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. Participants in the study will be treated with either a study drug or with placebo.
Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)
This is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression. The study is designed to transition from phase 2 to phase 3 in the same trial, with or without a pause in enrollment, depending on the speed of enrollment and interim results. For promising agents with limited availability, a phase 3 evaluation may occur at a later time. Up to two dose levels of the same agent may be assessed. Agents may also enter directly into phase 3 evaluation if sufficient safety and efficacy data are available from outside the trial.