The National Institutes of Health has launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. Part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, the randomized, placebo-controlled clinical trial will determine whether the therapeutics are able to restore balance to an overactive immune system.
The National Center for Advancing Translational Sciences (NCATS) will coordinate and oversee the trial, known as ACTIV-1 Immune Modulators, which expects to enroll approximately 2,000 hospitalized adults with moderate-to-severe COVID-19 at medical facilities in the United States and Latin America. NCATS’ Clinical and Translational Science Awards (CTSA) Program and the Trial Innovation Network will play a key role in adding U.S. study sites and enrolling patients, including those from communities disproportionately affected by COVID-19.