Researchers at the University of Rochester Medical Center have joined a pair of national trials to test the effectiveness of hydroxychloroquine in treating COVID-19.
The medication, approved by the federal Food and Drug Administration as a treatment for malaria, has had a controversial role in the coronavirus pandemic.
One reason those warnings are necessary, said the man leading the trial at URMC, is that the speed of the epidemic’s spread required accelerated studies that could not be clinically rigorous.
“When you are early in an epidemic or pandemic, your studies are only so good, and -- and they’re really observational,” said Dr. Michael Keefer, the chair of infectious diseases at URMC’s School of Medicine and Dentistry and the principal investigator on the hydroxychloroquine study.
Observational studies don’t use placebos -- they just watch what happens to people who get a certain treatment. There’s no clear way to compare those results to people who got other treatments -- or no treatment at all.
In contrast, the study at URMC will be placebo-controlled, Keefer said.
The side effects found in previous studies could be mitigated with carefully controlled dosing, he said.
“I’ve yet to see anything in the medical literature that says, ‘Just toss this out and forget about it.’ I mean, we don’t have the studies; we don’t have the definite proof to say that’s the way to go, and it would be a shame to toss out something that actually was helpful.”
Keefer said the research team at URMC is looking for 200 local participants. He said those should be people who have recently tested positive for the novel coronavirus.
Patients will be screened for heart conditions before being enrolled in the trial, Keefer said. “We want to be very careful in doing this and watch people very, very carefully,” he said.
Researchers were not concerned about the controversy surrounding the drug, said Keefer. “We don’t do politics, really. We do the trials.”