Overview

Safety Study of Inhaled Carbon Monoxide to Treat Sepsis-Induced Acute Respiratory Distress Syndrome (ARDS)

Status:
Not yet recruiting

Trial end date:
2025-09-01

Target enrollment:

Participant gender:

Summary

This study is a multi-center, randomized, partially double-blind, and placebo-controlled Phase Ib clinical trial of inhaled CO (iCO) for the treatment of sepsis-induced acute respiratory distress syndrome (ARDS). The purpose of this study is to evaluate the safety and accuracy of a Coburn-Forster-Kane (CFK) equation-based personalized iCO dosing algorithm to achieve a target carboxyhemoglobin (COHb) level of 6-8% in patients with sepsis-induced ARDS. We will also examine the biologic readouts of low dose iCO therapy in patients with sepsis-induced ARDS.

Phase:

Phase 1

Details

Lead Sponsor:

Brigham and Women's Hospital

Collaborators:

Duke University
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Weill Medical College of Cornell University

Treatments:

Carbon Monoxide