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The oral anti-inflammatory drug colchicine may prevent complications and hospitalizations in outpatients recently diagnosed with COVID-19, according to a press release from researchers in the ColCORONA trial.
After one month of therapy, there was a 21% reduction in the risk in the main composite endpoint of death or hospitalizations that lost statistical significance, compared with placebo among 4488 outpatients enrolled in the trial. global phase 3.
After excluding 329 patients without a confirmatory PCR test, however, it was reported that colchicine use 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,” said lead researcher Jean-Claude Tardif. MD, of the Montreal Heart Institute in Quebec, Canada, said theheart.org | Cardiology Medscape.
“I know that several countries will review the data very quickly and that Greece has approved them today,” he said. “So this provides hope to patients.”
After being burned by hydroxychloroquine and other treatments produced without peer review, the response to the ad moderated with the desire for more details.
Asked for a comment, Steven E. Nissen, MD, Cleveland Clinic Foundation, Cleveland, Ohio, was cautious. “The press release on the trial is inaccurate and lacks details such as dangerous relationships, confidence intervals and Pg values, ”he said theheart.org | Cardiology Medscape.
“It is impossible to evaluate the results of this trial without these details. Nor is it known how rigorously the data were collected,” he added. “We will have to look at 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 in COVID, said Paul Ridker, MD, MPH, who led the fundamental CANTOS trial of the anti-inflammatory drug canakinumab in post-MI, and is also president of the ACTIV-4B trial 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 commonly used gout and rheumatic disease agent 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 mortality in the Greek study of 105 patients on the effects of colchicine in the COVID-19 complication prevention study ( GRECCO-19).
Tardif said he hoped to have the data in the public domain and act quickly because the tests were “clinically persuasive” and “now the health system is saturated.”
“We received the results on Friday 22 January at 5pm, an hour later we were in meetings with our data security control board [DSMB]After 2 hours we issued a press release and a day later we sent a complete manuscript to a major scientific journal, so I don’t know if anyone has done it at that speed, “he said.” in fact, 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 during the previous 24 hours and who had a high-risk criterion, including the age of 70. years at least, body mass index ≥ 30 kg / m2, diabetes mellitus, uncontrolled hypertension, known respiratory disease, heart failure or coronary heart disease, fever ≥ 38.4 ° C in the last 48 hours, dyspnoea on presentation, bicitopenia, pancytopenia or the combination of high neutrophil count and low count of lymphocytes.
Participants were randomly assigned to receive 0.5 mg of placebo or colchicine twice daily for 3 days and then once daily for a further 27 days.
The number needed to prevent a complication of COVID-19 is about 60 patients, Tardif said.
Colchicine was well tolerated and resulted in fewer serious adverse events than with placebo, he said. Diarrhea occurred more often with colchicine, but no increase in pneumonia occurred. However, caution should be exercised in the treatment of patients with severe renal disease.
Tardif said he would not prescribe colchicine to an 18-year-old COVID patient who has no concomitant disease, but would for those who follow the study protocol.
“As long as a patient appears to me at risk for complication, I would definitely prescribe it,” he said. “I can tell you that when we held the meeting with the DSMB on Friday evening, I put each member in place and asked them,‘ If it was you, not even treating a patient, but if you had COVID today, take it from the data you saw? and all DSMB members said yes.
“So we will have this debate in the public domain when the paper is published, 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 U.S. 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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