Background: Severe acute respiratory syndrome COVID-19 infection has evolved into a global pandemic. This study has been designed to evaluate colchicine anti-inflammatory effect on the symptoms course, duration of hospitalization, morbidity and mortality rate, of COVID-19 patients.Methods: In this prospective, open-label, randomized and double blind clinical trial, 100 patients hospitalized with COVID-19 were randomized in a 1:1 allocation from May 21 to June 20, 2020, to either standard

more »

... treatment (Hydroxychloroquine) or colchicine with standard medical treatment. The study took place in Imam Reza hospital of Ardabil city in Iran, with trial registration ID: 47707 (irct.ir). Colchicine group were received 1 mg tablet of colchicine daily alongside the Hydroxychloroquine for 6 days. Primary end points were (1) Length of hospitalization; (2) symptoms and (3) Co-existed disease. Secondary end points were examined 2 weeks after discharge and included (1) mortality and morbidity; (2) re-admission and (3) symptoms. Results: Overall, 100 patients (59 [59%] female; median age, 56 years) fulfilled the admission criteria and were included and randomized at 2 clinical groups. There was no significant difference between the two groups in terms of age and sex. Two groups were not significantly different in terms of underlying diseases and various clinical and para clinical findings although there were not any different during Post-discharge follow-up except for duration of fever (P<0.05). Comparing two groups showed significantly different only in the duration of hospitalized (P<0.05). Although in colchicine group dyspnea was improved more rapid than the placebo group, but it was not meaningful. Conclusion: Colchicine can be effective in reducing systemic symptoms of COVID-19 by inhibiting inflammatory biomarkers.Current Controlled prospective Trials registration ID that has been approved by ICMJE and WHO ICTRP registry is IRCT20200418047126N1, and the date of registration is 2020-05-14.