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

Not 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
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

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305