The virus SARS-CoV-2 causes severe pneumonia which, in a proportion of patients progresses
towards an Acute Respiratory Distress Syndrome (ARDS) mainly related to the antiviral immune
response. To date, there is no available treatment that significantly improves outcome of
patients with COVID-19 pneumonia. Sphingosine-1-phosphate receptor 1 (S1P1) ligands control
vascular leakage in the airways and sphingosine-1-phosphate (S1P) receptor ligands devoid of
activity on sphingosine-1-phosphate receptor 3 (S1P3) show an excellent safety profile,
including ozanimod. Critically, S1P1 ligands mildly impact, but do not compromise viral
clearance and they reduced lung injury in preclinical models, even without concomitant use of
antivirals and with a synergistic effect when associated to antiviral agents. Ozanimod was
approved by the FDA for the treatment of relapsing multiple sclerosis at the end of March
2020, and was recently (October 2020) approved by Health Canada for the same indication. The
investigators believe that this immune modulator is at the top of the list of agents that
should be trialed in order to mitigate the morbidity and mortality of COVID-19.
The primary objective is to substantiate the impact of ozanimod on key outcomes of COVID-19
patient progression, which will guide decision making around sample size and the choice of
endpoints for future clinical trial.
Phase:
Phase 2
Details
Lead Sponsor:
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec François Lellouche