University Hospitals has secured two clinical trials that will provide the investigational antiviral drug remdesivir to hospitalized adults with a pneumonia due to the novel coronavirus. One trial will focus on COVID-19 patients with moderate illness. The second will focus on patients with more severe illness who may require care in the intensive care unit (ICU).
“This is some promising news in the midst of this COVID-19 situation,” said Daniel Simon, MD, Chief Clinical & Scientific Officer and President, UH Cleveland Medical. “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.”
The studies will be conducted by the UH Clinical Research Center, under the leadership of Grace McComsey, MD, Vice President of 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 primary goal of the first trial is to evaluate the efficacy of two different remdesivir regimens, compared to the standard of care, 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 saturation, through day 14. ClinicalTrials.gov has more details, here for the trial for patients with moderate illness, and here for the trial in patients with more severe illness.
Remdesivir has demonstrated activity against COVID-19 infection in animal studies. In addition, it’s been shown to be safe and tolerable, with a safety database of more than 500 people who have received remdesivir in Ebola and early phase studies to date. All study participants in both studies will be given active remdesivir intravenously, but will be randomized to either five days or 10 days of treatment.
The two UH COVID-19 clinical trials will be open at UH Cleveland Medical Center. UH also is hoping to open the trials at UH Ahuja, Parma and St. John medical centers. Other trials are also being explored and assessed.
“The goal, as always, is to ensure access to the most novel treatments for our UH patients and the communities we serve,” said Dr. Simon.