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The oral, anti-inflammatory drug colchicine can prevent complications and hospitalizations in non-hospitalized patients newly tested with COVID-19, according to a press release from ColCORONA trial researchers.
After 1 month of treatment, there was a 21% reduction in risk in primary mortality or hospitals that lost statistical significance, compared with placebo among 4488 patients enrolled in the global trial, level 3.
After 329 patients were excluded without a PCR test, however, colchicine use was reported to significantly reduce hospitalization by 25%, the need for mechanical ventilation by 50%, and mortality by 44%.
“We believe this is a medical fracture. There is no approved treatment to prevent COVID-19 complications in outpatients, to prevent them from reaching the hospital,” the chief medical officer said. Jean-Claude Tardif, MD, of the Montreal Heart Institute in Quebec, Canada, said theheart.org | Medscape Epistemology.
“I know a number of countries will be reviewing the data very quickly and Greece approved it today,” he said. “So this gives patients hope.”
After being ingested with hydroxychloroquine and other medications taken without peer review, the response to the ad was suppressed with a desire for more information.
Asked for comment, Steven E. Nissen, MD, Cleveland Clinic Foundation, Cleveland, Ohio, was cautious. “The press release on the case is unclear and does not contain detailed information such as risk ratios, times of confidence, and P. values, “he said theheart.org | Medscape Epistemology.
“It is impossible to evaluate the results of this test without these details. It is also uncertain how hard data were collected,” he said. “We need to see the manuscript to explain the results appropriately.”
The evidence in the press release is difficult to explain, but early intervention with anti-inflammatory therapy involves many biological interventions in COVID, said Paul Ridker, MD, MPH, who led the important CANTOS trial of the drug anti-inflammatory canakinumab in the -MI position, and is also chair 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 benefits reported so far are substantial,” said Ridker, of Brigham and Women’s Hospital in Boston, Massachusetts. theheart.org | Medscape Epistemology. “We want to see the full data as soon as possible. “
The commonly used gout and rheumatic disease agent costs around 26 cents in Canada and between $ 4 and $ 6 in the United States. As previously reported, it reduced the time to clinical decline and hospital stay but not mortality in the 105-patient Greek Study of Colchicine effects in the COVID-19 Prevention Problems (GRECCO-19) study.
Tardif said he looked forward to the data being in the public domain and taking swift action as the evidence was “clinically strong” and “the health system is now dense.”
“We received the results on Friday, January 22 at 5pm, an hour later we were in meetings with our data safety review board. [DSMB], 2 hours later we issued a press release, and a day later we submit a full manuscript to a major scientific journal, so I don’t know if anyone is on this. to do at this pace, “he said.” So we are. really proud of what we did. “
ColCORONA was designed to enroll 6000 outpatients, at least 40 years of age, who had been diagnosed with COVID-19 infection within the previous 24 hours, and who had at least one rod. high-risk measurements, including age at least 70 years, body mass index ≥ 30 kg / m2, diabetes mellitus, uncontrolled hip control, known respiratory disease, heart failure or coronary heart disease, fever ≥ 38.4 ° C within the last 48 hours, dyspnea at presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count.
Participants were randomly assigned to receive placebo or colchicine 0.5 mg twice daily for 3 days and then once daily for a further 27 days.
The number needed to prevent a single COVID-19 problem is about 60 patients, Tardif said.
Colchicine was recovering well and leading to fewer serious adverse events than with placebo, he said. Diarrhea occurred more frequently with colchicine, but there was no increase in pneumonia. Caution should be used, however, in the treatment of patients with severe renal disease.
Tardif said he would not prescribe colchicine to an 18-year-old COVID patient who does not have concomitant diseases, but would do so to those who meet the study protocol.
“As long as it seems to me that a patient is at risk of complications, I would definitely prescribe it,” he said. “I can tell you that when we held the meeting with the DSMB on Friday afternoon, I sent all members on the spot and I asked them, ‘If it were you – not even treating a patient, but if you had COVID today, would you do that take it based on the data that did you see? ‘and every member of the DSMB said yes.
“So we’ll have that debate in the public domain when the paper 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; U.S. National Institutes of Health, Lung, and Blood National Institutes of Health; Montreal philanthropist Sophie Desmarais; and the COVID-19 Therapeutic Accelerator launched by Bill & Melinda Gates Foundation, Wellcome, and Mastercard. CGI, Dacima, and Pharmascience of Montreal were also collaborators.
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