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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,113 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Remdesivir	Administered as an intravenous infusion
DRUG	Standard of Care	Standard of Care Treatment for COVID-19 Infection

Timeline

• Start date: 2020-03-15
• Primary completion: 2020-04-29
• Completion: 2020-06-26
• First posted: 2020-03-03
• Last updated: 2021-01-26
• Results posted: 2021-01-26

Locations

184 sites across 15 countries: United States, China, France, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study