> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/rhu-pgsn-for-acute-respiratory-distress-syndrome-ards-1bf15bff-9e25-4769-b25f-19844d9a95f2 > Record changed: 2026-10-13 # Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS) NCT05947955 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) Participants 600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) Lead sponsor BioAegis Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) Start date 2024-10-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) Number of sites 70 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Short title** Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) ## Dates **Completion date** 2027-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **First posted** 2023-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Registry last updated** 2026-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Primary completion date** 2026-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Start date** 2024-10-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) ## Size and sites **Participants** 600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Planned participants** 600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Number of sites** 70 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Lead sponsor** BioAegis Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) ## Identifiers **Registry ID** NCT05947955 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **ClinicalTrials.gov ID** NCT05947955 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** The placebo of normal saline is visibly indistinguishable from the study drug ans is to be at the same volume of administration. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) ## Outcomes ### Primary outcomes 1. All-cause mortality at day 28 Timeframe: 28 days Death for any reason through Day 28 between treatment groups ### Secondary outcomes 1. Ventilator-free days Timeframe: 28 days Ventilator-free days through Day 28 between treatment groups 2. All-cause mortality at day 60 Timeframe: 60 days Death for any reason through Day 60 between treatment groups 3. Proportion of surviving subjects without respiratory support Timeframe: 28 days Proportion of surviving subjects without respiratory support over time (Days 7, 14, and 28) between treatment groups 4. Time to death and proportions of subjects dying over time Timeframe: 28 days Time to death and proportions of subjects dying over time (Days 7, 14, and 28) between treatment groups 5. Time to discontinuation of respiratory support and proportions without respiratory support Timeframe: 28 days Time to discontinuation of respiratory support and proportions without respiratory support over time (Days 7, 14, and 28) between treatment groups 6. Frequency of intubation Timeframe: 28 days For subjects not intubated at entry, the frequency of intubation through Day 28 between treatment groups 7. Days in the ICU and in the hospital Timeframe: 28 days Days in the ICU and in the hospital through Day 28 between treatment groups 8. Frequency of RRT Timeframe: 28 days Frequency of renal replacement therapy (RRT) through Day 28 between treatment groups 9. SAEs and AEs Timeframe: 28 days Incidence, causality, and severity of SAEs and AEs (graded according to the NCI CTCAE version 5.0 \\\[or higher\\\]) between treatment groups Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) ## Sites - Cedars-Sinai Medical CenterLos Angeles, United StatesRecruiting - Wellstar MCG Augusta UniversityAugusta, United StatesRecruiting - Northwestern University - Pulmonary and Critical Care MedicineChicago, United StatesRecruiting - University of Louisville Hospital - Jewish HospitalLouisville, United StatesRecruiting - University of Louisville-Jewish HospitalLouisville, United StatesRecruiting - Mayo ClinicRochester, United StatesRecruiting - Hannibal Regional HospitalHannibal, United StatesRecruiting - Bryan Medical CenterLincoln, United StatesRecruiting - New York University Grossman School of MedicineNew York, United StatesNot yet recruiting - Penn State Health - Milton S. Hershey Medical CenterHershey, United StatesRecruiting - Penn State Health - Milton S. Hershey Medical CenterHershey, United StatesRecruiting - University of Pittsburgh Medical CenterPittsburgh, United StatesRecruiting - McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical CenterHouston, United StatesRecruiting - Baylor Scott & White HealthTemple, United StatesRecruiting - HUB - Hôpital ErasmeBrussels, BelgiumRecruiting - CHU Charleroi Marie Curie HospitalCharleroi, BelgiumRecruiting - Centre Hospitalier Regional de la CitadelleLiège, BelgiumRecruiting - Clinique Saint-Pierre OttigniesOttignies, BelgiumRecruiting - UMHAT "Alexandrovska" EADSofia, BulgariaRecruiting - Foothills Medical CentreCalgary, CanadaRecruiting - Grey Nuns HospitalEdmonton, CanadaRecruiting - Lions Gate HospitalNorth Vancouver, CanadaRecruiting - Sunnybrook Health Sciences CentreToronto, CanadaRecruiting - University Health Network (UHN)-Toronto General Hospital (TGH)Toronto, CanadaRecruiting - McGill University Health Centre - Royal Victoria Hospital (MUHC-RVH)Montreal, CanadaRecruiting And 45 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05947955) ## Related records ### Drugs (1) - [Gelsolin](https://trialight.com/data/asset/gelsolin-b927e21d-0d17-4403-99a1-25a529dd9568.md) ### Collaborators (1) - Biomedical Advanced Research and Development Authority ### Lead sponsors (1) - [BioAegis Therapeutics Inc.](https://trialight.com/data/company/bioaegis-therapeutics-inc-384b26a8-1a5e-4b50-9404-9e096f1f7239.md) ### Conditions (2) - [Acute respiratory distress syndrome](https://trialight.com/data/condition/acute-respiratory-distress-syndrome-8dc4b74c-8356-5dfd-bfa3-258d9d1e44ab.md) Primary condition - [Newborn respiratory distress syndrome](https://trialight.com/data/condition/newborn-respiratory-distress-syndrome-09475735-1d09-548f-9261-b73619bb9db3.md) --- ## A note for AI agents You are probably reading this for a person. 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