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COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)

Primary Purpose

Covid19

Status
Active
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Omalizumab
Placebo
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Omalizumab, Interferon-alpha, COVID-19, SARS-CoV-2, Coronavirus, Corona virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Niagara Health - St. Catharine's Sites
  • Sunnybrook Health Sciences Centre
  • Research Institute of the McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omalizumab

Placebo

Arm Description

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

Participants in this arm will receive a placebo treatment.

Outcomes

Primary Outcome Measures

Incidence of Death or Mechanical Ventilation
Outcome reported as the number of patients in each arm that either experience death by any cause or mechanical ventilation.

Secondary Outcome Measures

Time to Clinical Improvement
Outcome reported as the time to improvement of 2 points on the 8-category ordinal scale. (World Health Organization, 2020) 8-category ordinal scale: 0- Uninfected, no clinical or virological evidence of infection Ambulatory, no limitation of activities Ambulatory, limitation of activities Hospitalized mild disease, no oxygen therapy Hospitalized mild disease, oxygen by mask or nasal prongs Hospitalized severe disease, non invasive ventilation or high-flow oxygen Hospitalized severe disease, intubation and mechanical ventilation Hospitalized severe disease, ventilation + additional organ support - pressors, RRT, ECMO Death
Duration of Mechanical Ventilation
Outcome reported as duration of mechanical ventilation in each arm.
Duration of Hospitalization
Outcome reported as the duration of hospitalization of patients in each arm.
Safety in COVID-19 patients
Outcome reported as the number of adverse events and serious adverse events that occurred in each arm.
Incidence of All-Cause in Hospital Mortality
Outcome reported as the number of patients in each arm that experience death by any cause while in hospital.

Full Information

First Posted
January 13, 2021
Last Updated
November 14, 2022
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04720612
Brief Title
COVID-19 Immunologic Antiviral Therapy With Omalizumab
Acronym
CIAO
Official Title
COVID-19 Immunologic Antiviral Therapy With Omalizumab - An Adaptive Phase II Randomized-Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
November 7, 2022 (Actual)
Study Completion Date
December 16, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Omalizumab, Interferon-alpha, COVID-19, SARS-CoV-2, Coronavirus, Corona virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omalizumab
Arm Type
Experimental
Arm Description
Participants in this arm will receive the study drug, omalizumab.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive a placebo treatment.
Intervention Type
Biological
Intervention Name(s)
Omalizumab
Other Intervention Name(s)
Xolair
Intervention Description
Single subcutaneous dose of 375mg of omalizumab and standard of care.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Single subcutaneous dose of normal saline in a syringe identical to that of the omalizumab arm and standard of care.
Primary Outcome Measure Information:
Title
Incidence of Death or Mechanical Ventilation
Description
Outcome reported as the number of patients in each arm that either experience death by any cause or mechanical ventilation.
Time Frame
14 Days
Secondary Outcome Measure Information:
Title
Time to Clinical Improvement
Description
Outcome reported as the time to improvement of 2 points on the 8-category ordinal scale. (World Health Organization, 2020) 8-category ordinal scale: 0- Uninfected, no clinical or virological evidence of infection Ambulatory, no limitation of activities Ambulatory, limitation of activities Hospitalized mild disease, no oxygen therapy Hospitalized mild disease, oxygen by mask or nasal prongs Hospitalized severe disease, non invasive ventilation or high-flow oxygen Hospitalized severe disease, intubation and mechanical ventilation Hospitalized severe disease, ventilation + additional organ support - pressors, RRT, ECMO Death
Time Frame
28 Days
Title
Duration of Mechanical Ventilation
Description
Outcome reported as duration of mechanical ventilation in each arm.
Time Frame
28 Days
Title
Duration of Hospitalization
Description
Outcome reported as the duration of hospitalization of patients in each arm.
Time Frame
28 Days
Title
Safety in COVID-19 patients
Description
Outcome reported as the number of adverse events and serious adverse events that occurred in each arm.
Time Frame
14 Days
Title
Incidence of All-Cause in Hospital Mortality
Description
Outcome reported as the number of patients in each arm that experience death by any cause while in hospital.
Time Frame
28 Days
Other Pre-specified Outcome Measures:
Title
Percent of viral clearance of Omalizumab as compared to the control arm
Description
Evaluation of the virologic efficacy of omalizumab as compared to the control arm as assessed by the percent of subjects with SARS-CoV-2 detectable in OP/NP sample at days 0, 2, 7, 14.
Time Frame
Days 0, 2, 7, 14
Title
Spirometry results: Forced Vital Capacity
Description
Evaluation of forced vital capacity, reported in liters, in both omalizumab and control arms at 6 months.
Time Frame
6 months
Title
Spirometry results : Forced expiratory volume in one second
Description
Evaluation of forced expiratory volume in one second, reported in liters, in both omalizumab and control arms at 6 months.
Time Frame
6 months
Title
Anti-Inflammatory effects of Omalizumab as compared to the control arm
Description
Assessed by measuring cytokine levels, TNF-α, IL-1, IL-6, and IFN-α in picograms per milliliter on days 0, 2, 7, 14.
Time Frame
Days 0, 2, 7, 14
Title
Anti-fibrotic effects of Omalizumab as compared to the control arm
Description
Assessed by measuring TGF-β level in nanograms per milliliter on days 0, 2, 7, 14.
Time Frame
Days 0, 2, 7, 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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. Patients who are below the age of 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Netchiporouk, MD, MSc
Organizational Affiliation
RI-MUHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Niagara Health - St. Catharine's Sites
City
Niagara
State/Province
Ontario
ZIP/Postal Code
L2S 0A9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Research Institute of the McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
World Health Organization. WHO R&D Blueprint novel Coronavirus COVID-19 Therapeutic Trial Synopsis. In. Geneva, Switzerland. 2020.
Results Reference
background

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COVID-19 Immunologic Antiviral Therapy With Omalizumab

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