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Colchicine effective option for non-hospitalized COVID-19 patients at risk of complications: Lancet
Researchers at Montreal Health Innovation Coordinating Centre (MHICC) have found in a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial that Colchicine could be considered as a treatment option for non-hospitalized COVID-19 patients at risk of complications.At present there is lack of oral therapies available to prevent COVID-19 complications among this group of patients with a PCR-confirmed diagnosis of COVID-19.
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 results of the COLCORONA study have been published today in The Lancet Respiratory Medicine.
"Given 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", said Dr. Jean-Claude Tardif, Director of the MHI Research Centre, Professor at the Faculty of Medicine of the Université de Montréal and Principal Investigator of COLCORONA. "Our study showed that colchicine could be used to reduce the risk of complications for some patients with COVID-19."
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 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. 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.
Notwithstanding these results, it is recommended that studies such as this one be replicated in non-hospitalized patients with a PCR-confirmed diagnosis of COVID-19.
"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," said 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 United States National Institutes of Health.
COLCORONA (NCT04322682) is a randomized, double-blinded, placebo-controlled, home-based clinical trial. It was conducted in Canada, the United States, Europe, South America, and South Africa. 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 (0.5 mg twice daily for three days and once daily after) or placebo for 30 days.
For further reference log on to: http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00222-8/fulltext.
Dr Kartikeya Kohli is an Internal Medicine Consultant at Sitaram Bhartia Hospital in Delhi with super speciality training in Nephrology. He has worked with various eminent hospitals like Indraprastha Apollo Hospital, Sir Gangaram Hospital. He holds an MBBS from Kasturba Medical College Manipal, DNB Internal Medicine, Post Graduate Diploma in Clinical Research and Business Development, Fellow DNB Nephrology, MRCP and ECFMG Certification. He has been closely associated with India Medical Association South Delhi Branch and Delhi Medical Association and has been organising continuing medical education programs on their behalf from time to time. Further he has been contributing medical articles for their newsletters as well. He is also associated with electronic media and TV for conduction and presentation of health programs. He has been associated with Medical Dialogues for last 3 years and contributing articles on regular basis.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751