IRCT20210213050344N1.

Methods	Trial design: double‐blind RCT with 3 parallel arms Type of record: trial register entry Sample size: 375 Setting: outpatient Country: Iran Language: English Number of centres: NR Study purpose (treatment, prevention): treatment Trial registration number: IRCT20210213050344N1 Date of registration: 6 April 2021
Participants	Inclusion criteria Only mild symptoms and clinical manifestations of COVID‐19 disease 18 ‐ 80 years old Positive RT‐PCR test result People with underlying disease (to evaluate the effectiveness of the drug on people with underlying disease) Individuals who have completed and signed the written consent to participate in the project Blood oxygen level ≥ 93% Exclusion criteria Patients with severe clinical signs and symptoms of COVID‐19 Patients with HIV Patients with severe disease; liver, kidney, lung, and with COPD Pregnant or breastfeeding mothers Participation in another RCT Dissatisfaction with participating in the study
Interventions	Details of intervention Type and dose: ivermectin, 12 mg on the first day (arm 1) ivermectin, 12 mg on the first and second day (arm 2) Route of administration: oral Treatment details of control group Placebo on the first day (arm 3) Concomitant therapy: NR
Outcomes	Primary study outcome Clinical manifestations on days 0, 1, 3, 7, 14, 21 and 28 Blood oxygen levels on days 0, 1, 3, 7, 14, 21 and 28 Need for hospitalization on days 0, 1, 3, 7, 14, 21 and 28 Admission to ICU or intubation on days 0, 1, 3, 7, 14, 21 and 28 Deaths on days 0, 1, 3, 7, 14, 21 and 28 Relevant review outcomes planned Need for hospitalization on day 28 Admission to ICU or intubation on day 28 Deaths on day 28 Additional study outcomes None
Notes	Reason for awaiting classification: study completed, but results not published yet Recruitment status: completed Prospective completion date: May 2021, study completed Planned completion date more than 6 months ago: yes Date last update posted: 6 April 2021 Sponsor/funding: Shiraz University of Medical Sciences