Skip to main content
. 2022 Jun 21;2022(6):CD015017. doi: 10.1002/14651858.CD015017.pub3

NCT04894721.

Methods
  • Trial design: double‐blind RCT with 2 parallel arms

  • Type of record: trial register entry

  • Sample size: 750

  • Setting: outpatient

  • Country: Argentina

  • Language: English

  • Number of centres: NR

  • Study purpose (treatment, prevention): prevention

  • Trial registration number: NCT04894721

  • Date of registration: 20 May 2021

Participants
  • Inclusion criteria

    • Age > 18 years

    • Women of childbearing age with negative pregnancy test

    • In close contact group or epidemiological nexus of a positive COVID‐19 case

    • Able to understand and grant informed consent

    • RT‐PCR with a negative result

  • Exclusion criteria

    • Hypersensitivity or allergy to any component of the drug under evaluation

    • Age < 18 years

    • Use of immunosuppressants (including systemic corticosteroids) in last 30 days

    • Pregnant or lactating

    • Other acute infectious diseases

    • Autoimmune disease or chronic decompensated diseases, or both

    • Received a vaccine for COVID‐19 (1 or 2 doses) or who have received ivermectin (prior to 30 days of the study) or who are participating in another COVID‐19 prophylaxis study

Interventions
  • Details of intervention

    • Type and dose: ivermectin 0.6 mg/kg, once daily at 1 and 7 days

    • Route of administration: oral

  • Treatment details of control group

    • Placebo

  • Concomitant therapy: standard biosecurity care used in both study arms

Outcomes
  • Primary study outcome

    • Number of participants diagnosed with COVID‐19 at 14 days

  • Relevant review outcomes planned

    • Number of participants diagnosed with COVID‐19 at 14 days

  • Additional study outcomes

    • Contagion risk within 2 weeks

    • Prophylactic effect associated with patient's pre‐existing comorbidity

Notes
  • Reason for awaiting classification: study completed, but results not published yet

  • Recruitment status: completed

  • Prospective completion date: October 2021, study completed

  • Planned completion date more than 6 months ago: no

  • Date last update posted: 7 December 2021

  • Sponsor/funding: Ministry of Public Health, Argentina