U.S. Numbers of COVID-19 Diagnosis Continue to Rise; COLCORONA Trial Researchers Announce Increased U.S. Enrollment Options for this At-Home Study for Newly Diagnosed Patients­­­ with COVID-19

MONTREAL, July 27, 2020 /PRNewswire/ -- Montreal Heart Institute (MHI) today announced that the COLCORONA clinical trial has increased enrollment capacity in the United States (Los Angeles, San Francisco, Houston, Dallas, Miami, Gainesville, New York, New Jersey, Connecticut) as the positive case numbers of COVID-19 continue to rise. The COLCORONA trial recruits recently diagnosed, non-hospitalized adult patients with COVID-19 for participation in a free, at-home clinical trial designed to minimally burden patients. The largest trial of its kind, this at-home, contactless trial continues to also enroll in Canada, Spain and South Africa with more sites continually added.

"Our recent results in pre-clinical studies show the potential of colchicine to reduce the inflammatory storm and lung damage also seen in patients with COVID-19," said Dr. Jean-Claude Tardif, Director of the Research Center at MHI, Professor of Medicine at the University of Montreal, and COLCORONA principal investigator. "We are committed to including a large number of patients worldwide in this robust study to determine the ability of colchicine to keep patients out of the hospital, off ventilators and ultimately save lives."

Results from a recent study of acute respiratory distress syndrome (ARDS) in animals have shown that colchicine reduces lung injury and lung edema, and markedly improves blood oxygenation. Mortality in COVID-19 patients has been linked to the cytokine storm, where the body produces excessive pro-inflammatory molecules (cytokines) that eventually lead to ARDS and potentially death. Therefore, the results of this study strongly support the clinical development of colchicine to fight the complications of COVID-19. Full study results are available in preprint and support the continuation of the COLCORONA trial.

"At the moment, there is no available, FDA-approved treatment that can be given to patients at home to prevent them from worsening illness, hospitalization and death from COVID-19 complications. It is very important for us to find therapies that we can offer to patients now," said Dr. Norman Lepor, Director of Clinical Research for Westside Medical Associates of Los Angeles and COLCORONA primary investigator for Los Angeles.

The double-blind, placebo-controlled, randomized COLCORONA trial featuring a generic immunomodulator (colchicine) passed its futility analysis in June 2020 with an independent Data Safety Monitoring Board, allowing for continued enrollment. Colchicine, which is already available for treatment of gout, pericarditis, and Familial Mediterranean Fever, would be an affordable orally administered treatment option if results prove positive. 

What Patients Need to Know About the COLCORONA Trial to Enroll 

• Unlike most other studies, this study does not involve leaving your home. The study staff will contact you directly via phone or video-visits for follow-up. Medication or a placebo (a pill with no active ingredients) will be delivered to your home at no cost.
• If you are interested in joining, the study staff will determine if you are eligible to join. This study is one of the few enrolling newly diagnosed patients with mild to moderate symptoms who are not hospitalized and over the age of 40 (and recruits patients past the age of 70). 
• Participation in the study lasts 30 days. When the study is completed, the results will be announced, but will not include your identifying information.
• Patients and physicians interested in COLCORONA can call the study hotline at 1-877-536-6837, 24/7 or visit www.colcorona.net. If you have recently been diagnosed with COVID-19 and you are interested in participating in the COLCORONA trial, do not delay calling the hotline number.

About the COLCORONA Trial

COLCORONA is a contact-free, at-home, randomized, double-blind, placebo-controlled study run out of several regions in Canada, the United States, Europe, South America, 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), and Sophie Desmarais Montréal philanthropist, daughter of the late business mogul, Paul Desmarais Sr., Pharmascience, CGI, and DACIMA are also collaborators of COLCORONA.

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

About the Montreal Heart Institute

Founded in 1954, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in clinical and basic research, ultra-specialized care, professional training, and prevention. It houses the largest research center in Canada, the largest cardiovascular prevention center in the country, and the largest cardiovascular genetics center in Canada. The Institute is affiliated with the University of Montreal and has more than 2000 employees, including 245 physicians, as well as 650 people working in its Research Center.

About the Montreal Health Innovations Coordinating Center (MHICC)

The Montreal Health Innovations Coordinating Center (MHICC) is a leading academic clinical research organization and an integral part of the Montreal Heart Institute (MHI). The MHICC possesses an established network of collaborators in over 4500 clinical sites in more than 40 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials, and drug repurposing.

SOURCE Montreal Heart Institute

Related Links

http://www.colcorona.net