Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19)
Clara Health

Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19)

Sponsored by Gilead Sciences


The primary objective of this study is 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.

About 
COVID-19

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.

How is this study designed?

Study Type: Interventional (Clinical Trial) Estimated Enrollment: 1600 participants Primary Purpose: Treatment Official Title: 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 Actual Study Start Date: March 15, 2020 Estimated Study Completion Date: May 2020

Who is this study for?

Key Inclusion Criteria*:

  • Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
  • 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

Key Exclusion Criteria*:

  • Participation in any other clinical trial of an experimental treatment for COVID-19
  • Requiring mechanical ventilation at screening

* Note: Other protocol defined Inclusion/Exclusion criteria may apply.

What should I expect?

Arm 1: 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.

Arm 2: 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.

Arm 3: Active Comparator: Part A: Continued SOC Therapy Participants will receive continued standard of care therapy.

Arm 4: Experimental: 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.

Inpatient trial

Have questions or need help?

For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you'll be connected to the team.