Preliminary results from the ACTIV-1 Immune Modulator clinical trial show that immune modulator drugs, infliximab and abatacept, substantially improved clinical status and reduced deaths in adults hospitalized with COVID-19. The National Institutes of Health (NIH) launched this adaptive Phase 3 clinical trial in October 2020 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 was coordinated and overseen by the NIH’s National Center for Advancing Translational Sciences (NCATS).
NCATS’ Clinical and Translational Science Awards (CTSA) Program and the Trial Innovation Network played a key role in enrolling participants in the United States. More than half of the CTSA Program hubs also contributed their infrastructure and expertise to help advance the clinical trial.