NCT04834115.

Study name	Efficacy of ivermectin in outpatients with non‐severe COVID‐19
Methods	Trial design: triple‐blind RCT with 2 parallel arms Type of record: trial register entry Sample size: 400 Setting: outpatient Country: Paraguay Language: English Number of centres: 1 Study purpose (treatment, prevention): treatment Trial registration number: NCT04834115 Date of registration: 6 April 2021
Participants	Inclusion criteria Positive diagnostic RT‐qPCR or antigen test for SARS‐CoV‐2 Symptomatic people with up to 8 days from the onset of symptoms Asymptomatic cases with up to 5 days of positive test for SARS‐CoV‐2 Agreement to participate by signing the informed consent form Exclusion criteria Severity criteria defined in the Coronavirus Disease Epidemiological and Laboratory Surveillance Guide (Version 3/11/2020) Pregnant or breastfeeding women Women of childbearing age and without commitment to use contraceptive methods during the study Inability to complete the study Current treatment with drugs known to interact with ivermectin Known intolerance to ivermectin, its derivate, or any of its excipients Known Child‐Pugh C liver disease Prior ivermectin consumption in the 10 days prior to study entry
Interventions	Details of intervention Type and dose: ivermectin 0.2 mg/kg, single dose Route of administration: oral Treatment details of control group Placebo Concomitant therapy: NA
Outcomes	Primary study outcome Proportion of participants with hospitalization criteria at 30 days Relevant review outcomes planned Proportion of participants with ivermectin adverse events within 30 days Additional study outcomes Proportion of participants with COVID‐19 signs and symptoms up to 14 days Proportion of cohabitants who had COVID‐19 after the index case up to 30 days Quantitative levels of IgG for SARS‐CoV‐2 measured by enzyme‐linked immunosorbent assay
Starting date	17 November 2020
Contact information	Gabriela Avila, MD, MSc, PhD Facultad de Ciencias Médicas ‐ Universidad Nacional de Asunción Asunción 111421 Paraguay mavila@med.una.py
Notes	Recruitment status: recruiting Prospective completion date: 30 May 2021 Date last update posted: 6 April 2020 Sponsor/funding: Universidad Nacional de Asunción