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ColCORONA: Colchicine Reduces
Complications in Outpatient COVID-19
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Could Colchicine Be the New Aspirin?
The benefits of colchicine with regard to cardiovascular end points in COLCOT were at least as large as those of canakinumab in CANTOS.2
In conclusion, among patients with a recent myocardial infarction, colchicine at a dose of 0.5 mg daily led to a significantly lower percentage of patients with ischemic cardiovascular events than placebo.
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January 24, 2021
https://www.medscape.com/viewarticle/944593
The oral, anti-inflammatory drug colchicine can prevent complications and hospitalizations in patients newly diagnosed with COVID-19, according to a press release from the ColCORONA trial investigators.
After 1 month of therapy, there was a 21% risk reduction in the primary composite endpoint of death or hospitalizations that missed statistical significance, compared with placebo among 4488 outpatients enrolled in the global, phase 3 trial.
After excluding 329 patients without a confirmatory PCR test, however, the use of colchicine was reported to significantly reduce hospitalizations by 25%, the need for mechanical ventilation by 50%, and deaths by 44%.
"We believe that this is a medical breakthrough. There's no approved therapy to prevent complications of COVID-19 in outpatients, to prevent them from reaching the hospital," lead investigator Jean-Claude Tardif, MD, from the Montreal Heart Institute in Quebec, Canada, told theheart.org | Medscape Cardiology.
"I know that several countries will be reviewing the data very rapidly and that Greece approved it today," he said. "So this is providing hope for patients."
Having been burned by hydroxychloroquine and other treatments brought forth without peer review, the response to the announcement was tempered by a desire for more details.
Asked for comment, Steven E. Nissen, MD, Cleveland Clinic Foundation, Cleveland, Ohio, was cautious. "The press release about the trial is vague and lacks details such as hazard ratios, confidence intervals, and P values," he told theheart.org | Medscape Cardiology.
"It is impossible to evaluate the results of this trial without these details. It is also uncertain how rigorously data were collected," he added. "We'll need to see the manuscript to adequately interpret the results."
The evidence in the press release is hard to interpret, but early intervention with anti-inflammatory therapy has considerable biologic appeal in COVID, said Paul Ridker, MD, MPH, who led the pivotal CANTOS trial of the anti-inflammatory drug canakinumab in the post-MI setting, and is also chair of the ACTIV-4B trial currently investigating anticoagulants and antithrombotics in outpatient COVID.
"Colchicine is both inexpensive and generally well tolerated, and the apparent benefits so far reported are substantial," Ridker, from Brigham and Women's Hospital in Boston, Massachusetts, told theheart.org | Medscape Cardiology. "We are eager to see the full data as rapidly as possible."
The commonly used gout and rheumatic disease agent costs about 26 cents in Canada and between $4 and $6 in the United States. As previously reported, it improved the time to clinical deterioration but not mortality in the 105-patient Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention (GRECCO-19) study.
Tardif said he's looking forward to having the data in the public domain and that they acted swiftly because the evidence was "clinically persuasive" and "the health system is congested now."
"We received the results Friday, January 22 at 5 p.m., an hour later we were in meetings with our data safety monitoring board [DSMB], 2 hours later we issued a press release, and a day later we're submitting a full manuscript to a major scientific journal, so I don't know if anyone has done this at this speed," he said. "So we are actually very proud of what we did."
ColCORONA was designed to enroll 6000 outpatients, at least 40 years of age, who were diagnosed with COVID-19 infection within the previous 24 hours, and had a least one high-risk criterion, including age at least 70 years, body mass index ≥ 30 kg/m2, diabetes mellitus, uncontrolled hypertension, known respiratory disease, heart failure or coronary disease, fever of ≥ 38.4°C within the last 48 hours, dyspnea at presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count.
Participants were randomly assigned to receive either placebo or colchicine 0.5 mg twice daily for 3 days and then once daily for another 27 days.
The number needed to prevent one COVID-19 complication is about 60 patients, Tardif said.
Colchicine was well-tolerated and resulted in fewer serious adverse events than with placebo, he said. Diarrhea occurred more often with colchicine, but there was no increase in pneumonia. Caution should be used, however, in treating patients with severe renal disease.
Tardif said he would not prescribe colchicine to an 18-year-old COVID outpatient who doesn't have any concomitant diseases, but would for those meeting the study protocol.
"As long as a patient appears to me to be at risk of a complication, I would prescribe it, without a doubt," he said. "I can tell you that when we held the meeting with the DSMB Friday evening, I actually put each member on the spot and asked them, 'If it were you - not even treating a patient, but if you had COVID today, would you take it based on the data you've seen?' and all of the DSMB members said they would.
"So we'll have that debate in the public domain when the paper is out, but I believe most physicians will use it to treat their patients."
The trial was coordinated by the Montreal Heart Institute and funded by the Government of Quebec; the National Heart, Lung, and Blood Institute of the US National Institutes of Health; Montreal philanthropist Sophie Desmarais; and the COVID-19 Therapeutics Accelerator launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard. CGI, Dacima, and Pharmascience of Montreal were also collaborators.
