NCT04720612

COVID-19 Immunologic Antiviral Therapy With Omalizumab

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Interventions

Type	Name	Description
BIOLOGICAL	Omalizumab	Single subcutaneous dose of 375mg of omalizumab and standard of care.
OTHER	Placebo	Single subcutaneous dose of normal saline in a syringe identical to that of the omalizumab arm and standard of care.

Timeline

• Start date: 2021-10-15
• Primary completion: 2022-11-07
• Completion: 2022-12-16
• First posted: 2021-01-22
• Last updated: 2022-11-16

Locations

3 sites across 1 country: Canada