October 16, 2020 -- The U.S. National Institutes of Health (NIH) has launched an adaptive phase III trial called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-1 Immune Modulators, which is evaluating the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19.
The clinical trial will aim to determine if the drugs can modulate the immune response that results in cytokine storm, to reduce the need for ventilators and shorten hospital stays. The study is a randomized, placebo-controlled trial that uses the adaptive master protocol.
As part of the ACTIV initiative, the trial expects to enroll approximately 2,100 hospitalized adults with moderate to severe COVID-19 in the U.S. and Latin America.
The three drug candidates were selected from a pool of over 130 immune modulators initially under review. The selected immune modulators are:
All participants in the trial will receive remdesivir, which is the current standard-of-care treatment of hospitalized patients with COVID-19, and convalescent plasma and dexamethasone will be administered at the discretion of site investigators.
The National Center for Advancing Translation Sciences, part of the NIH, will coordinate and oversee the trial with funding from the Biomedical Advanced Research and Development Authority (BARDA).
Enrollment for the trial is now open and is expected to last approximately six months. Trial data will be overseen by an independent data and safety monitoring board.