A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir in Participants with Severe COVID 19

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Study Overview

This study is for patients in the hospital being treated for COVID-19

There are no approved medications to treat COVID 19, a new disease caused by a virus called SARS CoV2 that was just identified in late 2019. Some people who become sick with COVID 19 develop a very serious disease. The purpose of this study is to see if RDV can improve your health from being sick with COVID 19 infection. The other purpose of this study is to test if Remdesivir or RDV is safe and tolerated by people with severe COVID 19. We will find out all of these things, and also how long it stays in your body, using physical exams, laboratory tests, and any symptoms or problems you might experience during the study.

Study Description

This is a randomized, open-label study.
Randomized means the study treatment you take will be chosen by chance - like flipping a coin.  You will have a 1 out of 2 chance to receive RDV for 5 days and 1 out of 2 chance to receive RDV for 10 days. Whichever happens, you will still get standard of care treatment.
 Open-label means you and your study doctor will know which study treatment length you will get.
 If you qualify for the study and decide to join, you will get RDV by injections directly into the vein (intravenously, IV)
 You cannot choose which study group you are in. If you agree to take part in this study and meet all the requirements, you will be randomized to one of the following study treatment groups:
 
Study Treatment Group 1 – You will get standard of care treatment together with RDV 200mg Day 1 and then RDV 100mg on Days 2, 3, 4 and 5.
 
Study Treatment 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.

You will be in this study for 28 days, or until you leave the hospital or clinic, whichever is earlier. This does not include the screening period which can last up to 3 days.
While you are in this study, you will have physical examinations done every day, including during screening. There will be a follow up visit or phone call at day 28. You will have your blood taken for study testing at the screening visit and on days 1, 3, 5, 8, 10 and 14.  
 
You will receive RDV and standard of care treatment for 5 days (study treatment group 1) or 10 days (study treatment group 2). If your study doctor thinks you will need it, you will get standard of care treatment after you finish RDV.


  • Study Identifier: 842781

Recruitment Status

Enrolling By Invitation

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