THE COLCORONA CLINICAL TRIAL
ColCorona is a randomized, double-blind, placebo-controlled study. Following signature of the informed consent form, 6,000 COVID-19-positive non-hospitalized subjects meeting all inclusion and no exclusion criteria are randomized to receive either Colchicine (0.5 mg twice per day for 3 days and once daily for the following 27 days) or placebo (1:1 allocation ratio) for 30 days.
The ColCorona Clinical Trial protocol has been approved by ethics committees and regulatory agencies. The study is monitored by a data monitoring committee (DMC) of experienced clinical trialists and is funded by the Government of Quebec, the US National Institutes of Health, and the Bill & Melinda Gates Foundation.
Follow-up phone or video assessments occur at days 15 and 30 following randomization for evaluation of the occurrence of any trial endpoints or adverse events.
The primary objective of ColCorona Clinical Trial
The primary objective of the ColCorona study is to determine whether short-term treatment with Colchicine reduces by at least 25% the rate of death and lung complications related to COVID-19. The primary endpoint is the composite of death or the need for hospitalization due to COVID-19 infection in the 30 days following randomization. The secondary endpoints include the need for mechanical ventilation.
Why partner with Montreal Heart Institute (MHI)
Founded in 1954, the Montreal Heart Institute constantly aims for the highest standards of excellence in the health industry by its leadership in clinical and basic research, ultra-specialized care, professional training, and prevention.
The Institute, which houses the largest research center in Canada has acquired in depth knowledge about colchicine in a previous study called COLchicine Cardiovascular Outcomes Trial (COLCOT-1) published in the New England Journal of Medicine. Dr. Jean-Claude Tardif, director of the MHI Research Center, and his team demonstrated that a low daily dose of colchicine (0.5 mg) significantly reduced the risk of first and total ischemic cardiovascular events by 23% and 34% respectively compared to placebo in 4745 patients with a recent heart attack. Furthermore, colchicine has also shown in one pre-clinical study to reduce experimental (hyperoxic) lung injury.
How to become involved in the ColCorona Clinical Trial
There are many ways you can get involved in the ColCorona Clinical Trial as a healthcare professional:
Become a recruitment partner in your area
Display information about the ColCorona trial in your organization (health clinic, emergency room, pharmacies, local charities, COVID-19 testing sites, etc.)
Refer your COVID-19 positive patients to the hotline: 1 877-536-6837
Build awareness of the ColCorona trial amongst your peers by sending them information
If you are a healthcare professional and wish to become involved in the ColCorona Clinical Trial, please contact email@example.com for more information on how you can help.
ColCorona resources for Healthcare professionals
For communication materials to build awareness of the ColCorona Clinical Trial, please contact: firstname.lastname@example.org