Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioAegis Therapeutics Inc.
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Presence of systemic fungal, yeast, parasitic, or mycobacterial infection
Current or planned receipt of extracorporeal membrane oxygenation (ECMO)
Pregnant or lactating women
Trial design
Treatments tested in this trial
- Rhu-pGSN
- normal saline
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
BioAegis Therapeutics Inc.
Lead sponsor
Biomedical Advanced Research and Development Authority
Collaborator
Source ClinicalTrials.gov