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.
"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 immunomodulatory (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.