Official Title
COVID-19 Immunologic Antiviral Therapy With Omalizumab - An Adaptive Phase II Randomized-Controlled Clinical Trial
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 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.

Active, not recruiting
COVID19

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.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Canada
Locations

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

McGill University Health Centre/Research Institute of the McGill University Health Centre
NCT Number
Keywords
Omalizumab
Interferon-alpha
Covid-19
SARS-CoV-2
Coronavirus
Corona Virus
MeSH Terms
COVID-19
Omalizumab