COLCORONA: Protective Effect of Colchicine in COVID-19 Save
Lancet Respiratory Medicine has reported the results of the COLCORONA trial, showing that in patients with PCR-confirmed COVID-19 infection, colchicine led to a significantly lower rate of death or hospital admission from COVID.
Colchicine is an oral anti-inflammatory agent with direct effects on the inflammasome. Its efficacy in gout and pericarditis is well known. This trial aimed to investigate the effect of early colchicine use in preventing untoward outcomes with COVID-19 infection.
COLCORONA was an international, multicenter, phase 3, randomised, double-blind, adaptive, placebo-controlled trial. Non-hospitalized adult patients over age 40 yrs, infected with COVID-19 were eligible. COVID was diagnosed by either PCR testing or clinical criteria. Patients were given either colchicine (0·5 mg twice per day for 3 days and then once per day for 27 days thereafter) or matching placebo. The primary efficacy endpoint was the composite of death or hospital admission for COVID-19.
The trial enrolled 4488 patients between March and December 2020.
When considering all patients, there were fewer adverse outcomes with colchicine (4.7% vs. 5.8%) compared to placebo, but this did not meet significance for the primary endpoint (OR 0·79, 95·1% CI 0·61–1·03; p=0·081).
Yet when only PCR confirmed COVID-19 patients (n=4159; 93% of enrollees), the primary endpoint occurred in 4·6% of colchicine and 6% of placebo treated patients (OR 0·75, 0·57–0·99; p=0·042).
Diarrhea was more common with colchicine (13·7% vs 7·3%; p<0·0001).
Serious adverse events tended to be less with colchicine (6·3%) than placebo (p=0·051); but there were significantly fewer pneumonia cases with colchicine (2·9%) than placebo (4·1%) patients (p=0·021).
Thus, in PCR-confirmed COVD-19, colchicine demonstrated a protective effect if given prior to hospitalization, with fewer deaths, hospital admissions and pneumonia.
Colchicine is a safe, relatively inexpensive, anti-inflammatory agent could be considered in confirmed COVID infected patients at risk of complications.