los Angeles Medical Center, 27300 Iris Avenue
    • Mountain View, California, United States, 94040
      • El Camino Hospital
    • Newport Beach, California, United States, 92658
      • Hoag Memorial Hospital Presbyterian
    • Oakland, California, United States, 94611
      • Kaiser Permanente Oakland Medical Center
    • Ontario, California, United States, 91761
      • Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue
    • Orange, California, United States, 92868
      • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
    • Panorama City, California, United States, 91402
      • Kaiser Permanente Los Angeles Medical Center, 13651 Willard Street
    • Riverside, California, United States, 92505
      • Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue
    • Roseville, California, United States, 95661
      • Sutter Medical Center Sacramento, One Medical Plaza
    • Sacramento, California, United States, 95815
      • Sutter Medical Center Sacramento
    • San Diego, California, United States, 92120-2507
      • Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue
    • San Diego, California, United States, 92123
      • Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd
    • San Francisco, California, United States, 94080
      • Kaiser Permanente Oakland Medical Center, 1200 El Camino Real
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center-Infectious Disease Associates Medical Group
    • San Francisco, California, United States, 94115
      • Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd
    • San Jose, California, United States, 95119
      • Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850
    • San Leandro, California, United States, 94577
      • Kaiser Permanente Oakland Medical Center, 2500 Merced St
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway
    • Santa Monica, California, United States, 90404
      • Providence St. Johns Medical Center
    • Santa Rosa, California, United States, 95403
      • Sutter Santa Rosa Regional Hospital
    • Stanford, California, United States, 94305
      • Stanford Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver, University of Colorado Hospital
    • Denver, Colorado, United States, 80220
      • Rose Medical Center
    • Denver, Colorado, United States, 80208
      • SCL Health St. Joseph Hospital, 1375 East 19th Ave
    • Denver, Colorado, United States, 80218
      • SCL Health St. Joseph Hospital
    • Lafayette, Colorado, United States, 80026
      • SCL Health St. Joseph Hospital, 200 Exempla Circle.
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Permanente Hawaii Moanalua Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60612
      • John H. Stroger Jr. Hospital of Cook County
  • Indiana
    • Indianapolis, Indiana, United States, 46077
      • IU Health Methodist Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals & Clinics
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Silver Spring, Maryland, United States, 20910
      • Holy Cross Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital and Harvard Medical School
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5378
      • The University of Michigan Hospitals and Health Systems
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin Healthcare
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Montana
    • Missoula, Montana, United States, 59802
      • Providence St Patrick Hospital and International Heart Institute of MT Foundation
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Darmouth-Hitchhock Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Hillsborough, New Jersey, United States, 08844
      • Robert Wood Johnson University Hospital Somerset
    • New Brunswick, New Jersey, United States, 08901
      • Robert Wood Johnson University Hospital Somerset, 1 RWJ Place
    • Newark, New Jersey, United States, 07112
      • Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue
    • Paterson, New Jersey, United States, 07503
      • St. Joseph's University Medical Center
  • New York
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center
    • Bronx, New York, United States, 10468
      • James J. Peters Veterans Administration Medical Center
    • Jamaica, New York, United States, 11418
      • Jamaica Hospital Medical Center
    • Lagrangeville, New York, United States, 12540
      • Danbury Hospital
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New Hyde Park, New York, United States, 11040
      • North Shore University Hospital, 270-05 76th Ave
    • New York, New York, United States, 10029
      • ICAHN School of Medicine at Mount Sinai
    • New York, New York, United States, 10032
      • Columbia University Medical Center-New York Presbyterian Hospital
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital/Weill Cornell Medical Center
    • New York, New York, United States, 10003
      • Icahn School of Medicine at Mount Sinai, 350 East 17th Street
    • New York, New York, United States, 10019
      • Icahn School of Medicine at Mount Sinai, 1000 10th Avenue
    • New York, New York, United States, 10025
      • Icahn School of Medicine at Mount Sinai, 440 West 114th St.
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Oregon
    • Hillsboro, Oregon, United States, 97124
      • Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
    • Portland, Oregon, United States, 97227
      • Kaiser Sunnyside Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania, 51 N. 31st Street
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Prisma Health Richland Hospital
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Richland Hospital, 701 Grove Road
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Dallas, Texas, United States, 75203
      • The Liver Institute of Methodist Dallas Medical Center
    • Dallas, Texas, United States, 75235
      • UT Southwestern Medical Center Amelia Court, HIV Research Clinic
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd
    • Fort Worth, Texas, United States, 76104
      • Baylor University Medical Center, 1400 8th Ave
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Temple, Texas, United States, 76508
      • Baylor University Medical Center, 2401 S. 31st St.
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Virginia Hospital Center
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Medical Campus
    • Richmond, Virginia, United States, 23298
      • VCU Health Medical Center
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center Everett
    • Kennewick, Washington, United States, 99336
      • Kadlec Regional Medical Center
    • Olympia, Washington, United States, 98506
      • Providence St. Peter Hospital
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98104
      • Swedish Center for Comprehensive Care
    • Spokane, Washington, United States, 99204
      • MultiCare Deaconess Hospital
    • Tacoma, Washington, United States, 98405
      • MultiCare Tacoma General Hospital
    • Tacoma, Washington, United States, 98405
      • St Joseph Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Remdesivir, 10 Days; 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.	Drug: Remdesivir; Administered as an intravenous infusion; Other Names: Veklury®; GS-5734™; Drug: Standard of Care; Standard of Care Treatment for COVID-19 Infection
Experimental: Part A: Remdesivir (RDV), 5 Days; 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.	Drug: Remdesivir; Administered as an intravenous infusion; Other Names: Veklury®; GS-5734™; Drug: Standard of Care; Standard of Care Treatment for COVID-19 Infection
Experimental: Part B: Remdesivir, 10 Days (Extension); 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.	Drug: Remdesivir; Administered as an intravenous infusion; Other Names: Veklury®; GS-5734™; Drug: Standard of Care; Standard of Care Treatment for COVID-19 Infection
Experimental: Part B: Remdesivir 10 days (Mechanically Ventilated); 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	Drug: Remdesivir; Administered as an intravenous infusion; Other Names: Veklury®; GS-5734™; Drug: Standard of Care; Standard of Care Treatment for COVID-19 Infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on 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.	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)	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.	First dose date up to last dose date (maximum: 10 days) plus 30 days

