On January 22, the Montreal Heart Institute released a media communiqué about the results of the “COLCORONA” clinical trial on the use of colchicine to treat COVID-19 on an outpatient basis.
See French version. Update: the preprint was published on Jan 27. https://www.medrxiv.org/content/10.1101/2021.01.26.21250494v1
According to Wikipedia , colchicine is a very toxic tricyclic alkaloid, originally extracted from colchicum (plants of the genus Colchicum), mainly fall colchicum. (picture)
It is an agent known for more than 20 centuries, since “colchicum extract is described as a treatment for gout in De Materia Medica by Pedanius Dioscorides (published between AD 50 and 70 AD).”
The Montreal Heart Institute statement claims that “colchicine is the only effective oral medication for treating non-hospitalized patients.”
Please read it carefully again: it would be the “only effective oral medication” in outpatient care for COVID-19, nothing less!
What’s more, according to researchers at this institute, this is a world first. Never before, all over the planet, would an oral drug have shown any usefulness in treating COVID-19!
“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,” claims Dr. Jean-Claude Tardif , Director of the Montreal Heart Institute Research Center, Professor of Medicine at the Université de Montréal and Principal Investigator of the COLCORONA trial.
Results cannot be found on the clinical trial site or the trial page on clinicaltrials.gov – therefore it is not possible to analyze the study results at this stage.
From this media release, it appears the claims of the study’s authors may be incredibly exaggerated.
First of all, colchicine has already been the subject of several studies, as evidenced by this meta-analysis.
Then, we already know that several therapeutic agents, administered on an outpatient basis, make it possible to reduce the risks of hospitalization and death, as explained for example by Professor McCullough and 56 other authors, including several of world renown, in the article “Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-risk SARS-CoV-2 infection (COVID-19).”
There is ample evidence for the efficacy of molecules such as hydroxychloroquine and ivermectin, in combination with molecules such as azithromycin, doxycycline and zinc sulfate. And the results are already being shown, especially with studies showing a reduction in the need for hospitalization of 80% or more. See for example: https://c19study.com/
But what are Montreal researchers telling us? That all these other studies about COVID-19 outpatient care would not be scientific, and that only their own study would have identified an effective therapeutic agent in outpatient settings.
The press release states that “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 is a reduction of course, but very modest compared to the 80% and more observed in the studies of the ambulatory practices of Dr Brian Procter and Zev Zelenko.
The Montreal study involves an impressive 4,488 patients, mainly in Quebec. It is quite astonishing in this context that this 21% drop in the risk of death or hospitalization only “approached statistical significance” according to the press release. (underlined by the author)
Approaching statistical significance is not reaching it!
The press release then mentions significant results for a very large subset of 4,159 patients, where the risk of death would then have been reduced by 44%, which seems at first glance hardly compatible with the aforementioned non-significant drop of 21%.
Without access to the detailed results of the study, it is hardly possible to draw any conclusions other than to suggest the greatest caution.
The extremely knowledgeable “Covid19Crusher” on Twitter was not kind to the Montreal Heart Institute:
“Pathetically and outrageously, it falsely claims that colchicine is the only effective medication for outpatients.”
While the repurposing of molecules has been practiced since February 2020 to treat COVID-19, the press release continues with another pompous statement:
“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.”
If the press release was dated January 22, 2020, we would shout bravo. The problem is that it is dated January 22, 2021.
This is of course not the kind of rapidity that should be adopted in times of pandemic, especially in a province and a country practicing medical nihilism, with no treatment whatsoever of COVID-19 patients before hospitalization.
Note that colchicine is already in the outpatient treatment algorithm for COVID-19, published by Professor McCullough and 56 other authors.
Yes, the practical modalities of outpatient treatment are already very well known for COVID-19, and this Quebec / Canadian contribution seems very much behind the best in the field.
Despite its obvious weaknesses, the press release drew some rather laudatory and as usual very un-analytical articles in the media. As this is a local study, journalists in Quebec and Canada are shouting bravo.
The highly popular Journal de Montréal quoted Professor Tardif declaring: “We had to alert the planet quickly” … nothing less.
The pandemic has unfortunately taught us that in reality there remains very few journalists capable of any analysis in the media.
Already, there are signs that the people of Quebec want their colchicine, even though it may not be an effective treatment, if we are to rely on the non-significant result of the study relative to the drop in hospitalization and deaths by 21%. And let’s not forget, this decrease represents less than a quarter of what is obtained with other outpatient therapies, which are ignored by the authors of that study.
A relevant question in relation to this study is whether it would help to question the therapeutic nihilism practiced by Quebec and Canada, which refuse outpatient treatment to the population, including in nursing homes, where thousands of innocent people left their lives untreated, where about 80% of deaths have occurred, often in appalling conditions.
If the study helps abandon this therapeutic nihilism, that will be a good thing. Better late than never. However, the authorities should be brought to understand that it is multi-drug treatments, sequenced in time, that must be introduced rapidly as therapies to be taken at home, and not an isolated agent such as colchicine.
Colchicine reduces the risk of COVID-19-related complications
Positive results from COLCORONA trial show that colchicine is the only effective oral medication for treating non-hospitalized patients
MONTREAL, Jan. 22, 2021 (GLOBE NEWSWIRE) — 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.
Source: Montreal Heart Institute – See full release here.