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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS) (NCT05947955) is a Phase 2 interventional studying Acute Respiratory Distress Syndrome and Infections, sponsored by BioAegis Therapeutics INC.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Acute Respiratory Distress Syndrome and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 600 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 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. willing to sign a consent form obtained from subject/next of kin/legal proxy 5. Clear or convincing evidence of a precipitating infection during the 7 days preceding the diagnosis of ARDS in the judgement of the screening or primary care team 6. During the course of the study starting at screening and for at least 3 months after their final study treatment: 1. Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth control methods 2. Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 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 a precipitating infection during the 7 days preceding the diagnosis of ARDS in the judgement of the screening or primary care team 6. During the course of the study starting at screening and for at least 3 months after their final study treatment: 1. Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth control methods 2. Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner 3. All subjects must agree not to donate sperm or eggs Exclusion Criteria: 1. Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, atelectasis, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis are materially contributing to the clinical or radiological findings bas assessed by the care team or Investigator; an echocardiogram is strongly recommended as part of standard care to exclude a significant contribution of systolic or diastolic heart failure and volume overload. 2. Presence of systemic fungal, yeast, parasitic, or mycobacterial infection 3. Current or planned receipt of extracorporeal membrane oxygenation (ECMO) 4. Pregnant or lactating women 5. Previous splenectomy 6. Any vaccination in the previous 30 days 7. Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days 8. Known allergy to study drug or excipients 9. Weight \>125 kg 10. Active underlying cancer or treatment with systemic chemotherapy or radiation therapy during the last 60 days or likely to require similar treatments during the ensuing 6 months 11. Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease 12. Chronic mechanical ventilation or dialysis 13. Unsuitable for study participation, in the opinion of the Investigator, because of chronic, severe, end-stage, or life-limiting underlying disease unrelated to current infection likely to interfere with management and assessment of ARDS, only comfort or limited (non-aggressive) care is to be given, or life expectancy \<6 months unrelated to acute infection in the opinion of the Investigator.

Treatments Being Tested

DRUG

Rhu-pGSN

Intravenous administration based on actual body weight

DRUG

normal saline

intravenous administration in the same volume as the active therapy

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of California Irvine Medical Center
Irvine, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Wellstar MCG Augusta University
Augusta, Georgia, United States
Northwestern University - Pulmonary and Critical Care Medicine
Chicago, Illinois, United States
University of Louisville Hospital - Jewish Hospital
Louisville, Kentucky, United States
University of Louisville-Jewish Hospital
Louisville, Kentucky, United States
Mayo Clinic
Rochester, Minnesota, United States
Hannibal Regional Hospital
Hannibal, Missouri, United States
Bryan Medical Center
Lincoln, Nebraska, United States
New York University Grossman School of Medicine
New York, New York, United States
Penn State Health - Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Penn State Health - Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical Center
Houston, Texas, United States
Baylor Scott & White Health
Temple, Texas, United States
HUB - Hôpital Erasme
Brussels, Belgium
CHU Charleroi Marie Curie Hospital
Charleroi, Belgium
Centre Hospitalier Regional de la Citadelle
Liège, Belgium
Clinique Saint-Pierre Ottignies
Ottignies, Belgium
Acibadem City Clinic UMHAT Tokuda - Sofia
Sofia, Bulgaria

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05947955), the sponsor (BioAegis Therapeutics INC.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05947955 clinical trial 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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05947955?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05947955?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05947955. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05947955. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.