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Comparison · NCT04311697-deaths

Aviptadil IV in Escalating Doses + Standard of Care vs Placebo + Standard of Care: deaths from any cause

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. Aviptadil IV in Escalating Doses + Standard of Care vs Placebo + Standard of Care: deaths from any cause. Trial comparisons, record NCT04311697-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04311697-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3510.2750.436wilson
Risk in group 20.4620.3460.581wilson
Risk difference, group 1 minus group 2-0.11-0.2530.0331newcombe hybrid score
Risk ratio, group 1 over group 20.7610.5361.08log
Odds ratio, group 1 over group 20.6310.3451.16log
Number needed to treat, for one fewer death from any cause on Aviptadil IV in Escalating Doses + Standard of Care than on Placebo + Standard of Care9.06from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Aviptadil 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 Those requiring ECMO will be withdrawn from the study as treatment failures.
46131EG000
Group 2Placebo + 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 Those requiring ECMO will be withdrawn from the study as treatment failures.
3065EG001

Harm

What it counts
Total, all-cause mortality
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

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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