The National Institutes of Health 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.
This scanning electron microscope image shows SARS-CoV-2 (yellow)—also known as 2019-nCoV, the virus that causes COVID-19—isolated from a patient in the U.S., emerging from the surface of cells (blue/pink) cultured in the lab.
Credit: NIAID-RML
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, 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.
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. BARDA’s Clinical Studies Network will be responsible for operationalizing the trial through a task order awarded to contract research organization Technical Resources International, Inc.
Some of this content first appeared at https://www.nih.gov/news-events/news-releases/nih-begins-large-clinical-trial-test-immune-modulators-treatment-covid-19