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History of Changes for Study: NCT04292730
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
Latest version (submitted January 21, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 28, 2020 None (earliest Version on record)
2 March 10, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 March 13, 2020 Contacts/Locations and Study Status
4 March 17, 2020 Study Status and Contacts/Locations
5 March 20, 2020 Contacts/Locations and Study Status
6 March 24, 2020 Contacts/Locations and Study Status
7 March 27, 2020 Contacts/Locations and Study Status
8 April 1, 2020 Contacts/Locations and Study Status
9 April 6, 2020 Contacts/Locations, Outcome Measures, Arms and Interventions, Eligibility, Study Status, Study Design and Study Description
10 April 7, 2020 Contacts/Locations and Study Status
11 April 11, 2020 Contacts/Locations and Study Status
12 April 14, 2020 Contacts/Locations and Study Status
13 April 17, 2020 Contacts/Locations and Study Status
14 April 21, 2020 Contacts/Locations and Study Status
15 May 5, 2020 Contacts/Locations and Study Status
16 May 13, 2020 Contacts/Locations, Eligibility and Study Status
17 May 19, 2020 Contacts/Locations and Study Status
18 May 29, 2020 Recruitment Status, Contacts/Locations and Study Status
19 July 23, 2020 Recruitment Status, Study Status, Study Design and Arms and Interventions
20 December 15, 2020
Quality Control Review has not concluded Returned: December 30, 2020
IPDSharing, Outcome Measures, Study Status, Arms and Interventions, Document Section, References, Study Description and Study Identification
21 January 21, 2021 Study Status, Adverse Events
Comparison Format:
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Study NCT04292730
Submitted Date:  March 17, 2020 (v4)
Open or close this module Study Identification
Unique Protocol ID: GS-US-540-5774
Brief Title: 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
Official Title: 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
Secondary IDs: 2020-000842-32 [EudraCT Number]
Open or close this module Study Status
Record Verification: March 2020
Overall Status: Recruiting
Study Start: March 15, 2020
Primary Completion: May 2020 [Anticipated]
Study Completion: May 2020 [Anticipated]
First Submitted: February 28, 2020
First Submitted that
Met QC Criteria:		 February 28, 2020
First Posted: March 3, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:		 March 17, 2020
Last Update Posted: March 19, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Gilead Sciences
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to the time to discharge in participants with moderate coronavirus disease (COVID-19).
Detailed Description:
Open or close this module Conditions
Conditions: COVID-19
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 600 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 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:
  • GS-5734™
Drug: Standard of Care
Standard of care therapy per local written policies or guidelines
Experimental: 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:
  • GS-5734™
Drug: Standard of Care
Standard of care therapy per local written policies or guidelines
Active Comparator: Continued SOC Therapy
Participants will receive continued standard of care therapy.
 Drug: Standard of Care
Standard of care therapy per local written policies or guidelines
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Proportion of Participants Discharged by Day 14
[ Time Frame: First dose date or randomization date up to 14 days ]
Secondary Outcome Measures:
1. Proportion of Participants With Treatment Emergent Adverse Events Leading to Study Drug Discontinuation
[ Time Frame: First dose date up to 10 days ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Key Inclusion Criteria:

  • 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 with fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal
  • 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 with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
  • Requiring mechanical ventilation at screening
  • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
  • Creatinine clearance < 50 mL/min

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Open or close this module Contacts/Locations
Central Contact Person: Gilead Clinical Study Information Center
Telephone: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
Study Officials: Gilead Study Director
Study Director
Gilead Sciences
Locations: United States, California
Hoag Memorial Hospital Presbyterian
[Recruiting]
Newport Beach, California, United States, 92658
Stanford Hospital
[Recruiting]
Stanford, California, United States, 94305
United States, Washington
Providence Medical Research Center
[Recruiting]
Everett, Washington, United States, 98201
Swedish Center for Comprehensive Care
[Recruiting]
Seattle, Washington, United States, 98104
Hong Kong
Prince of Wales Hospital
[Recruiting]
Hong Kong, Hong Kong
Princess Margaret Hospital
[Recruiting]
Hong Kong, Hong Kong
Queen Mary Hospital
[Recruiting]
Hong Kong, Hong Kong
Korea, Republic of
Kyungpook National University Hospital
[Recruiting]
Daegu, Korea, Republic of, 41944
Seoul Medical Center
[Recruiting]
Seoul, Korea, Republic of, 02053
National Medical Center
[Recruiting]
Seoul, Korea, Republic of, 04564
Singapore
National University Hospital
[Recruiting]
Singapore, Singapore, 119228
Singapore General Hospital
[Recruiting]
Singapore, Singapore, 169856
National Centre for Infectious Diseases, Tan Tock Seng Hospital
[Recruiting]
Singapore, Singapore, 308442
Taiwan
National Taiwan University Hospital
[Recruiting]
Taipei City, Taiwan, 10002
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services