Colchicine with Infliximab Compared to Infliximab in Hospitalized Patients with COVID-19 Pneumonia: An Open-label Randomized Trial

Abstract

Background: Anti-inflammatory agents have been proposed to improve oxygenation and mortality rates in severe COVID-19 pneumonia. This study has assessed the impact of colchicine as a coadjuvant inflammatory agent to infliximab in adults hospitalized with severe COVID-19 pneumonia. Method: In this randomized, open-label clinical trial, 63 severe COVID-19 pneumonia patients according to the criteria of the National Institutes of Health, 18 to 85 years old, with an increase in TNF-α and IL-6 levels, were randomized to receive colchicine 1 mg for 7 days and infliximab as a single dose of 300 mg on the first day of treatment or infliximab as a single dose of 300 mg on the first day. The primary outcomes assessed were oxygenation parameters (PaO2/FiO2 ratio and lung infiltrate) after seven days, ICU and hospital length of stay, and in-hospital mortality rates. Secondary outcomes included laboratory data and drug safety after 7 days. Result: 52 patients with similar baseline characteristics completed the study. There were no significant differences in oxygenation parameters (PaO2/FiO2 ratio and lung infiltrate) after seven days, median ICU and hospital length of stay, and in-hospital mortality rates between the two groups. Laboratory data showed no differences between both the groups seven days after the treatment. Also, no serious side effects were observed during the study among the two groups, except for one patient, who experienced diarrhea. Conclusion: Our results cannot support the addition of colchicine to promote the improvement of clinical outcomes in severe COVID-19 pneumonia.