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Comparison · NCT04311697-acf22924

Aviptadil IV in Escalating Doses + Standard of Care vs Placebo + Standard of Care: Resolution of Respiratory Failure (Alive and Free of Respiratory Failure)

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: Resolution of Respiratory Failure (Alive and Free of Respiratory Failure). Trial comparisons, record NCT04311697-acf22924. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04311697-acf22924

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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 10.550.4640.632wilson
Risk in group 20.5080.3890.625wilson
Risk difference, group 1 minus group 20.0419-0.1030.186newcombe hybrid score
Risk ratio, group 1 over group 21.080.8141.44log
Odds ratio, group 1 over group 21.180.6522.15log
Number needed to treat, for one more participant with the outcome on Aviptadil IV in Escalating Doses + Standard of Care than on Placebo + Standard of Care23.9from 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 Those requiring ECMO will be withdrawn from the study as treatment failures.
72131OG000
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 Those requiring ECMO will be withdrawn from the study as treatment failures.
3365OG001

Outcome

Type
PRIMARY
Title
Resolution of Respiratory Failure (Alive and Free of Respiratory Failure)
Description
Participant is Alive and Free of Respiratory Failure (without subsequent relapse over 7 days) determined as no longer requiring acute care or more than low flow oxygen
Time frame
Day 28
Population

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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