Home › Trials › NCT05947955

Treatment for Acute Respiratory Distress Syndrome with rhu-pGSN

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

Phase 2 Interventional BioAegis Therapeutics Inc. · NCT05947955

This study is testing a new treatment called rhu-pGSN to see if it can help people with moderate-to-severe Acute Respiratory Distress Syndrome caused by pneumonia or infections feel better when combined with standard care.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorBioAegis Therapeutics Inc. Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations76 sites (Irvine, California and 75 other locations)
Trial IDNCT05947955 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial evaluates the efficacy and safety of rhu-pGSN in combination with standard care for patients suffering from moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) due to pneumonia or other infections. Participants will be screened within 24 hours of ARDS diagnosis and must exhibit acute hypoxemic respiratory failure. The study aims to identify eligible patients early and monitor their condition closely for potential progression. The trial is randomized, double-blind, and placebo-controlled, ensuring robust data collection and analysis.

Who should consider this trial

Good fit: Ideal candidates are hospitalized patients diagnosed with moderate-to-severe ARDS due to infections, requiring high-flow oxygen or mechanical ventilation.

Not a fit: Patients with mild ARDS or those not requiring significant respiratory support may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with moderate-to-severe ARDS.

How similar studies have performed: Other studies have explored treatments for ARDS, but the specific use of rhu-pGSN in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Irvine, California and 75 other locations

+26 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Respiratory Distress SyndromeInfectionsmoderate to severe ARDSrespiratory failurerhu-pGSN
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.