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The National Institutes of Health (NIH) has launched a Phase III clinical trial to assess the safety and effectiveness of three immunomodulants in treating COVID-19 inpatients.
some COVID-19 patients experience an immune response in which the immune system releases too much protein to trigger inflammation (known as a "cytokine storm"), which can lead to acute respiratory distress syndrome, multiple organ failure, and other life-threatening complications.
clinical trial is designed to determine whether regulating the immune response can reduce the need for ventilators and reduce hospital stays.
three immunomodulants include infliximab (REMICADE), developed by Johnson and Johnson, ORENCIA, developed by Bristol Myers Squibb, and Cenicriviroc (CVC), developed by AbbVie.
participants in the trial will receive Redsiway, the current standard of care for COVID-19 inpatients.
may use plasma and dexamison in post-rehabilitation patients, as appropriate, in accordance with national guidelines.
patients will be randomly assigned a placebo or immunomodulation agent.
as part of the Accelerated COVID-19 Treatment Intervention and Vaccine Program (ACTIV), the trial is expected to recruit approximately 2,100 moderate to severe COVID-19 hospitalized adult patients in medical facilities in the United States and Latin America.
. Francis S. Collins, director of the National Institutes of Health, said, "Immune regulators may provide another treatment in the ACTIV treatment kit."
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