COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)

McGill University

Status and phase: Active, not recruiting; Phase 2

Conditions: Covid19

Treatments: Other: Placebo; Biological: Omalizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04720612

CIAO (2021-7500)

Details and patient eligibility

About

To evaluate if omalizumab is effective in decreasing mortality in severe hospitalized COVID-19 cases.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Omalizumab

Experimental group

Description:

Participants in this arm will receive the study drug, omalizumab.

Treatment:

Biological: Omalizumab

Placebo

Placebo Comparator group

Description:

Participants in this arm will receive a placebo treatment.

Treatment:

Other: Placebo