University Hospitals Experts Comment About Results of NIAID's Remdesivir Clinical Trial

CLEVELAND – On April 29, 2020 the National Institute of Allergy and Infectious Diseases (NIAID) announced that its study of Gilead’s remdesivir showed that the medication is effective against COVID-19. Dr. Anthony Fauci, director of NIAID, provided data at a briefing at the White House. The findings represent the first treatment shown to improve outcomes in patients infected with the virus that has killed at least 218,000 people worldwide.

University Hospitals, which was one of the first hospitals in the nation to open a clinical trial of the drug, was not part of the government-sponsored study but one sponsored by the drug manufacturer Gilead.

“We are excited by the results of the randomized placebo controlled trial and are grateful for the opportunity to continue to enroll patients in a trial of patients with moderate and severe COVID infection to further clarify the optimal treatment regimen,” said Daniel Simon, MD, Chief Clinical and Scientific Officer at UH and President of UH Cleveland Medical Center.

UH’s two clinical trials provide remdesivir to hospitalized adults with pneumonia due to COVID-19. One trial focuses on COVID-19 patients with moderate illness. The second focuses on patients with more severe illness who may require care in the intensive care unit (ICU).

UH has enrolled 53 patients in its studies.

“These are very important results, and the first to bring scientifically sound optimism in the COVID treatment paradigm,” said Grace McComsey, MD, FIDSA, Vice President of Research and Associate Chief Scientific Officer at UH. “I would expect that the FDA will look into approving remdesivir for treatment of COVID-19 pretty quickly. Meeting the primary endpoint in a placebo-controlled study is the most stringent reason for the FDA to approve a drug.”

The data from the first 400 severely ill patients and 600 moderately ill patients is being analyzed, and a report regarding the severe group is expected within the next several weeks. Meanwhile, the study is continuing to enroll and treat patients and is expected to continue through May.

Leila Hojat, MD, principal investigator of the trials at UH, said, “Several preliminary and anecdotal reports on remdesivir from different trials have been released over the last several weeks, which overall provided a mixed impression of its efficacy. The NIH preliminary results are encouraging, and I have good confidence that they conducted their trial appropriately, that enough patients and sites were included, and that their study design will provide meaningful information. However, we cannot make a complete assessment without seeing the final data.”

The two UH COVID-19 clinical trials have enrolled patients from UH Cleveland Medical Center, UH Ahuja, Parma, Elyria, Bedford, Portage, St. John, and Samaritan medical centers.