U of M COVID-19 Clinical Trial Expands Participant Enrollment Opportunities
Author: | April 1, 2020
MINNEAPOLIS, MN- April 1, 2020 – A clinical trial led by the University of Minnesota on a post-exposure treatment for the coronavirus (COVID-19) is expanding participant enrollment opportunities.
This trial, which is testing hydroxychloroquine, an FDA-approved medicine for the prevention and treatment of malaria, as well as several autoimmune conditions, and known as Plaquenil(R), will now accept participants who meet the following:
Have no symptoms AND:
- Have been closely exposed to a person with confirmed COVID-19 within four days AND live in the same household as this person or are a healthcare worker or first responder,
Currently have symptoms that started within the last four days, are not hospitalized AND:
Have confirmed COVID-19, OR
Live with a person with confirmed COVID-19, OR
Are a healthcare worker or first responder with a known exposure.
The prevention trial seeks to enroll 900 more people within the next two weeks from across the United States and Canada. David Boulware, MD, MPH, a professor in the University of Minnesota Medical School’s Department of Medicine in the Division of Infectious Diseases, leads the trial with a collaborative team from throughout the University, including infectious disease faculty physicians, biostatisticians, pharmacologists and students.
“The more participation we get, the faster we will get results,” Boulware said. “We are in critical need of more public participation so that we can prove that hydroxychloroquine works. Our objective is to be fully enrolled in the prevention trial in about two weeks with final results in about four weeks. We will be performing the first interim analysis on April 8, but won’t be releasing any data, unless the trial stops.”
This is the first clinical trial to determine if hydroxychloroquine is effective in preventing COVID-19 in humans. In order to test this effect, the trial will provide hydroxychloroquine to half the study participants, while the other half will receive a vitamin. The research study medicine will be delivered to each participant’s home overnight, anywhere in the country.
The second, new trial is seeking to determine if hydroxychloroquine, given to non-hospitalized people with COVID-19, can prevent hospitalization and decrease the severity of symptoms. This treatment trial for those with symptomatic COVID-19 is seeking 1,300 participants.
“If effective, this may become a worldwide standard of care for helping prevent disease in other healthcare workers and people exposed,” Boulware said. “Hydroxychloroquine is an off-patent, generic medicine that is inexpensive. A five-day treatment course would cost approximately $12.”
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 COVID-19 exploded, he and his team, including Drs. Matthew Pullen, Caleb Skipper, Radha Rajasingham, Sarah Lofgren, and Mahsa Abassi, refocused their efforts.
For more information about the trial or to enroll, visit https://covidpep.umn.edu.
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