A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants with Severe COVID-19
- Conditions
- COVID-19-Infection
- Registration Number
- JPRN-jRCT2080225161
- Lead Sponsor
- Gilead Sciences, K.K.
- Brief Summary
Remdesivir administered for 5 days or 10 days to participants with severe COVID-19 resulted in similar improvements in clinical status at Day 14, as assessed by a 7-point ordinal scale, after adjustment for imbalances in baseline clinical status. - Patients on invasive mechanical ventilation may benefit from a treatment duration longer than 5 days. - Remdesivir administered for 5 days or 10 days was generally safe and well tolerated in participants with severe COVID-19.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 401
Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under ICH E6(R2)4.8.15 emergency use provisions as deemed necessary by the investigator (participants >= 18 years of age), or willing and able to provide assent (participants >= 12 and < 18 years of age, where locally and nationally approved) 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 >= 40kg (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 test =< 4 days before randomization
-Currently hospitalized
-SpO2 =< 94% on room air or requiring supplemental oxygen at screening
-Radiographic evidence of pulmonary infiltrates
-Participation in any other clinical trial of an experimental 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
-Evidence of multiorgan failure
-Mechanically ventilated(including V-V ECMO) >= 5 days,or any duration of V-A ECMO
-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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method