NCT04836299.

Study name	Clinical trial to "Study the Efficacy and Therapeutic Safety of Ivermectin: (SAINTBO)"
Methods	Trial design: double‐blind RCT with 2 parallel arms Type of record: trial register entry Sample size: 90 Setting: inpatient Country: Bolivia Language: English Number of centres: 1 Study purpose (treatment, prevention): treatment Trial registration number: NCT04836299 Date of registration: 8 April 2021
Participants	Inclusion criteria Confirmed case of COVID‐19 in national reference hospitals – COVID sentinel hospitals. Men and women aged 18–75 years inclusive Supply of signed and dated informed consent form Declared availability to comply with all study procedures and availability for duration of the study In good general health with mild or moderate symptoms during the first week of disease evolution (onset of symptoms maximum 7 days before recruitment) Ability to take oral medications and be willing to adhere to the medication consumption regimen prescribed in the study Must, in the opinion of the principal investigator, be able to comply with all requirements of the clinical trial (including home monitoring during isolation) Able and willing to comply with the requirements of the protocol. Voluntarily signed informed consent obtained prior to any proceeding related to the trial Exclusion criteria History of ivermectin allergy Hypersensitivity to any component of ivermectin or the excipients of the brand to be used COVID‐19 pneumonia: diagnosed by the treating physician or identified on a chest x‐ray Fever or cough present > 48 hours IgG positive against SARS‐CoV‐2 by a rapid diagnostic test Recent travel history to Loa loa endemic countries (Angola, Cameroon, Central African Republic, Chad, the Democratic Republic of the Congo, Ethiopia, Equatorial Guinea, Gabon, Republic of the Congo, Nigeria, and Sudan) Current use of quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, ciclosporin, tacrolimus, indinavir, ritonavir, or cobicistat Use of critical drugs such as warfarin
Interventions	Details of intervention Type and dose: ivermectin 0.6 mg/kg, single dose Route of administration: oral Treatment details of control group Placebo Concomitant therapy: NA
Outcomes	Primary study outcome Evolution of viral load within 3 days Clinical remission at 28 days Relevant review outcomes planned Clinical signs of toxicity or adverse effects within 28 days Need for supplemental oxygen at 28 days Need for mechanical ventilation at 21 days Additional study outcomes Hospital stay within 3 months
Starting date	8 May 2021
Contact information	Jorge L Aviles, MPH Universidad Mayor de San Simón Cochabamba Bolivia
Notes	Recruitment status: not yet recruiting Prospective completion date: 5 December 2021 Date last update posted: 8 April 2021 Sponsor/funding: Universidad Mayor de San Simón