Actively Recruiting
Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)
Led by PPD Development, LP · Updated on 2026-05-08
200
Participants Needed
40
Research Sites
8 weeks
Total Duration
On this page
Sponsors
P
PPD Development, LP
Lead Sponsor
B
Biomedical Advanced Research and Development Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of host-directed treatments in adults hospitalized with Acute Respiratory Distress Syndrome (ARDS) in this Phase 2 randomized, double-blinded, placebo-controlled study. The trial focuses on Cohort A, where participants will receive either the investigational drug vilobelimab or a placebo. This study is part of a broader master protocol assessing multiple therapeutic options for ARDS. Participants in Cohort A will be randomly assigned to receive an intravenous dose of either vilobelimab or placebo. The treatment plan includes up to six doses given on Days 1, 2, 4, 8, 15, and 22, provided the participant remains hospitalized and the investigator approves continuation. Alongside the study drug or placebo, all patients will continue to receive standard ARDS care. During the study, participants will undergo a screening period less than 24 hours before treatment, followed by hospital treatment and a follow-up period up to 90 days plus two weeks after hospital discharge. Assessments will include physical exams, lab tests, biomarker collections, ECGs, chest X-rays or CT scans, and questionnaires. Researchers will track outcomes such as mortality rates at Day 28, ventilatory status, oxygenation changes, hospital and ICU length of stay, and functional status using the WHO Ordinal scale and Karnofsky scale. Safety monitoring will continue through Day 90.
CONDITIONS
Brief Title
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with moderate or severe ARDS based on PaO2/FiO2 or SpO2/FiO2 assessment at randomization
- Hospitalized and able to receive intravenous treatment
- Willing to continue standard ARDS care as determined by investigator
You will not qualify if you...
- No additional exclusion criteria beyond those specified in the master protocol NCT06703073 for ARDS patients enrolled in this cohort
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Less than 24 hours
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - From Day 1 through hospital discharge (up to approximately 22 days)
Participants receive up to 6 doses of vilobelimab or placebo by IV during hospitalization, alongside standard care for ARDS.
Up to 6 dosing visits during hospitalization plus daily assessments while hospitalized
Duration - Up to approximately 90 days after enrollment
Participants are monitored after hospital discharge through Day 90 to assess recovery, survival, and functional status.
Periodic visits and assessments through Day 90 post enrollment
Trial Site Locations
Total: 40 locations
1
University of Alabama Hospital
Birmingham, Alabama, United States, 35233-1932
Not Yet Recruiting
2
Community Regional Medical Center
Fresno, California, United States, 93721-1324
Actively Recruiting
3
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806-1701
Actively Recruiting
4
University of California Irvine Medical Center
Orange, California, United States, 92868-3201
Actively Recruiting
5
University of California Davis Medical Center - Pulmonary Medicine
Sacramento, California, United States, 95816-4300
Actively Recruiting
6
Denver Health Hospital and Authority
Denver, Colorado, United States, 80204-4532
Actively Recruiting
7
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010-3017
Actively Recruiting
8
Nova Clinical Research
Bradenton, Florida, United States, 34209-4617
Actively Recruiting
9
North Florida / South Georgia Veterans Health System
Gainesville, Florida, United States, 32608-1135
Actively Recruiting
10
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Actively Recruiting
11
St. Luke's Boise Medical Center
Boise, Idaho, United States, 83712-6241
Actively Recruiting
12
Northshore University Healthsystem Research Institute
Evanston, Illinois, United States, 60201-1700
Not Yet Recruiting
13
OSF Saint Francis Medical Center-
Peoria, Illinois, United States, 61637-0001
Actively Recruiting
14
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Not Yet Recruiting
15
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805-0001
Actively Recruiting
16
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109-5000
Actively Recruiting
17
Henry Ford Health Hospital
Detroit, Michigan, United States, 48202-2608
Actively Recruiting
18
Mayo Clinic
Rochester, Minnesota, United States, 55905-0001
Actively Recruiting
19
Renown Institute for Heart & Vascular Health
Reno, Nevada, United States, 89502-1576
Withdrawn
20
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901-1928
Actively Recruiting
21
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065-6007
Not Yet Recruiting
22
Weill Cornell Medical College
New York, New York, United States, 10065-8722
Not Yet Recruiting
23
Montefiore Hospital - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
24
Westchester Medical Center
Valhalla, New York, United States, 10595-1530
Not Yet Recruiting
25
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-0001
Actively Recruiting
26
Durham VA Medical Center
Durham, North Carolina, United States, 27705-3875
Actively Recruiting
27
Duke Lung Transplant Clinic - Clinic 2F/2G - PPDS
Durham, North Carolina, United States, 27710-4000
Not Yet Recruiting
28
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106-1716
Not Yet Recruiting
29
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
30
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, United States, 43608-2603
Actively Recruiting
31
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104-3609
Actively Recruiting
32
Oregon Health and Science University
Portland, Oregon, United States, 97239-3011
Actively Recruiting
33
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425-8908
Actively Recruiting
34
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-0004
Actively Recruiting
35
Baylor All Saints Medical Center
Fort Worth, Texas, United States, 76104-4110
Actively Recruiting
36
Baylor St Luke's Medical Center
Houston, Texas, United States, 77030-4202
Not Yet Recruiting
37
Houston Methodist Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
38
Intermountain Medical Center
Murray, Utah, United States, 84107-5701
Actively Recruiting
39
University of Virginia Health System
Charlottesville, Virginia, United States, 22908-0816
Not Yet Recruiting
40
Swedish Medical Center
Seattle, Washington, United States, 98122-4379
Actively Recruiting
Research Team
J
Just Breathe Trial Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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