NCT04746365.

Methods	Trial design: double‐blind RCT with 3 parallel arms, only 2 arms relevant; the third arm investigates hydroxychloroquine Type of record: trial register entry Sample size: 300 Setting: inpatients Country: Egypt Language: English Number of centres: 1 Study purpose (treatment, prevention): treatment Trial registration number: NCT04746365 Date of registration: 9 February 2021
Participants	Inclusion criteria Participant (or legally authorized representative) provides written informed consent prior to initiation of any study procedures Understands and agrees to comply with planned study procedures Agrees to the collection of oropharyngeal swabs and venous blood per protocol Male or non‐pregnant female adult age ≥ 18 years at enrolment Has laboratory‐confirmed SARS‐CoV‐2 infection as determined by PCR, or other Severe cases according to WHO definition Exclusion criteria ALT/AST > 5 times the ULN Mortality within 12 hours of admission Pregnancy Anticipated transfer to another hospital within 24 hours Allergy to any study medication commercial or public health assay in any specimen prior to randomization Mechanically ventilated on admission
Interventions	Details of intervention for relevant arms: Type and dose: ivermectin 12 mg, 3 times daily on day 0, 3, and 6 Route of administration: oral Treatment details of control group Unclear if placebo or standard of care Concomitant therapy: NR
Outcomes	Primary study outcome Reduction in the WHO Ordinal Scale of clinical status by ≥ 2 points at 14 days Time to discharge at 14 days Relevant review outcomes planned Adverse events (grade 3 and 4) at 14 days Serious adverse events at 14 days Additional study outcomes Mortality at 14 days
Notes	Reason for awaiting classification: study completed, but results not published yet Recruitment status: completed Prospective completion date: February 2021, study completed Planned completion date more than 6 months ago: yes Date last update posted: 9 February 2021 Sponsor/funding: Elaraby Hospital