The lead investigator in one of the first large-scale U.S. studies of hydroxychloroquine’s prevention of COVID-19, which is underway at Detroit’s Henry Ford Health System, emphasized that the safe, controlled studies are necessary to determine the medication’s potential to keep people from being infected with the novel coronavirus.
The “Will Hydroxychloroquine Impede or Prevent COVID-19,” or WHIP COVID-19, study is a 3,000-subject look in Detroit at whether the medicine prevents front-line workers from contracting the virus. The randomized, double-blinded study is designed to determine whether the treatment works, and preliminary results are expected in about four months. There are currently no vaccines or preventative medications for the virus.
“We are not involved in politics; we are scientists,” says Dr. William W. O’Neill, leader of the study and a world-renowned interventional cardiologist and researcher who has pioneered multiple treatments for heart disease. “There are no proven ways to keep people safe from COVID-19. This is a drug that has been used safely for more than 70 years to prevent malaria and treat other issues like lupus, with the potential to have active effect on COVID-19. We owe it to people – particularly front-line workers – to scientifically determine if it works.”
Henry Ford has more than $100 million in annual research funding and is already involved in COVID-19 trials with partners around the world. There are more than 25 studies either underway or being reviewed at the health system to either treat or prevent COVID-19.
“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. Marcus Zervos, division head of infectious disease for Henry Ford Health System.
Participation in the study is on a volunteer basis. The FDA has provided the drug directly to Henry Ford physicians to distribute. Enrollment takes place at Henry Ford Hospital in Detroit. Many volunteers are part of the Detroit COVID Consortium, a recently announced health care collaboration on COVID-19 that includes Henry Ford, Ascension, Detroit Medical Center, Wayne State University, and Beaumont Health. O’Neill recently organized the group to coordinate and disseminate information about large-scale studies of COVID-19 treatments and bring the measures to health care workers sooner.
Requirements to participate in the study include:
- Badged employees of Michigan hospital systems
- Badged first responders
- Badged bus drivers
- Between 18 and 75 years of age
- Not exhibiting COVID-19 symptoms
- Never previously diagnosed with COVID-19
- No significant heart or retinal disease
- No one who is pregnant or nursing
Study coordinators will be in contact with those accepted to the study to schedule an enrollment visit, where they will be further screened for participation.
Once accepted into the study, volunteers will each provide a blood sample and receive a vial with unidentified, specific pills to take over the next eight weeks. Some will receive a once-a-week dose of hydroxychloroquine, some will receive a once-a-day dose, and some will receive a placebo (a pill that looks like medication but does not contain any medication or active ingredients). The study medication was specially procured for the study and will not impact the supply of medication for people who are taking it for other conditions.
Participants will not know whether their pills are placebos. They will be contact weekly and in-person at week four and week eight of the study to have blood drawn and see if they are exhibiting symptoms of COVID-19, as well as medication side effects. Results will be compared among the three groups to see if the medication had any effect.
“Whether this medication works or not, having those results produced in a scientific manner moves us toward the goal of knowing how to protect our frontline workers,” says 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.”
According to the U.S. Centers for Disease Control and Prevention, hydroxychloroquine, also known as hydroxychloroquine sulfate, is a U.S. Food and Drug Administration-approved arthritis medication that can also be used to prevent or treat malaria. It is available in the U.S. by prescription only. The drug is sold under the brand name Plaquenil and as a generic medicine. It is commonly used by patients with arthritis, lupus, or other rheumatic conditions.
Hydroxychloroquine has been associated most recently with off-label or study-based use to either treat those who test positive for COVID-19 or prevent people from contracting COVID-19.
Outside of the study, Henry Ford doctors are prescribing hydroxychloroquine as an off-label treatment for only sick, hospitalized, COVID-19-positive patients. These patients must meet specific criteria as outlined by the hospital system’s Division of Infectious Diseases. The use in this setting is also being examined in a separate, retrospective study at Henry Ford.
More information about the study is available here, as well as a questionnaire for those interested in participating.
Henry Ford is a $6.5 billion integrated health system comprised of six hospitals, a health plan, and more than 250 sites including medical centers, walk-in and urgent care clinics, pharmacies, eye care facilities, and other health care retail. Established in 1915 by auto industry pioneer Henry Ford, the health system now has 32,000 employees.