Quebec study of colchicine drug quells hype about its ability to treat COVID-19
MONTREAL – A drug that some researchers have claimed to be incredibly promising in the treatment of COVID-19 is, according to their further research, potentially promising.
An international study led by Quebec that tested the drug colchicine as a treatment for outpatients COVID-19 was published Thursday in The Lancet Respiratory Medicine Journal.
The full study comes about four months after meager preliminary results were enthusiastically announced in a press release.
In contrast, the peer-reviewed manuscript of the COLCORONA study – eagerly awaited by scientists around the world – issued rather lukewarm recommendations, including the need to replicate its findings.
He concludes that the anti-inflammatory drug colchicine, which is already readily available, “could” be used to treat some patients, “given the lack of oral therapies to prevent complications from COVID-19.”
The lead researcher said he was maintaining his initial assessment of the drug, but other researchers said they were not so sure.
“I believe the final document is even stronger than what we originally presented, and some of the misconceptions, hopefully, have been clarified,” said Dr. Jean-Claude Tardif of the Heart Institute of Montreal and principal investigator of the study.
But Dr. Emily McDonald, a researcher at the MUHC’s research institute that tracks the science of colchicine, says she’s not so enthusiastic.
“My perspective hasn’t changed much since the pre-print came out – they’re similar numbers,” McDonald said after reading the Lancet article.
“I can not see him [colchicine] be useful for a lot of Canadians at this point, ”she said.
The research results were not statistically significant for those who took colchicine and did not have a confirmed diagnosis.
But for participants whose COVID-19 infections were confirmed by a positive PCR test, “colchicine reduced the risk of the primary endpoint, which was the combination of death or hospitalization for COVID-19, of about 25%, ”which is statistically significant, Tardif told CTV News.
The benefit was most apparent in men over 40 with “at least one risk factor for disease progression” and who are at greater risk than women for complications from COVID-19, Tardif said.
However, McDonald retorts that this is a “barely” positive result.
“You have to treat a lot of people to avoid hospitalization,” she said – 70 people should take colchicine for 30 days and tolerate “side effects like diarrhea”.
A small number of blood clots were also detected in the group that received colchicine.
The study authors included additional data on blood clot observations in the peer-reviewed version, but the potential link between blood clots and colchicine was not explained.
Instead, Tardif said: “It was very likely [by] luck, and … was not a real signal.
McDonald told him, this kind of result is also a warning sign.
“I’m a little uncomfortable because the study methodology should have taken care of these random imbalances,” McDonald said. If something happens by chance, she says, it means there could be other concerns about the study participants and “maybe the randomization wasn’t perfect.”
She said she would like a study to be able to explain the cause of any side effects. If a doctor decides to prescribe colchicine for this indication, she advises making sure patients give informed consent first.
This is reflected in the way British Columbia is approaching the problem. It lists colchicine as a possible treatment option after first including it in their pharmaceutical arsenal when hospitals were under pressure.
But British Columbia is urging doctors to “mention the low likelihood of benefit and the possibility of harm, and then decide together if it’s worth it,” McDonald said.
“It might be worth it for some populations at much higher risk – especially men or the elderly with diabetes, for example.”
WILL COLCHICINE BE PRESCRIBED?
The study’s suggestion that doctors consider prescribing colchicine to certain patients also sparked renewed skepticism from those on the province’s drug review committee.
The first time the study raised questions was last January, when Tardif announced the preliminary results in a press release and in various interviews, describing colchicine as “a major scientific discovery” and suggesting that doctors could prescribe it right away.
Tardif said this week that he “does not regret” the decision because it was the right time “to disclose these results”, during a second wave where people were dying and in the hospital and he stated, “where we are trying to help society.” “
But scientists around the world criticized the lack of hard data in the press release. In response, Tardif and his co-authors quickly posted an as yet unpaired manuscript online for anyone to review.
This still has not alleviated many concerns and prompted the Medication Advisory Committee of the National Institute of Excellence in Health and Social Services (INESSS) to hold a press conference in February explaining that it was not recommending colchicine for now, given the number of side effects seen in the preprinted article – in particular, a risk of pulmonary embolism or blood clots.
It seems that this decision is still valid, at least for the moment. Committee members are not yet sure whether they will need to change their stance on colchicine, INESSS spokeswoman Olivia Jacques wrote in an email to CTV News.
“The results published yesterday in the Lancet are the same as the previous ones, only the conclusions are more nuanced,” she explained.
She said the committee will analyze the manuscript and consult with other experts.
A prominent Quebec expert has already spoken publicly. In an interview with La Presse, Dr Karl Weiss, head of infectious diseases at the Jewish General Hospital, said instead that “the colchicine file is closed.”
He said he prescribed colchicine at the start of the pandemic, when medics were going badly, “but I’m not prescribing it anymore.”
This is due to Canada’s good fortune and its supply of healthy vaccines, reducing the need for treatment at this time. But that’s certainly not the case for many other countries around the world still ravaged by COVID-19.
This is where colchicine could make a difference, Tardif said.
“There have definitely been a lot of comments and questions from doctors in India about this,” he said.
“We are pleased that the Bill and Melinda Gates Foundation has produced a report saying they believe colchicine is a very interesting addition” in several countries that are in urgent need of medical support, Tardif said.