COVID-19 Immunologic Antiviral therapy with Omalizumab (CIAO trial) - An Adaptive Phase II Randomized-Controlled Clinical Trial

Supervisor: Elena Netchiprouk, McGill University The ongoing COVID pandemic, caused by SARS-CoV-2, has resulted in more than 531 million infections and 6.3 million deaths. With the emergence of new variants escaping vaccine-induced immunity, COVID is unlikely to be eradicated. Furthermore, long COVID symptoms affect up to 50% of hospitalized patients and represent another public health threat. Despite unprecedented global research efforts, therapeutic knowledge gaps remain in severe illness and in long-COVID. Current treatments are limited by their side effect profiles and efficacy in new variants such as Omicron. Alternative treatments with dual antiviral and anti-inflammatory properties are required. Omalizumab is an anti-IgE monoclonal antibody approved by Health Canada to treat chronic idiopathic urticaria and asthma. The safety of omalizumab has been extensively demonstrated, particularly in patients with multiple comorbidities such as those seen in hospitalized COVID patients. Omalizumab's antiviral effect has been suggested to stem from enhancing antiviral cytokines. In addition, omalizumab suppresses degranulation of inflammatory cells thought to contribute to the inflammatory response and lung remodelling in severe COVID. Taken together, omalizumab's antiviral and anti-inflammatory properties support the need for a randomized controlled trial comparing omalizumab to placebo in the treatment of COVID. The CIAO trial is a randomized, placebo-controlled trial currently conducted at McGill University, Sunnybrook and Niagara Health Centres that examines the efficacy and safety of a single dose of omalizumab in hospitalized adult COVID patients. The viability of this trial is reflected by consistent recruitment rates and adherence to treatment protocols. By identifying a potentially efficacious treatment for hospitalized COVID patients, this study aims to improve patient survival and reduce the burden of this globally devastating disease on the healthcare system.