Cardiac Safety of Ozanimod Use, a Novel Sphingosine-1-Phosphate Receptor Ligand, in COVID-19 Patients Requiring Oxygen: Secondary Analysis of the COZI Randomized Clinical Trial
Bibliographic record
Abstract
Background Ozanimod is a novel immune modulator that could be useful in viral pulmonary infections by reducing lung inflammation. It is an S1P receptor ligand known to induce bradycardia and more serious adverse cardiac effects, such as atrioventricular block and QT interval prolongation. We present a substudy of the C OVID-19 Oz animod I ntervention (COZI) trial in which ozanimod was administered in acute pulmonary infection patients, to assess cardiac safety. Methods In this pilot randomized open-label trial, COVID-19 patients requiring oxygen support were randomized into 2 groups: standard-of-care + ozanimod (OZA) vs standard-of-care alone (SOC). All patients were monitored with a 14-day electrocardiogram monitor (CardioSTAT, Icentia, Quebec, QC) during their hospitalization. We evaluated the cardiac effects of ozanimod on heart rate (HR), PR interval length, and QT interval duration. Results A total of 42 patients were analyzed: 23 in the SOC group and 19 in the OZA group. Mean hourly HR over the first 10 days of treatment decreased in the OZA group, compared with that in the SOC group ( P < 0.0001). The maximum decrease in HR occurred on day 3. The maximum decrease in HR occurred on day 3, without a significant difference between groups: 49 beats per minute (interquartile range, 42-59) in the OZA group, and 54 beats per minute (48–60) in the SOC group, P = 0.45. No high-degree atrioventricular block was recorded. QT and PR interval median values were within the normal range in both groups, without a significant difference. Conclusions The maximal reduction in HR occurred 3 days after the onset of ozanimod treatment in patients hospitalized for COVID-19, but it did not remain significant over the 10-day treatment period. No relevant cardiac adverse event was observed.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".