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Colchicine, an oral anti-inflammatory, can prevent complications and hospitalizations in outpatients newly diagnosed with COVID-19, according to a statement from investigators of the ColCORONA study.
After one month of therapy, there was a 21% reduction in risk in the primary composite endpoint of death or hospitalizations that lost statistical significance, compared with placebo in 4488 outpatients enrolled in the Phase 3 global study.
However, after excluding 329 patients without a confirmatory PCR test, colchicine use significantly reduced hospitalizations by 25%, the need for mechanical ventilation by 50% and deaths by 44%.
“We believe this is a medical discovery. There is no approved therapy to prevent COVID-19 complications in outpatients, to prevent them from reaching the hospital,” said lead investigator Jean-Claude Tardif, MD, of the Heart Institute in Montreal, Quebec, Canada, he said theheart.org | Cardiology Medscape.
“I know that several countries will review the data very quickly and that Greece approved them today,” he said. “So it gives hope to patients.”
After being burned by hydroxychloroquine and other treatments without peer review, the response to the announcement was tempered by the 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 lacks details such as hazard reports, confidence intervals and P values, “he said theheart.org | Cardiology Medscape.
“It is impossible to evaluate the results of this study without these details. It is also uncertain how rigorously the data were collected,” he added. “We will have to see the manuscript to properly interpret the results.”
The evidence in the press release is difficult to interpret, but early intervention with anti-inflammatory therapy has a considerable biological impact in COVID, said Paul Ridker, MD, MPH, who led the pivotal CANTOS study of the anti-inflammatory drug canakinumab in post-MI configuration and is also the president of the ACTIV-4B study that is currently investigating anticoagulants and antithrombotics in outpatient COVID.
“Colchicine is both cheap and generally well tolerated, and the apparent benefits reported so far are substantial,” said Ridker of Brigham and Women’s Hospital in Boston, Massachusetts. theheart.org | Cardiology Medscape. “We look forward to seeing the full data as soon as possible.”
The agent commonly used for gout and rheumatic disease costs about 26 cents in Canada and between $ 4 and $ 6 in the United States. As previously reported, it reduced the time to clinical deterioration and hospital stay, but not the mortality in the Greek study of 105 patients on the effects of colchicine in the study to prevent complications of COVID-19 (GRECCO-19).
Tardif said he was looking forward to having data in the public domain and that they acted quickly because the evidence was “clinically persuasive” and “the health care system is now crowded”.
“We received the results on Friday, January 22, at 17:00, an hour later, we were meeting with our data security monitoring board [DSMB]”Two hours later, we issued a press release and a day later we are sending a complete manuscript to a major scientific journal, so I don’t know if anyone did it at this speed,” he said. So we’re actually very proud of what we’ve done. “
ColCORONA was designed to enroll 6,000 outpatients, at least 40 years old, who had been diagnosed with COVID-19 infection in the last 24 hours and had at least one high risk criterion, including the age of at least 70 years old, body mass index ≥ 30 kg / m2, diabetes mellitus, uncontrolled hypertension, known respiratory diseases, heart failure or coronary heart disease, fever ≥ 38.4 ° C in the last 48 hours, dyspnoea on presentation, bicitopenia, pancytopenia or a combination of high neutrophil count and low lymphocyte count .
Participants were randomly assigned to receive either placebo or colchicine 0.5 mg twice daily for 3 days and then once daily for another 27 days.
The number needed to prevent a COVID-19 complication is about 60 patients, Tardif said.
Colchicine was well tolerated and led to fewer serious side effects than placebo, he said. Diarrhea occurred more often with colchicine, but there was no increase in pneumonia. However, caution should be exercised in treating patients with severe kidney disease.
Tardif said he would not prescribe colchicine to an 18-year-old COVID patient who has no concomitant disease but would do so for those who meet the study protocol.
“As long as a patient seems to me to be at risk for a complication, I would definitely prescribe,” he said. “I can tell you that when I had the meeting with DSMB on Friday night, I actually put each member on the spot and asked them, ‘If it were you – you wouldn’t even treat a patient, but if you had COVID today , take it based on the data you saw? and all DSMB members said they would.
So we will have this debate in the public domain when the newspaper is out, but I think most doctors will use it to treat their patients.
The process was coordinated by the Montreal Heart Institute and funded by the Government of Quebec; National Heart, Lung, and Blood Institute of the US National Institutes of Health; Montreal Philanthropist Sophie Desmarais; and COVID-19 Therapeutics Accelerator launched by the Bill & Melinda Gates Foundation, Wellcome and Mastercard. CGI, Dacima and Pharmascience from Montreal were also collaborators.
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