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.
Biological: Omalizumab
Single subcutaneous dose of 375mg of omalizumab and standard of care.
Other Name: Xolair
Other: Placebo
Single subcutaneous dose of normal saline in a syringe identical to that of the omalizumab arm and standard of care.
Inclusion Criteria:
1. Positive RT-PCR assay for SARS-CoV-2;
2. COVID-19 disease requiring hospitalization
3. 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)
4. Age ≥18 years;
5. 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 Criteria:
1. Known hypersensitivity to Omalizumab or its excipients
2. Inability to give consent themselves or via proxy
3. Patients who received Omalizumab or another anti-IgE molecule in the last 12 months
4. 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.
5. Patients who are below the age of 18
Niagara Health - St. Catharine's Sites
Niagara, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
Elena Netchiporouk, MD, MSc, Principal Investigator
RI-MUHC