IRCT20111224008507N5.

Study name	Double‐blind placebo‐controlled clinical trial evaluating the effectiveness of Ivermectin in treatment of patients admitted with COVID‐19 in 2021
Methods	Trial design: double‐blind RCT with 2 parallel arms Type of record: trial register entry Sample size: 1000 Setting: inpatient Country: Iran Language: English Number of centres: 1 Study purpose (treatment, prevention): treatment Trial registration number: IRCT20111224008507N5 Date of registration: 22 February 2021
Participants	Inclusion criteria People with positive coronavirus rapid test or RT‐PCR Age > 5 years Weight > 15 kg No treatment with antiviral drugs before and during the study Informed consent for participation Exclusion criteria Underlying liver and kidney disease People with acquired immunodeficiency 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 Concomitant therapy: standard of care according to national treatment protocol administered in both study arms
Outcomes	Primary study outcome Duration until reduction in persistent cough Negative RT‐PCR result at 6 days Main complaint's recovery time Mortality, time point unclear Drug adverse effects (wheezing, itching, skin rash, oedema, and hypotension) Reduction in tachypnoea SaO2 > 94% Relevant review outcomes planned Mortality, time point unclear Drug adverse effects (wheezing, itching, skin rash, oedema, and hypotension) Negative RT‐PCR result at 6 days Additional study outcomes None
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: August 2022 Planned completion date more than 6 months ago: no Date last update posted: 4 March 2021 Sponsor/funding: Mazandaran University of Medical Sciences