Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06701669

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

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

200

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. Cohort B: Participants will be randomized to receive either a placebo or paridiprubart. This record describes the default procedures and analyses for Cohort B. 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 B: Paridiprubart

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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

You will not qualify if you...

  • Known allergy or hypersensitivity to paridiprubart or its excipients, including polysorbate 80

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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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JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart | DecenTrialz