Study Aims to Identify Promising Covid-19 Treatments for Larger Clinical Trials

NIAID recently launched a study designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against Covid-19 and merit advancement into larger clinical trials. The ACTIV-5 Big Effect Trial, which will enroll adult volunteers hospitalized with Covid-19 at as many as 40 U.S sites, is being conducted in collaboration with the NIH’s public-private partnership Accelerating Covid-19 Therapeutic Innovations and Vaccines (ACTIV) program.

“The ACTIV-5/BET study aims to streamline the pathway to finding urgently needed Covid-19 treatments by repurposing either licensed or late-stage-development medicines and testing them in a way that identifies the most promising agents for larger clinical studies in the most expedient way possible,” said NIH director Dr. Francis Collins.

The phase 2 adaptive, randomized, double-blind, placebo-controlled trial will compare different investigational therapies to a common control arm to determine which experimental treatments have relatively large effects. 

Approximately 100 hospitalized volunteers will be assigned to each study arm with each of the study sites testing no more than 3 investigational treatments at once.