Status:
TERMINATED
COVID-19 Ozanimod Intervention Study
Lead Sponsor:
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Collaborating Sponsors:
Celgene
Bristol-Myers Squibb
Conditions:
COVID-19
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 dat...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Confirmed COVID-19 (positive polymerase chain reaction (PCR) for COVID-19 from any specimen)
- Patients older than 18 years old and younger than 85 years old.
- BMI higher than 20 but lower than 40
- Patients with hypoxemia related to viral pneumonia (COVID-19) requiring oxygen or nasal high flow therapy (to maintain SpO2 above 92%) without criteria for immediate intubation or need for other respiratory supports (CPAP, non-invasive ventilation).
- Initiation of oxygen supplementation \< 72 hours
- eGFR (CKD EPI) \> 30 ml/min/1.73m2
- Serum troponin i \< 80 ng/L
- Heart rate ≥ 55 bpm if beta blockers or calcium channel blocker nondihydropyridine are used, and ≥ 60 bpm in the other patients
- Exclusion criteria Medical conditions
- Level of care B (unless patient agrees to intubation at study enrollment), C or D (patient admitted for palliative care; or physician is not committed to life-sustaining therapies)
- No SpO2 signal available (only if FreeO2 apparatus is used)
- Patient agitation (only if FreeO2 apparatus is used)
- Severe untreated sleep apnea
- History of or currently active primary or secondary immunodeficiency
- Recent (within the last 6 months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, class III/IV heart failure
- Known presence of Mobitz type II second-degree or third-degree atrioventricular block, sick sinus syndrome, or sinoatrial block, unless patient has a functioning pacemaker
- Child-Pugh score class C
- Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin measured during screening
- Persistent hypotension.
- Prior/concomitant therapy
- Receipt of a live vaccine within 4 weeks prior to randomization
- Receiving MAO inhibitor (tranylcypromine, selegiline or phenelzine)
- Receiving pharmacological treatment for a form of multiple sclerosis
- Use of long-term immunosuppressors (Ex. tacrolimus, cyclosporin, azathioprine, mycophenolate, sirolimus, methotrexate or chronic use of corticosteroid (\> 7.5 mg per day more than 3 months)
- Receiving Class Ia and class III anti-arrythmic drugs amiodarone, sotalol, flecainide, propafenone
- Patients receiving or anticipated to receive hydroxychloroquine or azithromycin.
- 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.
Exclusion
Key Trial Info
Start Date :
September 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04405102
Start Date
September 16 2020
End Date
May 12 2022
Last Update
February 20 2024
Active Locations (3)
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1
Hôpital de la Cité-de-la-Santé (CISSS de Laval)
Laval, Quebec, Canada, H7M 3L9
2
Hôpital Santa Cabrini Ospedale (CIUSSS EMTL)
Montreal, Quebec, Canada, H1T 1P7
3
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Canada, G1V 4G5