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

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™)

Sponsored by Gilead Sciences


The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to the normalization of temperature and oxygen saturation through Day 14 in participants with severe coronavirus disease (COVID-19).

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: 400 participants Primary Purpose: Treatment Actual Study Start Date: March 6, 2020 Estimated Study Completion Date: May 2020

Who is this study for?

Key Inclusion Criteria*: - 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 with fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal

Key Exclusion Criteria*: - Participation in any other clinical trial of an experimental treatment for COVID-19 - Evidence of multiorgan failure - Requiring mechanical ventilation at screening

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

What should I expect?

Arms

Experimental: 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.

Experimental: 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.

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.