COVID-19 Ozanimod Intervention Study (COZI)
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| ClinicalTrials.gov Identifier: NCT04405102 |
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Recruitment Status :
Recruiting
First Posted : May 28, 2020
Last Update Posted : June 1, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: Ozanimod Other: Standard of care | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 48 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Trial on Efficacy and Safety of Ozanimod for the Treatment of COVID-19 Patients Requiring Oxygen Support - A Pilot Trial |
| Actual Study Start Date : | September 16, 2020 |
| Estimated Primary Completion Date : | January 1, 2023 |
| Estimated Study Completion Date : | January 1, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ozanimod + 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.).
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Drug: Ozanimod
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.
Other Name: Zeposia (USA) 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). |
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Active Comparator: 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).
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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). |
- Daily Patient progression assessed with the World Health Organization-adapted 6-points ordinal scale [ Time Frame: through whole duration of the hospitalization, an average of 14 days ]Clinical improvement until hospital discharge
- The mean oxygen flow required to maintain the oxygen saturation (SpO2) target at 92% [ Time Frame: First 7 days of the trial ]Titrated every second with automated oxygen titration device (FreeO2)
- 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 [ Time Frame: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Exclusion criteria Medical conditions
- Level of care B, C or D (patient admitted for palliative care; or physician is not committed to life-sustaining therapies)
- No SpO2 signal available
- Patient agitation
- Severe 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 1a and class III anti-arrythmic drugs amiodarone, sotalol, flecainide, propafenone
- Patients receiving or anticipated to receive chloroquine 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405102
| Contact: Pascale Blais-Lecours, PhD | 418-656-8711 ext 2651 | pascale.blais-lecours@criucpq.ulaval.ca | |
| Contact: David Marsolais, PhD | 418-656-8711 ext 3085 | david.marsolais@criucpq.ulaval.ca |
| Canada, Quebec | |
| Hôpital de la Cité-de-la-Santé (CISSS de Laval) | Recruiting |
| Laval, Quebec, Canada, H7M 3L9 | |
| Contact: Andreea A Belecciu 450-668-1010 ext 24368 andreea.a.belecciu.cissslav@ssss.gouv.qc.ca | |
| Principal Investigator: Tuyen Nguyen, MD | |
| Sub-Investigator: Stéphanie Castonguay, MD | |
| Sub-Investigator: Nathalie Rivest, MD | |
| Canada | |
| Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval | Recruiting |
| Québec, Canada, G1V 4G5 | |
| Contact: Patricia Lizotte 418-656-8711 ext 3937 patricia.lizotte@criucpq.ulaval.ca | |
| Principal Investigator: François Lellouche, MD, PhD | |
| Sub-Investigator: David Marsolais, PhD | |
| Sub-Investigator: Nathalie Châteauvert, B.Sc, B. pharm, M.Sc | |
| Principal Investigator: | François Lellouche, MD | IUCPQ-UL | |
| Study Chair: | David Marsolais, PhD | CRIUCPQ-UL | |
| Study Chair: | Nathalie Châteauvert, B. pharm | CRIUCPQ-UL | |
| Study Director: | Pascale Blais-Lecours, PhD | CRIUCPQ-UL |
| Responsible Party: | François Lellouche, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec |
| ClinicalTrials.gov Identifier: | NCT04405102 |
| Other Study ID Numbers: |
2021-3474 |
| First Posted: | May 28, 2020 Key Record Dates |
| Last Update Posted: | June 1, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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S1P1 ligand SARS-CoV-2 Oxygen requirement WHO-adapted 6-points ordinal scale |