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Ozanimod Therapy in Patients With COVID-19 Requiring Oxygen Support: A Randomized Open-Label Pilot Trial
François Lellouche1, Pascale Blais-Lecours2, François Maltais1
1Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval, Quebec City, QC, Canada; Department of Medicine, Université Laval, Quebec City, QC, Canada.
Background:
Sphingosine-1-phosphate receptor ligands (SRLs) dampen immunopathologic damages in models of viral pneumonia.
Research Question:
Is it feasible to administer an SRL therapy, here ozanimod (OZA), to acutely ill patients infected with SARS-CoV-2?
Study Design And Methods:
The prospective randomized open-label COVID-19 Ozanimod Intervention (COZI) pilot trial was conducted in three Canadian hospitals. Patients admitted for COVID-19 requiring oxygen were eligible. Randomization was stratified for risk factors of poor outcome and oxygen needs at inclusion. Participants were allocated to standard of care or to standard of care plus OZA. OZA (oral, once daily, incremental dosage) was administered for a maximum of 14 days. Primary end point investigated for size effect and variance over time was the assessment of safety and efficacy, evaluated by the daily score on the World Health Organization-adapted six-point ordinal scale for clinical improvement analyzed under the intention-to-treat principle.
Results:
Twenty-three patients were randomized to the standard of care arm, and 20 were randomized to the OZA arm from September 2020 to February 2022. Evaluation of efficacy showed nonsignificant reductions of median (interquartile range) duration of respiratory support (6 [3-10] vs 9 [4-12] days; P = .34), median duration of hospitalization (9 [6-12] vs 10 [6-18] days; P = .20), and median time to clinical improvement (4 [3-7] vs 7 [3-11] days; P = .12) for OZA compared with standard of care, respectively. Heart rate was significantly lower with OZA (65 [ 63-67] vs 71 [69-72] beats/min; P < .0001). However, QT and PR intervals were not affected. No severe adverse drug reaction was reported.
Interpretation:
To our knowledge, SRL utility in severe pneumonia has never been tested in patients. This study shows for the first time that this new pharmacologic agent may safely be administered to patients hospitalized for viral pneumonia, with potential clinical benefits. Bradycardia was frequent but well tolerated.
Clinical Trial Registration:
ClinicalTrials.gov; No.: NCT04405102; URL: www.
Clinicaltrials:
gov.
Insights
Sphingosine-1-phosphate receptor ligands (SRLs) show potential for treating viral pneumonia. The ozanimod (OZA) intervention in COVID-19 patients was safe, though clinical benefits were not statistically significant in this pilot study.
Area of Science:
- Immunology and Pharmacology
- Infectious Diseases
- Clinical Trials
Background:
- Sphingosine-1-phosphate receptor ligands (SRLs) demonstrate efficacy in mitigating immunopathologic damage in viral pneumonia models.
- The study investigates the feasibility of administering SRL therapy, specifically ozanimod (OZA), to patients with acute SARS-CoV-2 infection.
Purpose of the Study:
- To assess the safety and efficacy of ozanimod (OZA) as a treatment for hospitalized COVID-19 patients.
- To determine if OZA can improve clinical outcomes in patients with SARS-CoV-2 infection.
Main Methods:
- A prospective, randomized, open-label pilot trial (COZI) involving three Canadian hospitals.
- Patients with COVID-19 requiring oxygen were randomized to standard of care or standard of care plus OZA (14-day incremental dosage).
- Primary endpoint: safety and efficacy assessed via WHO-adapted ordinal scale for clinical improvement.
Main Results:
- Twenty-three patients received standard care; 20 received standard care plus OZA.
- No significant differences in duration of respiratory support, hospitalization, or time to clinical improvement.
- OZA group showed a significantly lower heart rate (P < .0001) without affecting QT/PR intervals; no severe adverse drug reactions reported.
Conclusions:
- This is the first study to evaluate SRL utility in hospitalized patients with severe pneumonia.
- Ozanimod (OZA) appears safe for patients with viral pneumonia, with potential for clinical benefits.
- Bradycardia was a frequent side effect but was well-tolerated.
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