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NCATS Overseeing Large Phase 3 Clinical Trial to Test Immune Modulators for Treatment of COVID-19



UCLA CTSI News Archive

Fernando Da Cunha/Science Photo Library via NIH/NCATS

Illustration of a cytokine storm response to infection with the new coronavirus SARS-CoV-2. A cytokine storm is a severe immune reaction that results in greatly elevated levels of inflammatory immune proteins (cytokines, purple) in the body.

NIH has launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. The trial is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership and overseen by NCATS.  

Some patients with COVID-19 experience an immune response in which the immune system unleashes excessive amounts of proteins that trigger inflammation — called a “cytokine storm” — that can lead to acute respiratory distress syndrome, multiple organ failure and other life-threatening complications. The randomized, placebo-controlled clinical trial aims to determine whether modulating that immune response can reduce the need for ventilators and shorten hospital stays. 

The trial, known as ACTIV-1 Immune Modulators, expects to enroll approximately 2,100 hospitalized adults with moderate to severe COVID-19 at medical facilities in the United States and Latin America. NCATS’ Clinical and Translational Science Awards (CTSA) Program and the Trial Innovation Network are playing key roles in adding U.S. study sites and enrolling patients, including those from communities disproportionately affected by COVID-19. 

Learn more about the clinical trial.  

UCLA is participating in the ACTIV-1 (and ACTIV-2) studies, and the trials are high-priority for the local Trial Innovation Network (TIN) at UCLA CTSI.

UCLA CTSI TIN provides support to investigators conducting or looking to initiate multi-site clinical trials and studies at CTSI’s partner sites (including UCLA, Cedars-Sinai, Charles R. Drew University, and Lundquist/Harbor-UCLA). Learn more about TIN's services.