A phase 3 clinical trial evaluating the safety and efficacy of 3 immune-modulating agents in hospitalized adults with coronavirus disease 2019 (COVID-19) has been initiated.
The National Institutes of Health-led trial will assess 3 drugs: infliximab (Remicade), a tumor necrosis factor blocker, abatacept (Orencia), a selective T cell costimulation modulator, and cenicriviroc, an investigational immunomodulator that blocks 2 chemokine receptors, CCR2 and CCR5. The agents were selected from a pool of over 130 immune modulators based on several factors, including their relevance to COVID-19, strong evidence for use against inflammatory reaction and cytokine storm, and availability of large-scale clinical studies. The randomized, placebo-controlled phase 3 ACTIV-1 Immune Modulators trial will examine the effect of these agents on reducing the need for ventilators and shortening hospital stays in patients with COVID-19.
The trial will enroll approximately 2,100 hospitalized adults with moderate to severe disease at medical facilities in the US and Latin America. Patients will be randomized to receive either 1 of the 3 immune modulators or placebo as an add-on treatment to remdesivir, the current standard of care. Additional treatment with convalescent plasma and dexamethasone will be allowed if it is deemed appropriate. An independent data and safety monitoring board will provide oversight to ensure the trial is being conducted in a safe and effective manner.
“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,” said NIH Director Francis S. Collins, MD, PhD. “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.”
For more information visit nih.gov.
NIH begins large clinical trial to test immune modulators for treatment of COVID-19. [press release]. Bethesda, MD: National Institutes of Health; October 16, 2020.