Trial · NCT07317050
Clinical Trial With Aprotinin in the Acute Respiratory Distress Syndrome Treatment
NCT07317050, Phase 3, Recruiting, Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial With Aprotinin in the Acute Respiratory Distress Syndrome Treatment. Trials, record NCT07317050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07317050
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial With Aprotinin in the Acute Respiratory Distress Syndrome Treatment
- NCT number
- NCT07317050
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 156 participants, estimated
- Lead sponsor
- Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
- Conditions
- Acute Respiratory Distress Syndrome (ARDS)
- Interventions
- Aprotinin (inhaled), Placebo (Sodium Chloride)
- First posted
- 2026-01-05
- Last updated
- 2026-07-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ventilator-Free Days (VFD) in patients with moderate or severe ARDS | From first dose up to Day 28 | Number of days a patient is free from invasive mechanical ventilation (DLVI) within 28 days after first dose. A patient is considered ventilator-free after two consecutive calendar days of unassisted breathing. This outcome will be used to assess the efficacy of inhaled aprotinin compared with placebo. |
| Secondary | Number of participants with at least one treatment-emergent adverse event | From first dose up to Day 180 | Incidence, severity, and relationship to treatment of adverse events (AEs), coded according to MedDRA (Medical Dictionary for Regulatory Activities), in treated participants. This outcome evaluates the safety profile of aprotinin compared with placebo. |
| Secondary | Proportion of patients who die from any cause within 28, 90, or 180 days after receiving first dose of study treatment. | At Day 28, Day 90, and Day 180 | All-Cause Mortality. |
| Secondary | Number of days free from ICU or hospital | From first dose up to Day 28 | Total number of days a patient remains outside the intensive care unit (ICU) and outside the hospital within 28 days after receiving first dose of study treatment. |
| Secondary | Number of days on renal or vasoactive support within 28 days after first dose | From first dose up to Day 28 | Total number of days a patient requires renal replacement therapy or vasoactive support within 28 days after receiving first dose of study treatment. |
| Secondary | Sequential Organ Failure Assessment (SOFA) score | From Day 1 up to Day 28 | Sequential Organ Failure Assessment (SOFA) score evaluated daily from Day 1 to Day 14, and on Days 21 and 28. |
| Secondary | PaO₂/FiO₂ ratio during mechanical ventilation | From Day 1 up to Day 28 | Daily evaluation of the arterial oxygen partial pressure to inspired oxygen fraction (PaO₂/FiO₂) ratio during mechanical ventilation as an indicator of pulmonary function improvement in patients receiving study treatment. |
| Secondary | Plasma inflammatory biomarkers | Day 1 and Day 5 | Measurement of plasma levels of selected pro- and anti-inflammatory cytokines (GM-CSF, IFN-α, IFN-γ, IL-1α, IL-1β, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-17A, TNF-α), chemokines (IP-10/CXCL10, MCP-1/CCL2, MIP-1α/CCL3, MIP-1β/CCL4), and cell adhesion/response markers (ICAM-1, CD62E/E-selectin, CD62P/P-selectin) in plasma on Day 1 and Day 5 in all participants receiving study treatment. Evaluates the effect of aprotinina on systemic inflammation. |
| Secondary | Pulmonary biomarkers in bronchial and plasma samples | Day 1 and Day 5 | Determination of granular proteins, bradykinin, and kallikreins in bronchial brush and plasma samples on Day 1 and Day 5 as exploratory markers of pulmonary response and treatment effect of aprotinin. |
| Secondary | Plasma aprotinin levels | Day 1 and Day 5 | Measurement of plasma aprotinin concentrations on Day 1 and Day 5 in all participants receiving study treatment. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07317050
GET https://conductscience.org/api/trials/v1/NCT07317050/registered