This randomized, placebo-controlled, double-blind, proof-of-concept study is designed to expand on the preliminary findings
of safety, tolerability and efficacy of intranasal administration of Foralumab previously observed in non-hospitalized patients with mild to moderate COVID-19. The study will be conducted at up to seven sites in Brazil and enroll 80 hospitalized patients with severe COVID-19 and evidence of pulmonary involvement on a computed tomography (CT) scan at screening. Patients will be randomized 1:1 to receive intranasal Foralumab 100 µg or placebo. Additionally, the study will evaluate the effect of Foralumab on resolution of symptoms by chest CT, inflammatory biomarkers, T-cell subpopulations, safety and mucosal inflammatory response following 14 days of intranasal administration.