The University of Iowa Hospitals and Clinics announced Monday that it is participating in an international clinical trial for remdesivir, an antiviral drug, to evaluate its safety and effectiveness in treating the novel coronavirus.
The trial is for hospitalized patients aged 12 or older who meet the following criteria: have a laboratory confirmed COVID-19 infection requiring hospitalization, show evidence of lung infection, do not have underlying kidney or liver dysfunction, and are not pregnant or breastfeeding, according to a news release.
Dilek Ince, clinical associate professor of internal medicine, will lead the clinical trial at UIHC, the release said. She and her team will be reviewing patients admitted to UIHC and will be speaking with those who qualify for the trial.
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“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 in the release. “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.”
Those admitted into the trial will be randomized to receive remdesivir or a placebo solution for either five or 10 days. Patients will be observed while doctors look for signs that the drug improves outcomes.
The trial includes two studies at almost 70 locations around the world. All testing sites will enroll a combined 1,600 patients in a study on moderate severity and 2,400 patients in a study on severe novel-coronavirus, the release said.
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UIHC — the first location in the state to be involved with the trial — was approved to join the clinical trial on March 30 and has already enrolled patients.
As previously reported by The Daily Iowan, Jackson announced at a virtual state Board of Regents meeting on April 1 that the clinical trial for remdesivir was in place at UIHC. He said there were plans for the hospital to begin convalescent plasma protocol, which would take plasma from recovered COVID-19 patients who may have built up antibodies to treat new patients.
UIHC is only conducting COVID-19 testing on symptomatic patients currently, Jackson said during the meeting. The UI State Hygienic Lab will soon be able to test between 700 to 800 patients a day, and UIHC should be able to double its number of tests every week, he said.
“An emergency like this clearly exemplifies how critical our research mission is,” UI Vice President for Medical Affairs Brooks Jackson said in the release. “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.”