The National Institutes of Health today launched a Phase 3 clinical trial to evaluate three immune modulator drugs in hospitalized adults with COVID-19.
Some COVID-19 patients experience an immune response in which the immune system unleashes proteins that trigger inflammation, otherwise known as a cytokine storm, which can lead to acute respiratory distress syndrome, multiple organ failure and other life-threatening complications, according to an NIH news release.
NIH’s trial is looking to find if modulating the immune response can reduce the need for ventilators and thus shorten hospital stays because the therapeutic has restored balance to an overactive immune system.
ACTIV-1 IM expects to enroll approximately 2,100 hospitalized adults with moderate to severe COVID-19 in the U.S. and Latin America. The randomized, placebo-controlled trial is set to use an adaptive master protocol to swiftly weed out drugs that aren’t effective and incorporate additional experimental therapeutics into the trial.
So far, the ACTIV public-private partnership selected three agents for the study from a pool of over 130, with infliximab from Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceuticals, abatacept from Bristol-Myers Squibb (NYSE:BMY) and Cenicriviroc from AbbVie (NYSE:ABBV).
All trial participants will receive remdesivir, although the World Health Organization reported today that remdesivir has little to no effect in reducing coronavirus deaths. Convalescent plasma and dexamethasone will be allowed at the discretion of the site investigator and in accordance with the national guidelines. The patients will be randomly assigned to receive a placebo or one of the immune modulators as an add-on.
Enrollment is now open and the trial is expected to last for approximately six months, with results set to be made available shortly after the trial is completed, or possibly sooner if early data indicates that one or more of the drugs is beneficial.
“This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented timeframe, and focuses efforts on therapies that hold the greatest promise for treating COVID-19,” NIH Director Dr. Francis S. Collins said in the release. “Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multi-system conditions that can be caused by this very serious disease.”