Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06701682

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab

Led by PPD Development, LP · Updated on 2026-05-08

200

Participants Needed

40

Research Sites

166 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. 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.

CONDITIONS

Official Title

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with moderate or severe Acute Respiratory Distress Syndrome (ARDS) based on PaO2/FiO2 or SpO2/FiO2 at randomization
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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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

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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

2

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