COVID-19 Drugs: Canadian COLCORONA Study Shows That Colchicine Can Reduce Certain Complications Of COVID-19
: Canadian researchers from the Montreal Heart Institute (MHI) and the Université de Montréal announced the clinical trial findings of the COLCORONA study (NCT04322682), which was a phase 3, randomized, double-blind, adaptive, placebo-controlled, multicentre trial of the oral anti-inflammatory medication called Colchicine on hospitalized COVID-19 patients. The study was done in Brazil, Canada, Greece, South Africa, Spain, and the USA, and was led by the Montreal Heart Institute.
The study findings concluded that given the lack of oral therapies available to prevent COVID-19 complications among non-hospitalized patients and the observed benefit of colchicine in patients with a PCR-confirmed diagnosis of COVID-19, this anti-inflammatory drug could be considered as a treatment for those at risk of complications.
The study results were published in the peer reviewed Lancet journal: Respiratory Medicine.
Dr Jean-Claude Tardif, Director, MHI Research Centre, Professor, Faculty of Medicine, Université de Montréal told Thailand Medical News, “Considering the current pandemic, while awaiting collective immunity through vaccination around the world, the need for treatments to prevent COVID-19 complications among patients who contract the disease remains. Our study showed that colchicine could be used to reduce the risk of complications for some patients with COVID-19."
Dr Tardif is also the Principal Investigator of COLCORONA.
The pharmaceutical preparation Colchicine is an inexpensive and readily available anti-inflammatory drug. Orally administered, it is currently prescribed to treat gout, Familial Mediterranean Fever and pericarditis.
The COLCORONA study assessed colchicine's potential to reduce the risk of COVID-19-related complications in outpatients over 40 years of age with at least one risk factor for disease progression.
The clinical study's primary efficacy endpoint was the composite of death or hospitalization in patients with COVID-19. Of the 4,488 patients enrolled, including those without a PCR-confirmed diagnosis, the primary endpoint occurred in 4.7% of patients in the colchicine group and 5.8% of those in the placebo group, a non-statistically significant result.
It was found that for the 4,159 patients with a PCR-based diagnosis of COVID-19, the primary endpoint occurred in 4.6% of patients in the colchicine group and 6.0% of patients in the placebo group, a statistically significant result.
Serious adverse events were reported in 4.9% of patients in the colchicine group and 6.3% of those in the placebo group.
However notwithstanding these results, the study team recommended that studies such as this one be replicated in non-hospitalized patients with a PCR-confirmed diagnosis of COVID-19.
Dr Yves Rosenberg, M.D., M.P.H., chief of the Atherothrombosis and Coronary Artery Disease Branch at the National Heart, Lung, and Blood Institute, part of the Un
ited States National Institutes of Health commented, "The COLCORONA study expands on our knowledge of the role of oral, cheap and widely available repurposed drugs such as colchicine to treat people early on to prevent serious complications of COVID-19 and can help practitioners and their patients make informed treatment decisions."
The study included 4,488 non-hospitalized patients over 40 years of age with COVID-19 at the time of inclusion, with at least one identified risk factor for COVID-19 complications (e.g., diabetes, hypertension, known respiratory disease, obesity). Patients were randomized to receive colchicine (0.5mg twice daily for three days and once daily after) or placebo for 30 days.
The effect of colchicine on the primary endpoint was consistent across subgroups of patients on the basis of various clinical characteristics. Although the benefits of colchicine appeared to be more marked in patients with diabetes and men, there was no statistically significant heterogeneity in the results. Because the event rates were higher in patients with these characteristics, the effect of colchicine might have been more readily detectable. Diabetes is a pro-inflammatory state, which might explain the greater risk of complications of COVID-19 in patients with diabetes than in those without. Despite the link between weight, insulin resistance, and type 2 diabetes, the effects of colchicine did not differ whether the body-mass index was higher or lower than 30 kg per m2
. Sex-related differences in immune responses against SARS-CoV-2 exist. Men have higher plasma concentrations of IL-18 and IL-8, whereas women have stronger T-cell activation.
These differences might at least in part explain the apparent difference in response to colchicine in COVID-19. Of note, the concomitant use of an inhibitor of the renin-angiotensin system did not appear to modify the clinical response to colchicine.
Interestingly it was found that the risk of viral inflammatory pneumonitis appears to be lowered by colchicine in patients with COVID-19. Reassuringly, there was no evidence of an increased risk of bacterial pneumonia in COLCORONA.
In conclusion, in community-treated patients including those without a mandatory diagnostic test, the effect of colchicine on COVID-19-related clinical events was not statistically significant. Among patients with PCR-confirmed COVID-19, colchicine led to a lower rate of the composite of death or hospital admission than placebo.
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