As the anti-malarial drug hydroxychloroquine continues to attract controversy — including President Trump’s announcement this week that he’s taking it — physicians and scientists in Tampa Bay are among many across the globe still studying the medication as a tool to treat or prevent COVID-19.
Those efforts include a drug trial soon to be under way at the University of South Florida, and a fast-moving push at Tampa General Hospital to see how the medication works when tested on health care workers.
Thousands of workers from Tampa General have signed up for the national HERO Registry, a clinical research community focused on coronavirus exposure of health care workers, said Rachel Karlnoski, director of USF Health Clinical Research Operations.
The first study in the registry is testing the use of hydroxychloroquine in a population of 15,000 health care workers around the nation to see if the drug can help prevent COVID-19 infection in those who have been exposed to the virus.
“Tampa General was one of the highest contributors of data for the registry,” Karlnoski said.
So far, the hospital has treated seven Tampa-based health care workers with daily hydroxychloroquine medication for the trial, she said.
Dr. Seetha Lakshmi, an epidemiologist at USF Health and Tampa General, said it’s an ambitious undertaking.
“It’s designed to be completed in eight weeks,” she said, describing that timeline as unusual and accelerated. “We need answers on how to proceed, especially when it comes to preventing COVID-19 among health care workers.”
Trump disclosed this week that he is taking hydroxychloroquine daily as a preventative measure against COVID-19, despite warnings by top medical officials that it has not been proven safe. Early medical studies suggest that prolonged use of the drug could cause problems in the kidneys, liver and heart.
The U.S. Food and Drug Administration issued a safety warning for hydroxychloroquine and a similar drug, chloroquine, on April 24, warning people not to use the medication outside of a hospital or clinical trial settings. The agency cited the risk of heart rhythm problems.
The trial involving Tampa General workers is a blind study, meaning not all participants will be treated with hydroxychloroquine. Some will get a placebo.
“Because it has antiviral properties, we believe its use is probably in prevention rather than treatment," Lakshmi said. “But we just don’t know for sure. We have to find out for the sake of all of us. We need this study to find out what the truth is.”
At USF, some of the early coronavirus-related clinical trials have been stalled because of conflicting information over the safety of some medications like hydroxychloroquine.
“Researchers found that hydroxychloroquine emphasized dangerous heart arrhythmias and issues with the liver and kidneys, and the FDA chose to pause trials to put more safety measures in place,” said Karlnoski, the USF research director.
“USF had a clinical trial in the pipeline that was targeting people who tested positive for COVID-19 but did not require hospital care. But we had to postpone the study to amend our protocols based on the new FDA rules.”
The clinical trial would treat positive COVID-19 patients with hydroxychloroquine at home, using home health nurses to deliver and administer the drugs, she said. Because of the new FDA rules, USF researchers had to amend the trial to include regular electrocardiogram, or EKG, testing and blood tests to monitor heart rhythm and kidney and liver function.
Karlnoski said the postponed trial is about to begin re-accepting patients again.
Another issue that has slowed USF’s ability to jump-start clinical trials is the lower-than-expected number of coronavirus cases in the Tampa Bay region, she said.
“Our census is not as high as we anticipated. That’s a great thing,” Karlnoski said.
Tampa General has a COVID-19 unit made up of 18 intensive care beds and 30 “step down” beds for patients no longer in critical condition. Despite unit’s size, she said, the hospital has had only 23 COVID-19 patients at any one time, and only five on ventilators at one time.
“A majority of those patients came from nearby nursing homes,” Karlnoski said. “All of this impacts our ability to enroll patients in clinical trials. We need the population to recruit.”
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