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
BioAegis Therapeutics Inc.
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.
Description
Potential subjects hospitalized with pneumonia or other infections are to be screened within 24 hours of diagnosis of ARDS. The Sponsor aims to identify as early as possible patients in the hospital who have developed acute hypoxemic respiratory failure within 7 days of the precipitating infection (often fever, rigors, chills, increased heart rate, increased respiratory rate, pain, cough, etc.) leading to ARDS resulting in mechanical or noninvasive ventilation or high-flow nasal oxygen (HFNO) supplementation with ≥50% O2 at a flow rate of ≥30 L/min. Patients who do not qualify for the study at…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugRhu-pGSN
Intravenous administration based on actual body weight
- Drugnormal saline
intravenous administration in the same volume as the active therapy
Locations (76)
- University of California Irvine Medical CenterIrvine, California
- Cedars-Sinai Medical CenterLos Angeles, California
- Wellstar MCG Augusta UniversityAugusta, Georgia
- Northwestern University - Pulmonary and Critical Care MedicineChicago, Illinois
- University of Louisville Hospital - Jewish HospitalLouisville, Kentucky
- University of Louisville-Jewish HospitalLouisville, Kentucky