When researchers at the University of Rochester Medical Center began looking for volunteers earlier this month for a local trial of hydroxychloroquine to treat COVID-19, they hoped to enroll about 200 people.
That hasn’t happened.
“The slow enrollment data seems to indicate that it’s going to take forever to enroll the trial,” said Dr. Michael Keefer, who’s leading the research team.
URMC is one of several sites across the country conducting federally sponsored research into the drug’s ability to treat COVID-19, but the local problem of obtaining participants might be unique, as spread of the novel coronavirus slows in New York but accelerates in other states.
“The number of cases in Rochester are decreasing, so there’s actually less number of people who might qualify for some of these studies,” said Keefer. “It’s kind of a good problem we’re having.”
Now comes another headwind: This week, the federal Food and Drug Administration revoked the emergency authorization that allowed hydroxychloroquine to be used for COVID-19 treatment.
“It is no longer reasonable to believe that oral formulations of HCQ [hydroxychloroquine] and CQ [chloroquine] may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks,” the FDA said.
The revocation does not affect clinical trials, but Keefer said the FDA’s findings indicate that there could be better treatments to study. “We’ll be able to move to other research if the trial is stopped,” he said.
For now, the study at URMC is still underway, but Keefer said he’s in touch with researchers at the other institutions in the research network to decide if it will continue.
The National Institute of Allergy and Infectious Diseases, which oversees the research, did not immediately respond to questions about whether the research will continue.
Outside of clinical trials, doctors at both URMC and Rochester Regional Health had been using hydroxychloroquine in some patients earlier in the outbreak, but that stopped as some of the evidence that led to the FDA revoking its authorization emerged.
“We stopped using hydroxychloroquine weeks ago,” said Dr. Maryrose Laguio-Vila at Rochester Regional Health. “It was last prescribed for a patient with COVID in April.”
URMC stopped using the drug for COVID-19 treatment in May, said pharmacist Kelly Pillinger.
These shifts are to be expected with a new disease like COVID-19, Keefer said. “This happens in clinical research,” he said. “Things move so quickly.”