Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)

Purpose

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.

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, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥ 18), or willing and able to provide assent (age ≥ 12 to < 18, where locally and nationally approved) prior to performing study procedures - Aged ≥ 18 years (at all sites), or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC)) - Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization - Currently hospitalized - Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening

Exclusion Criteria

  • Participation in any other clinical trial of an experimental treatment for COVID-19 - Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing - Evidence of multiorgan failure - Mechanically ventilated [including veno-venous (V-V) extracorporeal membrane oxygenation (ECMO)] ≥ 5 days, or any duration of veno-arterial (V-A) ECMO. - 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 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
Experimental
Part B: Remdesivir, 10 Days (Extension) 		Part B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10.
  • Drug: Remdesivir
    Administered as an intravenous infusion
    Other names:
    • GS-5734™
    • Veklury®
  • Drug: Standard of Care
    Standard of Care Treatment for COVID-19 Infection
Experimental
Part B: Remdesivir 10 days (Mechanically Ventilated) 		Participants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10
  • 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