In a small randomized trial, Greek investigators found patients had improved time to clinical deterioration versus a control group.
In a small, randomized clinical trial in Greece, patients taking colchicine had improved time to clinical deterioration versus a control group.
Spyridon Deftereos, MD, PhD, led a team of investigators who wanted to evaluate the effect of colchicine treatment on cardiac and inflammatory biomarkers and clinical outcomes in patients hospitalized with coronavirus disease 2019 (COVID-19).
“In this randomized clinical trial, participants who received colchicine had statistically significantly improved time to clinical deterioration,” the investigators wrote. “There were no significant differences in high-sensitivity cardiac troponin or C-reactive protein levels.”
The study was a prospective, open-label, randomized clinical trial performed in 16 Greek hospitals in April. The primary clinical end point was defined as patients needing mechanical ventilation or death. The study used 105 patients and the clinical primary end point rate of clinical deterioration was 14.0% in the control group and 1.8% in the colchicine group.
Patients were given a 1.5mg dose followed by 0.5 mg after 1 hour and administered maintenance (0.5mg) doses twice daily along with standard medical care for up to 3 weeks.
The median (interquartile range) 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 (interquartile range) maximum C-reactive protein levels were 4.5 (1.4-8.9) mg/dL vs 3.1 (0.8-9.8) mg/dL (P = .73), respectively. The clinical primary end point rate was 14.0% in the control group (7 of 50 patients) and 1.8% in the colchicine group (1 of 55 patients) (odds ratio, 0.11; 95% CI, 0.01-0.96; P = .02). The mean event-free survival time was 18.6 (0.83) days in the control group vs 20.7 (0.31) in the colchicine group (log rank P = .03).
In terms of adverse reactions, both the control and colchicine groups were similar with the exception of bouts of diarrhea. Of the colchicine group, 45.5% of them had this side effect whereas 18% of the control group had it.
The investigators noted the study being open-label as its main limitation, and they cautioned these results should be interpreted cautiously.
“However, the observed difference was based on a narrow margin of clinical significance; therefore, these observations should be considered hypothesis generating,” they concluded.