Phase 3
Completed N=1,113
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
Source: ClinicalTrials.gov NCT04292730 ↗Enrolled (actual)
1,113
Serious AEs
7.1%
Results posted
Jan 2021
Primary outcomePrimary: Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 — 0.0; 1.0; 2.0; 0.0 percentage of participants — p=0.0174
◆ Published Evidence
Highly cited
1,276citations · ~213 / year
Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial.
Summary
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.
Linked Publications (3)
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Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial.
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Remdesivir for the treatment of COVID-19.
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Remdesivir for the treatment of COVID-19.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 |
0.0; 1.0; 2.0; 0.0; 0.5; 2.0 | 0.0174 sig |
| SECONDARY Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) |
51.3; 58.5; 46.5 | 0.3633 |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT04292730) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.