Actively Recruiting
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)
Led by PPD Development, LP · Updated on 2026-05-08
600
Participants Needed
40
Research Sites
168 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
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. Participants will be randomized to receive either a placebo or one of the active treatments. This record describes the default procedures and analyses for all cohorts. Each specific cohort may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in the corresponding intervention-specific records on clinicaltrials.gov listed below in the detailed description.
CONDITIONS
Official Title
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or their legally authorized representative provides informed consent and agrees to follow the study protocol
- Participant is 18 years of age or older at the time of consent
- Participant shows signs and symptoms of ARDS according to the Berlin definition
- Participants on noninvasive ventilation may be included
- Female participants of childbearing potential must agree to abstinence or use a primary form of contraception (excluding hormonal contraception) from screening through Day 28
- Participant agrees not to join another investigational interventional study during this study (through Day 90)
You will not qualify if you...
- Participant has ARDS or risk of ARDS due to trauma, large volume aspiration, or transfusion
- Participant has pulmonary edema from heart failure or fluid overload or hypoxemia mainly due to atelectasis without ARDS risk factors
- Participant shows significant improvement in oxygenation and ventilation 24 hours before or during screening
- Participant is pregnant, nursing, or has a positive pregnancy test
- Participant is expected to be transferred to a non-study hospital within 72 hours
- Participant is not expected to survive for 72 hours
- Participant has been on invasive mechanical ventilation or ECMO for more than 48 hours for ARDS at consent
- Participant has conditions making it unlikely to come off ventilation, per investigator judgment
- Participant has severe COPD requiring continuous home oxygen or mechanical ventilation (except CPAP or BiPAP for sleep apnea)
- Participant has interstitial lung disease or idiopathic pulmonary fibrosis requiring continuous home oxygen
- Participant has NY Heart Association Class IV congestive heart failure
- Participant has allergy to study medications or excipients
- Participant receives systemic immunosuppressive therapy for cancer or transplant anti-rejection medication (chronic low dose may be allowed per investigator)
- Participant is undergoing active cancer chemotherapy
- Participant received investigational immunomodulators or immunosuppressants within 5 half-lives or 30 days before randomization
- Participant has active tuberculosis, active Hepatitis B, or HIV with CD4 count under 50 or detectable viral load over 200 copies/mL
- Participant received other investigational drugs within 30 days before consent
- Participant had abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 28 days before screening, or poor wound healing from major surgery
- Participant is deemed unsuitable for the study by the investigator
- Additional cohort-specific exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not Yet 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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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