Background:The therapeutic potential of oral colchicine administration may help combat COVID-19 infection due to reduced disease severity and mortality risk.

Objective:This randomized trial aimed to assess the effect of colchicine treatment on the inflammatory and hematologic markers as well as clinical features in non-hospitalized patients with mild-to-moderate COVID-19 disease.

Method:In the present placebo-controlled randomized trial, 80 non-hospitalized COVID-19 patients were enrolled and followed for 14 days. Subjects randomly received oral colchicine or placebo tablets once a day for two weeks. The fever and cough clinical signs, as well as Creactive protein (CRP) and lymphopenia, were evaluated through the follow-up.

Results:No significant between-group differences were observed in terms of the duration of clinical symptoms, CRP, and lymphopenia at 0, 7, and 14 days of intervention. Although the proportion of participants with fever, cough, positive CRP, and lymphopenia was higher reduced in the colchicine group than the placebo during treatment, no significant differences were found between groups. Due to no adverse effects detected in this trial, colchicine therapy was well-tolerated and safe.

Conclusion:Our findings revealed that colchicine adjuvant therapy had no beneficial effect on clinical and para-clinical parameters in non-hospitalized COVID-19 patients during 14 days of intervention. The present trial does not support colchicine as a potential treatment against COVID-19 disease.

Clinical trial Registration:The present study protocol was approved by the IRCT (IRCT20200408046990N2, https://en.irct.ir/trial/47468).