NCT04602507.

Study name	Ivermectin in adults with severe COVID‐19
Methods	Trial design: quadruple‐blind RCT with 2 parallel arms Type of record: trial register entry Sample size: 100 Setting: inpatient Country: Columbia Language: English Number of centres: 1 Study purpose (treatment, prevention): treatment Trial registration number: NCT04602507 Date of registration: 26 October 2020
Participants	Inclusion criteria Age > 18 years Confirmed diagnosis of SARS‐CoV‐2 by PCR Diagnosis of severe pneumonia according to criteria of the National Institute of Health and the Colombian Consensus (suspected respiratory infection, organ failure, arterial SaO2 in room air < 90%, or respiratory rate > 30 breaths/minute) or diagnosis of acute respiratory distress syndrome according to criteria of the National Institute of Health and the Colombian Consensus (clinical findings, bilateral radiographic infiltrates, oxygenation deficit: mild: 200 mmHg < PaO2/FiO2 < 300 mmHg; moderate: 100 mmHg < PaO2/FiO2 < 200 mmHg and, severe: PaO2/FiO2 < 100 mmHg) < 14 days since the onset of symptoms Hospitalized in a general internal medicine ward, special care unit, or those designated for managing people with COVID‐19 Exclusion criteria Pregnant or lactating women Use of ivermectin in the 2 weeks before admission to the clinic Diseases affecting the blood–brain barrier (meningitis, encephalocranial trauma, acute subarachnoid haemorrhage) Limited understanding of explanations and consent, defined by the investigating physician People with HIV/AIDS Participation in another clinical trial
Interventions	Details of intervention Type and dose: ivermectin 0.4 mg/kg, single dose Route of administration: oral Treatment details of control group Placebo with standard of care Concomitant therapy: standard of care (details NR) administered in both study arms
Outcomes	Primary study outcome Cumulative incidence of ICU admission within 21 days Relevant review outcomes planned Cumulative incidence of ICU admission within 21 days Duration of hospitalization within 28 days Mortality at 21 days Adverse effects of ivermectin within 21 days Additional study outcomes ICU length of stay within 28 days Length of stay in ventilator time within 28 days
Starting date	7 December 2020
Contact information	Federico Rodríguez‐Vega, MD Clinica CES Medellín, Antioquia 050001 Colombia federicorodriguez@clinicaces.edu.co
Notes	Recruitment status: recruiting Prospective completion date: March 2021 Date last update posted: 10 December 2020 Sponsor/funding: CES University