Status:
UNKNOWN
COVID-19 Immunologic Antiviral Therapy With Omalizumab
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate if omalizumab is effective in decreasing mortality in severe hospitalized COVID-19 cases.
Detailed Description
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 staggerin...
Eligibility Criteria
Inclusion
- Positive RT-PCR assay for SARS-CoV-2;
- COVID-19 disease requiring hospitalization
- Dyspnea at rest or during minimal activity (sitting, talking, coughing, swallowing), OR
- Respiratory rate \> 22/min, OR
- PaO2 \< 65mmHg or O2Sat \< 90%, OR
- Infiltrate on chest radiography (CXR) (worsening CXR if baseline abnormal)
- Age ≥18 years;
- Ability to provide consent or to provide consent via a substitute decision maker
- 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
- Known hypersensitivity to Omalizumab or its excipients
- Inability to give consent themselves or via proxy
- Patients who received Omalizumab or another anti-IgE molecule in the last 12 months
- Patients receiving another monoclonal antibody to treat SARS-CoV-2/other indication prior to starting CIAO trial. However, once the study is initiated, if it is judged by the treating team/patient's doctor that patient's health/clinical status may benefit from a monoclonal antibody (e.g. tocilizumab), this will be allowed.
- Patients who are below the age of 18
Key Trial Info
Start Date :
October 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04720612
Start Date
October 15 2021
End Date
December 16 2022
Last Update
November 16 2022
Active Locations (3)
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1
Niagara Health - St. Catharine's Sites
Niagara, Ontario, Canada, L2S 0A9
2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
3
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H4A3J1