Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

NCT05947955
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
600
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Lead sponsor
BioAegis Therapeutics Inc.
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Start date
2024-10-03
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Number of sites
70
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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.
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Short title
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-03-01
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First posted
2023-07-17
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Registry last updated
2026-06-15
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Primary completion date
2026-10-01
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Start date
2024-10-03
clinicaltrials.gov

Participants
600
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Participant count basis
Estimated
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Planned participants
600
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Protocol amendments
5
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Randomisation ratio
1:1
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Number of sites
70
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
BioAegis Therapeutics Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05947955
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05947955
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Registry record
Open registry record
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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
clinicaltrials.gov

  1. All-cause mortality at day 28

    Timeframe: 28 days

    Death for any reason through Day 28 between treatment groups

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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

  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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (2)