Collaborators and Investigators

• Sponsor: Gilead Sciences

Publications and helpful links

General Publications

• Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.
• Goldman JD, Lye DCB, Hui DS, Marks KM, Bruno R, Montejano R, Spinner CD, Galli M, Ahn MY, Nahass RG, Chen YS, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wei X, Gaggar A, Brainard DM, Towner WJ, Munoz J, Mullane KM, Marty FM, Tashima KT, Diaz G, Subramanian A; GS-US-540-5773 Investigators. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. N Engl J Med. 2020 Nov 5;383(19):1827-1837. doi: 10.1056/NEJMoa2015301. Epub 2020 May 27.
• Olender SA, Perez KK, Go AS, Balani B, Price-Haywood EG, Shah NS, Wang S, Walunas TL, Swaminathan S, Slim J, Chin B, De Wit S, Ali SM, Soriano Viladomiu A, Robinson P, Gottlieb RL, Tsang TYO, Lee IH, Hu H, Haubrich RH, Chokkalingam AP, Lin L, Zhong L, Bekele BN, Mera-Giler R, Phulpin C, Edgar H, Gallant J, Diaz-Cuervo H, Smith LE, Osinusi AO, Brainard DM, Bernardino JI; GS-US-540-5773 and GS-US-540-5807 Investigators. Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care. Clin Infect Dis. 2021 Dec 6;73(11):e4166-e4174. doi: 10.1093/cid/ciaa1041.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2020
• Primary Completion (Actual): April 9, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Remdesivir
• Other Study ID Numbers: GS-US-540-5773; 2020-000841-15 (EudraCT Number); ISRCTN15874265 (Other Identifier: ISRCTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No