Comparison · NCT04475588-sae
Arm A - Itolizumab + BSC vs Arm B - Best Supportive Care (BSC): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Arm A - Itolizumab + BSC vs Arm B - Best Supportive Care (BSC): serious adverse events. Trial comparisons, record NCT04475588-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04475588-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.136 | 0.0475 | 0.333 | wilson | |
| Risk in group 2 | 0.3 | 0.108 | 0.603 | wilson | |
| Risk difference, group 1 minus group 2 | -0.164 | -0.48 | 0.112 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.455 | 0.11 | 1.87 | log | |
| Odds ratio, group 1 over group 2 | 0.368 | 0.0597 | 2.27 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A - Itolizumab + BSC than on Arm B - Best Supportive Care (BSC) | 6.11 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm A - Itolizumab + BSC | Itolizumab IV infusion Itolizumab IV infusion: First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks.~BSC: similar to Arm B Drug: Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc | 3 | 22 | EG000 |
| Group 2 | Arm B - Best Supportive Care (BSC) | Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc | 3 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 30 days
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Itolizumab in COVID-19 Complications
- NCT number
- NCT04475588
- Phases
- PHASE2
- Conditions
- Acute Respiratory Distress Syndrome, Cytokine Release Syndrome, Covid19
- Interventions
- Itolizumab IV infusion, Best supportive care (BSC)
- Lead sponsor
- Biocon Limited
- Results first posted
- 2021-05-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04475588?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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