A Phase 2 Study of Inhaled CO for the Treatment of ARDS
Abstract
We are conducting a multi-center, prospective, randomized, partially double-blind, placebo-controlled Phase II clinical trial of inhaled CO (iCO) for the treatment of ARDS. Our objective is to evaluate the safety, tolerability, and efficacy of low dose iCO (200 ppm) in patients with ARDS. One hundred intubated, adult subjects with ARDS will be randomized in a 1:1 ratio to receive either inhaled CO or inhaled air placebo for up to 90 minutes daily for a total of 5 consecutive days. The primary safety endpoint is to evaluate safety of inhaled CO by determining carboxyhemoglobin (COHb) levels and the incidence of pre-specified administration-related adverse events (AEs). The primary efficacy endpoint is the lung injury score (LIS) as measured on study days 1-5 and day 7. The secondary endpoint is to compare the effects of iCO versus placebo on biomarkers of mitochondrial dysfunction, inflammasome activation, and lipid mediators. Seven sites have received approval from the USAMRMC Office of Research Protections (ORP) Human Research Protection Office (HRPO). Seven sites are activated for enrollment and are currently screening. Four subjects have been enrolled to date.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2021
- Accession Number
- AD1158152
Entities
People
- Augustine M K Choi
- Jeremy Weingarten
Organizations
- Cornell University