Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
NCT05947955 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG normal saline
- DRUG Rhu-pGSN
Study Locations (20)
Other
- HUB - Hôpital Erasme — Brussels
- CHU Charleroi Marie Curie Hospital — Charleroi
- Centre Hospitalier Regional de la Citadelle — Liège
- Clinique Saint-Pierre Ottignies — Ottignies
- Acibadem City Clinic UMHAT Tokuda - Sofia — Sofia
Pennsylvania
- Penn State Health - Milton S. Hershey Medical Center — Hershey
- Penn State Health - Milton S. Hershey Medical Center — Hershey
- University of Pittsburgh Medical Center — Pittsburgh
California
- University of California Irvine Medical Center — Irvine
- Cedars-Sinai Medical Center — Los Angeles
Kentucky
- University of Louisville Hospital - Jewish Hospital — Louisville
- University of Louisville-Jewish Hospital — Louisville
Texas
- McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical Center — Houston
- Baylor Scott & White Health — Temple
Georgia
- Wellstar MCG Augusta University — Augusta
Illinois
- Northwestern University - Pulmonary and Critical Care Medicine — Chicago
Minnesota
- Mayo Clinic — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-10-03 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05947955
The ClinicalTrials.gov registry entry for NCT05947955 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioAegis Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Acute Respiratory Distress Syndrome appearing as the primary indexed condition, and to 2 interventions — of which normal saline is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05947955 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, Pennsylvania, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05947955 about?
NCT05947955 is a clinical study titled "Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)". 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 ...
What is the current status of trial NCT05947955?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 600 participants. The study started on 2024-10-03. Estimated completion is 2027-03-01.
What conditions does trial NCT05947955 study?
This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome, Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05947955?
The interventions under investigation include: normal saline (DRUG), Rhu-pGSN (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05947955?
This trial is sponsored by BioAegis Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05947955 being conducted?
This trial has 20 study locations across California, Georgia, Illinois, Kentucky, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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