Study Detail

5774 Safety & Antiviral Activity of Remdesivir for moderate COVID-19

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

Status: Closed

Type: Interventional

Funder: Gilead Sciences Inc

Sponsor: Gilead Sciences Inc

CI: -

IRAS-Number: 282026

CPMS-ID: 45459

Approval Date: 25 March 2020

Summary:

A number of antiviral drugs are being tested as potential treatments for COVID-19 infection including the antiviral drug remdesivir. The purpose of this study is to compare the safety and effectiveness of two different treatment plans of remdesivir with the normal hospital treatment in patients with moderate COVID-19. Approximately 1600 patients will participate worldwide with up to 100 patients from 15 hospitals in the UK. The first part of the study will include 600 patients with moderate COVID-19. They will receive one of the following on a random basis: 1) 200mg Intravenous remdesivir on Day 1 followed by 100mg on Days 2-5 plus the usual standard hospital care; 2) 200mg Intravenous remdesivir on Day 1 followed by 100mg on Days 2-10 plus the usual standard hospital care; 3) the usual standard hospital care. The second part of the study will include a total of 1,000 patients with moderate COVID-19 (some of whom were included in the first part of the study). Patients newly enrolled to this part of the study and those who received only the usual standard hospital care in the first 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 they leave hospital and will be reviewed again after 28 days. The study is paid for by Gilead Sciences, Inc.

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 moderate COVID-19, assess the efficacy of two RDV regimens compared to standard of care and the safety and tolerability of RDV compared to standard of care. In Part A, 600 patients with moderate COVID-19 will be randomised in a 1:1:1 ratio to: - RDV 200mg on Day 1 followed by 100mg on Days 2-5 and continued standard of care therapy or - RDV 200mg on Day 1 followed by 100mg on Days 2-10 and continued standard of care therapy or - Standard of care therapy In Part B, 1000 patients may receive: - RDV 200mg on Day 1 followed by 100mg on Days 2-10 and continued standard of care therapy (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 1600 patients will participate worldwide with 50 patients from 11 hospitals in the UK.

Study URL:

https://www.gilead.com/purpose/advancing-global-health/covid-19/remdesivir-clinical-trials

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