Study Detail

5773 Safety and Antiviral Activity of Remdesivir for severe COVID-19

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Severe COVID-19

Status: Closed

Type: Interventional

Funder: Gilead Sciences Inc

Sponsor: Gilead Sciences Inc

CI: -

IRAS-Number: 282007

CPMS-ID: 45460

Approval Date: 25 March 2020

Description:

In December 2019, a novel coronavirus emerged in China which was named COVID-19. This has spread rapidly throughout the world. As of 18-Mar-2020 there have been 2,626 cases in the UK of which 103 patients have died. COVID-19 is a major health emergency. There are currently no approved treatments available for COVID-19. Anti-viral drugs being tested as potential treatments include remdesivir (RDV). The evaluation of the safety and potential efficacy of RDV is urgently needed. RDV has shown activity against human coronaviruses in lab and animal tests and has an acceptable safety profile based on animal studies and 500 people who have received RDV previously. The purpose of this study is to provide intravenous RDV to patients with severe COVID-19, assess the efficacy of two RDV regimens and the safety and tolerability of RDV. All patients will continue standard of care therapy. In Part A, 400 patients with severe COVID-19 who are not mechanically ventilated will be randomised in a 1:1 ratio to: - RDV 200mg on Day 1 followed by 100mg on Days 2-5 or - RDV 200mg on Day 1 followed by 100mg on Days 2-10 In Part B, 2000 patients may receive: - RDV 200mg on Day 1 followed by 100mg on Days 2-10 for patients who are mechanically ventilated - RDV 200mg on Day 1 followed by 100mg on Days 2-10 for an extension treatment group (unless the 5-day dosing regimen in Part A is selected) Patients will undergo daily assessments until Day 14 or they are discharged from hospital. There will be a Day 28 follow-up visit. Assessments will include physical examination, vital signs, laboratory testing, and assessment of respiratory status. This study is sponsored by Gilead Sciences, Inc. Approximately 2400 patients will participate worldwide with 100 patients from 11 hospitals in the UK.basis • 200mg Intravenous remdesivir on Day 1 followed by 100mg on Days 2-5 plus the usual standard hospital care • 200mg Intravenous remdesivir on Day 1 followed by 100mg on Days 2-10 plus the usual standard hospital care The second part of the study will include a total of 5600 patients (some of whom were included in the first part of the study) and will include some patients who are mechanically ventilated. Patients newly enrolled to this part of the study will all receive: • 200mg Intravenous remdesivir on Day 1 followed by 100mg on Days 2-10 plus the usual standard hospital care Patient information including breathing status will be recorded daily for 14 days or until patients leave hospital and will be reviewed again after 28 days. The study is paid for by Gilead Sciences, Inc.

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