NIH launches phase 3 trial to test immune modulators for COVID-19
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The NIH announced the launch of an adaptive phase 3 clinical trial that will evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19.
Patients with COVID-19 sometimes experience an immune response that causes the immune system to unleash an excessive amount of proteins, triggering inflammation. Referred to as a “cytokine storm,” the reaction can lead to acute respiratory distress syndrome, multiple organ failure and other life-threatening complications, the NIH noted.
The clinical trial will determine if modulating the immune response can reduce the need for ventilators and shorten hospital stays, the NIH said.
The trial, called Accelerating COVID-19 Therapeutic Interventions and Vaccine initiative 1, Immune Modulators (ACTIV-1 IM), will help determine if therapeutics are able to restore balance to an overactive immune system.
“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 Francis S. Collins, MD, PhD, said in a statement. “Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multisystem conditions that can be caused by this very serious disease.”
The randomized, placebo-controlled trial will use an adaptive master protocol, which can allow a coordinated and efficient evaluation of multiple investigational agents as they become available, the NIH said. This will allow for the flexibility to remove drugs that prove ineffective, while rapidly incorporating additional experimental agents into the trial.
The NIH expects to enroll approximately 2,100 hospitalized adults with moderate to severe cases of COVID-19 in the United States and Latin America.
The trial selected three agents for the study from a pool of over 130 immune modulators that were initially reviewed based on several factors, including their relevance to COVID-19, evidence for use against inflammatory reaction and cytokine storm, and availability for large-scale clinical studies. The agents are Remicade (infliximab, Janssen), Orencia (abatacept, Bristol Meyers Squibb), and Cenicriviroc (CVC, AbbVie).
All trial participants will receive remdesivir. Convalescent plasma and dexamethasone will be allowed at the discretion of the site investigator and in accordance with national guidelines. Participants will receive a placebo or one of the immune modulators at random. Trial enrollment is now open and expected to last 6 months.
Perspective
Back to TopAmesh A. Adalja, MD, FIDSA, FACP, FACEP
It’s clear that some of the severity of COVID-19 is related to a dysregulated immune response to the virus. We have seen anecdotal evidence of immune modulators having some benefit in patients with evidence of cytokine storm, and it is crucial to understand which immune modulators have the most promising impact and in which patients that benefit is most evident. It’s especially important to know what benefit they provide beyond dexamethasone.
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NIH. NIH begins large clinical trial to test immune modulators for treatment of COVID-19. Accessed October 16, 2020.
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