A Phase 2 interventional study of Ozanimod and Standard of care in COVID-19, sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec. Terminated at 3 sites in Canada. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec · Phase 2, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 43 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria Medical conditions
Prior/concomitant therapy
Prior/concurrent clinical study experience -Current enrolment in an interventional arm of a clinical trial with similar endpoints to the COZI trial
Other exclusions
-Patients or legal/authorized representatives who refuse to participate to the study.
During hospitalization, the experiment treatment of Ozanimod will be given with the standard of care (Recommendations for standard of care management of COVID-19 will be provided for anticoagulation, fluid resuscitation, corticoids and other immunomodulators, antipyretics agents, antiviral agents and other treatments. These recommendations are subject to modifications based on the new literature data.).
Drug: Ozanimod · Other: Standard of care
During hospitalization, patient will be given standard of care (Recommendations for standard of care management of COVID-19 will be provided for anticoagulation, fluid resuscitation, corticoids and other immunomodulators, antipyretics agents, antiviral agents and other treatments. These recommendations are subject to modifications based on the new literature data).
Other: Standard of care
The investigational medical product (IMP) for this study is ozanimod. Ozanimod 0.23 mg be administered once daily for 4 days and then ozanimod 0.46 mg will be administered once daily for ten days.
Also known as: Zeposia (USA)
During hospitalization, patient will be given standard of care (Recommendations for standard of care management of COVID-19 will be provided for anticoagulation, fluid resuscitation, corticoids and other immunomodulators, antipyretics agents, antiviral agents and other treatments. These recommendations are subject to modifications based on the new literature data).
Daily Patient progression assessed with the World Health Organization-adapted 6-points ordinal scale
Clinical improvement until hospital discharge
Time frame: through whole duration of the hospitalization, an average of 14 days
The mean oxygen flow required to maintain the oxygen saturation (SpO2) target at 92%
Titrated every second with automated oxygen titration device (FreeO2)
Time frame: First 7 days of the trial
Rate of non invasive ventilation (NIV) / high flow nasal therapy (HFNT) use
Time frame: through whole duration of the hospitalization, an average of 14 days
Rate of intubation
Time frame: through whole duration of the hospitalization, an average of 14 days
Ventilator-free and oxygen-free days at day 28
Time frame: through whole duration of the hospitalization, an average of 14 days
Rate of ICU admission/length of stay/mortality
Time frame: through whole duration of the hospitalization, an average of 14 days
Severity index measurement
Sepsis-related organ failure assessment (SOFA), national early warning score (NEWS2), early warning score for oxygen therapy (EWS.O2), decrease of at least 2 points on the 6-point ordinal scale
Time frame: through whole duration of the hospitalization, an average of 14 days
Plan to share: No
This study is terminated, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec