BARDA to aid COVID-19 clinical trial

The Biomedical Advanced Research and Development Authority (BARDA) has enlisted its clinical studies network’s services to assist with a COVID-19 clinical trial.

Officials said Technical Resources International, Inc. (TRI), a BARDA subsidiary, would support the clinical trial in conjunction with the
National Institutes of Health-led Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative (ACTIV-1).

The work scope involves evaluating three immune modulator drugs in treating hospitalized adults with COVID-19, noting the National Center for Advancing Translational Sciences (NCATS) is slated to 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. The analysis is a randomized, double-blind, placebo-controlled adaptive trial enrolling 2,100 hospitalized adults with moderate to severe COVID-19 at medical facilities in the United States and Latin America.

The study will evaluate infliximab, abatacept, and Cenicriviroc, with authorities noting the agents would be evaluated as add-on therapy to remdesivir as the current standard of care for hospitalized COVID-19 patients.

The ACTIV-1 master protocol enables federal and private sector partners to swiftly act, maximize investments in advanced research and medical countermeasure development, and gain answers to guide COVID-19 patient clinical care.