Excessive inflammation may have a role in COVID-19 problems, according to evidence. Colchicine, an anti-inflammatory medicine used orally, is thought to play a function in combating inflammatory damage in COVID-19. The results of the placebo-controlled COLCORONA study, published in the Lancet Journal, demonstrate that colchicine did not prevent fatalities or hospitalisations among persons with confirmed or suspected COVID-19 who were treated at home. However, the medicine proved to be helpful in individuals whose diagnoses were verified by PCR testing.

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The COLCORONA study

Patients were randomised to receive either colchicine (0.5 mg twice daily for three days, then once daily for the next 27 days) or a matched placebo. The primary effectiveness outcome for COVID-19 was a composite of death or hospitalisation. At the end of the trial, 97.9 per cent of patients had their vital status available. The analyses were carried out in accordance with the intention to treat the concept. At 30 days, 4.7 per cent of the 2,235 COLCORONA patients assigned to colchicine died or were hospitalised with COVID-19, compared to 5.8 per cent of the 2,253 patients assigned to placebo (OR 0.79, 95.1 per cent CI 0.611.03).

Results

Among the 4159 patients with PCR-confirmed COVID-19, the advantage was statistically significant since the main endpoint occurred in 96 (46%) of 2075 patients in the colchicine group and 126 (60% ) of 2084 patients in the placebo group (p0.05). Serious adverse events (6.3 per cent vs 4.9 per cent; P = 0.051) and pneumonia cases (4.1 per cent vs 2.9 per cent; P = 0.021) were quantitatively greater in the placebo group than in the colchicine group. Diarrhoea, on the other hand, was nearly twice as prevalent in colchicine-treated individuals (13.7 per cent vs 7.3 per cent; P 0.0001).

"Our trial found that colchicine reduced the primary outcome of mortality or hospitalisation by 25% in community-treated patients with PCR-confirmed COVID-19", stated Jean Claude Tardif, MD (Montreal Heart Institute, Canada), "For individuals with PCR-confirmed COVID-19, the number required to treat (NNT) to avoid one fatality or hospitalisation is 70. In the context of a pandemic, we feel that an NNT of 70 is reasonable for medicine like colchicine, which is affordable, safe, and widely available. Furthermore, the NNT is 29 for patients with diabetes, 31 for those aged 70 and more, 39 for males, 52 for those with respiratory disease, and 25 for those with cardiovascular disease."

The dose used in COLCORONA (0.5 mg twice daily for three days, then once daily for 27 days) was slightly lower than that used in another autoinflammatory disease (familial Mediterranean fever), and the patients enrolled in the study are unlikely to represent the highest-risk patients for severe COVID19 (median age in the treatment group was 53 years, and 55.4 per cent were female). Given the lack of oral treatments to prevent COVID-19 problems in community-treated patients and the efficacy of colchicine in patients with PCR-proven COVID-19, this safe and affordable anti-inflammatory drug may be evaluated for usage in individuals at risk of problems.

The PRINCIPLE study

The Platform Randomised Trial of Interventions against COVID-19 is being led by academics from the University of Oxford. The experiment in older people- (PRINCIPLE) experiment is evaluating therapies for early-stage COVID-19 that can shorten overall recovery time and symptoms burden, as well as avoid hospitalisation. Colchicine is a very affordable anti-inflammatory medicine that has been routinely used in the United Kingdom for many years to treat acute gout. Although the medicine has demonstrated promise in lowering hospital admissions in patients with COVID-19 in Canada's COLCORONA study, nothing is known about its usefulness in lowering recovery time or disease burden.

Previously, only patients with COVID-19 who were 50 years or older and at the highest risk of disease consequences were eligible to enrol in the PRINCIPLE study. For the colchicine arm, participants must now be between the ages of 18 and 64 and have shortness of breath as a result of the disease or certain underlying health problems that put them at risk of severe sickness or be over 65. Participants are eligible to enrol in the experiment only within the first 14 days after contracting COVID-19. The PRINCIPLE study has revealed that azithromycin and doxycycline are not effective therapies for COVID-19 in their early stages. The experiment is still enrolling participants over the age of 50 to evaluate budesonide, an inhaled corticosteroid.

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.