covery and vival of patients with moderate to severe acute spiratory distress syndrome (ARDS) due to OVID-19: a multicenter, single-arm, Phase IV itolizumab rial: .

Background: Itolizumab, an anti-CD6 monoclonal antibody, down-regulates COVID-19-mediated inflammation and the acute effects of cytokine release syndrome. This study aimed to evaluate the safety and efficacy of itolizumab in hospitalized COVID-19 patients with PaO/FiO ratio (PFR) ≤200 requiring oxygen therapy.

Research Design And Methods: This multicenter, single-arm, Phase 4 study enrolled 300 hospitalized adults with SARS-CoV-2 infection, PFR ≤200, oxygen saturation ≤94%, and ≥1 elevated inflammatory markers from 17 COVID-19 specific tertiary Indian hospitals.