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Study aim: This study will be performed to determine the efficacy of colchicine versus placebo in the treatment of outpatients with COVID-19. Design: A two-arm, parallel, randomized, single-blind, controlled clinical trial on 500 COVID-19 outpatients. Random blocks will be used for randomization. Settings and conduct: This study will be performed on outpatients with COVID-19 in an outpatient clinic under infectious disease specialists' supervision. After confirming the disease with the RT-PCR test and meeting the inclusion criteria, they will be randomly assigned to one of the two groups. Also, the participants will be blinded. Participants/Inclusion and exclusion criteria: Patients with the new coronavirus infection 2019 (COVID-19) confirmed by the RT-PCR test with the approval of an infectious disease specialist and an indication for outpatient treatment status (do not have any of the following): PaO2/FiO2 < 300, SpO2 < 93%, Respiratory rate > 30, Progressive lung involvements in CT scan The patient must meet at least one of the following high-risk criteria: 70 years of age or older, obesity (BMI ≥ 30 kg/m2), diabetes, uncontrolled blood pressure (systolic blood pressure > 150 mm Hg), known case of respiratory disease (Including asthma or COPD), known case of heart failure, known case of coronary artery disease, fever > 38.4°C in the last 48 hours, shortness of breath at the time of enrollment, Bicytopenia, Pancytopenia or a combination of neutrophilia and lymphopenia. Intervention groups: The control group will receive placebo tablet BID for the first three days, then QD for the next 27 days. The intervention group will receive colchicine 0.5 mg tablet BID for the first three days, then QD for the next 27 days. Main outcome variables: 1) Require hospitalization 2) Death
IRCTID: IRCT20201024049134N3
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