2020‐005015‐40/SK.

Methods	Trial design: double‐blind RCT with 2 parallel arms Type of record: trial register entry Sample size: 832 Setting: outpatient Country: Slovakia Language: English Number of centres: NR Study purpose (treatment, prevention): prevention Trial registration number: 2020‐005015‐40 Date of registration: 25 March 2021
Participants	Inclusion criteria Male or female adult > 50 years of age SARS‐CoV‐2 infection diagnosed either through a rapid antigen‐based test or an RNA based RT‐PCR diagnostic test performed in nasopharyngeal sample Onset of COVID‐19 symptoms < 120 hours prior to screening Written informed consent Not pregnant and use contraception Exclusion criteria Intake of ivermectin within 30 days before screening Routine intake of antivirals, including antiretroviral treatment Allergy, hypersensitivity or contraindication to ivermectin, metabolites or excipients Subjects with symptoms of disease severity Subjects requiring hospitalization for any reason Epidemiological risk or suspicion of being infected by Loa loa or other filariases Previous enrolment in this trial or participation in any other drug investigational trial within the past 30 days Weight < 50 kg Pregnancy or lactation Inability to take oral medications Acute/chronic disease or deficiency Active cardiac disease or a history of cardiac dysfunction Concomitant use of barbiturates, sodium oxybate, valproic acid or warfarin Laboratory abnormalities relevant for the trial, including but not limited to: neutropenia < 500/mm3, thrombocytopenia < 100,000/mm3 Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the subject because of participation in the study, affect the ability of the subject to participate in the study or impair interpretation of the study data Employees of the investigator or clinical trial site, with direct involvement in the proposed trial or other studies under the direction of that investigator or clinical trial site, as well as family members of the employees or the principal investigator Persons committed to an institution by virtue of an order issued either by the judicial or other authorities
Interventions	Details of intervention Type and dose: ivermectin 9 mg to 18 mg, no details on frequency scheme Route of administration: oral Treatment details of control group Placebo Concomitant therapy:NR
Outcomes	Primary study outcome Percentage of subjects requiring SARS‐CoV‐2 hospitalization during 28 days after first investigational product administration Relevant review outcomes planned Percentage of subjects requiring SARS‐CoV‐2 hospitalization during 28 days after first investigational product administration any adverse event related to Ivermectin treatment Additional study outcomes change in subjects’ clinical status on Day 28
Notes	Reason for awaiting classification: study terminated, interim results might be published Recruitment status: terminated due to low recruitment Prospective completion date: June 2021, study terminated Planned completion date more than 6 months ago: yes Date last update posted: NR Sponsor/funding: Chemo Research SL