Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)
Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community.
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.
DURATION: August 2020 - Ongoing
STUDY TYPE: COVID-19
DESIGN: Randomized, parallel assigned, triple masked interventional study
POPULATION: Individuals 18 years and older with laboratory-confirmed SARS-CoV-2 infection
NUMBER OF SITES: 251
SITE LOCATIONS: US, Argentina, Brazil, Guatamala, Mexico, Philippines, South Africa