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UH Approved For Clinical Trials Of Possible COVID-19 Antiviral

Both trials have been approved by the U.S. Food and Drug Administration and the UH Institutional Review Board. [University Hospitals]
The entrance of the University Hospitals main campus

University Hospitals is approved to begin clinical trials of an antiviral drug that could possibly help treat COVID-19 patients. UH will receive the antiviral Saturday.

The clinical trials will evaluate if the antiviral remdesivir speeds up recovery for patients with moderateto severe pneumonia due to COVID-19, said UH Vice President of Research and Associate Chief Science Officer Grace McComsey.

“We are gearing up to start, and we already have demand and lots of questions about it,” McComsey said.

Remdesivir was developed for use against Ebola, McComsey said, but was not effective against it. However, lab tests have shown positive results in using the drug against MERS and SARS, two other coronavirus strains.

The drug, from manufacturer Gilead, was also implemented as compassionate use for a few patients in Washington and China, McComsey said, and had favorable results.

The antiviral is not being tested as a form of prevention, McComsey said. Instead, the trials will assess whether it aids in recovery.

“We have to be careful not to make people feel it’s going to be a 100 percent success, but this is definitely a good option because it hits the virus directly,” McComsey said. “It’s not just supportive care.”

The studies will assess the effectiveness of the drug for patients with moderate to severe pneumonia as a result of the coronavirus. It will compare a five-day treatment versus a 10-day treatment.

Patients must test positive within four days of enrolling to qualify for the trial, McComsey said. All patients need to show pneumonia in X-rays, and patients must show low blood oxygen levels to enroll in the severe illness trial.

All patients enrolled will be given remdesivir intravenously during the trial. One trial aims to measure the proportion of participants who are discharged on or before 14 days of hospitalization. The second will evaluate whether five or 10 days of treatment is more effective at normalizing patient temperature and oxygen levels over two weeks.

“It’s how it speeds recovery that is important. And whether five days is different than 10 days, is still unclear,” McComsey said.

There is no placebo group. Patients will receive either five or 10 days of treatment, decided randomly. The results will be compared against historical controls from Italy and China.

“Unfortunately, we can’t just wait to have a nicely done, large randomized study, because a lot of people would die if we did nothing,” McComsey said. “We have to use our judgement.”

UH expects to receive the antiviral Saturday, McComsey said. It could take as many as six months to enroll, she said, and even more time for the trials to finish and results to come out.

“My guess would be, like the vaccine, as much as you try to expedite these studies, to do them well with good rigor, you need about a year at least, from the time you start to get results,” McComsey said.

The timeline also depends on other variables, she said, including the other hospitals participating in the trials and how many patients are enrolled.

“It depends how bad the pandemic will reach each of our states, and how many patients we can put on study,” McComsey said. “It’s kind of hard to predict.”

UH is also looking into trials for other possible treatments. Several drugs could be used clinically to treat coronavirus, McComsey said, despite not being designed to treat it. But those treatments would need approval from the U.S. Food and Drug Administration, as would remdesivir.

The two UH COVID-19 clinical trials will be open at UH Cleveland Medical Center. UH officials want to open the trials at UH Ahuja, Parma and St. John medical centers in the future.