Policy & Regulation
TRI, BARDA & NIH to support the ACTIV-1 IM study for treating COVID-19
21 October 2020 -

Contract research company Technical Resources International Inc (TRI) reported on Tuesday the receipt of an agreement to conduct the Randomized Master Protocol for Immune Modulators for Treating COVID-19 (ACTIV-1 IM) study under the Biomedical Advanced Research and Development Authority's (BARDA) Medical Countermeasures Clinical Studies Network and the National Institutes of Health (NIH).

In some COVID-19 patients, the immune system unleashes excessive amounts of proteins that trigger inflammation, called a "cytokine storm", that can lead to acute respiratory distress syndrome, multiple organ failure and other life-threatening complications. ACTIV-1 IM will evaluate the safety and efficacy of three immune modulator drugs designed to restore balance to an overactive immune system.

NIH's National Center for Advancing Translational Sciences (NCATS) will coordinate and oversee the trial with funding support provided by BARDA, part of the HHS Office of the Assistant Secretary for Preparedness and Response, in support of the Operation Warp Speed goals.

ACTIV-1 IM is expected to enroll 2,100 hospitalized adults with moderate to severe COVID-19 at medical facilities in the US and Latin America. The ACTIV selected three agents from a pool of over 130 immune modulators. The initial agents are infliximab (REMICADE) from Janssen Research & Development LLC, abatacept (ORENCIA) from Bristol Myers Squibb and Cenicriviroc (CVC) from AbbVie.

Under the partnership's trial, all participants will receive remdesivir, the current standard of care treatment of hospitalized patients with COVID-19. They will be randomly assigned to receive a placebo or one of the immune modulators as an add-on treatment. The trial will study the different combination treatment regimens with respect to illness severity, recovery speed, mortality and resource utilisation.

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