Overview

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

Status:
Completed
Trial end date:
2020-06-26
Target enrollment:
0
Participant gender:
All
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 on Day 11.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Antiviral Agents
Remdesivir
Criteria
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.