Garcia 2021.

Study name	Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID‐19 in Peru (SAINT‐Peru): a structured summary of a study protocol for randomized controlled trial
Methods	Trial design: triple‐blind RCT with 2 parallel arms Type of record: trial register entries and published protocol Sample size: 186 Setting: outpatient Country: Peru Language: English Number of centres: 2 Study purpose (treatment, prevention): treatment Trial registration number: NCT046355943, PER‐034‐20 Date of registration: 19 November 2020
Participants	Inclusion criteria COVID‐19 symptomatology (cough, fever, anosmia, etc.) lasting < 96 hours, with a positive nasopharyngeal swab PCR test for SARS‐CoV‐2 Age 18 years No use of ivermectin in the month prior to the visit No known history of ivermectin allergy Able to give informed consent Not current user of CYP 3A4 or P‐gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporin, tacrolimus, indinavir, ritonavir, cobicistat, or critical CYP3A4 substrate drugs such as warfarin Exclusion criteria COVID‐19 pneumonia diagnosed by the attending physician (oxygen saturation < 95% or lung examination) Positive pregnancy test for women of childbearing age Positive IgG against SARS‐CoV‐2 by rapid diagnostic test at screening
Interventions	Details of intervention Type and dose: ivermectin 0.3 mg/kg, once daily for 3 days Route of administration: oral Treatment details of control group Placebo Concomitant therapy: NA
Outcomes	Primary study outcome Proportion of participants with a positive SARS‐CoV‐2 PCR result from a nasopharyngeal swab 7 days after treatment Relevant review outcomes planned Participants progressing to severe disease or death during the trial Proportion of drug‐related adverse events at 7 days Additional study outcomes Mean viral load at baseline and on 4, 7, 14, and 21 days Proportion of participants with fever and cough at days 4, 7, 14, and 21 days Proportion of participants with a positive rapid diagnostic test at 21 days Participants progressing to severe disease or death during the trial Proportion of drug‐related adverse events at 7 days Seroconversion at 21 days Levels of IgG, IgM, and IgA ≤ 21 days Frequency of innate immune cells ≤ 7 days Results from cytokine Human Magnetic 30‐Plex Panel ≤21 days Presence of intestinal helminths at baseline and at 14 days
Starting date	29 August 2020
Contact information	Hansel Mundaca, MD Hospital Nacional Cayetano Heredia Lima, Peru hansel.mundaca@upch.pe
Notes	Recruitment status: recruiting Prospective completion date: April 2021 Planned completion date more than 6 months ago: yes Date last update posted: 18 March 2021 Sponsor/funding: Universidad Peruana Cayetano Heredia