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Covid19Phase 2CIAONCT04720612

COVID-19 Immunologic Antiviral Therapy With Omalizumab

A Phase 2 study testing Omalizumab in people with Covid19, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate if omalizumab is effective in decreasing mortality in severe hospitalized COVID-19 cases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Omalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
3 sitesCanada
Study dates
15 Oct 2021to 16 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Research Institute of the McGill University Health Centre

    Montreal, Quebec, H4A3J1

  • Niagara Health - St. Catharine's Sites

    Niagara, Ontario, L2S 0A9

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

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

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

Read the 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.

Conditions
Covid19
Being tested
Omalizumab, Placebo
Keywords
Omalizumab, Interferon-alpha, COVID-19, SARS-CoV-2, Coronavirus, Corona virus
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmalizumabBiological

    Also called Xolair

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

  • PlaceboOther

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

Study groups in NCT04720612
Study groupRoleWhat they receive
OmalizumabExperimentalParticipants in this arm will receive the study drug, omalizumab.
Receives: Biological: Omalizumab
PlaceboPlacebo comparatorParticipants in this arm will receive a placebo treatment.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 14 Days

Secondary outcomes (5)

  1. 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

    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

    Measured: 28 Days

  2. Duration of Mechanical Ventilation

    Outcome reported as duration of mechanical ventilation in each arm.

    Measured: 28 Days

  3. Duration of Hospitalization

    Outcome reported as the duration of hospitalization of patients in each arm.

    Measured: 28 Days

  4. Safety in COVID-19 patients

    Outcome reported as the number of adverse events and serious adverse events that occurred in each arm.

    Measured: 14 Days

  5. 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.

    Measured: 28 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start15 Oct 2021
  3. Primary completion7 Nov 2022
  4. Study completion16 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04720612
Sponsor's protocol ID
CIAO (2021-7500)
Acronym
CIAO
Status last verified
Nov 2022
First submitted
13 Jan 2021
Last updated
16 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • World Health Organization. WHO R&D Blueprint novel Coronavirus COVID-19 Therapeutic Trial Synopsis. In. Geneva, Switzerland. 2020.

  • Le M, Khoury L, Lu Y, Prosty C, Cormier M, Cheng MP, Fowler R, Murthy S, Tsang JLY, Ben-Shoshan M, Rahme E, Golchi S, Dendukuri N, Lee TC, Netchiporouk E. COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)-a Randomized Controlled Clinical Trial. Open Forum Infect Dis. 2024 Feb 23;11(4):ofae102. doi: 10.1093/ofid/ofae102. eCollection 2024 Apr.

    PubMed 38560604

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omalizumab in people with Covid19, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Death or Mechanical Ventilation (time frame: 14 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04720612, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.

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