To evaluate if omalizumab is effective in decreasing mortality in severe hospitalized COVID-19 cases.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Single subcutaneous dose of 375mg of omalizumab and standard of care.
Single subcutaneous dose of normal saline in a syringe identical to that of the omalizumab arm and standard of care.
Niagara Health - St. Catharine's Sites
Niagara, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
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.
Time frame: 14 Days
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
Time frame: 28 Days
Duration of Mechanical Ventilation
Outcome reported as duration of mechanical ventilation in each arm.
Time frame: 28 Days
Duration of Hospitalization
Outcome reported as the duration of hospitalization of patients in each arm.
Time frame: 28 Days
Safety in COVID-19 patients
Outcome reported as the number of adverse events and serious adverse events that occurred in each arm.
Time frame: 14 Days
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.
Time frame: 28 Days
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