The DCRI has been selected by Technical Resources International, Inc. (TRI), a clinical research organization based in Bethesda, MD, as the U.S. Coordinating Center for ACTIV-1, a master protocol that will initially examine three immune modulators that may prevent the overactive immune response that occurs in some severe COVID-19 cases.
The trial is a public-private partnership overseen by the National Institutes of Health (NIH) designed to advance therapeutics and vaccines for COVID-19. The U.S. Coordinating Center for ACTIV-1 will be led by Danny Benjamin, MD, PhD, MPH, distinguished professor of pediatrics in infectious diseases, and Brian Smith, MD, MPH, distinguished professor of pediatrics in neonatology. Christoph Hornik, MD, PhD, MPH, associated professor of pediatrics in critical care medicine, designed the clinical pharmacology component of the trial, and Kevin Anstrom, PhD, professor of medicine in biostatistics and bioinformatics, will lead the analysis of study results.
ACTIV-1 is a Phase 3 clinical trial and will enroll approximately 2,160 adults in the U.S. and Latin America hospitalized with moderate to severe cases of COVID-19. The trial will study how these three drugs impact severity of illness, speed of recovery, mortality, and hospital resource utilization.
“Our experience managing large trial networks allows us to activate sites quickly and efficiently,” Benjamin said. “We’re honored to be working on an important trial that seeks to improve care for patients being impacted by the COVID-19 pandemic.”
This award is the third major project awarded to the DCRI for COVID-19 research. In April, the DCRI was awarded $50 million from the Patient-Centered Outcomes Research Institute (PCORI) to launch the Healthcare Workers Exposure and Outcomes (HERO) Registry, designed to better understand how the pandemic was impacting frontline workers. In late September, the Institute, along with partners UNC Center for Health Equity Research and Community-Campus Partnerships for Health, received $80 million to serve as a coordinating center for a four-year program that will expand access to COVID-19 testing in underserved and vulnerable communities.
“I am proud that the DCRI has responded swiftly to some of the most pressing needs presented by this public health crisis,” said DCRI Executive Director Adrian Hernandez, MD, MHS. “By leveraging our experience in conducting rapid-cycle research, our teams will be able to find answers that can help improve outcomes and hopefully save lives.”
ACTIV-1 is part of the NIH’s Accelerating COVID-19 Therapeutics Interventions and Vaccines (ACTIV) program. ACTIV brings together government partners, industry partners, and nonprofits to accomplish three main goals:
- Establish a collaborative framework for prioritizing therapeutic candidates and accelerating vaccine evaluation
- Accelerate clinical trials of promising agents and leveraging existing clinical trial networks while maintaining rigorous safety standards
- Coordinate regulatory processes and leverage assets among all partners
ACTIV-1 is overseen by The National Center for Advancing Translational Sciences (NCATS), part of NIH, and funding support is provided by Operation Warp Speed through 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.
The trial will be led by protocol principal investigator William Powderly, MD, of Washington University in St. Louis and is expected to last six months.
This article originally appeared on DCRI News.