ClinicaliQ Trial Snapshot
- Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS) — Recruiting • Phase II • Respiratory / COPD / Asthma • NCT05947955.
- What is being tested: BTI-203 evaluates rhu-pGSN (recombinant human plasma gelsolin), an anti-inflammatory agent, combined with standard care versus placebo in a randomized, double-blind Phase 2 trial designed to assess efficacy and safety in moderate-to-severe ARDS.
- Patient eligibility overview: The trial recruits patients with moderate-to-severe ARDS (PaO₂/FiO₂ ratio ≤150) secondary to pneumonia or other infections, representing a critically ill population with significant respiratory compromise requiring intensive management.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : 1. Infection followed within a week of documented bilateral infiltrates/opacities consistent with ARDS, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist * Investigator or designee to note radiologic findings in the electronic case report form (eCRF) * Radiology report and conclusion should be summarized in the eCRF * A digital copy of the radiograph uploaded and saved for review 2. Acute hypoxemic respiratory failure (moderate-to-severe ARDS) for ≤48 hours associated with suspected or confirmed infection (moderate-to-severe ARDS defined by the ratio of arterial pressure of O2 to the fraction of inspired O2 ≤150). Eligible subjects will be intubated for mechanical ventilation, receiving noninvasive ventilation by continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or on HFNO at least 30 L/min of 50% or greater inspired O2. Although it is expected that most eligible subjects will be receiving positive end-expiratory pressure (PEEP) or CPAP ≥5 cm H2O consistent with the original Berlin definition (ARDS Definition Task Force 2012), these measures will not be mandated as entry criteria. 3. Age ≥18 years 4. Informed consent obtained from subject/next of kin/legal proxy 5. Clear or convincing evidence of…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.