Henry Ford Health System will lead the first large-scale study in the nation to determine the effectiveness of hydroxychloroquine in preventing COVID-19.
“If this works out, we'll save the lives of first responders around the world,” said Detroit Mayor Mike Duggan, in announcing the trial Thursday afternoon.
“If this works out, we'll save the lives of first responders around the world,” Detroit Mayor Mike Duggan said.
The Detroit-based hospital system seeks 3,000 health care workers and first responders for the study, which may determine whether the drug helps prevent COVID-19, especially among those most exposed to the deadly virus.
Rather than several months required for development and approval under normal circumstances, the effort took just 10 days, said Dr. Adnan Munkarah, Henry Ford’s chief clinical officer. It was fast-tracked after Duggan and metro Detroit health care providers pleaded with the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration for approval, according to Henry Ford officials.
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The virus that has wreaked hell on metro Detroit has created an urgency unprecedented in memory. By midday Thursday, the Motor City reported 2,858 cases, including 101 deaths, or nearly a quarter of all deaths statewide, despite making up just 7 percent of the state population. The rest of Wayne County had 2,221 cases and almost as many deaths as the city (93). Nearby Oakland has 2,183 confirmed cases and 119 deaths; Macomb County reported 1,332 cases and 58 deaths.
The virus is decimating the ranks of Detroit’s first-responders. As of Thursday, 106 police department officers and employees, 24 fire department employees and firefighters, and eight employees of Detroit’s transportation department had been sidelined after testing positive for COVID-19. Hundreds remain in quarantine, Duggan said in an afternoon news conference.
Hydroxychloroquine, an antimalarial drug, is also used to treat rheumatoid arthritis, lupus and other inflammatory diseases. Henry Ford doctors said it’s a relatively well-tolerated medicine. Serious side effects are rare, but common side effects include stomach pain, nausea, vomiting, headache and itching, according to Henry Ford. Mayo Clinic also offers a long list of symptoms that include dizziness, blurred vision and blistering.
Participants won’t know whether they’re receiving a regimen of hydroxychloroquine or a placebo. That allows researchers to tease out from the comparison groups whether the drug had an impact.
The FDA will provide hydroxychloroquine directly to Henry Ford physicians to distribute during the trial.
If researchers deem the drug effective as a preventative medication for COVID-19, the study may expand to determine whether hydroxychloroquine should be used in other COVID-19 treatment options, the doctors said.
In fact, Henry Ford doctors have already been prescribing hydroxychloroquine off-label for some patients hospitalized with COVID-19.
“We need this in our front lines for our Detroit police officers and EMTs, but also our health care workers, people in the emergency room and in our intensive care units, who are day in and day out, putting their lives on the line to protect our community,” said Dr. Steven Kalkanis, Henry Ford’s chief academic officer.
Despite the risks they face every day, “they do it willingly, and so we owe it to really define once and for all ‘Does this regimen work?’” he said.
Participants will give a blood sample and over eight weeks take a once-a-week dose of hydroxychloroquine or a placebo. They will be contacted weekly to report whether they develop symptoms of COVID-19, including dry cough, fever or breathing issues, and any medication side effects. They will have their blood drawn again at eight weeks so researchers can compare results between the drug and placebo groups.
“Nobody's promising any results here. We don't know,” Duggan said. “But what you've got is some of the finest scientists in America that believe this has potential, and the only way we're going to find out is to give it a try. It might not work but you might change the world,” he said.
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