Status Acronym ISRCTN EudraCT NCT (clinicaltrials.gov) DRKS
Active GS-US-540-5774 2020-000842-32 NCT04292730

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

Purpose / Objectives

Primary Outcome

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

 

Secondary Outcomes

To evaluate the safety and tolerability of RDV compared to SOC

 

Diagnosis

  • COVID-19 infection

Target population

Inclusion criteria

  1. Willing and able to provide written informed consent (participants ≥18 years of age) or assent (participants ≥ 12 and < 18 years of age, where locally and nationally approved) 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
  2. 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 IRB/IEC)
  3. SARS-CoV-2 infection confirmed by PCR ≤ 4 days before randomization
  4. Currently hospitalized and requiring medical care for COVID-19
  5. SpO2 > 94% on room air at screening
  6. Radiographic evidence of pulmonary infiltrates
  7. Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Protocol Appendix 3.

 

Exclusion criteria

  1. Participation in any other clinical trial of an experimental agent treatment for COVID-19
  2. Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2
  3. Requiring mechanical ventilation at screening
  4. ALT or AST > 5 x ULN
    Note: if per local practice only ALT is routinely measured, exclusion criteria will be evaluated on ALT alone
  5. 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
  6. Positive pregnancy test (Protocol Appendix 3)
  7. Breastfeeding woman
  8. Known hypersensitivity to the study drug, the metabolites, or formulation excipient

 

Study design

  • Phase III
  • Open Label
  • Randomized

Intervention

Two part open-label study: part A consists of 3 treatment groups, part B is a single group

 

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.

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.

Part A: Continued SOC Therapy

  • Participants will receive continued standard of care therapy.

Part B: Extension Treatment, Remdesivir 5 or 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.

 

Documents (password protected)

Responsibilities in overall study

Sponsor

Gilead Sciences, Inc.