Efficacy of colchicine in moderately symptomatic COVID-19 patients: a study protocol for a double-blind, randomized, placebo-controlled trial

Abstract

Background: Inflammation is playing a major role in the pathophysiology of severe COVID-19 disease. The main causes of mortality are cytokine syndrome and immune thromboembolism. Colchicine is an anti-inflammatory drug but its action is mediated by completely different pathophysiologic routes than that of corticosteroids and non-steroidal anti-inflammatory agents. Colchicine inhibits neutrophil chemotaxis, inhibits inflammasome signaling and reduces interleukin-1β, reduces neutrophil-platelet interaction and aggregation. Colchicine is a readily available, cheap drug, has been used safely for many years. Specific targeted anti-inflammatory drugs like tocilizuma and anakinra are costly. A previous study suggested a significant clinical benefit from colchicine in patients hospitalized with COVID-19. But they did not compare with placebo. So, we have designed this study. Methods: This is a prospective, double-blind, randomized, placebo-controlled clinical trial. The study will be conducted at Dhaka medical college hospital, Bangladesh. Real time-polymerase chain reaction (RT-PCR) positive COVID-19 patients with moderate symptoms will be included in this study. Participants will be randomized into two groups at 1:1 ratio. Patients of one group will be treated with standard treatment along with colchicine for 14 days. The patients in other group will be treated with standard treatment along with placebo for the same duration. The primary outcome of the study will be time to develop clinical deterioration, defined as the time from randomization to a deterioration of two points (from the status at randomization) on a seven-category ordinal scale. Conclusions: Enrolment of participants has begun at the study site. A total of 300 participants will be enrolled. Trial Registration: ClinicalTrials.gov identifier: NCT04527562.