A pilot trial for ozanimod therapy in hospitalized COVID-19 patients

Background: Sphingosine-1-phosphate (S1P) receptor ligands reduce lung damage and endothelial activation in models of virus-induced pneumonia. Feasibility of initiating S1P receptor ligand therapy during pneumonia needs confirmation. Objective(s): Evaluate safety/efficacy outcomes of ozanimod therapy in COVID-19 patients. Method(s): In a prospective multicentric open-label pilot trial, adults with COVID-19 requiring O were recruited (3 Canadian centres, starting Sept. 2020). Patients were randomized to standard of care (SOC) or SOC + ozanimod (per os). Modified WHO-adapted 6-points ordinal scale for clinical improvement was computed daily and adverse events were recorded. Result(s): As of Jan. 2022, 41 patients (out of 48) were enrolled and 18 received ozanimod. Stratification at randomization balanced groups for risk factors of poor outcome and initial O2 requirement. No serious drug reaction was reported. Asymptomatic bradycardia occurred with ozanimod. So far, 36 patients completed the study-ending phone call (day 90). Ordinal scale-related outcomes are shown in Table 1. Since enrollment is ongoing, data is shown for the whole cohort. Conclusion(s): This small scale trial provides the very first evidence supporting the possibility of initiating S1P receptor ligand therapy during active COVID-19 pneumonia.