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

IRCT20180612040068N1.

Methods
  • Trial design: triple‐blind RCT with 3 parallel arms; only 2 arms relevant; the other arm investigate metronidazol

  • Type of record: trial register entry

  • Sample size: 135

  • Setting: inpatient

  • Country: Iran

  • Language: English

  • Number of centres: 1

  • Study purpose (treatment, prevention): treatment

  • Trial registration number: IRCT20180612040068N1

  • Date of registration: 19 April 2021

Participants
  • Inclusion criteria

    • Hospitalized patient with positive SARS‐CoV‐2 test

    • > 18 years old

    • Willing to participate in the study

  • Exclusion criteria

    • Allergic history to metronidazole or ivermectin or hypersensitivity reaction to them during trial

    • Pregnant patients

    • COPD patients suspected of ILD

    • Long history of diabetes

    • Cirrhotic patients

    • Epileptic patients

    • Patients with severe renal failure and GFR < 20 mL/min

    • Participating in another RCT

Interventions
  • Details of intervention

    • Type and dose: ivermectin, once daily (weight‐adjusted)

    • Route of administration: oral

  • Treatment details of control group

    • No treatment except standard of care

  • Concomitant therapy: standard of care (no details provided) administered in all study arms

Outcomes
  • Primary study outcome

    • Length of time to recover from shortness of breath

    • Length of time to not require oxygen

    • Reduction of CRP

    • Normalization of lymphopenia, measured by specialists

    • Length of hospital stay

    • Likelihood of admission to ICU

    • Likelihood of mortality

  • Relevant review outcomes planned

    • Likelihood of admission to ICU

    • Likelihood of mortality

  • Additional study outcomes

    • None

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

  • Recruitment status: completed

  • Prospective completion date: April 2021, study completed

  • Planned completion date more than 6 months ago: yes

  • Date last update posted: 19 April 2021

  • Sponsor/funding: Shiraz University of Medical Sciences