NCT04407507.

Methods	Trial design: clinical study of unclear design with 2 parallel arms Type of publication: trial registry entry with posted results Setting: outpatient Recruitment dates: July 2020 to January 2021 Country: Mexico Language: English Number of centres: NR, multicentred Study purpose (treatment, prevention): treatment Trial registration number: NCT04407507 Date of registration: 29 May 2020
Participants	Number of participants (randomized/analysed): 66/56; 66 participants analysed for safety outcomes; unclear if participants were actually randomized Age (mean): overall 39 (SD 14.19) years Males, n: overall 18 (27.3%) Severity of condition according to study definition: outpatients with mild or no symptoms Severity of condition according to WHO scale: 1 to 3 Time from symptom onset to enrolment: NR Comorbidities: NR Virus detection performed at baseline (test‐positive at baseline): NR, but RT‐PCR positivity defined as inclusion criterion Inclusion criteria: diagnosis of acute severe respiratory syndrome due to SARS‐CoV‐2 defined by RT‐PCR; asymptomatic or mild symptoms treated as outpatients; signed informed consent Exclusion criteria: severe COVID‐19; positive to proof of infection by some other virus such as influenza H1N1, SARS syndrome, etc.; recurrent urinary tract infections; ALT or AST > 5 times ULN; pregnant or lactating; receiving antihypertensive medication verapamil, the immunosuppressant cyclosporin A or the antipsychotic trifluoperazine, or both; known allergy or hypersensitivity to dewormers; using an antioxidant supplement; history of filariasis, strongyloidiasis, scabies, river blindness, or any parasitic disease in the last 12 months
Interventions	Details of intervention Type and dose: ivermectin 12 mg, once daily for 3 days Route of administration: oral Treatment details of control group Placebo Concomitant therapy: standard of care including paracetamol administered in both study arms Duration of follow‐up: 21 days Treatment cross‐overs: none
Outcomes	Primary study outcome Participants with a disease control status defined as no disease progression to severe at 14 days Relevant review outcomes reported None Additional study outcomes reported SARS‐CoV‐2 viral load at 5 and 14 days Presence and frequency of symptoms associated with COVID‐19 within 14 days
Notes	Reason for awaiting classification: study did not pass reseach integrity, because relevant information to assure trustworthiness are missing. Trialist was contacted for clarification. Response received from the trialist stating that the full article is under revision for a journal publication; before publication the author did not want to share details or data. Date of results first posted: 21 May 2021 Sponsor/funding: Investigacion Biomedica para el Desarrollo de Farmacos SA de CV