Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
A Phase 2 Randomized Double-blind Placebo-controlled Study To Evaluate The Efficacy And Safety Of Adjunctive Recombinant Human Plasma Gelsolin With Standard Care For Moderate-to-Severe ARDS Due To Pneumonia Or Other Infections
About This Trial
BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN plus standard of care (SOC) in subjects with moderate-to-severe ARDS (P/F ratio ≤150) due to pneumonia or other infections. Potential subjects hospitalized with pneumonia or other infections are to be screened within 24 hours of diagnosis of ARDS.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Rhu-pGSN
Intravenous administration based on actual body weight
normal saline
intravenous administration in the same volume as the active therapy