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

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: Remdesivir (RDV), 5 Days 		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.
  • Drug: Remdesivir
    Administered as an intravenous infusion
    Other names:
    • GS-5734™
    • Veklury®
  • Drug: Standard of Care
    Standard of Care Treatment for COVID-19 Infection
Experimental
Part A: Remdesivir, 10 Days 		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.
  • Drug: Remdesivir
    Administered as an intravenous infusion
    Other names:
    • GS-5734™
    • Veklury®
  • Drug: Standard of Care
    Standard of Care Treatment for COVID-19 Infection
Active Comparator
Part A: SOC Therapy 		Participants will receive continued standard of care therapy.
  • Drug: Standard of Care
    Standard of Care Treatment for COVID-19 Infection
Experimental
Part B: Extension Treatment, Remdesivir 10 Days 		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.
  • Drug: Remdesivir
    Administered as an intravenous infusion
    Other names:
    • GS-5734™
    • Veklury®
  • Drug: Standard of Care
    Standard of Care Treatment for COVID-19 Infection

More Details

Status
Completed
Sponsor
Gilead Sciences

Study Contact