The National Institute of Allergy and Infectious Diseases (NIAID) launched a study to determine whether certain approved therapies or investigational drugs show promise against COVID-19.
The ACTIV-5 Big Effect Trial is being conducted in partnership with the National Institutes of Health’s public-private partnership Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV) program. The goal is to determine if these drugs and therapies, which are all in late-stage clinical development, merit larger clinical trials.
“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,” NIH Director Francis Collins said.
The Phase 2 trial will compare different investigational therapies to a common control arm to determine which experimental treatments have relatively large effects. The study will enroll adult volunteers hospitalized with COVID-19 at as many as 40 U.S sites. 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,” NIAID Director Anthony Fauci said. “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 and AbbVie, in conjunction with the antiviral drug remdesivir, compared to placebo plus remdesivir. The trial will also test the investigational monoclonal antibody lenzilumab, developed by Humanigen, 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.
The study’s primary purpose is to evaluate the efficacy of the different investigational therapeutics relative to the control arm in hospitalized adults based on the volunteers’ status on day eight. The study’s secondary point of evaluation is to evaluate the efficacy of the different investigational therapeutics as assessed by the amount of time it takes for each volunteer to recover from COVID-19.