Detroit’s HFHS to Lead First Large-scale Study in U.S. of Effectiveness of Anti-malarial Drug in COVID-19 Prevention

Detroit’s Henry Ford Health System on Thursday announced it will lead the first large-scale study in the U.S. of the effectiveness of an anti-malarial drug in preventing COVID-19 in health care workers and first responders who volunteer to participate.
Henry Ford is leading a large-scale study on the effectiveness on malaria drugs in preventing COVID-19. // Stock photo

Detroit’s Henry Ford Health System on Thursday announced it will lead the first large-scale study in the U.S. of the effectiveness of an anti-malarial drug in preventing COVID-19 in health care workers and first responders who volunteer to participate.

The study of hydroxychloroquine used preventatively could begin as early as next week.

“This is going to be the first major, definitive study in health care workers and first responders of hydroxychloroquine as a preventative medication,” says Dr. William W. O’Neill, a world-renowned interventional cardiologist and researcher who has pioneered multiple treatments for heart disease, and the study’s organizer at Henry Ford. “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?”

Dr. Marcus Zervos, division head of infectious disease at Henry Ford, will oversee the study with O’Neill.

“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,” says Detroit Mayor Mike Duggan, acknowledging U.S. Food and Drug Administration Commissioner Dr. Stephen M. Hahn. “I also deeply appreciate Dr. Hahn’s prompt support for this important effort.”

Health care workers and first responders will be enrolled at Henry Ford Hospital Detroit. There are currently no FDA-approved therapies to prevent or treat COVID-19. According to the U.S. Centers for Disease Control and Prevention, hydroxychloroquine, or hydroxychloroquine sulfate, is an FDA-approved arthritis medicine that can also be used to prevent or treat malaria. It is available in the U.S. by prescription only. It is sold under the drug name Plaquenil and is also sold as a generic medicine.

“Metro Detroit has a history of stepping up when things get tough,” says Dr. Adnan Munkarah, executive vice president and chief clinical officer of Henry Ford. “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.”

The study is called WHIP COVID-19 Study and is a more than 3,000-subject look at whether the drug prevents front-line workers from contracting the virus. Once they provide a blood sample, the study subjects will receive vials with unidentified pills to take over the following eight weeks. Participants could be given a once-a-week dose of hydroxychloroquine, a once-a-day dose, or a placebo. The study medicine was specially procured for the study and will not impact the supply of medicine for people who already take the medicine for other conditions.

Participants will not know what group they are in. They will be contacted weekly and in-person at week four and week eight of the study to see if they are exhibiting any symptoms of COVID-19 such as a dry cough, fever, or breathing issues, as well as medication side effects. At eight weeks, they will have blood drawn again. Results will be compared among the three groups to see if the medication had any effect.

“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,” says Dr. Steven Kalkanis, 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 health care, public safety, and service. Henry Ford Health System is poised to do anything we can to help them stay safe.” ​

The CDC describes hydroxychloroquine, which has been used for 75 years, as a relatively well-tolerated medicine. The most common adverse reactions reported are stomach pain, nausea, vomiting, and headache. The side effects can often be lessened by taking hydroxychloroquine with food. Hydroxychloroquine may also cause itching in some people. Minor side effects including nausea, occasional vomiting, or diarrhea do not usually require stopping the drug. Serious side effects are rare but can occur.

If the study finds the drug effective as a preventative measure, it is possible the study could expand to include hydroxychloroquine in other COVID-19 treatment options. Henry Ford doctors are prescribing hydroxychloroquine as an off-label treatment for only hospitalized COVID-19 positive patients who meet specific criteria as outlined by the hospital system’s Division of Infectious Diseases.

The FDA will provide the drug to the health system to distribute. Recruiting for the study has not yet begun. More information is available here.

Henry Ford has more than $100 million in annual research funding and is already involved in numerous COVID-19 trials with partners around the world.

The health system is a $6 billion integrated health system comprised of six hospitals, a health plan, and more than 250 other sites. It was established in 1915 and has 32,000 employees.