A Phase 2 Study of Inhaled CO for the Treatment of ARDS
Technical Report,15 Sep 2018,14 Sep 2019
Weill Medical College of Cornell University New York United States
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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 11 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. All 5 sites have received approval from the USAMRMC Office of Research Protections ORP Human Research Protection Office HRPO. All sites are activated for enrollment and are currently screening. One subject has been enrolled and completed 4 days of treatment.
- Medicine and Medical Research