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The BIRCH Study is testing the effectiveness and safety of a potential new oral drug for COVID-19 called GS-5245. Researchers want to see if it can lower the chance for serious disease and the need to be hospitalized.
Being in the study is voluntary. Even if you decide to join and then change your mind, you can stop participating at any time.
To be considered for the study, you must:
You may be at risk for serious disease if you are 50 years of age or older and/or have certain medical conditions, such as cancer, heart disease, kidney disease, lung disease, diabetes, or HIV. These are not all of the risk factors. Talk to your doctor to learn more.
The study doctor will first explain all the details of the study and hand you a document called the Informed Consent Form. Think it over and ask any questions you have. If you agree to join, you will give your permission by signing the form before any study tests can begin.
To see if you qualify, the study team will collect information about your health and medical history and run some tests. This is called screening. If you qualify, your first study visit and study drug dose may occur on the same day.
The study lasts about 29 days, with at least 6 visits for tests and health checks. At least 2 visits will be in person. Other visits may be in person, on the computer (virtual), or over the telephone.
You will be placed by chance in a group to take either the study drug, GS-5245, or placebo.
The placebo looks like GS-5245 but does not have any active medicine in it. This helps researchers to better understand the effects of GS-5245. You and the study doctor will not know which group you are in. This helps to keep the study fair.