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. 2021 Jul 28;2021(7):CD015017. doi: 10.1002/14651858.CD015017.pub2

NCT04894721.

Study name Prophylaxis for COVID‐19: ivermectin in close contacts of COVID‐19 cases (IVERNEX‐TUC) 
Methods
  • Trial design: double‐blind RCT with 2 parallel arms

  • Type of record: trial register entry

  • Sample size: 750

  • Setting: after high‐risk exposure

  • 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

Starting date 20 March 2021
Contact information Maria Peral, PhD
SI.PRO.SA, Ministerio de Salud Pública
Tucumán
4000
Argentina
mperal@fm.unt.edu.ar
Notes
  • Recruitment status: recruiting

  • Prospective completion date: 30 May 2021

  • Date last update posted: 20 May 2021

  • Sponsor/funding: Ministry of Public Health, Argentina