There is presently no available, FDA-approved medicine that can be administered at a patient’s home that can prevent the negative progression of SARS-CoV-2 symptoms leading to hospitalization and potentially death. Can a widely available, generic drug used for gout change this? Based on preclinical animal research, the Montreal Heart Institute thinks potentially it can. Now the Montreal Heart Institute’s COLCORONA clinical trial has expanded its enrollment capacity in the United States as the number of positive COVID-19 cases 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. Purportedly the largest of its kind, this at-home, contactless trial continues to additionally enroll participants in Canada, Spain and South Africa. Recent expansion in America includes Los Angeles, San Francisco, Houston, Dallas, Miami, Gainesville, New York, New Jersey and Connecticut.
What is Colchicine?
Orally administered, this medicine is used to treat gout and Behcet’s disease, Colchicine is actually preferred over NSAIDS or steroids in the former diagnosis according to some reports. Other uses include the prevention of pericarditis and familial Mediterranean fever. The use of this drug, in the form of autumn crocus has been used for at least a few thousand years to treat joint swelling. A medicinal form was approved by the U.S. Food and Drug Administration (FDA) in 1961 and is available in generic form in that country and the United Kingdom. At least one of the drug’s packagers in the U.S. is Hikma Pharmaceuticals USA Inc. By 2017, at least according to some reports, its was the 201st most commonly prescribed medication in America with over two million prescriptions. The drug has an impact of reducing inflammation via multiple mechanisms.
Like most drugs,its does come associated with side effects including gastrointestinal issues especially at higher doses. Severe side effects can involve low blood cells and rhabdomyolysis. Although it isn’t clear if use during pregnancy is safe, at least some data indicate its use is safe during breastfeeding. Excessive doses can lead to death.
Preclinical (Animal) Research: the Hypothesis for the Study
The Montreal Heart Institute shred in their recent press release that 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.
COVID-19 deaths are associated with, or linked to the cytokine storm, where the body produces excessive pro-inflammatory molecules (cytokines) that eventually lead to ARDS and potentially fatality. Because the preclinical animal research had such promising results, the Montreal Heart institute mobilized resources and capital to commence a regulatory-approved study in humans. The results of the preclinical research was published in the preprint server called Research Square.
What is the COLCORONA Trial?
The COLCORONA Trial is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. The study targets up to 6,000 subjects meeting all inclusion criteria and no exclusion criteria are randomized to receive either colchicine or placebo tablets for 30 days. See the study’s website.
Led by the Montreal Heart Institute, the sponsors first and foremost seek to determine whether short-term treatment with colchicine reduces the rate of death and lung complications related to COVID-19. A secondary objective centers on the safety of the treatment in the targeted patient population. Safety and efficacy are based on data from randomized patients. The sponsor set up an independent data and safety monitoring board (DSMB) to periodically review study results as well as the overall conduct of the study, and thereby makes recommendations to the study Executive Steering Committee (ESC)as to continue, stop or modify the study protocol.
What Patients Should Know
This study is very different in that it doesn’t require the patient to leave home. Study staff contact the patient directly via phone or video-visits for follow-up. Medication or a placebo is delivered to the home at no cost. This study is one of a few that is enrolling newly diagnosed patients with mild to moderate symptoms who are not hospitalized and over the age of 40 (and that recruits patients past the age of 70). Study participation lasts 30 days. When the study is completed, the results will be announced, but will not include any patient identifying information.
COLCORONA Trial Sponsors & Collaborators
The study 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, US. National Health Institute (NIH) and Sophie Desmarais Montreal philanthropist (daughter of the late Paul Desmarais Dr—Pharmascience, CGI and DACIMA Software, and electronic data capture system.
Principal Investigator Point of View
Dr. Jean-Claude Tardif, Director of the Research Center at Montreal Heart Institute and Professor of Medicine at the University of Montreal as well as principal investigator of the COLCORONA trial, reports, “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.” Dr. Tardif continued, “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.”
Although this study is actually remote or virtual, allowing patients to stay at home, it does involve prominent research center participation including the University of California, San Francisco General Hospital, New York University School of Medicine, the Hospital Universitario La Paz in Madrid, Spain, and, of course, the Montreal Heart Institute.
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.
Dr. Jean-Claude Tardif, Director of the Research Center at Montreal Heart Institute and Professor of Medicine at the University of Montreal as well as principal investigator of the COLCORONA trial
Other investigators associated with participating centers include:
University of California, San Francisco, SFGH
New York University School of Medicine
Hospital Universitario La Paz
Call to Action: Do you meet the inclusion criteria and have interest in participating in the COLCORONA trial? Call the study hotline at 1-877-536-6387, 24/7 or visit www.colcorona.net.