COVID-19 Immunologic Antiviral Therapy With Omalizumab

NCT04720612 | Unknown Phase 2 DMC

• 1 other identifier: CIAO (2021-7500)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Covid19

Keywords

Omalizumab; Interferon-alpha; COVID-19; SARS-CoV-2; Coronavirus; Corona virus

Outcome Measures

Primary Outcomes (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.

  14 Days

Secondary Outcomes (5)

• Time to Clinical Improvement

  28 Days

• Duration of Mechanical Ventilation

  28 Days

• Duration of Hospitalization

  28 Days

• Safety in COVID-19 patients

  14 Days

• Incidence of All-Cause in Hospital Mortality

  28 Days

Other Outcomes (5)

• Percent of viral clearance of Omalizumab as compared to the control arm

  Days 0, 2, 7, 14

• Spirometry results: Forced Vital Capacity

  6 months

• Spirometry results : Forced expiratory volume in one second

  6 months

Study Arms (2)

Omalizumab

EXPERIMENTAL

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

Biological: Omalizumab

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive a placebo treatment.

Other: Placebo

Interventions

Omalizumab BIOLOGICAL

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

Also known as: Xolair

Omalizumab

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (3)

Niagara Health - St. Catharine's Sites

Niagara, Ontario, L2S 0A9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A3J1, Canada

Location

Related Publications (2)

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

  BACKGROUND

• 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.

  PMID: 38560604 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Elena Netchiporouk, MD, MSc

  RI-MUHC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Scientist and Assistant Professor of Dermatology

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 22, 2021
• Study Start: October 15, 2021
• Primary Completion: November 7, 2022
• Study Completion: December 16, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)