Clinical Trial With Aprotinin in the Acute Respiratory Distress Syndrome Treatment

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.

NCT Number	NCT07317050
Lead Sponsor	Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
Conditions	Acute Respiratory Distress Syndrome (ARDS)
Enrollment	156 participants
Start Date	2026-06-18
Primary Completion	2030-03-01 (estimated)
Study Completion	2030-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-15