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. 2022 Jun 21;2022(6):CD015017. doi: 10.1002/14651858.CD015017.pub3

CTRI/2020/06/025960.

Methods
  • Trial design: open‐label RCT with 2 parallel arms

  • Type of record: trial register entry

  • Sample size: 100

  • Setting: inpatient

  • Country: India

  • Language: English

  • Number of centres: 1

  • Study purpose (treatment, prevention): treatment

  • Trial registration number: NextCTRI/2020/06/025960

  • Date of registration: 18 June 2020

Participants
  • Inclusion criteria

    • Symptomatic people infected with SARS‐CoV‐2 virus diagnosed on RT‐PCR test, admitted to hospital

    • Age 18–70 years

  • Exclusion criteria

    • Age < 18 and > 70 years

    • Pregnant and lactating women

    • Unwilling to give written informed consent

    • Seriously‐ill people requiring intensive care

    • Known hypersensitivity to ivermectin

    • People who have participated in another investigational drug or research study within 30 days of screening

    • People who are using any medication or has any disease which in the judgement of the Investigator will interfere with the conduct or interpretation of the study

Interventions
  • Details of intervention

    • Type and dose: ivermectin 12 mg, once daily for 3 days

    • Route of administration: oral

  • Treatment details of control group

    • Standard of care, no details provided

  • Concomitant therapy: NR

Outcomes
  • Primary study outcome

    • Eradication of virus by testing for SARS‐CoV‐2 by RT‐PCR test at 7 days

  • Relevant review outcomes planned

    • Viral clearance at 7 days

    • Safety of ivermectin within 15 days

  • Additional study outcomes

    • Duration of hospitalization

    • Reduction in inflammatory markers at days 1, 5, and 10

    • Resolution of signs and symptoms of COVID‐19 at 3, 5, and 10 days

Notes
  • Reason for awaiting classification: unclear if standard of care administered in ivermectin group

  • Recruitment status: not yet recruiting

  • Prospective completion date: NR

  • Planned completion date more than 6 months ago: unclear

  • Date last update posted: 17 June 2020

  • Sponsor/funding: Symbiosis Medical College for Women, Lavale