COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04720612

Elena Netchiporouk (Responsible Party)

Not reported

2021-01-22

Not recruiting

RCT

Randomized

Adaptive

Blind label

multi-center

Treatment

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

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

2

McGill University Health Centre/Research Institute of the McGill University Health Centre

18

100

Canada

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

40

Incidence of Death or Mechanical Ventilation

None

Phase 2

[{"arm_notes": "", "treatment_id": 924, "treatment_name": "Omalizumab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]