An international study will test whether a common anti-inflammatory drug can ward off serious complications from COVID-19 and possibly prevent patients from ending up in the hospital.
The study, which would involve 6,000 participants in the U.S., Canada and Europe, is designed to be "contactless" — participants will receive the drug, called colchicine, by mail, and will be monitored by phone or video visits. Participants will receive the drug within 48 hours of a COVID-19 diagnosis.
"This is one of the very few COVID-19 trials designed specifically for patients who have not yet been hospitalized," Dr. Priscilla Hsue, a professor of medicine at the University of California, San Francisco (UCSF) and principal investigator for one of the sites involved in the trial, said in a statement. "We suspect that early treatment, before the onset of severe symptoms requiring hospitalization, may provide the best chance to improve outcomes. By the time extensive lung damage has developed, it may be too late to intervene successfully."
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Colchicine is a widely available drug used to treat gout, a type of arthritis that causes pain and swelling in the joints, particularly the big toe, according to the National Institutes of Health. The drug works by reducing joint pain, inflammation and swelling.
The researchers hypothesized that early treatment with colchicine in COVID-19 patients may prevent a so-called cytokine storm, an aggressive immune system reaction that can damage the body's organs. Some researchers theorize this cytokine storm may play a role in causing serious complications from COVID-19. They note that children, who are less likely to experience a cytokine storm, also tend to have mild cases of the disease.
"This is an important trial that may provide definitive answer as to benefits of inflammation reduction for prevention of COVID19-related complications," Dr. Jean-Claude Tardif, director of the Montreal Heart Institute Research Centre, said in the statement. Tardif is the lead investigator of the study, which is called Colchicine Coronavirus SARS-CoV-2 Trial.
To be eligible, participants must be age 40 or older with at least one risk factor for serious COVID-19 complications, such as chronic heart or lung disease, diabetes or high blood pressure. They also need to have been diagnosed with COVID-19 in the last 24 hours before signing up.
UCSF and New York University School of Medicine will host two study sites in the U.S. The study will be led by researchers at the Montreal Heart Institute and involve several additional sites in Canada and Europe.
Participants apply for the study by phone, sign consent forms online and receive medication via courier soon after, the researchers said. They will have a phone or video follow-up visit after 15 and 30 days. The researchers will examine whether the drug reduced hospitalizations and deaths from COVID-19.
The study will be a "randomized double-blind placebo-controlled trial," which means that participants will be randomly assigned to receive either Colchicine or a placebo, and neither they nor their doctors will know which intervention the patients received.
People can learn more about the study by visiting the trial website, and they can enroll by calling (877) 536-6837.
Originally published on Live Science.
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