Health care workers and first responders will be volunteer participants in the Henry Ford Health System trial of the drug as preventive therapy against COVID-19.
Hydroxychloroquine will be tested in the first large-scale study in the US to determine the drug's effectiveness in preventing COVID-19 among healthcare workers and first responders.
The study of the antimalarial drug, titled "WHIP-COVID-19," is being conducted by Henry Ford Health System (HFHS), in Detroit, MI, and could begin as early as next week, according to a press release from HFHS.
“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?”
“There has been a lot of talk about this drug, but only a small, non-blinded study in Europe...This is going to be the first major, definitive study in healthcare workers and first responders of hydroxychloroquine as a preventative medication."
Participation in the randomized, placebo-controlled study is strictly on a volunteer basis. More than 3000 hospital healthcare workers and first responders from the Detroit metro area will be enrolled.
Participants will first provide a blood sample and then receive vials of unidentified, specific pills to take for the next 8 weeks. The vials will include either a once-a-week dose of hydroxychloroquine, a once-a-day dose, or a placebo.
Researchers will contact participants weekly and in person at weeks 4 and 8 to determine if they are experiencing any symptoms of COVID-19, ie, dry cough, fever, respiratory issues or medication side effects. Blood will again be drawn at week 8 and results among the 3 groups compared.
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. There is currently no FDA-approved therapy to treat or prevent infection with SARS-CoV-2.
Earlier this week, FDA an Emergency Use Authorization for the emergency use of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate as COVID-19 treatments for hospitalized patients who meet specific criteria.
The FDA will provide the drug directly to Henry Ford Health System physicians to distribute. Recruiting has not yet begun. More information can be found at www.HenryFord.com/whipCOVID19.
For more COVID-19 coverage for primary care, visit our COVID-19 Resource Page.