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

Hosseini 2021.

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

  • Type of record: trial register entry and published protocol

  • Sample size: 120

  • Setting: inpatient and outpatient

  • Country: Iran

  • Language: English

  • Number of centres: 1

  • Study purpose (treatment, prevention): treatment

  • Trial registration number: IRCT20200506047323N6

  • Date of registration: 17 November 2020

Participants
  • Inclusion criteria

    • Age ≥ 20 years old

    • Weight ≥ 35 kg

    • Positive PCR test for COVID‐19

    • Non‐hospitalized people with mild COVID‐19 as well as hospitalized (≤ 48 hours) people with moderate COVID‐19

    • Signed informed consent voluntarily and knowingly

  • Exclusion criteria

    • Severe and critical pneumonia due to COVID‐19

    • Underlying diseases, including AIDS, asthma, loiasis, and severe liver and kidney disease

    • Use of anticoagulants (e.g. warfarin) and angiotensin‐converting enzyme inhibitors (e.g. captopril)

    • History of drug allergy to ivermectin

    • Pregnancy or breastfeeding

Interventions
  • Details of intervention

    • Type and dose: ivermectin 0.2 mg/kg, single dose

    • Route of administration: oral

  • Treatment details of control group

    • No treatment except standard of care according to patient setting

  • Concomitant therapy

    • Outpatients: standard of care including hydroxychloroquine administered in both study arms

    • Inpatients: standard of care including lopinavir/ritonavir and interferon beta‐1a administered in both study arms

Outcomes
  • Primary study outcome

    • Length of hospital stay within 7 days

    • Need for ICU within 7 days

    • Need for mechanical ventilation within 7 days

    • For outpatients only: need for hospitalization within 7 days

  • Relevant review outcomes planned

    • For outpatients: incidence of serious adverse reactions within 7 days

  • Additional study outcomes

    • For inpatients: incidence of serious adverse reactions within 7 days

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

  • Recruitment status: completed

  • Prospective completion date: 25 February 2021

  • Date last update posted: 17 November 2020

  • Sponsor/funding: Bandare‐abbas University of Medical Sciences