The National Institute of Allergy and Infectious Diseases (NIAID), a member of the National Institutes of Health, published a study on October 13, 2020, aiming to figure out whether particular approved therapies or experimental drugs in late-stage development stages show traces of progress against the novel coronavirus and deserve to go further into clinical trials.
The ACTIV-5 Big Effect Trial will take into account adult volunteers hospitalized with the disease in up to 40 U.S. sites. It’s conducted in collaboration with the NIH’s public-private partnership to speed up research.
NIH Director Francis S. Collins, M.D., Ph. D., said:
“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.”
The Process
The Phase 2 adaptive, double-blind, aleatory, placebo-controlled trial will put different investigational therapies side to side and analyze which of them result in large effects.
About 100 hospitalized volunteers will be available for each study arm, and each of the study facilities won’t be testing more than three investigational treatments simultaneously.
“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,” stated Anthony S. Fauci, M.D., and NIAID Director.
“This study design is both an efficient way of finding those promising treatments and eliminating those that are not,” he added.
The researchers have high hopes regarding the whole project, and they ai to improve the situation with the ongoing pandemic by sorting out promising research from the rest.