COVID-19 Ozanimod Intervention Study

Phase 2

Terminated

• Conditions: COVID-19
• Interventions: Drug: Ozanimod; Other: Standard of care

• Registration Number: NCT04405102
• Lead Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-28
• Study Start: 2020-09-16
• Primary Completion: 2022-03-14
• Study Completion: 2022-05-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozanimod + standard of care	Standard of care	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.).
Standard of care	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).
Ozanimod + standard of care	Ozanimod	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.).

Primary Outcome Measures

Name	Time	Method
Daily Patient progression assessed with the World Health Organization-adapted 6-points ordinal scale	through whole duration of the hospitalization, an average of 14 days	Clinical improvement until hospital discharge

Secondary Outcome Measures

Name	Time	Method
Rate of non invasive ventilation (NIV) / high flow nasal therapy (HFNT) use	through whole duration of the hospitalization, an average of 14 days
Rate of ICU admission/length of stay/mortality	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%	First 7 days of the trial	Titrated every second with automated oxygen titration device (FreeO2)
Rate of intubation	through whole duration of the hospitalization, an average of 14 days
Ventilator-free and oxygen-free days at day 28	through whole duration of the hospitalization, an average of 14 days
Severity index measurement	through whole duration of the hospitalization, an average of 14 days	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

Trial Locations

Locations (3)

Hôpital Santa Cabrini Ospedale (CIUSSS EMTL); 🇨🇦 Montréal, Quebec, Canada

Hôpital de la Cité-de-la-Santé (CISSS de Laval); 🇨🇦 Laval, Quebec, Canada

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval; 🇨🇦 Québec, Canada