THE LANCET Infectious Diseases

Safety and efficacy of inhaled IBIO123 for mild-to-moderate COVID-19: a randomised, double-blind, dose-ascending, placebo-controlled, phase 1/2 trial

Bruno Maranda, MD, Sébastien M Labbé, PhD, Magali Lurquin, BSc, Pascal Brabant, RN, Alexandre Fugère, MSc, Jean-François Larrivée, BSc, Djordje Grbic, PhD, Annie Leroux, BSc, Frédéric Leduc, PhD, Prof Andrés Finzi, PhD, Simon Gaudreau, PhD, Yolandi Swart, MD, on behalf of the IBIO-INH-001 Investigators

COVID-19 severity is associated with its respiratory manifestations. Neutralising antibodies against SARS-CoV-2 administered systemically have shown clinical efficacy. However, immediate and direct delivery of neutralising antibodies via inhalation might provide additional respiratory clinical benefits. IBIO123 is a cocktail of three, fully human, neutralising monoclonal antibodies against SARS-CoV-2. We aimed to assess the safety and efficacy of inhaled IBIO123 in individuals with mild-to-moderate COVID-19.