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Colchicine reduces the risk of COVID-19-related complications
January 23, 2021
https://www.icm-mhi.org/en/pressroom/news/colchicine-reduces-risk-covid-19-related-complications
Positive results from COLCORONA trial show that colchicine is the only effective oral medication for treating non-hospitalized patients
MONTREAL, January 22, 2021 - The Montreal Heart Institute (MHI) announced today that the COLCORONA clinical trial has provided clinically persuasive results of colchicine's efficacy to treat COVID-19. The study results have shown that colchicine has reduced by 21% the risk of death or hospitalizations in patients with COVID-19 compared to placebo. This result obtained for the global study population of 4488 patients approached statistical significance. The analysis of the 4159 patients in whom the diagnosis of COVID-19 was proven by a naso-pharyngeal PCR test has shown that the use of colchicine was associated with statistically significant reductions in the risk of death or hospitalization compared to placebo. In these patients with a proven diagnosis of COVID-19, colchicine reduced hospitalizations by 25%, the need for mechanical ventilation by 50%, and deaths by 44%. This major scientific discovery makes colchicine the world's first oral drug that could be used to treat non-hospitalized patients with COVID-19.
"Our research shows the efficacy of colchicine treatment in preventing the 'cytokine storm' phenomenon and reducing the complications associated with COVID-19," said Dr. Jean-Claude Tardif, Director of the MHI Research Center, Professor of Medicine at the Université de Montréal and Principal Investigator of the COLCORONA trial. "We are pleased to offer the first oral medication in the world whose use could have a significant impact on public health and potentially prevent COVID-19 complications for millions of patients."
Treating patients at risk of complications with colchicine as soon as the diagnosis of COVID-19 is confirmed by PCR reduces their risk of developing a severe form of the disease and, consequently, reduces the number of hospitalizations. Prescribing colchicine to patients could help alleviate the problems of hospital congestion and reduce healthcare costs here and around the world.
"Our innovative research program also proves that the Montreal Heart Institute can make rapid scientific breakthroughs in a way that is economically viable for patients by repurposing existing drugs," continued Dr. Jean-Claude Tardif.
COLCORONA is a contact-less, randomized, double-blind, placebo-controlled clinical trial that took place at home. It has been conducted in Canada, the United States, Europe, South America and South Africa. It was designed to determine whether colchicine could reduce the risk of severe complications associated with COVID-19. COLCORONA was conducted among approximately 4,500 COVID-19 patients not hospitalized at the time of enrollment, with at least one risk factor for COVID-19 complications. This is the world's largest study testing an orally administered drug in non-hospitalized patients with COVID-19.
COLCORONA was coordinated by the Montreal Heart Institute's Montreal Health Innovations Coordinating Center (MHICC), and funded by the Government of Quebec, the National Heart, Lung, and Blood Institute of the U.S. National Institutes of Health (NIH), Montreal philanthropist Sophie Desmarais, and the COVID-19 Therapeutics Accelerator, an initiative launched by the Bill & Melinda Gates Foundation, Wellcome and Mastercard. CGI, Dacima and Pharmascience of Montreal were also collaborators in the trial.
The Montreal Heart Institute and its global partners would like to warmly thank the participants and researchers for their collaboration in the COLCORONA clinical trial.
For more information, visit 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 Université de Montréal and has more than 2,000 employees, including 245 doctors and more than 85 researchers. icm-mhi.org
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 4,500 clinical sites in more than 35 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials, and drug repurposing. mhicc.org
About Pharmascience
Founded in 1983, Pharmascience Inc. is the largest pharmaceutical employer in Quebec. With its head office located in Montreal and its 1,500 employees, Pharmascience Inc. is a private pharmaceutical company with deep roots in Canada, and whose global reach spans across more than 60 countries. Ranked 47th among the top 100 Canadian investors in Research and Development (R&D), thanks to $49,5 million investment in 2018, Pharmascience Inc. is one of the largest manufacturer of generic drugs in the country. pharmascience.com
About CGI
Founded in 1976, CGI is one of the world's largest information technology (IT) and management consulting firms. From hundreds of locations around the world, CGI offers a complete portfolio of services and solutions: strategic IT and management consulting services, systems integration services, intellectual property solutions as well as IT and business process management services in delegated mode. cgi.com/canada
About Dacima
Founded in 2006, Dacima Software Inc. is a leading innovator in Electronic Data Capture (EDC) software for clinical research. Dacima's EDC software, Dacima Clinical Suite, is a fully feature EDC software application with integrated modules for patient randomization (IWRS), supply management, ePRO, eDiary, medical coding and eConsent. Dacima's flexible and highly configurable EDC platforms allow for the design of all types of study designs including clinical trials, patient registries, observational studies and web surveys through an intuitive user-friendly web interface. dacimasoftware.com
About the COVID-19 Therapeutics Accelerator
The Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard with support from public and philanthropic donors to speed up the response to the COVID-19 pandemic by identifying, assessing, developing, and scaling up treatments. Its partners are committed to equitable access, including making products available and affordable in low-resource settings.
https://www.therapeuticsaccelerator.org/
Media Contacts:
Camille Turbide
Camille.turbide@gmail.com
Canada : + 514 755-5354
Europe : +33 07 85 95 11 29
United States
Christy Maginn
christymmaginn@msn.com
+ 1 703 297-7194
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