Colchicine could potentially play a role in the treatment of hospitalized patients with coronavirus disease 2019 (COVID-19), according to the findings of a recently conducted randomized clinical trial.
The open-label, prospective study (GRECCO-19) assessed the effect of treatment with low-dose colchicine on cardiac and inflammatory biomarkers as well as clinical outcomes. A total of 105 patients hospitalized with COVID-19 in 16 tertiary hospitals in Greece between April 3 and April 27, 2020 were included in the study.
Patients were randomized to receive either standard of care (n=50; 47.6%) or standard of care plus colchicine (n=55; 52.4%); the 2 groups were generally similar with most of the patients also receiving chloroquine or hydroxychloroquine and azithromycin. Colchicine administration included a 1.5mg loading dose and a 0.5mg dose 60 minutes later, followed by maintenance doses of 0.5mg twice daily for up to 3 weeks.
“Primary end points were (1) maximum high-sensitivity cardiac troponin level; (2) time for C-reactive protein to reach more than 3 times the upper reference limit; and (3) time to deterioration by 2 points on a 7-grade clinical status scale, ranging from able to resume normal activities to death,” the authors stated. Secondary outcomes of the study included the percent of patients who required mechanical ventilation, all-cause mortality, and adverse events.
The median age of patients included in the study was 64 years old (interquartile range [IQR], 54-76) and 58.1% (n=61) of participants were male. The study authors reported that no significant differences were observed between the control and the colchicine groups when analyzing median peak high-sensitivity cardiac troponin levels (0.0112 [IQR, 0.0043-0.0093] vs 0.008 [IQR, 0.004-0.0135] ng/mL, respectively; P=.34) or median maximum C-reactive protein levels (4.5 [IQR, 1.4-8.9] vs 3.1 [IQR, 0.8-9.8] mg/dL, respectively; P =.73).
Findings of the analysis did reveal, however, that the primary clinical end point rate was significantly higher for patients who received standard of care alone compared with those who received colchicine (14.0% vs 1.8%, respectively; OR, 0.11; 95% CI, 0.01-0.96; P =.02). Additionally, the authors reported that the average event-free survival time was 18.6 days (SD, 0.83) for patients in the control group vs 20.7 days (SD, 0.31) for patients in the colchicine group (log rank P =.03).
Adverse events were found to be similar between the 2 groups, however, it was reported that more patients in the colchicine group experienced diarrhea than in the control group (45.5% vs 18.0%; P =.003).
“In this randomized clinical trial, participants who received colchicine had statistically significantly improved time to clinical deterioration. There were no significant differences in high-sensitivity cardiac troponin or C-reactive protein levels,” the study authors concluded. “These findings should be interpreted with caution,” they added.
Deftereos SG, Giannopoulos G, Vrachatis DA, et al. Effects of colchicine vs standard care on cardiac and inflammatory biomarkers and clinical outcomes in patients hospitalized with coronavirus Disease 2019 [published online June 24, 2020]. JAMA Open. doi: jamanetworkopen.2020.13136.