Comparison · NCT04311697-sae
Aviptadil IV in Escalating Doses + Standard of Care vs Placebo + Standard of Care: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Aviptadil IV in Escalating Doses + Standard of Care vs Placebo + Standard of Care: serious adverse events. Trial comparisons, record NCT04311697-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04311697-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 | 0.443 | 0.361 | 0.528 | wilson | |
| Risk in group 2 | 0.492 | 0.375 | 0.611 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0496 | -0.194 | 0.0959 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.899 | 0.658 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 0.819 | 0.451 | 1.49 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Aviptadil IV in Escalating Doses + Standard of Care than on Placebo + Standard of Care | 20.2 | 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 | Aviptadil IV in Escalating Doses + Standard of Care | Patients will be administered Aviptadil IV in escalating doses of 50 pmol, 100 pmol, 150 pmol/kg/hr~Aviptadil by intravenous infusion + standard of care: Aviptadil by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures. | 58 | 131 | EG000 |
| Group 2 | Placebo + Standard of Care | Patients will first be treated with placebo infusion + maximal intensive care~Normal Saline Infusion + standard of care: Saline by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures. | 32 | 65 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Source ClinicalTrials.gov
Trial
- Title
- Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure
- NCT number
- NCT04311697
- Phases
- PHASE2, PHASE3
- Conditions
- Critical COVID-19 With Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS), Corona Virus Infection, Acute Lung Injury
- Interventions
- Aviptadil by intravenous infusion + standard of care, Normal Saline Infusion + standard of care
- Lead sponsor
- APR Applied Pharma Research s.a.
- Results first posted
- 2023-07-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04311697?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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