Phase 3
N=4,838
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04292899 ↗Enrolled (actual)
4,838
Serious AEs
27.4%
Results posted
Dec 2020
Primary outcome: 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 percentage of participants — p=0.1563
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Remdesivir (Drug); Standard of Care (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Apr 2020
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 |
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.
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). 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.