Emory University commenced a COVID-19 vaccine clinical trial with the first agent to be evaluated, Gilead’s Remdesivir. The Emory Vaccine Treatment and Evaluation Unit (VTEU) was activated last week by the National Institute of Allergy and Infectious Diseases (NIAID).
NIAID Activates Emory VETEU Status
Emory is one of several sites nationwide participating in the potential COVID-19 vaccine study. As TrialSite News has discussed, Emory’s principal investigator, Dr. Aneesh Mehta, also serves as lead for the National Ebola Training and Education Center (NETEC). The Emory VTEU is led by Drs. Nadine Rouphael, Evan Anderson, and Carlos Del Rio.
With its VTEU status activated by NIAID, Emory has emerged as one of the leading sites nationwide in the fight against COVID-19. VTEUs report that the SaportaReport has been actively testing new vaccines targeting infectious diseases for over half a century.
Emory’s Hope Clinic of the Emory Vaccine Center and the Emory Children’s Center Vaccine Research Clinic are both parts of the Emory VTEU.
VTEU’s Part of the Recently Launched IDCRC
The NIAID VTEUs are members of the Infectious Diseases Clinical Research Consortium (IDCRC). The IDCRC was launched in December 2019. With an infusion of $29 million per year for seven years, NIAID, part of the NIH, announced this investment that is assembling a powerful group of investigators and scientists in infectious disease who will prioritize patient vaccines, diagnostics, and other interventions involved in the clinical trials process. Principal investigators for the IDCRC include 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 Professor in Vaccinology and director, Center for Vaccine Development, University of Maryland.
The NIAID Study
Emory is participating in the NIAID-funded adaptive, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of Remdesivir in hospitalized adult patients diagnosed with COVID-19. The multicenter study may be conducted up to 50 sites worldwide.
The study consists of a 2-arm comparison between various therapeutic agents (including Gilead’s Remdesivir) and a placebo. The sponsor (NIAID) and the sites (including Emory VTEU) will include interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one approach (within the protocol) proves to be efficacious, this treatment will then become the control arm for comparison against a new treatment.
Independent Safety Monitoring Board (DSMB)
A DSMB has been set up to actively monitor interim data to make recommendations about early study closure or changes to study arms. Randomization will be stratified by 1) site, and 2) severity of illness at enrollment, 3) severe disease (e.g. requiring mechanical ventilation or oxygen a SpO2 </= 94% or tachypnea (respiratory rate >/= 24 breaths/min)) or mild-moderate disease (SpO2 > 94% and respiratory rate < 24 breaths/min without supplemental oxygen). Patients will be assessed daily while hospitalized. Discharged patients will attend study visits at Days 15 and 29, and all will undergo a series of efficacy, safety, and laboratory assessments.
Aneesh Mehta, MD, principal investigator of the study, Affiliate Faculty, Emory Vaccine Center, Associate Professor, Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine
Nadine Rouphael, MD, Affiliate Faculty, Emory Vaccine Center, Associate Professor, Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine
Evan Anderson, MD, Associate Professor, Emory University School of Medicine
Carlos Del Rio, MD, Professor, Emory Vaccine Center, Professor and Chair, Hubert Department of Global Health, Rollins School of Public Health, Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine
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