Krolewiecki 2020.

Study characteristics
Methods	Trial design: open‐label RCT with 2 parallel arms Type of publication: preprint Setting: inpatient Recruitment dates: May to September 2020 Country: Argentina Language: English Number of centres: 4 Study purpose (treatment, prevention): treatment Trial registration number: NCT04381884 Date of registration: 11 May 2020
Participants	Number of participants (randomized/analyzed): 45/45 Age (mean): overall 41 (SD 12.48) years Males, n: overall 25 (56%) Severity of condition according to study definition: hospitalized, with mild‐to‐moderate disease Severity of condition according to WHO scale: 4 to 5 Co‐morbidities: obesity, diabetes, hypertension, respiratory disease Virus detection performed at baseline (test‐positive at baseline): RT‐PCR (100%) Inclusion criteria: men or women; aged 18–69 years; SARS‐CoV‐2 confirmed by PCR; hospitalized people with symptoms onset 5 days before executing the informed consent; no co‐morbidities affecting the patient's prognosis, rendering them at high risk; documented acceptance to participate by means of the execution of the informed consent; women of childbearing age must have a negative pregnancy test and use adequate contraceptive methods during participation in the study and for 1 month after the last medication dose in the case of those receiving ivermectin Exclusion criteria: allergy or hypersensitivity to ivermectin or its inactive ingredients, or both; people meeting COVID‐19 severity criteria, with respiratory distress or requiring intensive care; using medications having potential activity against SARS‐CoV‐2 such as hydroxychloroquine, chloroquine, lopinavir, ritonavir, remdesivir, or azithromycin in the last 3 months; use of immunodepressants (including systemic corticosteroids) in the last 30 days; known HIV infection with CD4 count < 300 cell/µL; pregnancy or lactating; other infectious diseases or medical conditions such as malabsorption syndromes affecting proper ivermectin absorption; acute allergy conditions or with severe allergic reactions background; autoimmune disease or decompensated chronic diseases, or both; uncontrolled, intercurrent diseases including renal impairment, hepatic impairment, symptomatic congestive heart failure, unstable chest angina, heart arrhythmia or psychiatric conditions that may limit adherence to CT requirements
Interventions	Details of intervention Type and dose: ivermectin 0.6 mg/kg (rounding to the lower full (6 mg) or half (3 mg) dose), once daily for 5 days Route of administration: oral Treatment details of control group No treatment except standard of care Concomitant therapy: standard of care (no details provided) administered in both study arms Duration of follow‐up: 30 days Treatment cross‐overs: none
Outcomes	Primary study outcome Reduction in SARS‐CoV‐2 viral load at 5 days Relevant review outcomes reported Adverse events within 30 days Serious adverse events within 30 days Additional study outcomes reported Need for invasive mechanical ventilation at 7 days Relationship between ivermectin plasma concentrations and the primary outcome Clinical evolution at 7 days
Notes	Date of publication: 11 November 2020 Sponsor/funding: Laboratorio Elea Phoenix S.A. (provided intervention drug) Correspondence with the author team: author request sent (publication status); author responded Information on ethics votum: name of responsible ethics committee, reference number of proposal, and votum provided by author via personal correspondence