UT Southwestern announces open enrollment for at-home COLCORONA clinical trial

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UT Southwestern has launched a clinical trial to evaluate the therapeutic benefit of colchicine as a treatment to prevent complications and death related to severe cases of COVID-19.
Photo courtesy of Montreal Heart Institute.

DALLAS – Aug. 19, 2020 – UT Southwestern Medical Center is the first facility in Dallas and the surrounding region to participate in the international COLCORONA trial. This study is evaluating the therapeutic benefit of colchicine as a treatment to prevent complications and death related to severe cases of COVID-19. Recently diagnosed patients or individuals who are showing symptoms and have a household member diagnosed with COVID-19 over the age of 40 and from Dallas and the surrounding areas can enroll in this free, at-home clinical trial.    

COLCORONA is evaluating a generic immunomodulator called colchicine, commonly used to treat conditions such as gout, pericarditis, and Familial Mediterranean Fever, to see whether it reduces the complications of COVID-19, including in the respiratory system. The study has been designed to have minimal burden on patients and is one of the few current studies of COVID-19 infection in which nonhospitalized individuals can participate. 

“Lung injury and subsequent difficulty in breathing is experienced in up to 10 percent of patients with COVID-19 and can, unfortunately, often be fatal,” says Nancy Rollins, M.D., co-investigator for the COLCORONA trial at UTSW, where she is a professor of pediatrics and radiology, associate dean of clinical research, and holds the Charles Cameron Sprague, M.D., Chair in Medical Science. “Colchicine has shown promise in other smaller studies and we are excited to be part of this large international trial that will provide us with a definitive answer on how it works in patients with COVID-19.”

To be eligible for COLCORONA, patients should be nonhospitalized, over the age of 40, and recently diagnosed with COVID-19. Once enrolled, the medicine or placebo is delivered directly to participants’ homes at no cost, and participants will have the support of a dedicated health care team 24/7 for any questions. The study staff will contact patients directly via phone or video visits for follow-up.

Patients and physicians interested in COLCORONA can call the study hotline at 1-877-536-6837, 24/7 or visit www.colcorona.net.

“Our partnership with UTSW for COLCORONA allows this at-home trial to be available to an even wider number of patients,” says Jean-Claude Tardif, M.D., director of the Research Centre at the Montreal Heart Institute (MHI), professor of medicine at the University of Montreal, and COLCORONA principal investigator.

The COLCORONA trial continues to expand enrollment with sites in the United States in California (Los Angeles, San Francisco), Texas (Houston, Dallas), Florida (Miami) and the New York tri-state area as well as in Canada, Spain, and South Africa, with more sites continually added.

About the COLCORONA Trial 

COLCORONA is a contact-free, at-home, randomized, double-blind, placebo-controlled study run out of Canada, the United States, Europe, and South Africa. COLCORONA is coordinated by the Montreal Health Innovations Coordinating Center (MHICC) and funded by the Government of Quebec, the Bill & Melinda Gates Foundation, the National Heart, Lung, and Blood Institute (NHLBI) of the United States National Institutes of Health (NIH). Montreal philanthropist Sophie Desmarais, Pharmascience, CGI, and DACIMA are also collaborators of COLCORONA.

The Montreal Heart Institute and its partners worldwide would like to thank all the patients and investigators for their continued participation in the COLCORONA study.

For more information about the study, visit www.colcorona.net.

About UT Southwestern Medical Center

UT Southwestern, one of the premier academic medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty has received six Nobel Prizes and includes 24 members of the National Academy of Sciences, 16 members of the National Academy of Medicine, and 13 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 2,500 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in about 80 specialties to more than 105,000 hospitalized patients, nearly 370,000 emergency room cases, and oversee approximately 3 million outpatient visits a year.