Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

ClinicalTrials.gov ID: NCT05947955

Public ClinicalTrials.gov record NCT05947955. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 17, 2026, 9:53 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05947955
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: BioAegis Therapeutics Inc.; Industry
Enrollment: 600 participants

Conditions and interventions

Conditions

Interventions

Rhu-pGSN Drug
normal saline Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 2, 2024
Primary completion: Sep 30, 2027
Completion: Feb 29, 2028
Last update posted: Sep 9, 2026

2024 – 2028

United States locations

U.S. sites: 13
U.S. states: 10
U.S. cities: 12

Facility	City	State	ZIP	Site status
Cedars-Sinai Medical Center	Los Angeles	California	90048	Recruiting
Wellstar MCG Augusta University	Augusta	Georgia	30912	Recruiting
Northwestern University - Pulmonary and Critical Care Medicine	Chicago	Illinois	60611	Recruiting
University of Louisville Hospital - Jewish Hospital	Louisville	Kentucky	40202	Recruiting
University of Louisville-Jewish Hospital	Louisville	Kentucky	40202	Recruiting
Mayo Clinic	Rochester	Minnesota	55905	Recruiting
Hannibal Regional Hospital	Hannibal	Missouri	63401	Recruiting
Bryan Medical Center	Lincoln	Nebraska	68506	Recruiting
New York University Grossman School of Medicine	New York	New York	10016	Not yet recruiting
Penn State Health - Milton S. Hershey Medical Center	Hershey	Pennsylvania	17033	Recruiting
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	15261	Recruiting
McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical Center	Houston	Texas	77030	Recruiting
Baylor Scott & White Health	Temple	Texas	76508	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 56 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05947955, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 9, 2026 · Synced Sep 17, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05947955 live on ClinicalTrials.gov.

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