Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: March 06, 2020
End Date: May 01, 2020
Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
1-833-445-3230 (GILEAD-0)
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 <18, where locally and nationally approved) 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])
- Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
- Currently hospitalized
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening Key
Exclusion Criteria:
- 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 is prohibited < 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.
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 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.