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GS-US-540-5774


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
Therapeutic Area Covid-19
Principal Investigator Debra Poutsiaka, MD
Min Age 18 Years
Gender All
Contact By Invitation Only
More Information https://clinicaltrials.gov/ct2/show/NCT04292730

Overview

The purpose of this study is to provide Remdesivir (RDV) to participants with moderate COVID-19. The primary objective of this study is to evaluate the efficacy of 2 RDV regimens compared to standard of care (SOC), with respect to the proportion of participants discharged on or before Day 14

Study Details

Inclusion Criteria

  • SARS-CoV-2 infection confirmed by PCR ≤ 4 days before randomization
  • Currently hospitalized with fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, ≥ 37.8 °C rectal
  • Radiographic evidence of pulmonary infiltrates

Exclusion Criteria

  • Participation in any other clinical trial of an experimental agent 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
  • Requiring mechanical ventilation at screening

Study Requirements

If you qualify and agree to be in the study, you will be randomized to be in one of three study groups. Study Group 1 – You will get standard of care treatment together with RDV 200mg on Day 1 and then RDV 100mg on Days 2, 3, 4 and 5 (or until discharge).

Study Group 2 – You will get standard of care treatment together with RDV 200mg on Day 1 and then RDV 100mg on Days 2, 3, 4, 5, 6, 7, 8, 9 and 10 or until discharge.

Study Group 3 – You will get standard of care treatment as determined by the doctors taking care of you. You will not get any RDV.

The study screening period can last up to 3 days, and treatment period and follow up will be for 28 days.

You will have daily physical examination. You will have your blood taken for study testing at the screening visit and on days 1, 3, 5, 8, 10 and 14. Your doctor may also take your blood for testing on other days if they think they should. There will be a 28 day follow up visit. If you are already discharged from the hospital, 28 day follow up will be done by phone call.