KU Med Center’s trial of hydroxychloroquine off to strong enrollment start despite Trump’s controversial advocacy

photo by: Sara Shepherd

The University of Kansas Medical Center campus in Kansas City, Kan., shown from 39th Street facing east, is pictured June 11, 2017.

When the University of Kansas Medical Center announced in mid-April that it was joining a wide-ranging clinical trial for a drug controversially touted by President Donald Trump as a potential treatment for COVID-19, it naturally raised some eyebrows.

Studies at the time had been inconclusive in determining the efficacy of hydroxychloroquine in treating COVID-19. But Trump continued his advocacy for the drug — normally used to treat malaria and lupus — before announcing earlier this month he’d begun taking hydroxychloroquine as a preventative measure.

That announcement drew backlash, as the drug’s use is still up for debate as an option to prevent getting COVID-19, and some health experts said the president was putting people’s health at risk by advocating for an unproven drug.

But that’s exactly what the study KU Medical Center is a part of is trying to evaluate. The study hopes to enroll some 15,000 health care workers across the country to determine if hydroxychloroquine works as a prophylactic — or preventative — measure for those on the frontlines of fighting COVID-19.

The difference between hydroxychloroquine as a COVID-19 treatment and something to prevent getting the disease in the first place is key, Dr. Mario Castro told the Journal-World.

Castro is a pulmonologist at KU Medical Center and the vice chair for clinical and translational research. As KU’s principal investigator in the study, he said that the impact COVID-19 is having on the health care industry requires all types of evaluation in a quest to find answers.

“There’s unfortunately a lot to learn still about how we prevent and treat COVID and we really need to build that evidence,” he said. “We tend not to be influenced so much by what’s out there in the press but what’s in scientific journals.”

On Friday, the largest survey of hydroxychloroquine as a treatment for COVID-19 revealed that patients with confirmed cases of the disease were actually at an exponentially increased risk of heart issues and death if treated with the drug.

Castro said that while studies have shown hydroxychloroquine almost definitively doesn’t work to treat COVID-19, and can be dangerous in cases, the drug is safely managed for their trial’s participants — and the drug functions differently when evaluated as a preventative measure.

“Our scientific basis behind this study is we really need to know whether hydroxychloroquine will work as a prophylactic or preventative measure for COVID-19,” he said. “At this point we have no available treatment or prophylactic for health care workers.”

Also important to note, he said, is that hydroxychloroquine has been around for decades and has been deemed perfectly safe for other uses.

“The thing we try to stress is we’ve been using this drug for over 50 years. We are comfortable in its use for prevention treatment and use for other cases,” Castro said. “As with everything we do in medicine, we know how to manage the potential risk. The safeness of the drug in that kind of setting far outweighs any kind of risk.”

So far, KU Med Center had enrolled nearly 500 participants for the study, which was the goal when it was announced in April. Enrollment will still continue for another few weeks, Castro said.

Kansas Department of Health and Environment Secretary Dr. Lee Norman said Friday in response to a question from the Journal-World that people who are frontline caregivers can self-identify and enroll themselves in the trial.

Norman said he wasn’t aware if the dosage of hydroxychloroquine or the schedule at which trial participants take the drug was different than how patients across the country with COVID-19 had taken it as a possible treatment.

“I do know that there are significant concerns about the cardiac rhythm disturbance possibilities from hydroxychloroquine, but the study is still ongoing and hasn’t been terminated because of the more recent findings,” he said.


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