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

January 21, 2021 updated by: Gilead Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1113

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Hopital 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
        • Universitätsklinikum 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, 20157
        • Asst Fatebenefratelli Sacco
      • Milano, Italy, 20127
        • UOC Malattie Infettive, IRCCS Ospedale San Raffaele
      • Padova PD, Italy, 35121
        • UOC Malattie Infettive e Tropicali, Azienda Ospedaliera di Padova
      • Parma, Italy, 43126
        • Azienda Ospedaliero Universitaria di Parma
      • Pavia, Italy, 27100
        • Malattie Infettive I, Fondazione IRCCS Policlinico 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 Universitario Vall d'Hebron
      • Barcelona, Spain, 8036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Bizkaia, Spain, 48903
        • Hospital Universitario Cruces
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28041
        • Hospital Universitario 12 De Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Málaga
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Valencia, Spain, 46026
        • Hospital Universitari i Politècnic La Fe
    • Madrid
      • Alcalá De Henares, Madrid, Spain, 28805
        • Hospital Principe 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
        • Hopitaux Universitaires de Geneve
      • 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
        • NHS Lothian, Royal lnfirmary 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 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 University
    • 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
        • Cook County General Hospital
    • 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, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02215
        • Center for Virology and Vaccine Research, Beth Israel Deaconess 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 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 Irving 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.
      • New York, New York, United States, 10065
        • Weill Cornell Medical College/NYU Presbyterian Hospital
    • 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 Hospital
      • Richmond, Virginia, United States, 23298
        • VCU Health Medical Center
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Medical Research Center
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: Remdesivir (RDV), 5 Days
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.
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, 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
Active Comparator: Part A: SOC Therapy
Participants will receive continued standard of care therapy.
Drug: Standard of Care
Standard of Care Treatment for COVID-19 Infection
Experimental: Part B: Extension Treatment, 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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 11
Time Frame: 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.
Day 11

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Time Frame: 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.
First dose date up to last dose date (maximum: 10 days) plus 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-540-5774
  • 2020-000842-32 (EudraCT Number)
  • ISRCTN85762140 (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
  • Statistical Analysis Plan (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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