COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)

  • End date
    Jul 17, 2023
  • participants needed
  • sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre
Updated on 4 October 2022


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.

Condition Covid19
Treatment Placebo, omalizumab
Clinical Study IdentifierNCT04720612
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Patients who are below the age of 18
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
Clear my responses

How to participate?

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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