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COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04720612
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : February 4, 2022
Sponsor:
Information provided by (Responsible Party):
Elena Netchiporouk, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Description
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Brief Summary:
To evaluate if omalizumab is effective in decreasing mortality in severe hospitalized COVID-19 cases.

Condition or disease Intervention/treatment Phase
Covid19 Biological: Omalizumab Other: Placebo Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: COVID-19 Immunologic Antiviral Therapy With Omalizumab - An Adaptive Phase II Randomized-Controlled Clinical Trial
Actual Study Start Date : October 15, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Omalizumab
Participants in this arm will receive the study drug, omalizumab.
 Biological: Omalizumab
Single subcutaneous dose of 375mg of omalizumab and standard of care.
Other Name: Xolair
Placebo Comparator: Placebo
Participants in this arm will receive a placebo treatment.
 Other: Placebo
Single subcutaneous dose of normal saline in a syringe identical to that of the omalizumab arm and standard of care.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Death or Mechanical Ventilation [ Time Frame: 14 Days ]
    Outcome reported as the number of patients in each arm that either experience death by any cause or mechanical ventilation.


Secondary Outcome Measures :
  1. Time to Clinical Improvement [ Time Frame: 28 Days ]

    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

    1. Ambulatory, no limitation of activities
    2. Ambulatory, limitation of activities
    3. Hospitalized mild disease, no oxygen therapy
    4. Hospitalized mild disease, oxygen by mask or nasal prongs
    5. Hospitalized severe disease, non invasive ventilation or high-flow oxygen
    6. Hospitalized severe disease, intubation and mechanical ventilation
    7. Hospitalized severe disease, ventilation + additional organ support - pressors, RRT, ECMO
    8. Death

  2. Duration of Mechanical Ventilation [ Time Frame: 28 Days ]
    Outcome reported as duration of mechanical ventilation in each arm.

  3. Duration of Hospitalization [ Time Frame: 28 Days ]
    Outcome reported as the duration of hospitalization of patients in each arm.

  4. Safety in COVID-19 patients [ Time Frame: 14 Days ]
    Outcome reported as the number of adverse events and serious adverse events that occurred in each arm.

  5. Incidence of All-Cause in Hospital Mortality [ Time Frame: 28 Days ]
    Outcome reported as the number of patients in each arm that experience death by any cause while in hospital.


Other Outcome Measures:
  1. Percent of viral clearance of Omalizumab as compared to the control arm [ Time Frame: Days 0, 2, 7, 14 ]
    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.

  2. Spirometry results: Forced Vital Capacity [ Time Frame: 6 months ]
    Evaluation of forced vital capacity, reported in liters, in both omalizumab and control arms at 6 months.

  3. Spirometry results : Forced expiratory volume in one second [ Time Frame: 6 months ]
    Evaluation of forced expiratory volume in one second, reported in liters, in both omalizumab and control arms at 6 months.

  4. Anti-Inflammatory effects of Omalizumab as compared to the control arm [ Time Frame: Days 0, 2, 7, 14 ]
    Assessed by measuring cytokine levels, TNF-α, IL-1, IL-6, and IFN-α in picograms per milliliter on days 0, 2, 7, 14.

  5. Anti-fibrotic effects of Omalizumab as compared to the control arm [ Time Frame: Days 0, 2, 7, 14 ]
    Assessed by measuring TGF-β level in nanograms per milliliter on days 0, 2, 7, 14.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720612


Contacts
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Contact: Elena Netchiporouk, MD, MSc 514-934-1934 ext 34999 elena.netchiporouk@mcgill.ca

Locations
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Canada, Ontario
Niagara Health - St. Catharine's Sites Recruiting
Niagara, Ontario, Canada, L2S 0A9
Contact: Jennifer Tsang    905-378-4647 ext 42919    jennifer.tsang@mcmaster.ca   
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Robert Fowler    416-480-6100 ext 7471    rob.fowler@sunnybrook.ca   
Canada, Quebec
Research Institute of the McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A3J1
Contact: Elena Netchiporouk, MD, MSc       elena.netchiporouk@mcgill.ca   
Principal Investigator: Elena Netchiporouk, MD, MSc         
Principal Investigator: Todd C Lee, MD MPH FIDSA         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Elena Netchiporouk, MD, MSc RI-MUHC
More Information
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Publications:
World Health Organization. WHO R&D Blueprint novel Coronavirus COVID-19 Therapeutic Trial Synopsis. In. Geneva, Switzerland. 2020.

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Responsible Party: Elena Netchiporouk, Junior Scientist and Assistant Professor of Dermatology, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT04720612    
Other Study ID Numbers: CIAO (2021-7500)
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: February 4, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elena Netchiporouk, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Omalizumab
Interferon-alpha
COVID-19
 SARS-CoV-2
Coronavirus
Corona virus
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents