Dr KK Aggarwal
Medscape excerpts: Colchicine, an anti-inflammatory drug used to treat gout and rheumatic disease, may be a promising treatment for COVID-19, a randomized, open-label trial suggests.
In the Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention (GRECCO-19), investigators randomly assigned 105 patients who had COVID-19 to receive either the standard of care or the standard of care plus colchicine for 3 weeks. They found that for patients in the colchicine group, the time to clinical deterioration improved, although there were no significant differences between the groups in cardiac and inflammatory biomarkers.
The key lies on its anti-inflammatory properties combined with an antithrombogenic effect that was indeed observed in our cohort and has also been reported in the literature. The study was published online June 24 in JAMA Network Open.
The researchers conducted an open-label, prospective study that spanned roughly 3 weeks (April 3 to April 27, 2020).
They randomly assigned 105 patients who had COVID-19 (58.1% men; median age, 64 years; interquartile range [IQR], 54 – 76 years) to receive either low-dose colchicine (1.5-mg loading dose, followed by 0.5 mg after 60 min and then maintenance doses of 0.5 mg/day twice daily) plus standard medical treatment (n = 50 patients) or standard treatment only (n = 55 patients).
The treatment groups were “largely similar” in demographic characteristics, clinical status at presentation, baseline laboratory evaluation, and baseline clinical score (4 in both groups). Most patients were being treated with chloroquine or hydroxychloroquine and azithromycin (98.1% and 92.4%, respectively).
The researchers established three primary endpoints and three secondary endpoints. Primary endpoints included maximum high-sensitivity cardiac troponin level; time for C-reactive protein (CRP) to reach >3 times the upper reference limit; and time to deterioration by 2 points on a 7-point clinical status scale. Secondary endpoints included percentage of participants who required mechanical ventilation; all-cause mortality; and the number, type, severity, and seriousness of adverse events.
Results showed that hospital duration was 1 day longer in the control group compared to the colchicine group (median duration, 12 days [IQR, 9 – 22] vs 13 days [IQR, 9 – 18]; P = .91).
No significant differences were found between the groups in the first two primary outcomes. The median peak high-sensitivity cardiac troponin values were 0.0112 (0.0043 – 0.0093) ng/mL in the control group and 0.008 (0.004 – 0.0135) ng/mL in the colchicine group (P = .34). The median maximum CRP levels were 4.5 (1.4 – 8.9) mg/dL in the control group and 3.1 (0.8 – 9.8) mg/dL in the colchicine group (P = .73).
However, the clinical primary endpoint rate was 14.0% in the control group vs 1.8% in the colchicine group (odds ratio, 0.11; 95% confidence interval, .01 – .96; P = .02).
The mean event-free survival time was 18.6 (.83) days in the control group vs 20.7 (.31) days in the colchicine group (log rank P = .03). Most adverse events were similar in the two groups; however, diarrhea was more frequent in the colchicine group than in the control group.
There was an attenuation of the maximum D-dimer levels in the colchicine group vs the control group, “suggesting an anti-inflammatory and antithrombogenic effect,”
Improved time to clinical deterioration was prespecified clinical endpoint, as per protocol design, [and] indeed, the clinical endpoint occurred only in 1 of 55 patients in the colchicine group and in 7 of 50 patients in the control group,
Of the eight patients who met the clinical endpoint, one required noninvasive mechanical ventilation, six required invasive mechanical ventilation, and one suffered sudden cardiorespiratory arrest.
If future studies, such as the COLCORONA study and his own group’s COLHEART-19 study, now ongoing, show similar results, “colchicine may become a standard tool in the COVID-19 therapeutic toolbox,”