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IOWA CITY - The University of Iowa Hospitals and Clinics on Monday became the state's first to participate in an international clinical trial for 'the most promising drug available to treat COVID-19.”
The trial evaluating the safety and efficacy of Remdesivir will involve hospitalized patients who agree to join the trial and are 12 and older and meet other criteria, according to a UI Health Care news release.
UIHC, Iowa's only academic medical center, already has enrolled patients to participate.
The UI joining a trial like this makes the potentially lifesaving drug available to Iowans facing the most severe effects of the pandemic, according to Dilek Ince, a UI clinical associate professor of internal medicine leading Iowa's portion of the trial.
'Being the academic medical center for the state gives us an advantage in being selected,” she said in a statement.
Remdesivir is an anti-viral drug that in laboratory testing has been shown to be effective in treating coronavirus - including MERS and SARS, which appeared in 2012 and 2003, respectively, according to Ince.
The drug also was effective in SARS-CoV-2, the currently spreading type of coronavirus that causes COVID-19. Although the drug's testing with Ebola showed its safety in humans, it was not effective against that disease, the UIHC said.
Among the criteria to participate in this UIHC trial, patients must be over 12 and be confirmed COVID-19 patients with evidence of lung infection. But they cannot have any significant underlying kidney or liver dysfunction, or be pregnant or breastfeeding.
Ince and her team are reviewing UIHC admitted COVID-19 patients for potential trial participants. Those who agree will be randomly assigned to receive either the drug or a placebo solution for five or 10 days, according to UIHC.
The team will evaluate participants' conditions and record them at specific intervals. Evidence the drug helps would include increased survival in those with severe disease or shortening the duration of symptoms in those with less-severe disease.
Researchers also are interested in whether the drug affects 'viral shedding” which would have implications for decreasing transmission between humans. They also will be tracking possible side effects.
The international trial includes two studies at more than 70 sites around the world - enrolling 1,600 patients in the study of moderate disease and 2,400 patients in the study of severe disease. Once enrollment reaches those thresholds across all the sites, the trials will close and evaluation will begin.
Preliminary results from studies already conducted in China are expected in one to two months, Ince said.
UIHC also is pursuing other treatment trials for COVID-19, and was seeking approval to use donated plasma from recovering coronavirus patients to help those hospitalized.
'It was amazing because it can take weeks or months to get all the approvals to begin a study, but this was done in a matter of three days,” Ince said of the Remdesivir trial. 'Our university and our hospital have made everything to do with COVID-19 a priority. Everybody collaborated to get this going as soon as possible.”
In a statement, UI Vice President for Medical Affairs Brooks Jackson said clinical research to improve patient care is core to the mission.
'An emergency like this clearly exemplifies how critical our research mission is,” Jackson said. 'We are glad to be playing our part in finding ways to treat this disease and bringing these treatments to Iowans as soon as possible.”
Funding the study is Gilead Sciences, which developed Remdesivir and is supplying it.