Gout Drug Colchicine Shows Benefits in Severe COVID-19 Treatment
Primarily used for treating gout, low-dose colchicine is known to combine anti-inflammatory action with a favorable safety profile. Greek researchers sought to determine if the drug could be helpful in treating patients with severe COVID-19 and documented some positive effects after a small clinical trial. Here are more details.
ATHENS, GREECE – Could a common gout drug be beneficial in treatment of patients hospitalized with COVID-19?
That is the question addressed in a new report in JAMA Network Open. Greek researchers from Attikon Hospital of National and Kapodistrian University of Athens and colleagues conducted a randomized clinical trial of 105 patients to test the effectiveness of colchicine. Researchers determined that the rate of clinical deterioration, defined as the primary endpoint, was higher in the control group than in the colchicine group. In addition, the study team observed that the time to clinical deterioration was shorter in the control group than in the colchicine arm.
On the other hand, authors said no difference was observed in the primary biochemical end point -- high-sensitivity troponin concentration -- although patients in the colchicine group had a smaller increase in dimerized plasma fragment D compared with patients in the control group.
“The hypothesis-generating findings of this study suggest a role for colchicine in the treatment of patients with coronavirus disease 2019,” they note.
Researchers embarked on the prospective, open-label, randomized clinical trial (the Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention) because low-dose colchicine combines anti-inflammatory action with a favorable safety profile.
At 16 tertiary hospitals in Greece, patients hospitalized with COVID-19 were randomized in a 1:1 allocation from April 3 to April 27, 2020, to either standard medical treatment or colchicine with standard medical treatment.
The intervention group received colchicine administration -- 1.5-mg loading dose followed by 0.5 mg after 60 min and maintenance doses of 0.5 mg twice daily -- with standard medical treatment for as long as three weeks. Most of the trial participants, 58.1%, were men, with a median age of 64. 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). 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.
Primary end points were
- maximum high-sensitivity cardiac troponin level;
- time for C-reactive protein to reach more than 3 times the upper reference limit; and
- time to deterioration by 2 points on a 7-grade clinical status scale, ranging from able to resume normal activities to death.
The percentage of participants requiring mechanical ventilation; all-cause mortality and number, type, severity, and seriousness of adverse events were defined as secondary endpoints.
Results indicate that indicate that 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). Researchers report that the mean (SD) event-free survival time was 18.6 (0.83) days the in the control group vs 20.7 (0.31) in the colchicine group (log rank P = .03).
Adverse events were similar in the two groups, except for diarrhea, which was more frequent with colchicine group than the control group (25 patients [45.5%] vs 9 patients [18.0%]; P = .003), according to the study.
“In this randomized clinical trial, participants who received colchicine had statistically significantly improved time to clinical deterioration,” the authors conclude. “There were no significant differences in high-sensitivity cardiac troponin or C-reactive protein levels. These findings should be interpreted with caution.”