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The oral, anti-inflammatory drug colchicine can prevent complications and hospitalizations in patients not recently diagnosed with COVID-19 in hospitals, according to a press release from ColCORONA investigators.
After 1 month of treatment, there was a 21% risk reduction in the primary composite endpoint of death or hospitalizations that missed statistical significance compared to placebo among 4488 outpatients enrolled in the global phase 3 study.
However, after excluding 329 patients without a confirmatory PCR test, 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 it is a medical breakthrough. There is no approved therapy to prevent complications of COVID-19 in outpatients, to prevent them from reaching the hospital,” said Jean-Claude Tardif, MD, managing director of Montreal Heart Institute in Quebec, Canada, told theheart.org | Medscape Cardiology.
“I know that several countries are going to review the data very quickly and that Greece is approving it today,” he said. “So it offers hope for patients.”
The response to the announcement, which has been fueled by hydroxychloroquine and other treatments produced without peer review, is 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 does not contain details such as danger ratios, confidence intervals and P values, ”he said theheart.org | Medscape Cardiology.
“It is impossible to evaluate the results of this trial without these details. It is also uncertain how strictly data was collected,” he added. “We will have to look at the manuscript to adequately interpret the results.”
The evidence in the press release is difficult to interpret, but early intervention with anti-inflammatory therapy has significant biological appeal at COVID, said Paul Ridker, MD, MPH. He led the important CANTOS trial of the anti-inflammatory drug canakinumab in the post. MI institution, and is also chair of the ACTIV-4B trial currently investigating the anticoagulant and antithrombotic drugs in outpatient COVID.
“Colchicine is inexpensive and generally well tolerated, and the apparent benefits reported so far are significant,” said Ridker of Brigham and Women’s Hospital in Boston, Massachusetts. theheart.org | Medscape Cardiology. “We are eager to see the full data as soon as possible.”
Commonly used gout and rheumatic disease cost about 26 cents in Canada and between $ 4 and $ 6 in the United States. As previously reported, this reduced the time to clinical deterioration and hospital stay, but not deaths in the Greek study of 105 patients on the effects of colchicine in the study COVID-19 complications (GRECCO-19).
Tardif said he was looking forward to having the information in the public domain and that it acted quickly because the evidence was ‘clinically convincing’ and that ‘the health system is now under pressure’.
‘We received the results on Friday 22 January at 17:00, an hour later we were in meetings with our data security council [DSMB], 2 hours later we issued a press release, and a day later we sent a complete manuscript to a major scientific journal, so I do not know if anyone did it so quickly, “he said. proud of what we have done. ‘
ColCORONA is designed to enroll 6000 outpatients, at least 40 years of age, diagnosed with COVID-19 infection within the previous 24 hours, and having at 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 heart disease, fever of ≥ 38.4 ° C during the past 48 hours, shortness of breath at presentation, bicytopenia, pancitopenia, or the combination of high neutrophil count and low lymphocyte count.
Participants were randomly assigned to receive placebo or 0.5 mg colchicine twice daily for 3 days and then once daily for an additional 27 days.
The number needed to prevent one COVID-19 complication is about 60 patients, Tardif said.
Colchicine is well tolerated and has led to less serious side effects than with placebo, he said. Diarrhea was more common with colchicine, but there was no increase in pneumonia. However, be careful when treating patients with severe kidney disease.
Tardif said he would not prescribe colchicine to an 18-year-old COVID outpatient who has no concomitant illnesses, but for those who adhere to the study protocol.
“As long as a patient seems to me to have a complication, I would no doubt prescribe it,” he said. “I can tell you that, when we held the meeting with the DSMB on Friday night, I actually put each member on the spot and asked them, ‘If it was you – not even a patient, but if you were today have a HISTORY? take it based on the data you saw? ‘and all the DSMB members said they would do it.
“We will therefore conduct the debate in the public domain when the newspaper is out, but I believe most doctors will use it to treat their patients.”
The trial was coordinated by the Montreal Heart Institute and funded by the Quebec government; the National Institute for Heart, Lung and Blood of the U.S. National Institutes of Health; The Montreal Philanthropist, Sophie Desmarais; and the COVID-19 Therapeutics Accelerator introduced by the Bill & Melinda Gates Foundation, Wellcome and Mastercard. Montreal’s CGI, Dacima and Pharmascience were also collaborators.
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