The University of Minnesota is launching a clinical trial on a post-exposure treatment for coronavirus COVID-19 disease.
This trial is testing hydroxychloroquine, an FDA-approved medicine for the prevention and treatment of malaria, available since the 1950s and known as Plaquenil. Recent work shows that hydroxychloroquine is active in a laboratory setting against the novel SAS-CoV2 virus, and the trial is designed to see if it translates into benefits for people.
The trial seeks to enroll up to 1,500 people who have had household contact or those who are healthcare workers that have been exposed to someone with known COVID-19 disease within the past 3 days and who presently are not ill. The trial is national in scope.
In order to determine if taking the medicine hydroxychloroquine can prevent a person with exposure to the coronavirus from becoming ill or in reducing the severity of illness, the trial will provide hydroxychloroquine to half the study participants, while the other half will receive a vitamin.
To be eligible, one must live with someone who has diagnosed coronavirus COVID-19 or be a healthcare worker with a high-risk exposure within the past 3 days. The research study medicine will be delivered to their home overnight. If you think you may be eligible to participate in the trial, email firstname.lastname@example.org for further instructions.
The trial is being limited to only high-risk exposures, so that the trial may be completed as quickly as possible with the fewest number of volunteers. At this time, people who may have been exposed to coronavirus in the community are currently not eligible to participate.
The University of Minnesota trial seeks research volunteers who have been:
1. Closely exposed to a person with confirmed COVID-19 disease within three days; AND,
2. Are a household contact or a healthcare worker; AND,
3. Do not have current symptoms of COVID-19 disease.
This is a first clinical trial to determine if this medicine is effective in preventing COVID-19 disease in humans. The trial is led by David Boulware, MD, MPH, a professor of Medicine in the Division of Infectious Diseases, with a collaborative team from throughout the University including infectious disease faculty physicians, biostatisticians, pharmacologists and students. The U of M is funding the trial.
“If effective, this may become a worldwide standard of care for helping prevent disease in other healthcare workers and people exposed,” Dr. Boulware said in a university news release. “Hydroxychloroquine is an off-patent, generic medicine that is inexpensive. A 5-day treatment course would cost approximately $12.”
He added that if the medicine does not work to prevent infection, “we should find something better, and we need to work quickly to find something else.”
Dr. Boulware and his research team are known for their work focused on meningitis in Africa, testing new diagnostics and new antifungal therapies. However, as the community spread of coronavirus exploded, he and his team refocused their efforts.
“Just standing around to wait was inappropriate,” Dr. Boulware said. “When confronted with a problem, saying that someone should do something about the problem, that someone might be you.”
For more information about the trial, contact email@example.com.