COVID-19 Immunologic Antiviral Therapy With Omalizumab

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study ID
NCT04720612
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — BIOLOGICAL
    Single subcutaneous dose of 375mg of omalizumab and standard of care.
  • Placebo — OTHER
    Single subcutaneous dose of normal saline in a syringe identical to that of the omalizumab arm and standard of care.

Study Details

To evaluate if omalizumab is effective in decreasing mortality in severe hospitalized COVID-19 cases.

Key Dates

Start date
Oct 15, 2021
Status verified
Nov 2022
Primary completion
Nov 7, 2022
Completion
Dec 16, 2022

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab
    Participants in this arm will receive the study drug, omalizumab.
  • Placebo Comparator: Placebo
    Participants in this arm will receive a placebo treatment.

Primary Outcome Measure

Incidence of Death or Mechanical Ventilation [ Time Frame: 14 Days ]

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