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The oral, anti-inflammatory drug colchicine may prevent complications and hospitalizations in uninvited patients recently diagnosed with 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 endpoint of death or hospitalization that lacked statistical significance, compared to placebo in 4,488 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 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,” said lead investigator Jean-Claude Tardif, MD, of the Montreal Heart. Institute in Quebec, Canada theheart.org | Medscape Cardiology.
“I know several countries will revise the data very soon and Greece has approved them today,” he said. “So this offers hope for patients.”
After being burned by hydroxychloroquine and other treatments spawned without peer review, the response to the announcement was 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 lacks details such as risk 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 rigorously the data was collected,” he added. “We’ll 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 significant biological appeal in COVID, said Paul Ridker, MD, MPH, who led the pivotal CANTOS study of the anti-inflammatory drug canakinumab in the post. -MI and is also chair of the ACTIV-4B study currently investigating anticoagulants and antithrombotic agents in outpatient COVID.
“Colchicine is both cheap 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 want to see the full data as soon as possible.”
The widely used gout and rheumatic pathogen costs about 26 cents in Canada and between $ 4 and $ 6 in the United States. As previously reported, it shortened time to clinical deterioration and hospitalization, but not mortality in the Greek study of 105 patients in the effects of colchicine in COVID-19 Complications Prevention (GRECCO-19).
Tardif said he looks forward to having the data in the public domain and they have acted quickly because the evidence was “clinically compelling” and “the health system is now overloaded.”
“We received the results Friday, January 22 at 5:00 pm, an hour later we were in a meeting with our data security check [DSMB]”We released a press release 2 hours later, and a day later we submit a full manuscript to a major science journal, so I don’t know if anyone did this so quickly,” he said. Actually very proud of what we did . “
ColCORONA is designed to enroll 6,000 outpatients at least 40 years old who had been diagnosed with COVID-19 infection within the last 24 hours, and who had at least one high risk criterion, including age of at least 70 years, body mass index ≥ 30 kg / m2diabetes mellitus, uncontrolled hypertension, known respiratory disease, heart failure or coronary disease, fever ≥ 38.4 ° C in the past 48 hours, shortness of breath at presentation, bicytopenia, pancytopenia or the 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 an additional 27 days.
The number needed to prevent one COVID-19 complication is about 60 patients, Tardif said.
Colchicine was well tolerated and resulted in less serious side effects than placebo, he said. Diarrhea was more common with colchicine, but there was no increase in pneumonia. However, caution is advised when treating patients with severe kidney disease.
Tardif said he would not prescribe colchicine to an 18-year-old COVID outpatient clinic that has no concomitant illness, but it would prescribe colchicine to those who meet the study protocol.
“As long as a patient appears to be at risk for a complication, I would no doubt prescribe it,” he said. “I can tell you that when we held the meeting with the DSMB Friday night, I basically put every member on the scene and asked them, ‘If it was you – don’t even treat a patient, but if you had COVID today, you would take it based on the data you saw? ”and all DSMB members said they would.
“So we’ll keep that debate in the public domain when the paper is out, but I think 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 Heart, Lung and Blood Institute of the US National Institutes of Health; Sophie Desmarais, Montreal philanthropist; and the 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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