COVID-19 Immunologic Antiviral Therapy With Omalizumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-12-16

Brief Summary

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

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Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Omalizumab

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

Group Type EXPERIMENTAL

Omalizumab

Intervention Type BIOLOGICAL

Single subcutaneous dose of 375mg of omalizumab and standard of care.

Placebo

Participants in this arm will receive a placebo treatment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single subcutaneous dose of normal saline in a syringe identical to that of the omalizumab arm and standard of care.

Interventions

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Omalizumab

Single subcutaneous dose of 375mg of omalizumab and standard of care.

Intervention Type BIOLOGICAL

Placebo

Single subcutaneous dose of normal saline in a syringe identical to that of the omalizumab arm and standard of care.

Intervention Type OTHER

Other Intervention Names

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Xolair

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No