NIH launches Phase 3 trial for COVID-19 immune modulators

Clinical trial will test efficacy and safety of three immune modulators

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BETHESDA, Md.—The National Institutes of Health reported today that it has launched an adaptive Phase 3 clinical trial to evaluate safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19.
COVID-19 patients can experience an immune response in which the immune system unleashes excessive amounts of proteins that trigger inflammation, called a cytokine storm. This can lead to acute respiratory distress syndrome, multiple organ failure and other life-threatening complications. 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 (IM), will determine if the therapeutics are able to restore balance to an overactive immune system. Part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, the trial expects to enroll approximately 2,100 hospitalized adults with moderate to severe COVID-19 at medical facilities in the U.S. and Latin America.
“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. 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,” said Francis S. Collins, M.D., Ph.D, director of the NIH.
The National Center for Advancing Translational Sciences (NCATS), part of the NIH, will coordinate and oversee the trial with funding support from the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response.
William G. Powderly, M.D., director of the Institute for Clinical and Translational Sciences and co-director of the Division of Infectious Diseases at Washington University School of Medicine in St. Louis, will be the protocol team chair for this study. NCATS’ Clinical and Translational Science Awards (CTSA) program and the Trial Innovation Network will also play a key role in adding U.S. study sites and enrolling patients, including patients from communities that are disproportionately affected by COVID-19.
“The CTSA program’s nimbleness and innovation in conducting clinical trials — along with the network’s extensive capacity and broad geographical reach — have positioned it to rapidly implement this important trial,” noted Christopher P. Austin, M.D, director of NCATS. “The innovative trial design will allow efficient evaluation of three different potential COVID-19 treatments concurrently, delivering new possible treatments for patients more quickly and valuable insights into the science of clinical translation.”
ACTIV-1 IM is a randomized, placebo-controlled trial that uses an adaptive master protocol, which allows a coordinated and efficient evaluation of multiple investigational agents as they become available. This gives the trial maximum flexibility to weed out drugs that don’t demonstrate effectiveness, identify those that do and rapidly incorporate additional experimental agents into the trial.
The ACTIV public-private partnership selected three agents for the study from a pool of over 130 immune modulators. The decision was based on several factors: the drugs’ relevance to COVID-19, strong evidence for use against inflammatory reactions and cytokine storms, and availability for large-scale clinical studies.
The initial agents being studied are infliximab (Remicade), developed by Janssen Research & Development, LLC., one of the Janssen Pharmaceutical Companies of Johnson & Johnson; abatacept (Orencia), developed by Bristol Myers Squibb; and Cenicriviroc (CVC), an investigational late-stage agent developed by AbbVie. BARDA’s Clinical Studies Network will be responsible for operationalizing the trial through a task order awarded to Technical Resources International, Inc.
All trial participants will receive remdesivir, which is the current standard of care treatment in hospitalized COVID-19 patients. Convalescent plasma and dexamethasone will be allowed at the discretion of the site investigator, in accordance with national guidelines. 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.
Enrollment is now open, and the trial is expected to last for about six months. Results will be available shortly after trial completion, with the possibility of sooner results if analysis conducted during the trial indicates that one or more of the drugs is beneficial. An independent data and safety monitoring board will oversee the trial and conduct periodic reviews of the accumulating data.

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