Trials / Terminated
TerminatedNCT04745351
Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 249 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Remdesivir | Administered as Intravenous (IV) infusion once daily |
| DRUG | RDV Placebo | Administered as IV saline once daily |
| DRUG | Standard of Care | Standard of Care Treatment for COVID-19 Infection |
Timeline
- Start date
- 2021-03-31
- Primary completion
- 2022-04-20
- Completion
- 2022-05-24
- First posted
- 2021-02-09
- Last updated
- 2023-05-12
- Results posted
- 2023-05-12
Locations
63 sites across 6 countries: United States, Brazil, Portugal, South Africa, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04745351. Inclusion in this directory is not an endorsement.