NCT04886362.

Study name	Ivermectina Colombia (IVERCOL)
Methods	Trial design: quadruple‐blin RCT with 2 parallel arms Type of record: trial register entry Sample size: 966 Setting: outpatient Country: Colombia Language: English Number of centres: NR Study purpose (treatment, prevention): treatment Trial registration number: NCT04886362 Date of registration: 14 May 2021
Participants	Inclusion criteria Age ≥ 18 years Positive antigen test or RT‐PCR for SARS‐CoV‐2 < 7 days from symptoms onset Indication for outpatient management Mild disease according to the official guide "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 8):" People with mild symptoms, with or without radiological signs of pneumonia, with oxygen saturation > 90% Able to provide consent to participate Exclusion criteria People who at the time of admission require hospitalization or supplemental oxygen, or both History of allergy to ivermectin Medical history of liver disease Belong to another clinical trial evaluating the efficacy of an investigational drug against COVID‐19 Immunosuppression or HIV, acute or chronic kidney failure, current neoplasia Current use of warfarin, erdafitinib, or quinidine Received vaccination for SARS‐CoV‐2 Ivermectin consumption prior to inclusion in the research protocol Not accepting of the conditions of home care and monitoring Desists from participating in the study Pregnancy or breastfeeding women
Interventions	Details of intervention Type and dose: ivermectin 0.6 mg/kg, twice daily for 5 days Route of administration: oral Treatment details of control group Placebo Concomitant therapy: NA
Outcomes	Primary study outcome Composite outcome, first outcome that occurs in each participant during 28 days Hypoxaemia (oxygen saturation ≤ 90%) and need for supplemental oxygen in home care programme or Need for hospitalization includes general bed or ICU or Death from any cause Relevant review outcomes planned Number and type of serious and non‐serious adverse events within 28 days Additional study outcomes Proportion of participants with ≥ 4 points on the WHO scale at 28 days Number of days with supplemental oxygen requirement at 28 days Number of days on ICU management at 28 days Number of days with endotracheal intubation at 28 days Number of days of hospitalization at 28 days
Starting date	July 2021
Contact information	Juan Carlos Chacón Jimenez, MD ceivercol@suramericana.com.co
Notes	Recruitment status: not yet recruiting Prospective completion date: September 2021 Date last update posted: 14 May 2021 Sponsor/funding: Ayudas Diagnosticas Sura S.A.S.