Status:
COMPLETED
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
Lead Sponsor:
Gilead Sciences
Conditions:
COVID-19
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- Willing and able to provide written informed consent prior to performing study procedures (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
- Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
- Currently hospitalized and requiring medical care for COVID-19
- Peripheral capillary oxygen saturation (SpO2) \> 94% on room air at screening
- Radiographic evidence of pulmonary infiltrates
- Key
Exclusion
- Participation in any other clinical trial of an experimental treatment for COVID-19
- Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2
- Requiring mechanical ventilation at screening
- 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 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2020
Estimated Enrollment :
1113 Patients enrolled
Trial Details
Trial ID
NCT04292730
Start Date
March 15 2020
End Date
June 26 2020
Last Update
January 26 2021
Active Locations (184)
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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