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

NCT04944082.

Study name Remdesivir‐ivermectin combination therapy in severe Covid‐19
Methods
  • Trial design: open‐label RCT with 2 parallel arms

  • Type of record: trial register entry

  • Sample size: 60

  • Setting: inpatient

  • Country: Egypt

  • Language: English

  • Number of centres: NR

  • Study purpose (treatment, prevention): treatment

  • Trial registration number: NCT04944082

  • Date of registration: 29 June 2021

Participants
  • Inclusion criteria

    • Adult, hospitalized severe COVID‐19 patients

    • Both genders

    • Given informed consent (COVID‐19 infection confirmed by PCR, severe illness is defined as patients with SpO2 ≤ 94% on room air, including patients on supplemental oxygen)

  • Exclusion criteria

    • Patients under 18 years old

    • Pregnant women

    • Advanced renal diseases (cr. clearance < 30 mL/hr)

    • Raised liver enzymes > 3 times normal

    • Arrhythmia

Interventions
  • Details of intervention

    • Type and dose: ivermectin 6 mg, once daily for 4 days

    • Route of administration: oral

  • Treatment details of control group

    • Standard of care alone

  • Concomitant therapy: standard of care (remdesivir) administered in both study arms

Outcomes
  • Primary study outcome

    • Improvement in level of oxygenation

    • Need for ventilator support

    • Development of complication by end of 4th day

    • Mortality rate

  • Relevant review outcomes planned

    • Need for ventilator support

    • Mortality rate

    • Development of complication by end of 4th day

  • Additional study outcomes

    • None

Starting date 1 July 2021
Contact information Maiada K. Hashem
Lecturer 
Assiut University, Department of Chest Diseases
Assiut
Egypt
Notes
  • Recruitment status: not yet recruiting

  • Prospective completion date: December 2021

  • Planned completion date more than 6 months ago: no

  • Date last update posted: 29 June 2021

  • Sponsor/funding: Assiut University