Maine Med patients begin taking part in COVID-19 drug trials

Maine Medical Center, the 637-bed flagship hospital of MaineHealth in Portland, has begun enrolling patients in clinical trials of a drug that may ultimately help treat people with COVID-19.

The medical center has joined two clinical studies examining the effectiveness of the drug, Remdesivir, against moderate and severe cases of the disease, according to a news release Tuesday.

MMC enrolled its first patient in the study of treatment for severe cases on April 9, and now has three patients in that study. The hospital has not yet enrolled patients in the study of moderate disease.

The two studies will enroll up to 7,600 patients worldwide, and are sponsored by the drug’s manufacturer, California-based Gilead Sciences Inc. (Nasdaq: GILD). The company developed the intravenous medicine for use against the Ebola virus in 2018.

A preliminary study of 53 patients showed the drug had some effect with COVID-19, but that use is not legally approved by the federal Food and Drug Administration. Meanwhile, Remdesivir has received much attention, and President Donald Trump on March 20 said the drug was available for “compassionate use” in extreme cases of COVID-19. Days later, Gilead suspended that access, citing the need for clinical trials.

To be eligible for the MMC studies, participants must be at least 12 years old, hospitalized with COVID-19, have no significant kidney or liver dysfunction and not be pregnant or breastfeeding.

Currently, MMC is the only hospital in Maine enrolling patients in the studies, according to the release.

David Seder, the MMC principal investigator for the studies and the hospital’s chief of critical care, said, “Unless clinical research is conducted to identify which treatments are effective, doctors, nurses and other frontline caregivers will continue to be limited in how they can care for these patients. Clinical trials require multidisciplinary teams who are dedicated to advancing science and patient care so we can develop effective, evidence-based therapies.”

MMC Chief Academic Officer Doug Sawyer added, “While participation in a clinical trial does not guarantee patients they will be cured, and not everyone is eligible for participation, without such trials we will never learn more about how to fight this novel disease.”