Status:
COMPLETED
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
Lead Sponsor:
Gilead Sciences
Conditions:
COVID-19
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.
Eligibility Criteria
Inclusion
- Key
- 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
- 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 \[including veno-venous (V-V) extracorporeal membrane oxygenation (ECMO)\] ≥ 5 days, or any duration of veno-arterial (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.
Key Trial Info
Start Date :
March 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
4891 Patients enrolled
Trial Details
Trial ID
NCT04292899
Start Date
March 6 2020
End Date
June 30 2020
Last Update
December 31 2020
Active Locations (183)
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1
Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue
Anaheim, California, United States, 92806
2
Alta Bates Summit Medical Center
Berkeley, California, United States, 94609
3
Mills-Peninsula Medical Center
Burlingame, California, United States, 94010
4
Eden Medical Center
Castro Valley, California, United States, 94546