NIH Studying Approved and Investigational Therapies for Use Against COVID-19
The National Institute of Allergy and Infectious Diseases (NIAID) has begun a phase 2 study of the potential of approved therapies and late-stage investigational drugs for hospitalized COVID-19 patients.
The study, termed the ACTIV-5 Big Effect Trial (ACTIV-5/BET), is enrolling adults with COVID-19 at up to 40 sites in the U.S. It is being conducted in partnership with the National Institutes of Health’s Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV) program.
In the randomized ACTIV-5/BET trial, licensed drugs and investigational therapies that show promise against COVID-19 compared with controls will be propelled into larger COVID-19 trials. Around 100 hospitalized patients will be randomly assigned to each study arm. No more than three investigational therapies will be tested at once.
The first candidate to be tested in the trial includes monoclonal antibody risankizumab from Boehringer Ingelheim and AbbVie. This drug is currently FDA-approved for severe plaque psoriasis, but ACTIV-5/BET will test it in combination with remdesivir vs. placebo.
ACTIV-5/BET will also test lenzilumab, Humanigen’s late-stage investigational drug for the prevention and treatment of cytokine storm, in combination with remdesivir.