[ad_1]
Editor’s Note: Find the latest news and advice on COVID-19 in Medscape’s Coronavirus Resource Center.
Colchicine, an oral anti-inflammatory drug, may prevent complications and hospitalizations in outpatients newly diagnosed with COVID-19, according to a press release from investigators in the ColCORONA trial.
After 1 month of treatment, there was a 21% reduction in the risk of the composite primary endpoint of non-statistically significant death or hospitalizations, compared with placebo among 4488 ambulatory patients enrolled in the global phase 3 trial.
However, after excluding 329 patients without a confirmatory PCR test, 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 from COVID-19 in ambulatory patients, to keep them from reaching the hospital,” the researcher Principal Jean-Claude Tardif, MD, of the Montreal Heart Institute in Quebec, Canada, says theheart.org | Medscape Cardiology.
“I know several countries will be looking at the data very quickly and Greece approved it today,” he said. “So that gives hope to the patients.”
After being burned by hydroxychloroquine and other treatments put in place without peer review, response to the ad was tempered by a desire for more detail.
When asked about the comments, Steven E. Nissen, MD, Cleveland Clinic Foundation, Cleveland, Ohio, was cautious. “The trial press release is vague and lacks details such as risk ratios, confidence intervals and P values ”, he said theheart.org | Medscape Cardiology.
“It is impossible to assess the results of this trial without these details. It is also not known with what rigor the data were collected,” he added. “We will need to see the manuscript to correctly interpret the results.”
The evidence in the press release is difficult to interpret, but early intervention with anti-inflammatory treatment has considerable biological appeal in COVID, said Paul Ridker, MD, MPH, who led the pivotal CANTOS trial of the drug. anti-inflammatory canakinumab in the post-MI, and also chairs the ACTIV-4B trial which is currently studying anticoagulants and antithrombotics in outpatient COVID.
“Colchicine is both inexpensive 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 all the data as quickly 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 time to clinical deterioration and hospitalization, 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 looked forward to the data being in the public domain and that they acted quickly because the evidence was “clinically compelling” and “the health system is now crowded.”
“We received the results on Friday January 22 at 5 p.m. an hour later we were in a meeting with our Data Security Oversight Committee [DSMB], 2 hours later we released a press release, and a day later we are submitting a full manuscript to a major scientific journal, so I’m not sure if anyone has done this at this speed ”, a- he declared. actually very proud of what we have done. “
ColCORONA was designed to recruit 6,000 ambulatory patients, aged 40 or older, who were diagnosed with COVID-19 infection within the previous 24 hours and who had at least one high risk endpoint, including age at least 70 years, body mass index ≥ 30 kg / m2, diabetes mellitus, uncontrolled hypertension, known respiratory disease, heart or coronary insufficiency, fever ≥ 38.4 ° C within the last 48 hours, dyspnea on presentation, bicytopenia, pancytopenia or a combination of high neutrophil count and ‘a low number of lymphocytes.
Participants were randomized to receive either placebo or colchicine 0.5 mg twice a day for 3 days, then once a day for another 27 days.
The number needed to prevent a complication from COVID-19 is around 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 there was no increase in pneumonia. However, caution should be exercised when treating patients with severe renal impairment.
Tardif said he would not prescribe colchicine for an 18-year-old COVID outpatient who does not have a concurrent illness, but would do so for those who follow the study protocol.
“As long as a patient seems to me to be at risk of complication, I would prescribe it, without a doubt,” he said. “I can tell you that when we had the meeting with the DSMB on Friday night, I actually put every member on the job and asked them, ‘If that was you – not even treating a patient, but if you had COVID today, would you take it based on the data you saw? and all the DSMB members said they would.
“So we’ll have this debate in the public domain when the document is released, 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 Government of Quebec; the National Heart, Lung, and Blood Institute of the United States National Institutes of Health; Montreal philanthropist Sophie Desmarais; and the COVID-19 therapeutic accelerator launched by the Bill & Melinda Gates Foundation, Wellcome and Mastercard. CGI, Dacima and Pharmascience of Montreal were also collaborators.
Follow Patrice Wendling on Twitter: @pwendl. Find out more at theheart.org | Medscape Cardiology, join us on Twitter and Facebook.
[ad_2]
Source link