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NCT05947955 · ClinicalTrials.gov registry record · Phase 2

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

A Phase 2 study of Acute Respiratory Distress Syndrome and Infections, sponsored by BioAegis Therapeutics.

Recruiting
Registry status
Phase 2
Development phase
600
Enrollment target
20
Study locations

NCT05947955 is a Phase 2 study of Acute Respiratory Distress Syndrome and Infections that is actively recruiting participants, run by BioAegis Therapeutics. The registered enrollment target is 600 participants, above the 348-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (72% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT05947955, a Phase 2 study of Acute Respiratory Distress Syndrome and Infections, is actively recruiting participants, sponsored by BioAegis Therapeutics.

RECRUITING
Registry status
Phase 2
Development phase
600 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Acute Respiratory Distress Syndrome Infections

Interventions

  • DRUG normal saline
  • DRUG Rhu-pGSN

Study Locations (20)

Other

  • HUB - Hôpital Erasme - Brussels
  • CHU Charleroi Marie Curie Hospital - Charleroi
  • Centre Hospitalier Regional de la Citadelle - Liège
  • Clinique Saint-Pierre Ottignies - Ottignies
  • Acibadem City Clinic UMHAT Tokuda - Sofia - Sofia

Pennsylvania

  • Penn State Health - Milton S. Hershey Medical Center - Hershey
  • Penn State Health - Milton S. Hershey Medical Center - Hershey
  • University of Pittsburgh Medical Center - Pittsburgh

California

  • University of California Irvine Medical Center - Irvine
  • Cedars-Sinai Medical Center - Los Angeles

Kentucky

  • University of Louisville Hospital - Jewish Hospital - Louisville
  • University of Louisville-Jewish Hospital - Louisville

Texas

  • McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical Center - Houston
  • Baylor Scott & White Health - Temple

Georgia

  • Wellstar MCG Augusta University - Augusta

Illinois

  • Northwestern University - Pulmonary and Critical Care Medicine - Chicago

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2024-10-03
Est. Completion 2027-03-01
Phase Phase 2

Sponsor

BioAegis Therapeutics

3 total trials

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What the Registry Record Tells You About NCT05947955

The ClinicalTrials.gov registry entry for NCT05947955 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 348-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (72% higher). The listed sponsor is BioAegis Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Acute Respiratory Distress Syndrome appearing as the primary indexed condition, and to 2 interventions - of which normal saline is the first listed.

NCT05947955 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Pennsylvania, California.

Frequently Asked Questions

What is clinical trial NCT05947955 about?

NCT05947955 is a clinical study titled "Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)". 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 ...

What is the current status of trial NCT05947955?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 600 participants. The study started on 2024-10-03. Estimated completion is 2027-03-01.

What conditions does trial NCT05947955 study?

This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome, Infections.

What interventions are being tested in trial NCT05947955?

The interventions under investigation include: normal saline (DRUG), Rhu-pGSN (DRUG).

Who is sponsoring clinical trial NCT05947955?

This trial is sponsored by BioAegis Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05947955 being conducted?

This trial has 20 study locations across California, Georgia, Illinois, Kentucky, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.