Clinical Trials & Research News

Henry Ford to Study Use of Hydroxychloroquine to Prevent COVID-19

Hydroxychloroquine is a promising COVID-19 drug for ill patients, and the first large-scale study will uncover its effectiveness to protect frontline workers.

COVID-19 Drug

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By Samantha McGrail

- Henry Ford Health System will lead the first large-scale study in the US to determine the effectiveness of hydroxychloroquine in preventing COVID-19 among healthcare workers and first responders. 

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Experts believe the study of the anti-malarial drug, titled “WHIP COVID-19 Study,” could begin early as next week, after a plea from healthcare workers and first responders who will be eligible to volunteer to participate. 

“This is going to be the first major, definitive study in healthcare workers and first responders of hydroxychloroquine as a preventative medication,” said William W. O’Neill, MD, the Henry Ford Health System’s study’s organizer, an interventional cardiologist and researcher who has pioneered multiple treatments for heart disease. 

“There has been a lot of talk about this drug, but only a small, non-blinded study in Europe. We are going to change that in Metro Detroit and produce a scientific answer to the question: Does it work?”

Hydroxychloroquine is currently an FDA approved arthritis medicine that can also be used to treat malaria. It is available in the US by prescription only and is sold generically as Plaquenil. The drug is most often used by patients with arthritis, lupus, or other rheumatic conditions.

Recently, the drug has been floated as a COVID-19 treatment, with the Trump administration naming hydroxychloroquine as one of the most promising drugs for COVID-19 patients.

“Metro Detroit has a history of stepping up when things get tough,” said Adnan Munkarah, Henry Ford Health System’s executive vice president and chief clinical officer. “We have a commitment to do that right now – to look at all options in a scientific way – in the face of this worldwide pandemic.”

WHIP COVID-19 is a randomized, volunteer-based study consisting of over 3,000 individuals. It will look at whether hydroxychloroquine prevents frontline workers from contracting the virus. 

“We are glad to see Henry Ford’s lead on this volunteer study that could help protect medical workers and first responders across southeast Michigan,” Mayor Duggan said, acknowledging U.S. Food & Drug Administration Commissioner Dr. Stephen M. Hahn. “I also deeply appreciate Dr. Hahn’s prompt support for this important effort.”

After providing a blood sample, individuals will receive vials of unidentified, specific pills to take for the next eight weeks. The vials will either include a once-a-week dose of hydroxychloroquine or a once-a-day dose of a placebo. 

Over the weeks, experts will check on the participants to see if they are displaying any COVID-19 symptoms such as dry cough, fever, or breathing issues. At the eight-week mark, results will be compared among the groups. Marcus Zervos, MD, will oversee the study with O’Neill.

“Given our broad clinical trials and translational research infrastructure, we are grateful to bring this type of large-scale effort to the COVID-19 battle,” said Steven Kalkanis, MD, CEO of Henry Ford Medical Group and senior vice president and chief academic officer of Henry Ford Health System. “We see the heroics of the frontline responders in healthcare, public safety and service. Henry Ford Health System is poised to do anything we can to help them stay safe.”

If the study finds hydroxychloroquine effective against COVID-19, it is possible that it could be deemed as a treatment for the virus. Currently, doctors are prescribing the drug as an off-label treatment for currently hospitalized COVID-19 patients who meet specific criteria. 

Earlier this week, FDA  an Emergency Use Authorization (EUA) for the emergency use of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate as COVID-19 treatments. 

As part of the EUA, HHS  30 million doses of hydroxychloroquine sulfate, donated by Sandoz, and chloroquine, donated by Bayer Pharmaceuticals, to distribute to hospitals across the country.