University Hospitals in Cleveland, Ohio has secured participation in two clinical trials that will offer the investigational antiviral drug remdesivir (Gilead) to hospitalized patients with pneumonia due to COVID-19. One clinical trial will focus on COVID-19 patients with moderate illness while the other deals with those with more severe illness who may need to be in the intensive care unit (ICU).
UH Research Leadership
These studies will be conducted by the UH Clinical Research Center, under the leadership of Grace McComsey, MD, Vice President Research and Associate Chief Scientific Officer at UH. “The need for rigorous, professionally conducted research—activity that goes on every day in our UH Clinical Research Center—is critical in the midst of the COVID-19 pandemic,” said Dr. McComsey. “There is no established treatment for the novel coronavirus that causes COVID-19. The trials we are preparing to conduct are especially significant because they test an active antiviral treatment, rather than just supportive care.”
The Clinical Trials
The first study seeks to evaluate the efficacy of two different remdesivir regimens, compared to the standard of care, as measured by the proportion of participants discharged on or before day 14 of their hospitalization. The primary goal of the second trial is to evaluate the efficacy of two different remdesivir regimens and their ability to normalize patients’ temperature and oxygen situation through day 14.
The two studies will open at UH Cleveland Medical Center. UH is hoping to open the trials at UH Ahuja, Parma and St. John Medical Centers. These sites are exploring other trials as well.
The Drug: Remdesivir
Remdesivir has demonstrated activity against COVID-19 infection in animal studies. Also, it has been shown to be safe and tolerable, with a safety database of more than 500 people who have received the drug in Ebola and early phase studies to date. All of the study participants here in Cleveland will be given active remdesivir intravenously, but will be randomized to either five days or 10 days of treatment.
UH President Comments
Dr. Daniel Simon, Chief Clinical & Scientific Officer and President, UH Cleveland Medical reported “Our UH research team has worked closely with the manufacturer, Gilead, in recent days to secure the studies. We are grateful to be one of the first sites in the U.S. to participate in these clinical trials. Both trials are now approved by the U.S. Food and Drug Administration (FDA) and our Institutional Review Board, and we are expecting shipment of the experimental drug remdesivir in the next couple of days.”
About University Hospital Clinical Research Center
UH Clinical Research Center seeks to responsibly grow research and scientific innovation to improve patient care. The center engages in research providing a unique opportunity to have substantial impact. They strive to advance and change the standard of care by leveraging discovery and innovation. This research center offers support across all aspects of clinical and translational research and is the centralized infrastructure that supports their investigators across the University Hospitals health system.
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