JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab
Start Date
10/28/2025
Completion Date
9/1/2028
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 C: Participants will be randomized to receive either a placebo or bevacizumab. This record describes the default procedures and analyses for Cohort C. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.
Detailed Description
This is a master protocol for a Phase 2 platform clinical trial to evaluate host-directed therapeutic candidates (i.e., investigational product, IP) for the treatment of hospitalized participants diagnosed with ARDS. The safety and efficacy of each IP will be studied within its own cohort (IP versus Placebo). All patients will continue to receive standard treatments for ARDS as per the investigator. An individual participant will complete the study in approximately 90 days. The study will include a screening period (\<24 hours from providing informed consent to treatment), in-hospital treatment period with IP/placebo starting on Day 1 through discharge from the hospital, and a follow-up period after discharge from the hospital through the end of study (Day 90 + 2 weeks). Outcome data will be assembled for each patient over time (such as ventilatory status, oxygenation, and survival). Functional status using the WHO Ordinal scale and Karnofsky scale will be collected. Resource utilization will be calculated (length of stay in a critical care setting, days intubated, and survival). All participants will undergo a series of physical exams, laboratory assessments/biomarker collections, ECG, Chest X-ray or CT scan, and questionnaires through Day 90. Exploratory biomarkers will be evaluated over time to facilitate clinical learning. This record only includes information relevant to the bevacizumab cohort.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Cohort C: bevacizumab
Cohort C: placebo
Conditions
Locations
University of Alabama Hospital
Birmingham, Alabama 35233-1932
United States
Community Regional Medical Center
Fresno, California 93721-1324
United States
Long Beach Memorial Medical Center
Long Beach, California 90806-1701
United States
University of California Irvine Medical Center
Orange, California 92868-3201
United States
University of California Davis Medical Center - Pulmonary Medicine
Sacramento, California 95816-4300
United States
Stanford Medical Center
Stanford, California 94305-2200
United States
Denver Health Hospital and Authority
Denver, Colorado 80204-4532
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010-3017
United States
Nova Clinical Research
Bradenton, Florida 34209-4617
United States
North Florida / South Georgia Veterans Health System
Gainesville, Florida 32608-1135
United States
Sarasota Memorial Hospital
Sarasota, Florida 34239
United States
St. Luke's Boise Medical Center
Boise, Idaho 83712-6241
United States
Northshore University Healthsystem Research Institute
Evanston, Illinois 60201-1700
United States
OSF Saint Francis Medical Center-
Peoria, Illinois 61637-0001
United States
Tufts Medical Center
Boston, Massachusetts 02111
United States
Lahey Hospital and Medical Center
Burlington, Massachusetts 01805-0001
United States
University of Michigan Hospital
Ann Arbor, Michigan 48109-5000
United States
Henry Ford Health Hospital
Detroit, Michigan 48202-2608
United States
Mayo Clinic
Rochester, Minnesota 55905-0001
United States
Renown Institute for Heart & Vascular Health
Reno, Nevada 89502-1576
United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901-1928
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065-6007
United States
Weill Cornell Medical College
New York, New York 10065-8722
United States
Montefiore Hospital - Moses Campus
The Bronx, New York 10467
United States
Westchester Medical Center
Valhalla, New York 10595-1530
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599-0001
United States
Durham VA Medical Center
Durham, North Carolina 27705-3875
United States
Duke Lung Transplant Clinic - Clinic 2F/2G - PPDS
Durham, North Carolina 27710-4000
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106-1716
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Mercy Health - St. Vincent Medical Center
Toledo, Ohio 43608-2603
United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104-3609
United States
Oregon Health and Science University
Portland, Oregon 97239-3011
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425-8908
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232-0004
United States
Baylor All Saints Medical Center
Fort Worth, Texas 76104-4110
United States
Baylor St Luke's Medical Center
Houston, Texas 77030-4202
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
Intermountain Medical Center
Murray, Utah 84107-5701
United States
University of Virginia Health System
Charlottesville, Virginia 22908-0816
United States
Swedish Medical Center
Seattle, Washington 98122-4379
United States