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

IRCT20200422047168N2.

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

  • Type of record: trial register entry

  • Sample size: 60

  • Setting: inpatient

  • Country: Iran

  • Language: English

  • Number of centres: 1

  • Study purpose (treatment, prevention): treatment

  • Trial registration number: IRCT20200422047168N2

  • Date of registration: 30 May 2020

Participants
  • Inclusion criteria

    • Aged > 18 years

    • RT‐PCR test results for SARS‐CoV‐2 virus were positive after sampling (nasopharynx and oropharynx swab samples)

    • Manifestations of virus pneumonia in CT scans of their lungs were quite obvious

    • SpO2 saturation ≤ 93%

  • Exclusion criteria

    • History of renal failure

    • Taking drugs that interfere with ivermectin

    • People who have been admitted to other clinical trials

Interventions
  • Details of intervention

    • Type and dose: ivermectin 0.15–0.2 mg/kg, single dose

    • Route of administration: oral

  • Treatment details of control group

    • No treatment except standard of care

  • Concomitant therapy: standard of care including chloroquine, lopinavir/ritonavir (Kaletra) administered in both study arms

Outcomes
  • Primary study outcome

    • Unclear from protocol, either mortality or participants discharged within 7 days

  • Relevant review outcomes planned

    • None

  • Additional study outcomes

    • Treatment period

    • Duration of infection

    • Duration of admission time

    • Duration of ICU admission time

    • Fever, blood SpO2 percentage, respiratory rate, heart rate, discharge situation within 7 days

    • Use of non‐invasive respiratory methods within 7 days

    • Use of invasive respiratory methods within 7 days

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

  • Recruitment status: completed

  • Prospective completion date: NR

  • Date last update posted: 30 May 2020

  • Sponsor/funding: Ahvaz University of Medical Sciences