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

IRCT20200329046892N3.

Methods
  • Trial design: double‐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: IRCT20200329046892N3

  • Date of registration: 29 March 2021

Participants
  • Inclusion criteria

    • All COVID‐19 patients admitted to the coronavirus ward of Razi Hospital in Rasht for period of April to July 2021

    • ≥ 18 years old

    • Patients admitted with fever (oral temperature greater than 37.2 °C), dry cough, severe tiredness or dyspnea

    • positive PCR or lung involvement on chest X‐ray/CT scan

  • Exclusion criteria

    • Lack of informed consent

    • Lack of patient co‐operation

    • Pulmonary embolism or intravascular thrombosis

    • Any major drug interaction between routine patient's drugs with any of the study drugs

    • Pregnancy and lactation

    • Simultaneous presence in other research study

Interventions
  • Details of intervention

    • Type and dose: ivermectin, 12 mg once/day for 2 days + standard care for 10 days

    • Route of administration: oral

  • Treatment details of control group

    • placebo once/day for 2 days + standard care for 10 days

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

Outcomes
  • Primary study outcome

    • Time required to improve clinical symptoms within 10 days of treatment start

  • Relevant review outcomes planned

    • Mortality

  • Additional study outcomes

    • Body temperature

    • Heart rate

    • Blood pressure

    • Respiration rate

    • Duration of hospitalization

    • SpO2

    • Creatine phosphokinase, before intervention, day 5 and 10

    • CRP, before intervention, day 5 and 10

    • ESR, before intervention, day 5 and 10

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

  • Recruitment status: completed

  • Prospective completion date: July 2021, study completed

  • Planned completion date more than 6 months ago: yes

  • Date last update posted: 29 March 2021

  • Sponsor/funding: Rasht University of Medical Sciences