COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)—a Randomized Controlled Clinical Trial

Abstract

Background Omalizumab is an anti-IgE monoclonal antibody used to treat moderate to severe chronic idiopathic urticaria, asthma and nasal polyps. Recent research suggested that omalizumab may enhance the innate antiviral response and have anti-inflammatory properties. Objective We aimed to investigate the efficacy and safety of omalizumab in adults hospitalized for COVID-19 pneumonia. Methods This was a phase II randomized, double blind, placebo-controlled trial comparing omalizumab versus placebo (in addition to standard of care) in hospitalized COVID-19 patients. The primary endpoint was the composite of mechanical ventilation and/or death at day 14. Secondary endpoints included all-cause mortality at day 28, time to clinical improvement, and duration of hospitalization. Results Of 41 patients recruited, 40 were randomized (20 received the study drug and 20 placebo). The median age of the patients was 74 years and 55.0% were male. Omalizumab was associated with a 92.6% posterior probability of a reduction in mechanical ventilation and death on day 14 with an adjusted odds ratio (aOR) of 0.11 (95% Credible Interval (CrI) 0.002-2.05). Omalizumab was also associated with a 79.4% posterior probability of reduced all-cause mortality on day 28 with an aOR of 0.45 (95% CrI 0.06-3.12). No statistically significant differences were found for the time to clinical improvement and duration of hospitalization. Numerically fewer adverse events were reported in the omalizumab group and there were no drug-related serious adverse events. Conclusion These results suggest that omalizumab could prove protective against death and mechanical ventilation in hospitalized COVID-19 patients. This study could also support the development of a phase III trial program investigating the antiviral and anti-inflammatory effect of omalizumab for severe respiratory viral illnesses requiring hospital admission.

COVID-19 Clinical Features and Outcome in Italian Patients Treated with Biological Drugs Targeting Type 2 Inflammation

“…This randomized, double-blind, controlled phase II trial showed that omalizumab may be effective in reducing progression to mechanical ventilation or death at day 14 and also useful for reducing all-cause mortality on day 28. This study also provides the first clinical evidence for a possible antiviral and/or anti-inflammatory effect of omalizumab in non-atopic patients hospitalized for a severe viral respiratory disease [ 34 ].…”