A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID 19 in Hospitalized Adults

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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 because it is a new disease caused by a virus that was just identified in 2019 in China. Some people who become sick with COVID-19 have serious disease and must be hospitalized. This can be fatal for a small percentage of patients. This trial will study the safety and efficacy of Remdesivir in adults that are hospitalized with COVID-19. The drug has been tested before in humans with other diseases. In this study, we would like to make sure that it is safe for use in humans with COVID-19 and see if it can improve patients’ health when they are sick with COVID-19.

Study Description

We are studying a drug called remdesivir. This drug has been studied in animals and in people. It is given as an infusion, which means that it is given through a plastic tube attached to a needle that is put into a vein in the arm.
 
To find out if remdesivir (the study drug) works, we need to compare it to getting something that does not have the drug in it, something called a placebo. The placebo looks like the study drug but does not have the drug in it.  The placebo is also given as an infusion. Some people in the study will get the placebo.
 
There are 2 study groups. If you join the study, you will be randomly put into one of two groups. This is decided by chance. Out of every 2 people on this study, 1 will get the study drug and 1 will get placebo. You will have a 50:50 chance of getting the study drug.  You and the study staff will not know what group you are in or if you are getting the study drug or the placebo. When the study is over, we learn if the study drug is safe and if it was successful in treating people with COVID-19. 

If you agree to join this study, we will first do some tests to make sure it is safe for you to join. This includes tests of your blood and a swab of the back of your throat (also known as an OP swab). 
Only hospitalized adults 18 years old and older who are not pregnant and not breastfeeding and who test positive for COVID-19 can join this study.
 

  • Study Identifier: 842784

Recruitment Status

Enrolling By Invitation

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If you need assistance finding a non-cancer study or if you have any questions, please email psom-ocr@pobox.upenn.edu