🏛️ Verified NIH Record • Updated 2026-06-12

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS) (NCT05947955)

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: BioAegis Therapeutics Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Cedars-Sinai Medical Center — Los Angeles, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (70 Sites)

Showing the first 25 of 70 sites.

  • Cedars-Sinai Medical Center — Los Angeles, California
  • Wellstar MCG Augusta University — Augusta, Georgia
  • Northwestern University - Pulmonary and Critical Care Medicine — Chicago, Illinois
  • University of Louisville Hospital - Jewish Hospital — Louisville, Kentucky
  • University of Louisville-Jewish Hospital — Louisville, Kentucky
  • Mayo Clinic — Rochester, Minnesota
  • Hannibal Regional Hospital — Hannibal, Missouri
  • Bryan Medical Center — Lincoln, Nebraska
  • New York University Grossman School of Medicine — New York, New York
  • Penn State Health - Milton S. Hershey Medical Center — Hershey, Pennsylvania
  • Penn State Health - Milton S. Hershey Medical Center — Hershey, Pennsylvania
  • University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
  • McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical Center — Houston, Texas
  • Baylor Scott & White Health — Temple, Texas
  • HUB - Hôpital Erasme — Brussels,
  • CHU Charleroi Marie Curie Hospital — Charleroi,
  • Centre Hospitalier Regional de la Citadelle — Liège,
  • Clinique Saint-Pierre Ottignies — Ottignies,
  • UMHAT "Alexandrovska" EAD — Sofia,
  • Foothills Medical Centre — Calgary, Alberta
  • Grey Nuns Hospital — Edmonton, Alberta
  • Lions Gate Hospital — North Vancouver, British Columbia
  • Sunnybrook Health Sciences Centre — Toronto, Ontario
  • University Health Network (UHN)-Toronto General Hospital (TGH) — Toronto, Ontario
  • McGill University Health Centre - Royal Victoria Hospital (MUHC-RVH) — Montreal, Quebec

📞 Contact the Study Coordinator

Phone: (848) 992-5888

Email: hlevy@hlevyconsulting.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