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

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: COVID-19

Treatments: Drug: Remdesivir; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04292730

GS-US-540-5774

2020-000842-32 (EudraCT Number)

ISRCTN85762140 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,113 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,113 participants in 4 patient groups

Part A: Remdesivir (RDV), 5 Days

Experimental group

Description:

Participants will receive continued standard of care (SOC) therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.

Treatment:

Drug: Standard of Care

Drug: Remdesivir

Part A: Remdesivir, 10 Days

Experimental group

Description:

Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Treatment:

Drug: Standard of Care

Drug: Remdesivir

Part A: SOC Therapy

Active Comparator group

Description:

Participants will receive continued standard of care therapy.

Treatment:

Drug: Standard of Care

Part B: Extension Treatment, Remdesivir 10 Days

Experimental group

Description:

Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Treatment:

Drug: Standard of Care

Drug: Remdesivir