The Quebec study on colchicine, whose launch caused a stir in March, is continuing. Preliminary results released Friday evening were deemed promising enough for the study to continue and for the researchers to verify whether the drug is effective against COVID-19.
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“I’m pretty happy. This is very, very good news for the study and, potentially, for the patients ”, rejoiced the Dr Jean-Claude Tardif, director of the research center of the Montreal Heart Institute and principal investigator of this study, called COLCORONA.
The Montreal Heart Institute is trying to find out if colchicine, an anti-inflammatory, can prevent the most serious complications of COVID-19. The long awaited preliminary results were needed to see if it was worth continuing the study (a step called the “futility test”). If the results were disappointing, the study would have been stopped. Note that it could also have been if the results had been so exceptional that they would have already shown the effectiveness of the drug even before the end of the study.
“It was almost impossible for this to happen, it would have had a gigantic effect,” says Dr Late talking about this option. “The fact that they tell us not to stop, at this stage, I interpret that as very good news. ”
PHOTO PROVIDED BY THE MONTREAL CARDIOLOGY INSTITUTE
The Dr Jean-Claude Tardif
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Note that, since the study is conducted in double blind, neither the patients nor the researchers know the detailed progression. The Dr Tardif thus received a letter of a few sentences written by the completely independent review committee, simply informing him that the study was authorized to continue.
Less than a dollar a day
The colchicine study was launched as a matter of urgency in March by the Montreal Heart Institute, with financial assistance from the Government of Quebec and support from Quebec companies CGI and Pharmascience. Since then, the Bill & Melinda Gates Foundation and the National Heart, Lung, and Blood Institute in the United States have also given their support.
Colchicine is an anti-inflammatory already marketed against some diseases, including gout. The Dr Late is betting that the drug can calm the immune system and prevent the “inflammatory storms” that cause the most serious damage in patients with COVID-19. The great advantage of this drug is that it costs less than a dollar a day and that it is already available in all pharmacies around the world.
The study is being done with patients with COVID-19 who may develop complications, but who are not hospitalized. Its design is unique: patients are supplied with tablets that contain either colchicine or a placebo. Patients consume them at home and are subject to remote medical monitoring. The objective is to see if the patients taking colchicine develop fewer complications than those in the placebo group.
Final results this summer
The study aimed to recruit 6000 patients, of whom 4500 have already been enrolled in Canada and the United States as well as in Europe, Africa and South America.
“We had to adjust because there are quite a few fewer cases in Canada and Quebec, but we are in many hot spots in the United States. We opened Houston two days ago, we opened Miami today. We’re opening two locations in Los Angeles soon, we’re starting in Brazil next week… I hope to hit the target very soon, ”says Dr Late. According to the researcher, we should know definitively if colchicine is effective or not against COVID-19 by the end of the summer.
I am very optimistic, but I remain cautious in my comments. There have been too many claims … Remember all the falsehoods that have been said about hydroxychloroquine. I don’t want to make that kind of statement at all.
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The Dr Jean-Claude Tardif
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Promising signs of a Greek study
On Wednesday, a Greek study also on colchicine was published in the journal JAMA Network Open. This is a very small study that involved only 105 hospital patients.
The researchers observed that seven patients in the control group saw their condition deteriorate significantly, compared to only one in the group taking colchicine. “The results may seem very impressive, but these are very small figures. You have to be careful: the history of medicine tends to show that small studies show exaggerated results, “warns the Dr Tardif.
He also points out that the Greek study was not carried out in double blind, which makes it less reliable. The publishers who published it warn that the results “must be interpreted with caution” and present the conclusions as “hypotheses”.
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