The US National Institutes of Health (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, said a statement of the agency.
Some COVID-19 patients experience an immune response in which the immune system unleashes excessive amounts of proteins that trigger inflammation. 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, will determine if the therapeutics are able to restore balance to an overactive immune system, said the NIH, Xinhua news agency reported on Friday.
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.
All participants in the trial will receive remdesivir, which is the current standard of care treatment of hospitalized patients with COVID-19. Convalescent plasma and dexamethasone will be allowed at the discretion of the site investigator and in accordance with national guidelines, said the NIH.
The participants 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 hospital resource utilization, according to the NIH.