The National Institutes of Health is launching a late-stage clinical trial to determine whether three drugs used for controlling immune system could be used to treat respiratory distress and organ failure in severely ill Covid-19 patients.
The trial, know as ACTIV-1 Immune Modulators (IM), will determine if the therapeutics are able to restore balance to an overactive immune system. The NIH study will evaluate two drygs already on the market, Johnson & Johnson´s Remicade and Bristol-Mayer´s Squibb Co´s Orencia, along with an investigational drug called CVC from AbbVie Inc.
“This is the fifth master protocol to be launched under de ACTIV partnership in an unprecedent timeframe, and focuses efforts on therapies that hold the greatest promise for trating Covid-19,” said NIH Director Francis S. Collins, M.D., Ph. D. “Immune modulators provide another treatment modality in the ACTIVE therapeutic toolkit to help manage the complex, multi-system conditions that can be used by this very serious disease.”
The study will evaluate whether any of the medicines, know as immune modulators, can control an overreaction of the patient´s systemic Covid-19 inflammatory response.
This phenomen, know an a “cytokine storm” for the proteins that proteins that trigger the inflammation, can lead to respiratory distress, multiple organ failure and other severe reactions in hospitalized patients. Cytokines are part of the body´s normal immune reaction, but one that in this instance has gone haywire.
Enrollment is now open, and the trial is expected to last approximately six months. Results will be available shortly after the trial is completed, or possible sooner if analysis conducted during the trial indicates that one or more of the drugs is beneficial. To ensure that the trial is being conducted in a safe and effective manner, an independent data and safety monitoring board will oversee the trial and conduct periodic reviews of the accumulating data.