UI Health Care participating in Remdesivir clinical trial for COVID-19 treatment
University of Iowa Hospitals & Clinics, the patient care mission of University of Iowa Health Care, is the first in the state of Iowa to participate in an international clinical trial for a Remdesivir, believed to be the most promising drug available to treat COVID-19. The trial, which is evaluating the safety and efficacy of Remdesivir, is for hospitalized patients ages 12 and older who meet specific criteria and agree to join.
UI Hospitals & Clinics was approved to join the clinical trial on Monday, March 30, and already has enrolled patients.
Dilek Ince, MD, clinical associate professor of internal medicine - infectious diseases, is leading the Iowa portion of the clinical trial. She said Remdesivir is an anti-viral drug that has been shown in laboratory testing to be effective for coronaviruses, including MERS and SARS, which appeared in 2012 and 2003, respectively and most recently against, SARS-CoV-2, the virus that causes COVID-19. It was also tested as a treatment for Ebola in human studies. While those studies demonstrated its safety in humans, it was not effective against that disease.
Dr. Ince and her team are reviewing all patients admitted to UI Hospitals & Clinics with COVID-19 and will speak directly with those who meet the criteria to participate in the trial. Criteria include age 12 and older, laboratory-confirmed SARS-CoV-2 (COVID-19) infection requiring hospitalization, evidence of lung infection as shown in imaging, no underlying significant kidney or liver disfunction, and not pregnant or breastfeeding.
Those who agree to participate will be randomized to receive the drug or a placebo solution for either five or 10 days. Patients’ condition will be monitored and recorded at specific intervals. Doctors will look for evidence that the drug improves outcomes, including survival in patients with severe disease or shortening the duration of symptoms in those with less severe disease. They also are interested in whether the drug has an effect on viral shedding, which has implications for decreasing transmission of the disease between humans. Finally, they will be tracking any side effects of the drug.
This trial includes two studies at more than 70 sites worldwide. All of the sites combined will enroll 1,600 patients in a study of moderate disease severity and 2,400 patients in a study of severe disease. Once the study enrollment across all sites has reached those thresholds, the trials will close and evaluation can begin.
Ince said preliminary results from earlier Remdesivir studies conducted in China are expected within the next 1-2 months.
Ince said she and her team have been actively pursuing joining a trial like this in order to make treatments available to Iowans facing the severe effects of this pandemic. “Being the academic medical center for the state gives us an advantage in being selected,” she said.
The UI Carver College of Medicine has an active Infectious Disease Research Unit with extensive expertise in studying new treatments like this.
“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. “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.”
Brooks Jackson, MD, MBA, UI vice president for medical affairs and the Tyrone D. Artz Dean of the UI Carver College of Medicine, noted that clinical research to improve patient care is a fundamental part of the college’s mission. “An emergency like this clearly exemplifies how critical our research mission is,” he 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.”
Gilead Sciences Inc., which developed Remdesivir, is funding the study and supplying the drug.