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

Phase 3

Completed

• Conditions: COVID-19-Infection

• Registration Number: JPRN-jRCT2080225160
• Lead Sponsor: Gilead Sciences, K.K.

Brief Summary

Remdesivir administered for 5 days to participants with moderate COVID-19 resulted in significantly better odds of improvement in clinical status at Day 11, as assessed by a 7-point ordinal scale compared with those who received only standard of care treatment. - Remdesivir administered for 5 days or 10 days was generally safe and well tolerated with a similar safety profile as standard of care in participants with moderate COVID-19.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-10
• Results First Posted: 2020-08-21
• Study Completion: 2020-11-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 596

Inclusion Criteria

Willing and able to provide written informed consent (participants >= 18 years of age) or assent (participants >= 12 and < 18 years of age) prior to performing study procedures. For participants >= 12 and < 18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures
-Aged >= 18 years (at all sites), or aged >= 12 and < 18 years of age weighing >= 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC))
-SARS-CoV-2 infection confirmed by PCR =< 4 days before randomization
-Currently hospitalized and requiring medical care for COVID-19
-SpO2 > 94% on room air at screening
-Radiographic evidence of pulmonary infiltrates

Exclusion Criteria

-Participation in any other clinical trial of an experimental agent treatment for COVID-19
-Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing
-Requiring mechanical ventilation at screening
-ALT or AST > 5 X 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified