Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

Clinical Editorial

Official title: 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

Summary: 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.

Conditions: Acute Respiratory Distress Syndrome, Infections

Keywords: moderate to severe ARDS, respiratory failure, rhu-pGSN

Study type: INTERVENTIONAL

Primary purpose: TREATMENT

Phases: PHASE2

Enrollment: 600 (ESTIMATED)

Status: RECRUITING

Completion: 2027-03-01 (ESTIMATED)

Source Reference

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DOI

NCT05947955

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Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

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