Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Cohort A: Participants will be randomized to receive either a placebo or vilobelimab. This record describes the default procedures and analyses for Cohort A. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.
• ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization
Locations
United States
California
Community Regional Medical Center
RECRUITING
Fresno
Long Beach Memorial Medical Center
RECRUITING
Long Beach
University of California Irvine Medical Center
RECRUITING
Orange
University of California Davis Medical Center - Pulmonary Medicine
RECRUITING
Sacramento
Colorado
Denver Health Hospital and Authority
RECRUITING
Denver
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Nova Clinical Research
RECRUITING
Bradenton
North Florida / South Georgia Veterans Health System
RECRUITING
Gainesville
Sarasota Memorial Hospital
RECRUITING
Sarasota
Idaho
St. Luke's Boise Medical Center
RECRUITING
Boise
Illinois
OSF Saint Francis Medical Center-
RECRUITING
Peoria
Massachusetts
Tufts Medical Center
NOT_YET_RECRUITING
Boston
Lahey Hospital and Medical Center
RECRUITING
Burlington
Michigan
University of Michigan Hospital
RECRUITING
Ann Arbor
Henry Ford Health Hospital
RECRUITING
Detroit
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Durham VA Medical Center
RECRUITING
Durham
New Jersey
Robert Wood Johnson Medical School
RECRUITING
New Brunswick
Nevada
Renown Institute for Heart & Vascular Health
WITHDRAWN
Reno
New York
Montefiore Hospital - Moses Campus
RECRUITING
The Bronx
Ohio
Mercy Health - St. Vincent Medical Center
RECRUITING
Toledo
Oklahoma
The University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Oregon Health and Science University
RECRUITING
Portland
South Carolina
Medical University of South Carolina (MUSC)
RECRUITING
Charleston
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Baylor All Saints Medical Center
RECRUITING
Fort Worth
Houston Methodist Hospital
NOT_YET_RECRUITING
Houston
Utah
Intermountain Medical Center
RECRUITING
Murray
Washington
Swedish Medical Center
RECRUITING
Seattle
Contact Information
Primary
Just Breathe Trial Team
crgjustbreathealerts.sm@thermofisher.com
Please email
Time Frame
Start Date: 2025-06-21
Estimated Completion Date: 2028-09
Participants
Target number of participants: 200
Treatments
Experimental: Cohort A: vilobelimab
Placebo_comparator: Cohort A: placebo
Related Therapeutic Areas
Sponsors
Collaborators: Genentech, Inc., Edesa Biotech Inc., Biomedical Advanced Research and Development Authority, InflaRx GmbH
Leads: PPD Development, LP