UH among first to test drug

Clinical trials set for hospitalized adults with pneumonia due to coronavirus

University Hospitals has secured two clinical trials that will provide the investigational antiviral drug remdesivir to hospitalized adults with pneumonia due to the novel coronavirus.

One trial will focus on COVID-19 patients with moderate illness, while the second will focus on patients with more severe illness who may require care in the intensive care unit.

Hospital officials are aiming to enroll 20 people in each trial. The study will be national, with other sites to be established across the nation. In total, nationally, officials are hoping for 500 people in each trial.

The studies will be conducted by the UH Clinical Research Center under the leadership of Dr. Grace McComsey, vice president of research and associate chief scientific officer.

According to UH, remdesivir was previously investigated for

Ebola, but turned out in lab studies to work on the virus that causes COVID-19.

“It was given to a handful of COVID-19 cases on a compassionate use basis, and it looks promising, but obviously we need to study it rigorously to make sure it is safe and effective,” McComsey said. “No participants in the study will get a placebo, everyone will get real active drug.

“The need for professionally conducted research is critical in the midst of the COVID-19 pandemic,” she added. “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.”

According to UH, 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.

Remdesivir has demonstrated activity against COVID-19 infection in animal studies, UH officials confirm. In addition, the drug has 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.

McComsey noted all participants in both studies will be given active remdesivir intravenously, but will be randomized to either five days or 10 days of treatment.

Dr. Daniel Simon, chief clinical and scientific officer and president, UH Cleveland Medical, believes the studies are promising news in the midst of the pandemic.

“Our UH research team has worked closely with the manufacturer, Gilead Sciences, Inc., in recent days to secure the studies, and we are grateful to be one of the first sites in the United States to participate in these clinical trials,” he said. “Both trials are now approved by the U.S. Food and Drug Administration and our Institutional Review Board.”

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,” Simon said.

McComsey echoed her colleague, adding the health care system took a proactive approach in its response as the number of confirmed cases grew across the country.

“We realized that it was coming near us,” she said. “We literally worked weekends and nights to get the studies activated in a record time. When our staff knew these may save lives, they were excited to work on these studies and to contribute. That’s exactly what should happen in a time like this.”