Phase 3
Completed N=4,838
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
Source: ClinicalTrials.gov NCT04292899 ↗Enrolled (actual)
4,838
Serious AEs
27.4%
Results posted
Dec 2020
Primary outcomePrimary: Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 — 8.0; 10.7; 8.5; 16.8 percentage of participants — p=0.1563
◆ Published Evidence
Highly cited
1,437citations · ~240 / year
Remdesivir for 5 or 10 Days in Patients with Severe Covid-19.
Summary
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.
Linked Publications (4)
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Remdesivir for 5 or 10 Days in Patients with Severe Covid-19.
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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.
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Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care.
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Remdesivir for Treatment of COVID-19 Requiring Oxygen Support: A Cross-Study Comparison From 2 Large, Open-Label Studies.
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 14 |
8.0; 10.7; 8.5; 16.8; 4.0; 5.1 | 0.1563 |
| SECONDARY Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) |
71.5; 75.1 | 0.7678 |
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 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 (NCT04292899) 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.