drugset / Trial / NCT07317050

Clinical Trial With Aprotinin in the Acute Respiratory Distress Syndrome Treatment

NCT07317050

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multicentre, double-blind, placebo-controlled Phase III randomized clinical trial designed to evaluate the efficacy and safety of inhaled aprotinin in adult patients with moderate or severe acute respiratory distress syndrome (ARDS). A total of 156 critically ill patients admitted to intensive care units will be randomized to receive either inhaled aprotinin or placebo in addition to standard supportive care. The primary objective is to determine whether aprotinin improves clinical outcomes based on a composite endpoint of ventilator-free days at 28 days.

Timeline

Start
2026-06-18
Primary completion
2030-03-01
Completion
2030-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Aprotinin Unknown 500 iu Inhaled