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The oral anti-inflammatory drug colchicine may prevent complications and hospitalizations in outpatients with a recent diagnosis of COVID-19, according to a press release from the ColCORONA study researchers.
After 1 month of therapy, there was a 21% risk reduction in the primary composite outcome of death or hospitalizations that lost statistical significance, compared with placebo among 4,488 outpatients enrolled in the phase 3 global study.
After excluding 329 patients without a confirmatory PCR test, however, the use of colchicine significantly reduced hospitalizations by 25%, the need for mechanical ventilation by 50% and deaths by 44%.
“We believe this is a medical breakthrough. There is no approved therapy to prevent complications of COVID-19 in outpatients, to prevent them from reaching the hospital,” lead investigator Jean-Claude Tardif, MD, of the Montreal Heart Institute in Quebec, Canada , said theheart.org | Medscape Cardiology.
“I know that several countries will be reviewing the data very quickly and that Greece approved it today,” he said. “So this is giving patients hope.”
Having been burned by hydroxychloroquine and other treatments carried out without peer review, the response to the ad was tempered by a desire for more details.
Asked to comment, Steven E. Nissen, MD, Cleveland Clinic Foundation, Cleveland, Ohio, was cautious. “The press release about the study is vague and lacks details such as risk rates, 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 accurately the data was collected, ”he added. “We need 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 considerable biological appeal at COVID, said Paul Ridker, MD, MPH, who led the central CANTOS study of the cannabinumab anti-inflammatory drug in the post-IM setting, and he is also president of the ACTIV-4B study currently investigating anticoagulants and antithrombotics in COVID outpatients.
“Colchicine is 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 | Medscape Cardiology. “We are looking forward to seeing the full data as soon as possible.”
The agent commonly used for gout and rheumatic diseases costs about 26 cents in Canada and between $ 4 and $ 6 in the United States. As previously reported, it reduced the time for clinical deterioration and hospital stay, but not mortality, in the Greek study of 105 patients on the effects of colchicine in preventing complications from COVID-19 (GRECCO-19).
Tardif said he hopes to have the data in the public domain and that it acted quickly because the evidence was “clinically persuasive” and “the health care system is congested now”.
“We received the results on Friday, January 22 at 5 pm, an hour later we were in meetings with our data security monitoring committee [DSMB], 2 hours later, we issued a press release and, a day later, we are sending a complete manuscript to an important scientific journal, so I don’t know if anyone did it at this speed, “he said.” So, we are actually very proud of what we did. “
ColCORONA was designed to enroll 6,000 outpatients, at least 40 years old, who were diagnosed with COVID-19 infection in the past 24 hours and had at least one high-risk criterion, including age of at least 70, body mass ≥ 30 kg / mtwo, diabetes mellitus, uncontrolled hypertension, known respiratory disease, heart failure or coronary heart disease, fever ≥ 38.4 ° C in the last 48 hours, dyspnoea at presentation, bicitopenia, pancytopenia or a combination of high neutrophil count and low lymphocyte count .
Participants were randomly assigned to receive either 0.5 mg placebo or colchicine twice daily for 3 days and once daily for an additional 27 days.
The number needed to prevent a COVID-19 complication is about 60 patients, said Tardif.
Colchicine was well tolerated and resulted in fewer serious adverse events than placebo, he said. Diarrhea occurred more frequently with colchicine, but there was no increase in pneumonia. Care should be taken, however, when treating patients with severe kidney disease.
Tardif said he would not prescribe colchicine to an 18-year-old COVID outpatient who did not have concomitant illnesses, but to those who complied with the study protocol.
“As long as a patient appears to me to be at risk of complication, I would prescribe him, no doubt,” he said. “I can say that when we held the DSMB meeting on Friday night, I put each member on the spot and asked them, ‘If it were you – not even treating a patient, but if you had COVID today, you would do it. based on the data you saw? ‘and all DSMB members said yes.
“So we will have this debate in the public domain when the article is released, but I believe that most doctors will use it to treat their patients.”
The trial was coordinated by the Montreal Heart Institute and funded by the Government of Quebec; the National Heart, Lung and Blood Institute of the US National Institutes of Health; Montreal philanthropist Sophie Desmarais; and the COVID-19 Therapeutics Accelerator launched by the Bill & Melinda Gates Foundation, Wellcome and Mastercard. CGI, Dacima and Pharmascience of Montreal were also collaborators.
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