The National Institutes of Health has started a phase three trial to test the safety and effectiveness of three therapeutic drugs for the coronavirus.
The human trial will test to see if the drugs can reduce the need for ventilators and shorten hospital stays by helping restore balance to an overactive immune system. Some COVID-19 patients experience a “cytokine storm” in which the immune system produces excessive amounts of proteins that trigger inflammation, leading to acute respiratory distress syndrome, multiple organ failure and other possibly fatal complications.
The trial, called ACTIV-1 Immune Modulators, will test infliximab by Janssen Pharmaceuticals, abatacept by Bristol Myers Squibb and Cenicriviroc by AbbVie. Researchers expect to enroll about 2,100 hospitalized adults with moderate and severe COVID-19 at medical sites in the U.S. and Latin America.
“This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented time frame, and focuses efforts on therapies that hold the greatest promise for treating COVID-19,” NIH Director Dr. Francis S. Collins said in a statement Friday.
All trial participants will receive remdesivir as part of the current treatment standards. Some could receive convalescent plasma and dexamethasone. Trial subjects will be randomly assigned to receive a placebo or one of the trial drugs.
Researchers will study the different combinations of treatment regimens and how they affect illness severity, recovery speed, mortality and hospitalization.
Enrollment for the trial is open. The trial is expected to last about six months. An independent board will oversee the trial to make sure it is being carried out safely and effectively.