Vallejos 2021.

Study characteristics
Methods	Trial design: double‐blind RCT with 2 parallel arms Type of publication: journal publication Setting: outpatient Recruitment dates: August 2020‐Febuary 2021 Country: Argentina Language: English Number of centres: 1 Study purpose (treatment, prevention): treatment Trial registration number: NCT04529525 Date of registration: 27 August 2020
Participants	Number of participants (randomized/analysed): 501/501 Age (mean): overall 42 years Males, n: overall 246 (53%) Severity of condition according to study definition: mild disease, defined as not requiring home oxygen or hospitalization Severity of condition according to WHO scale: 1 to 3 Time from symptom onset to study enrolment (median): overall 4 (IQR 3 to 6) days Comorbidities: any pre‐existing condition, obesity, diabetes, hypertension, respiratory disease Virus detection performed at baseline (test‐positive at baseline): RT‐PCR (100%) Vaccination status: NR, study period before vaccination was available Inclusion criteria: age > 18 years, reside in the province of Corrientes at the time of diagnosis; confirmed diagnosis of COVID‐19 by PCR test for detection of SARS‐CoV‐2 in the last 48 hours; women of childbearing age, using a contraceptive method of proven efficacy and safety; weight at inclusion > 48 kg Exclusion criteria: current home oxygen use, requiring hospitalization for COVID‐19 at the time of diagnosis; history of hospitalization for COVID‐19; pregnant or breastfeeding women; known allergy to ivermectin or the components of ivermectin or placebo tablets; presence of malabsorptive syndrome; presence of any other concomitant acute infectious disease; known history of severe liver disease; recent or expected need for dialysis; concomitant use of hydroxychloroquine or antiviral drugs due to a pathology other than COVID‐19 at the time of admission; use of ivermectin up to 7 days before randomization; participation in a research study that involved the administration of a drug within the last 30 days
Interventions	Details of intervention Type and dose: ivermectin 12 mg to 24 mg (weight‐adjusted), once daily for 2 days Route of administration: oral Treatment details of control group: Placebo Concomitant therapy NA Duration of follow‐up: 30 days Treatment cross‐overs: none
Outcomes	Primary study outcome Percentage of hospitalization at 30 days Relevant review outcomes planned Percentage of hospitalization at 30 days or death (outcome provided by study author via personal communication) Negative swab at 3 and 12 days after entering the study Number of participants with non‐serious adverse events at 30 days All‐cause mortality at 30 days Serious adverse events at 30 days Additional study outcomes Time to hospitalization Time to invasive mechanical ventilation support Percentage of use of invasive mechanical ventilation support at 30 days Percentage of dialysis in each arm at 30 days
Notes	Date of publication: 2 July 2021 Sponsor/funding: Ministry of Health of the Province of Corrientes, Argentina Correspondence with the author team: author request sent (trial protocol, details on compliance rate, review relevant outcome data); response received from the author Information on ethics votum: ethics committee approval number reported by a nationally‐recognized ethics committee, as defined in the country's clinical trial regulations

ALT: alanine transaminase; AST: aspartate aminotransferase; BMI: body mass index; COVID‐19: coronavirus disease 2019; CRP: C‐reactive protein; CT: computer tomography; ECG: electrocardiograph; ICU: intensive care unit; IgG: immunoglobulin G; IQR: interquartile range; LDH: lactose dehydrogenase; PaO₂/FiO₂: partial pressure of oxygen/fraction of inspired oxygen; PCR: polymerase chain reaction; n: number; NA: not available; NR: not reported; NSAID: non‐steroidal anti‐inflammatory drug; PCR: polymerase chain reaction; RAT: rapid antigen test; RCT: randomized controlled trial; RT‐PCR: reverse transcription polymerase chain reaction; rRT‐PCR: real‐time reverse transcription polymerase chain reaction; SaO₂:oxygen saturation as measured by blood analysis; SARS‐CoV‐2: severe acute respiratory syndrome coronavirus 2; SD: standard deviation; SpO₂: oxygen saturation as measured by pulse oximeter; WHO: World Health Organization.