NIH trial will test existing drugs against COVID-19
The National Institute of Allergy and Infectious Diseases will repurpose approved or late-stage investigational therapies and test them against COVID-19 to determine if they warrant larger trials, the NIH said.
The ACTIV-5 Big Effect Trial (ACTIV-5/BET) will be conducted in partnership with NIH’s public-private partnership Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV) program.
The phase 2 adaptive, randomized, double-blind, placebo-controlled trial will recruit adult patients hospitalized with COVID-19 in up to 40 sites across the United States. Each study group will have approximately 100 volunteers, and each testing site will investigate up to three treatments.
The NIH said the trial will test two monoclonal antibodies — risankizumab (Boehringer Ingelheim, AbbVie) and lenzilumab (Humanigen) — in combination with remdesivir (Gilead Sciences), compared with control groups that will receive placebo and remdesivir.
“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 S. Collins, MD, PhD, said in a press release.
Two randomized clinical trial demonstrated that remdesivir alone shortens time to recovery in hospitalized patients with COVID-19, and reduces mortality when given in combination with baricitinib (Eli Lilly).
The goal of the new trial “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 S. Fauci, MD, said in the release. “This study design is both an efficient way of finding those promising treatments and eliminating those that are not.”