BARDA engaged Technical Resources International, Inc. (TRI), part of BARDA’s medical countermeasures clinical studies network, to support a large clinical trial as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, led by the National Institutes of Health. To meet Operation Warp Speed goals, this adaptive phase 3 clinical trial, named ACTIV-1, will evaluate three immune modulator drugs in treating hospitalized adults with COVID-19.
The National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health, will coordinate and oversee the clinical trial with funding and other support from BARDA; (TRI) will operationalize the clinical trial and provide other research support services.
This clinical trial is a randomized, double-blind, placebo-controlled adaptive trial, and beginning this month, the study will enroll approximately 2,100 hospitalized adults with moderate to severe COVID-19 at medical facilities in the United States and Latin America. The study initially will evaluate infliximab (REMICADE), developed by Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson; abatacept (ORENCIA), developed by Bristol Myers Squibb; and Cenicriviroc (CVC), an investigational late-stage agent developed by AbbVie. Each agent will be evaluated as add-on therapy to remdesivir as the current standard of care for hospitalized COVID-19 patients . The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization.
By structuring a clinical trial that uses an adaptive platform trial design to test multiple agents with shared control groups, the ACTIV-1 master protocol allows federal and private sector partners to act quickly, maximize investments in advanced research and medical countermeasure development, and obtain much needed answers to help guide clinical care of COVID-19 patients.
The partnership with NCATS and Technical Resources International, Inc. supports BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio. Read the NIH news release and visit BARDA’s COVID-19 Portfolio to learn more.