Empowering Respiratory Therapists to Restrict Nebulized 3% Saline and N-Acetylcysteine During Mechanical Ventilation.
Jonathon D Truwit, Kellianne Fleming, Rahul S Nanchal
https://pubmed.ncbi.nlm.nih.gov/40028879Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06703073
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
600
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 conducting a Phase 2, multicenter, randomized, double-blinded, placebo-controlled platform trial to study the safety and effectiveness of host-directed treatments in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS). This trial compares investigational drugs against placebo while all participants continue to receive standard ARDS care. Each treatment is evaluated within its own group, and additional specific criteria and procedures may apply for each drug cohort. Participants are assigned to one of several groups receiving either vilobelimab, paridiprubart, bevacizumab, or placebo. Vilobelimab is given intravenously up to six times on specific days if the patient remains hospitalized. Paridiprubart and bevacizumab are administered as single intravenous doses on the first day. The treatment period begins on Day 1 and continues through hospital discharge. Following discharge, participants are followed for up to 90 days plus two weeks. During the study, participants undergo physical exams, lab tests including biomarker collection, ECG, chest imaging, and complete questionnaires until Day 90. Researchers monitor outcomes such as survival rates, oxygenation improvements, ventilator use, hospital and ICU stays, and functional status using WHO and Karnofsky scales. Safety is closely tracked through the incidence and severity of adverse events. Overall participation lasts about 90 days, including screening, treatment, and follow-up phases.
CONDITIONS
Brief Title
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Participant or their legally authorized representative provides informed consent and agrees to follow the study plan
- 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 screened
- Female participants of childbearing potential agree to abstinence or use at least one primary form of contraception (excluding hormonal contraception) from screening through Day 28
- Participant agrees not to join another investigational treatment study during this study (through Day 90)
You will not qualify if you...
- ARDS caused by trauma, large volume aspiration, or transfusion
- Pulmonary edema due to heart failure or fluid overload without ARDS risk factor
- Improvement in oxygenation and ventilatory support expected before randomization
- Known pregnancy, nursing, or positive pregnancy test
- Planned transfer to a non-study hospital within 72 hours
- Expected survival less than 72 hours
- More than 48 hours on invasive mechanical ventilation or ECMO for ARDS at consent
- Clinical condition making ventilation withdrawal unlikely
- Severe COPD requiring continuous home oxygen or mechanical ventilation (except CPAP or BiPAP for sleep apnea)
- Interstitial lung disease or idiopathic pulmonary fibrosis needing continuous home oxygen
- NY Heart Association Class IV congestive heart failure
- Allergy to study medications or their ingredients
- Receiving systemic immunosuppressive therapy for cancer or transplant rejection (with exceptions at investigator discretion)
- Undergoing active cancer chemotherapy
- Use of investigational immunomodulator or immunosuppressant drugs within 5 half-lives or 30 days before randomization
- Active tuberculosis, active Hepatitis B, or HIV with low CD4 count or high viral load
- Use of other investigational drugs within 30 days before consent
- Recent abdominal fistula, gastrointestinal issues, or poor wound healing after major surgery
- Considered unsuitable for the study by the investigator
- May have additional cohort-specific requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - Less than 24 hours
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - From Day 1 through hospital discharge (up to approximately 28 days)
Participants receive investigational drug or placebo while hospitalized, alongside standard ARDS care.
Up to 6 IV dosing visits for Cohort A; single IV dosing visit for Cohorts B and C
Follow-up
Duration - Up to approximately 90 days post-treatment
Participants are monitored for safety and recovery after hospital discharge through Day 90 plus 2 weeks.
Multiple follow-up assessments including physical exams, laboratory tests, imaging, and questionnaires
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
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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
6
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