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

NCT05076253.

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

  • Type of record: trial register entry

  • Sample size: 72

  • Setting: inpatient

  • Country: Thailand

  • Language: English

  • Number of centres: 1

  • Study purpose (treatment, prevention): treatment

  • Trial registration number: NCT05076253

  • Date of registration: 13 October 2021

Participants
  • Inclusion criteria

    • Adult men and women age 18‐80 years

    • Non‐pregnant or breast‐feeding women

    • Had mild to moderate symptoms as defined by the WHO severity score for COVID‐19

  • Exclusion criteria

    • Were allergic to ivermectin

    • Have the potential for a drug‐drug interaction with ivermectin such as tamoxifen or warfarin

    • Previously treated with ivermectin in the last 7 days

    • Had received any herbal medicine

    • Had severe chronic illness (severe congestive heart failure, chronic kidney disease stage 4‐5, chronic liver disease, terminal cancer diseases)

    • Had concurrent bacterial infection or unwilling to participate in the trial

    • Patients with severe symptoms, likely due to cytokine release syndrome

    • Uncontrolled comorbidities and immunocompromized states

Interventions
  • Details of intervention

    • Type and dose: ivermectin 12 mg, once daily for 5 days

    • Route of administration: oral

  • Treatment details of control group

    • Placebo

  • Concomitant therapy: standard of care including favipiravir or andrographolide, corticosteroids, cetrizine and paracetamol administered in both study arms

Outcomes
  • Primary study outcome

    • Viral clearance of SARS‐ CoV‐2 intervention in 7 days and 14 days

  • Relevant review outcomes planned

    • Viral clearance of SARS‐ CoV‐2 intervention in 7 days and 14 days

    • Mortality rate in 28 days

  • Additional study outcomes

    • Duration of hospitalization

    • Frequency of clinical worsening in 28 days

    • Need for mechanical ventilation in 28 days

    • Mortality rate in 28 days

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

  • Recruitment status: completed

  • Prospective completion date: December 2021, study completed

  • Planned completion date more than 6 months ago: no

  • Date last update posted: 15 December 2021

  • Sponsor/funding: Bangkok Metropolitan Administration Medical College and Vajira Hospital