Official Study Title: Big Effect Trial for the Treatment of COVID-19 (ACTIV-5/BET-B)
The primary purpose of the ACTIV-5/BET study is to evaluate the clinical efficacy of different investigational therapeutics in adults hospitalized for severe COVID-19.
What does the study involve?
After providing informed consent volunteers will randomly be assigned to receive one of the products being investigated as potential treatments for severe COVID-19, or a placebo. Study volunteers will be assessed daily by clinical staff while hospitalized. Once discharged, the volunteers will have study visits on days 15, 22, 29 and 60 on an outpatient basis, with some of these visits potentially conducted by phone if there are infection control concerns or other restrictions. All volunteers will undergo a series of tests, including testing of blood samples and oropharyngeal swabs on day one of the study prior to receiving an investigational therapy and again on days three, five, eight and 11, while hospitalized. These tests will be performed again on days 15 and 29 whether the study volunteer remains hospitalized or returns for clinical follow up as an outpatient.
Who can participate?
Adults who are hospitalized with COVID-19 at as many as 40 U.S. sites.
Where is it taking place?
Is there a cost?
There is no cost to the volunteer.
Is compensation provided?
There is no monetary compensation provided to volunteers.
Number of visits
Daily while hospitalized, and approximately 4 after being discharged from the hospital.