The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has 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 Francis S. Collins, MD. PhD.
The Phase II 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 three investigational treatments at once.
“The goal here is to identify as quickly as possible the experimental therapeutics that demonstrate the most clinical promise as COVID-19 treatments and move them into larger-scale testing,” said NIAID Director Anthony S. Fauci, MD. “This study design is both an efficient way of finding those promising treatments and eliminating those that are not.”
The trial will test risankizumab, a monoclonal antibody developed by Boehringer Ingelheim (Ridgefield, Conn.) and AbbVie (North Chicago, Ill.), in conjunction with the antiviral drug remdesivir, compared to a placebo plus remdesivir. The ACTIV-5/BET trial will also test the investigational monoclonal antibody lenzilumab, developed by Humanigen (Burlingame, Calif.), with remdesivir, compared to placebo and remdesivir. Remdesivir has demonstrated clinical benefit for patients with severe COVID-19 requiring supplemental oxygen and is considered standard of care for hospitalized COVID-19 patients.
Edited by Gary Cramer