Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

Recruiting Phase 2 Interventional Study
Acute Respiratory Distress Syndrome Infections
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
600 (estimated)
Sponsor
BioAegis Therapeutics Inc. · Industry
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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 A…
Trial Locations
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Eligibility 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 radio…
Contacts

Howard Levy, MD PhD

848-992-5888

hlevy@hlevyconsulting.com

CONTACT

Dmytro Pomishchyk

502-648-2138

dmytro.pomishchyk@ergomedgroup.com

CONTACT