Trials for a Treatment

Ince leads clinical trials for experimental drug remdesivir to treat COVID-19

As medical professionals worldwide explored treatment options for COVID-19, a University of Iowa Health Care infectious disease research team participated in a clinical study on remdesivir—an intravenous antiviral drug that’s shown the potential to shorten recovery time and reduce deaths.

Dilek Ince (06R, 08F, 09F), MD, a clinical associate professor of internal medicine and an infectious diseases specialist, led the UI portion of an international clinical trial of remdesivir, which yielded promising results in an initial National Institutes of Health study.

Ince and her colleagues started seeking COVID-19 treatment options as the virus spread throughout China. They saw potential in remdesivir, which had previous success against the coronaviruses that cause SARS and MERS.

In the early NIH results, the antiviral drug demonstrated an ability to inhibit COVID-19 from replicating or infecting other cells—a hopeful development amid the hundreds of trials for coronavirus treatments that had shown little or conflicting data on their usefulness.

Two days after the NIH published its study results in late April, the U.S. Food and Drug Administration issued emergency use authorization to expedite the drug’s availability to more patients with severe cases of COVID-19. The Iowa Department of Public Health distributed the state’s allocation of remdesivir to hospitals based on criteria, including an area’s number of hospitalized patients, number of intensive care unit patients, trends in disease activity, and available equipment and personnel.

UI Hospitals & Clinics also was one of approximately 180 sites worldwide participating in a pair of clinical trials sponsored by Gilead Sciences, the biopharmaceutical company that developed remdesivir. Ince led a team of six researchers that tested patients with moderate and severe cases of COVID-19, tracking their progress for up to 28 days. In the moderate case study, patients were randomized to receive either the drug through an IV daily or the standard of care for five or 10 days. Patients with severe cases received daily remdesivir infusions for 10 days.

Ince’s team was approved for the Gilead study on March 30, enrolled its first patient the next morning, and registered 37 patients before enrollment closed on May 29.

On June 1, Gilead Sciences announced topline results from the phase 3 clinical trial of remdesivir in patients with moderate COVID-19. The study found that patients in a five-day remdesivir treatment group were 65% more likely to have clinical improvement at day 11, compared with patients receiving standard of care. The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care also were favorable, trending toward, but not reaching, statistical significance, according to the Gilead announcement.

While Ince was encouraged by the preliminary findings, she believes more testing is necessary to determine the drug’s effectiveness, which populations it can help most, and how early treatment should start. Thousands of patients will need to be tested worldwide before any solid conclusions can be made from the study, though so far, no patients have experienced any adverse effects, she says.

Ince adds that the emergency use authorization granted by the FDA for remdesivir was for hospitalized patients with severe COVID-19 only. The FDA authorization is temporary and does not replace a formal new drug application submission, review, and approval process. Once the drug becomes more widely available, treatment for patients with moderate COVID-19 may be a possibility.

Ince’s early interest in biological sciences and working with patients led her to choose medical school. She studied infectious diseases in her native Turkey before conducting bench research in antimicrobial resistance as a research fellow at Massachusetts General Hospital in Boston. Originally planning to return to Turkey after completing a few years of research in Boston, Ince instead pursued clinical training and additional research opportunities at Iowa. Involved in the UI Carver College of Medicine’s Infectious Disease Research Unit for the past 10 years, Ince has focused on transplant infectious diseases and leading the antimicrobial stewardship program.

“My husband [Mirac (07F)] and I were looking at places where we could get excellent residency and fellowship training—and also have a family,” says Ince. “We thought Iowa would give us a very good opportunity.”

Throughout her first research study as principal investigator, Ince has been impressed with the commitment of her staff to providing the best possible care for patients with COVID-19.

“Everybody has been going above and beyond in this pandemic for patients, for their coworkers, and for patients’ families,” says Ince. “Everybody has been so compassionate and hardworking. It’s been amazing to see the whole staff at the university respond like this.”

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