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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
Recruiting
Trial ID: NCT04292730
Purpose
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 on Day 11.
Official Title
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
Stanford Investigator(s)
Aruna Subramanian
Clinical Professor, Medicine - Infectious Diseases
Eligibility
Key Inclusion Criteria:
- 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 Criteria:
- 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.
Intervention(s):
drug: Remdesivir
drug: Standard of Care
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305