COVID-19 Immunologic Antiviral therapy with Omalizumab (CIAO trial)

The coronavirus disease (COVID-19) has affected over 35,000,000 people across 216 countries, resulting in the death of at least 1,000,000 individuals and the numbers continue to climb exponentially. Despite these staggering numbers, there is currently no standard treatment for COVID-19. Omalizumab is a humanized anti-IgE antibody approved by Health Canada for the treatment of moderate to severe asthma and chronic spontaneous urticaria (CSU). Omalizumab has an excellent safety profile and has been effectively used in children, pregnant women, and patients with severe lung diseases (e.g. asthma, Chronic Obstructive Pulmonary Disease (COPD) and bronchopulmonary aspergillosis). Preclinical and clinical data indicates that omalizumab decreases the duration of hospitalization and need for mechanical ventilation in virally-induced respiratory exacerbations in patients with the aforementioned comorbidities. Additionally, omalizumab has been shown to attenuate inflammatory and pro-coagulable responses, similar to what is found in the acute respiratory distress syndrome (ARDS), the leading cause of mortality due to COVID-19. Although omalizumab demonstrates anti-viral and anti-inflammatory properties, it has not yet been tested for use against the coronavirus species. We therefore hypothesize that omalizumab may have therapeutic potential to treat COVID-19. To test this hypothesis, we propose to to conduct a Phase II, adaptive, placebo-controlled, randomized clinical trial to evaluate if omalizumab improves survival in hospitalized COVID-19 patients with a history of atopy, CSU or asthma relative to the current of standard care. Confirming the efficacy of omalizumab in COVID-19 may help improve patient outcomes and reduce the burden on the health care system.