A Phase 2 interventional study of Omalizumab and Placebo in Covid19, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Status unknown at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-16.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 2, Interventional, and Treatment
To evaluate if omalizumab is effective in decreasing mortality in severe hospitalized COVID-19 cases.
Coronavirus disease 2019 (COVID-19) has affected over 88 million people, resulting in the death of at least 1.9 million individuals and numbers continue to climb exponentially. Despite these staggering numbers, there are currently very few effective treatments for COVID-19. The immune response to COVID-19 virus appears to follow 2 phases. During the incubation and early disease, interferon (ex. INF-α) signaling and adaptive immunity preclude the disease from progressing. If, and when, this immune response is impaired, the virus may cause pathologic inflammation leading to massive organ dysfunction leading to acute respiratory distress syndrome (ARDS).
Omalizumab is a humanized anti-IgE antibody approved by Health Canada for the treatment of moderate-severe asthma and chronic spontaneous urticaria. Omalizumab has been shown to exhibit antiviral and anti-inflammatory effects in virally exacerbated asthma cases that may be relevant to the treatment of COVID-19.
This is a double blind randomized placebo-controlled trial to evaluate the efficacy of a single dose of omalizumab in reducing all cause mortality at day 29 in severe hospitalized COVID-19 cases. Moreover, time to improvement/hospital discharge, incidence and duration of mechanical ventilation and safety will be assessed.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Dyspnea at rest or during minimal activity (sitting, talking, coughing, swallowing), OR
Patients who are pregnant may also be eligible if consent is provided. Patients who have received one of the SARS-CoV2 vaccines and/or bamlanivimab are eligible to participate in the study
Exclusion Criteria:
Participants in this arm will receive the study drug, omalizumab.
Biological: Omalizumab
Participants in this arm will receive a placebo treatment.
Other: Placebo
Single subcutaneous dose of 375mg of omalizumab and standard of care.
Also known as: Xolair
Single subcutaneous dose of normal saline in a syringe identical to that of the omalizumab arm and standard of care.
Incidence of Death or Mechanical Ventilation
Outcome reported as the number of patients in each arm that either experience death by any cause or mechanical ventilation.
Time frame: 14 Days
Time to Clinical Improvement
Outcome reported as the time to improvement of 2 points on the 8-category ordinal scale. (World Health Organization, 2020) 8-category ordinal scale: 0- Uninfected, no clinical or virological evidence of infection 1. Ambulatory, no limitation of activities 2. Ambulatory, limitation of activities 3. Hospitalized mild disease, no oxygen therapy 4. Hospitalized mild disease, oxygen by mask or nasal prongs 5. Hospitalized severe disease, non invasive ventilation or high-flow oxygen 6. Hospitalized severe disease, intubation and mechanical ventilation 7. Hospitalized severe disease, ventilation + additional organ support - pressors, RRT, ECMO 8. Death
Time frame: 28 Days
Duration of Mechanical Ventilation
Outcome reported as duration of mechanical ventilation in each arm.
Time frame: 28 Days
Duration of Hospitalization
Outcome reported as the duration of hospitalization of patients in each arm.
Time frame: 28 Days
Safety in COVID-19 patients
Outcome reported as the number of adverse events and serious adverse events that occurred in each arm.
Time frame: 14 Days
Incidence of All-Cause in Hospital Mortality
Outcome reported as the number of patients in each arm that experience death by any cause while in hospital.
Time frame: 28 Days
Percent of viral clearance of Omalizumab as compared to the control arm
Evaluation of the virologic efficacy of omalizumab as compared to the control arm as assessed by the percent of subjects with SARS-CoV-2 detectable in OP/NP sample at days 0, 2, 7, 14.
Time frame: Days 0, 2, 7, 14
Spirometry results: Forced Vital Capacity
Evaluation of forced vital capacity, reported in liters, in both omalizumab and control arms at 6 months.
Time frame: 6 months
Spirometry results : Forced expiratory volume in one second
Evaluation of forced expiratory volume in one second, reported in liters, in both omalizumab and control arms at 6 months.
Time frame: 6 months
Anti-Inflammatory effects of Omalizumab as compared to the control arm
Assessed by measuring cytokine levels, TNF-α, IL-1, IL-6, and IFN-α in picograms per milliliter on days 0, 2, 7, 14.
Time frame: Days 0, 2, 7, 14
Anti-fibrotic effects of Omalizumab as compared to the control arm
Assessed by measuring TGF-β level in nanograms per milliliter on days 0, 2, 7, 14.
Time frame: Days 0, 2, 7, 14
Plan to share: No
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McGill University Health Centre/Research Institute of the McGill University Health Centre