Emory University will take part in an NIH-sponsored global clinical trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adult patients diagnosed with COVID-19. The drug remdesivir is the first agent to be evaluated.
The Emory Vaccine Treatment and Evaluation Unit (VTEU) was activated 3/11/2020 by The National Institute of Allergy and Infectious Diseases (NIAID), meaning it can begin enrollment as part of this phase three therapeutic clinical trial.
The clinicaltrials.gov identifier is NCT04280705.
Emory is one of several sites being activated for the trial. The study will be conducted in up to 75 sites globally. Dr Aneesh Mehta, an investigator in both the national VTEU network and National Ebola Training and Education Center (NETEC), serves as the Emory principal investigator for this study. The Emory VTEU is led by Drs. Nadine Rouphael, Evan Anderson and Carlos Del Rio.
“This important study will allow our patients to access the highest level clinical care, driven by the best data from around the world, while contributing to the science of caring for patients with COVID-19,” says Mehta.
COVID-19 starts as an upper respiratory tract infection, often indistinguishable from other more common respiratory tract infections. First detected in Wuhan, China, the novel coronavirus has spread rapidly around the globe. Worldwide, the number of COVID-19 cases has topped 100,000, while in the United States the total has grown to more than 1,000.
Emory is playing a key role in the effort to expedite clinical trials to combat COVID-19. VTEUs have performed high-quality clinical research for more than half a century to test new vaccines and therapies for infectious diseases in clinical trials of adults and children. The Emory VTEU includes the Hope Clinic of the Emory Vaccine Center and the Emory Children's Center Vaccine Research Clinic, both renowned in clinical and translational research in infectious diseases vaccines, treatment and prevention.
The VTEUs are a component of the Infectious Diseases Clinical Research Consortium (IDCRC). The IDCRC principal investigators are David S. Stephens, MD, professor and chair of the Department of Medicine in Emory University School of Medicine and vice president for research of Emory’s Woodruff Health Sciences Center, and Kathy Neuzil, MD, Myron M. Levine MD Professor in Vaccinology and director, Center for Vaccine Development, University of Maryland Baltimore.
“This COVID-19 outbreak is expanding rapidly,” says Stephens. “Thanks to the foresight of the NIAID we have a critical infrastructure in place to move quickly as well, harnessing some of the brightest minds in the academic medical community to fight COVID-19.”
About The IDCRC: The Infectious Diseases Clinical Research Consortium was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. It consists of nine VTEUs and the IDCRC Leadership Group. The IDCRC is made up of infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Johns Hopkins University, Vanderbilt University Medical Center, Baylor College of Medicine, University of Washington, University of Alabama at Birmingham, Cincinnati Children's Hospital Medical Center, FHI360, Fred Hutchinson Cancer Research Center, Kaiser Permanente Washington Health Research Institute, University of Rochester, Saint Louis University and the NIH NIAID Division of Microbiology and Infectious Diseases.
About NETEC: The therapeutic trial is also being conducted in conjunction with The National Ebola Training and Education Center (NETEC) Special Pathogens Research Network (SPRN), which is led by Emory University, the University of Nebraska Medical Center, and the New York Health and Hospitals Corporation, Bellevue Hospital Center. NETEC has created sustainable infrastructure and culture of readiness for managing suspected and confirmed special pathogen incidents across United States public health and health care delivery systems. By partnering with ten leading medical centers around the country, NETEC has established a network of containment units and teams to care for patients with these high consequence pathogens. Those regional treatment centers are: Emory University Hospital and Children’s Healthcare of Atlanta-Egleston Hospital, Massachusetts General Hospital, Bellevue Hospital, Johns Hopkins Hospital, University of Minnesota Medical Center, University of Nebraska Medical Center/Nebraska Medicine, University of Texas Medical Branch at Galveston, Denver Health Medical Center, Providence Sacred Heart Medical Center and Children’s Hospital and Cedars-Sinai.