IRCT20111224008507N4.

Study name	Double‐blind placebo‐controlled clinical trial of evaluating the effectiveness of Ivermectin in treatment of outpatients with COVID‐19 in 2021
Methods	Trial design: double‐blind RCT with two parallel arms Type of record: trial register entry Sample size: 1000 Setting: outpatient Country: Iran Language: English Number of centres: 1 Study purpose (treatment, prevention): treatment Trial registration number: IRCT20111224008507N4 Date of registration: 31 January 2021
Participants	Inclusion criteria People with positive coronavirus rapid test or RT‐PCR positive No need for hospitalization Weight > 15 kg Age > 5 years No treatment with antiviral drugs before and during the study Informed consent for inclusion Exclusion criteria Underlying liver and kidney disease People with AIDS Pregnancy and lactation
Interventions	Details of intervention Type and dose: ivermectin 0.4 mg/kg, once daily for 3 days Route of administration: oral Treatment details of control group Placebo with standard of care Concomitant therapy: standard of care according to national treatment protocol administered in both study arms
Outcomes	Primary study outcome Clinical improvement Negative RT‐PCR result at 6 days Relevant review outcomes planned Drug adverse effects Negative RT‐PCR result at 6 days Additional study outcomes The main complaint's recovery time Need to be hospitalized, time point unclear Mortality, time point unclear
Starting date	19 February 2021
Contact information	Dr Mohammad Sadegh Rezai Mazandaran University of Medical Sciences Boali Hospital, Pasdaran Blv. 485838477 Sari, Mazandaran Iran drmsrezaii@yahoo.com
Notes	Recruitment status: recruiting Prospective completion date: 22 August 2022 Date last update posted: 6 March 2021 Sponsor/funding: Mazandaran University of Medical Sciences