Colchicine study lags behind and still struggles to find its guinea pigs

Highly funded by Quebec, the COLCORONA study by the Montreal Heart Institute is struggling to complete the recruitment of guinea pigs to effectively test the effects of colchicine on COVID-19 patients.

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Seven months after the start of a large study on colchicine, an already existing drug that could reduce the risk of complications from COVID-19, the goal of recruiting 6,000 participants has still not been met.

“Getting results depends on recruiting. We are still recruiting participants in order to reach the critical mass allowing us to do the second interim analysis of the study, ”admitted Camille Turbide, who manages communications for the research group.

The project manager at the Heart Institute, D^r Jean-Claude Tardif, however, maintained last July that the results would be known definitively by the end of the summer and that colchicine could be quickly administered in the days following the final report.

In the heart of fall and the second wave, the results are still pending.

Quebec involved

Basing much hope on this study, the Department of Health awarded a grant of $ 5.3 million to the team of Dr.^r Jean-Claude Tardif.

“[Avec] 6000 patients, and things are going smoothly, we think we will have news within three months “, declared on March 27, the former Minister of Health, Danielle McCann, adding that Quebec was following this research” of very close”.

The Department of Health now maintains that it is far too early to disclose any results.

“The recruitment and data collection must first be completed. Subsequently, there are stages of data processing and analysis, said MSSS spokesperson Robert Maranda. The preliminary results of a scientific study are never shared until the end of the study. ”

From time to time

At the start of the pandemic, the D^r Jean-Claude Tardif had told the Newspaper that the results of the study were expected in June.

“We should have the first results by the end of June. And there, we will see if they are interim or final, ”he promised.

The results were to indicate whether colchicine would be effective in fighting the inflammatory storm that is affecting several patients with COVID-19.

The study review committee, which has preliminary results, did indeed give its approval last June for the study to take its course.

However, nothing on the effectiveness of colchicine has been disclosed.

Difficult recruitment complicated the rest of the study. The group had to make agreements with many countries in order to find candidates.

The research group declined to specify the number of missing participants to conclude the study.

“We will be happy to share the results with you when the study is completed,” said Mr.^me Turbid.

The COLCORONA study is double-blind. Some are given the drug and others are given a placebo. Neither the patients nor the researchers are aware of the results yet.

The National Institute of Excellence in Health and Social Services still considers it premature, outside of a research protocol, to administer colchicine to patients with a confirmed or suspected diagnosis of COVID-19.

In 2017, the National Institute of Public Health raised an increase in the number of appeals concerning probable poisoning by colchicine to the Center antipoison du Québec (CAPQ). The hypothesis raised here is that the increase in these calls could be attributed to a greater use of this drug. “Although colchicine poisoning is relatively rare, it can be fatal. Unfortunately, there is currently no antidote to treat them, ”underlines the INSPQ.

Colchicine and the COLCORONA study

Comes from an autumn flower called colchicum.

• It has an anti-inflammatory effect.
• It is usually prescribed for the treatment of gout.
• Cost: $ 1 per day for treatment.
• 6000 guinea pigs wanted for the study, all over the world.
• A Quebec grant of $ 5.4 million for the study.
• A $ 3M grant from the Bill and Melinda Gates Foundation.
• Partnership with the US National Institutes of Health.

Recent advances for new drugs

Dapsone

The young Canadian company Pulmonem and researchers at McGill University are carrying out a phase 3 study on the effectiveness of dapsone, an already existing anti-inflammatory drug that can fight the inflammatory storm caused by COVID-19. The results are expected at the end of December.

Mystery molecule of the Institut Pasteur

Researchers from the Institut Pasteur in France have announced the discovery of a “miracle molecule” which inhibits virus replication, without however naming it for the moment. This is an already known drug. We will know more in “a few months”.

Antiviral SNG001

British laboratory Synairgen has developed an antiviral called SNG001 which, according to preliminary results recently released, significantly reduces the risk of developing a severe form of the disease. It is an inhaled treatment that uses a natural protein.

MUHC Studies and CHUM on steroids

MUHC and CHUM teams are looking for treatments to be administered to non-hospitalized patients to delay the effects of the virus. MUHC researchers are studying a molecule from the steroid family that is given by nasal spray and that could prevent the penetration of the virus. Scientists at the CHUM seek to achieve the same objective thanks to a natural probiotic.