On October 16, 2020, it was announced that the NIH 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(see larger image of SARS-CoV-2-infected cell at end). Some COVID-19 patients experience an immune response in which the immune system unleashes excessive amounts of proteins that trigger inflammation--called a “cytokine storm”--that can lead to acute respiratory distress syndrome (ARDS), multiple organ failure, and other life-threatening complications. The clinical trial aims to determine if modulating that immune response can reduce the need for ventilators and shorten hospital stays. The trial, known as ACTIV-1 Immune Modulators (IM), will determine if the therapeutics are able to restore balance to an overactive immune system. Part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) (https://www.nih.gov/research-training/medical-research-initiatives/activ) initiative, the trial expects to enroll approximately 2,100 hospitalized adults with moderate to severe COVID-19 at medical facilities in the United States and Latin America. The National Center for Advancing Translational Sciences (NCATS), part of NIH, will coordinate and oversee the trial with funding support from the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, in support of the Trump administration’s Operation Warp Speed (https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html goals.
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