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962: Is Colchicine a Promising Agent in COVID-19 Treatment?
Medscape excerpts: Colchicine is an anti-inflammatory drug commonly used to treat gout and rheumatic disease. The drug may be a promising treatment for COVID-19, suggests a randomized, open-label trial.
The Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention (GRECCO-19) randomized 105 patients with COVID-19 to receive either the standard of care or the standard of care plus colchicine for 3 weeks. Among patients in the colchicine group, the time to clinical deterioration was found to improve, although there were no significant differences between the groups in terms of cardiac and inflammatory biomarkers.
The key seems to lie on the drug’s anti-inflammatory properties combined with an antithrombogenic effect that was noted in the present cohort and has also been reported in the literature. The study was published online June 24 in JAMA Network Open.
This was an open-label, prospective study spanning roughly 3 weeks (April 3 to April 27, 2020).
Overall, 105 patients with COVID-19 (58.1% men; median age, 64 years; interquartile range [IQR], 54-76 years) were randomized 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) and standard medical treatment (n = 50 patients) or standard treatment alone (n = 55 patients).
The treatment groups were more or less similar in terms of demographic characteristics, clinical status at presentation, baseline laboratory evaluation, and baseline clinical score (4 in both groups). Most patients were undergoing treatment with chloroquine or hydroxychloroquine and azithromycin (98.1% and 92.4%, respectively).
The study had 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, while the secondary endpoints included percentage of participants who required mechanical ventilation; all-cause mortality; and the number, type, severity, and seriousness of adverse events.
Hospital duration was found to be 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).
There appeared to be no significant differences 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).
The clinical primary endpoint rate was 14.0% in the control group compared to 1.8% in the colchicine group (odds ratio, 0.11; 95% confidence interval, .01 – .96; P = .02).
The mean event-free survival time was found to be 18.6 (.83) days in the control group compared to 20.7 (.31) days in the colchicine group (log rank P = .03). Most adverse events were found to be similar in the two groups. Diarrhea was; however, more frequent in the colchicine group than in the control group.
An attenuation of the maximum D-dimer levels was evident in the colchicine group vs the control group, pointing to an anti-inflammatory and antithrombogenic effect.
Improved time to clinical deterioration was the prespecified clinical endpoint, according to the protocol design, and, the clinical endpoint was noted only in 1 of 55 patients in the colchicine group and in 7 of 50 patients in the control group.
Eight patients met the clinical endpoint. One of these required noninvasive mechanical ventilation, six required invasive mechanical ventilation, and one suffered sudden cardiorespiratory arrest.
If upcoming studies, such as the COLCORONA study and the COLHEART-19 study, show similar results, then colchicine may become a standard tool in the COVID-19 therapeutic armamentarium.
Dr KK Aggarwal
President CMAAO, HCFI and Past National President IMA