JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)

NCT06703073 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: BP-ARDS-P2-001 (Master Record)75A50124C00001
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 36

Brief Summary

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

Acute Respiratory Distress Syndrome (ARDS); ARDS (Acute Respiratory Distress Syndrome); ARDS; Acute Respiratory Distress Syndrome

Keywords

BARDA; JUST BREATHE; ARDS; Acute Respiratory Distress Syndrome; Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• All-cause mortality (ACM) rate at Day 28

  Day 28

Secondary Outcomes (19)

• ACM at Day 60 and Day 90

  Day 60 and Day 90

• ACM+ at Day 28, Day 60, and Day 90

  Day 28, Day 60, and Day 90

• Improvements in oxygenation measured as change from baseline in PaO2/FiO2 ratio up to and including Day 28 (or discharge, whichever is earlier)

  Up to and including Day 28 or until Discharge (whichever is earlier)

• Incidence of new invasive mechanical ventilation use during the study up to and including Day 28

  Up to and including Day 28

• Ventilator-free days up to and including Day 28

  Up to and including Day 28

Study Arms (6)

Cohort A: vilobelimab

EXPERIMENTAL

Drug: Cohort A: vilobelimab

Cohort A: placebo

PLACEBO COMPARATOR

Drug: Cohort A: placebo

Cohort B: paridiprubart

EXPERIMENTAL

Drug: Cohort B: paridiprubart

Cohort B: placebo

PLACEBO COMPARATOR

Drug: Cohort B: placebo

Cohort C: bevacizumab

EXPERIMENTAL

Drug: Cohort C: bevacizumab

Cohort C: placebo

PLACEBO COMPARATOR

Drug: Cohort C: placebo

Interventions

Cohort A: vilobelimab DRUG

Administered as an IV formulation of 800 mg per dose and up to 6 doses (planned for Days 1, 2, 4, 8, 15, and 22, if participant is in hospital setting and deemed appropriate by the investigator)

Cohort A: vilobelimab

Cohort A: placebo DRUG

Administered as an IV formulation of placebo of up to 6 doses (planned for Days 1, 2, 4, 8, 15, and 22, if participant is in hospital setting and deemed appropriate by the investigator)

Cohort A: placebo

Cohort B: paridiprubart DRUG

Administered as a single IV dose of 15 mg/kg up to maximum of 1440 mg on Day 1

Cohort B: paridiprubart

Cohort B: placebo DRUG

Administered as a single IV dose of placebo on Day 1

Cohort B: placebo

Cohort C: bevacizumab DRUG

Administered as a single IV dose of 500 mg on Day 1

Cohort C: bevacizumab

Cohort C: placebo DRUG

Administered as a single IV dose of placebo on Day 1

Cohort C: placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant (or their Legally Authorized Representative (LAR)) provides informed consent and agrees to comply with protocol requirements
• Participant is at least 18 years of age or older at the time of consent.
• Participant with signs and symptoms of ARDS according to the Berlin definition of ARDS.
• Note that participants on noninvasive ventilation may be screened.
• Participant of childbearing potential must agree to either abstinence or use at least one primary form of contraception, not including hormonal contraception, from the time of screening through Day 28. Additional cohort-specific requirements may apply
• Participant agrees to not participate in another investigational interventional study while participating in this study (i.e., through Day 90).

You may not qualify if:

• Participant with ARDS or at risk of developing ARDS due to the following reasons: trauma, large volume aspiration, or transfusion.
• Participant with pulmonary edema due to cardiogenic pulmonary edema/fluid overload or hypoxemia primarily attributable atelectasis, in the absence of a predisposing risk factor for ARDS.
• Participant who demonstrates an improvement in oxygenation and ventilatory support 24 hours prior to or during screening up to randomization, such that per investigator clinical judgement, the participant is expected to have significant improvement in lung function over subsequent 24 hours regardless of additional interventions.
• Participant is known to be pregnant, nursing, or with a positive (urine and/or serum test) pregnancy test.
• Participant is anticipated to be transferred to another hospital which is not a study site 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 the time of consent.
• Participant has an underlying clinical condition where, in the opinion of the Investigator and based on their clinical judgement, it would be extremely unlikely that the participant would come off ventilation
• Participant has severe COPD requiring continuous long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for CPAP or bi-level positive airway pressure used solely for sleep-disordered breathing.
• Participant has interstitial lung disease or idiopathic pulmonary fibrosis requiring continuous chronic home oxygen therapy.
• Participant has NY Heart Association Class IV congestive heart failure.
• Participant has a known allergy to any study medication or any of its excipients.
• Participant is receiving systemic immunosuppressive therapy for solid organ or hematopoietic cancer or transplant anti-rejection medication.
• NOTE: Patients on chronic low dose immunosuppressive therapy may be enrolled at the discretion of the investigator in consultation with the medical monitor.
• Participant is undergoing active cancer systemic chemotherapy.

Sponsors & Collaborators

• PPD Development, LP: lead
• Biomedical Advanced Research and Development Authority: collaborator
• InflaRx GmbH: collaborator
• Edesa Biotech Inc.: collaborator
• Genentech, Inc.: collaborator

Study Sites (36)

University of Alabama Hospital

Birmingham, Alabama, 35233-1932, United States

NOT YET RECRUITING

Community Regional Medical Center

Fresno, California, 93721-1324, United States

RECRUITING

Long Beach Memorial Medical Center

Long Beach, California, 90806-1701, United States

RECRUITING

University of California Irvine Medical Center

Orange, California, 92868-3201, United States

RECRUITING

University of California Davis Medical Center - Pulmonary Medicine

Sacramento, California, 95816-4300, United States

RECRUITING

Denver Health Hospital and Authority

Denver, Colorado, 80204-4532, United States

NOT YET RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010-3017, United States

RECRUITING

Nova Clinical Research

Bradenton, Florida, 34209-4617, United States

RECRUITING

North Florida / South Georgia Veterans Health System

Gainesville, Florida, 32608-1135, United States

RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

St. Luke's Boise Medical Center

Boise, Idaho, 83712-6241, United States

RECRUITING

Northshore University Healthsystem Research Institute

Evanston, Illinois, 60201-1700, United States

NOT YET RECRUITING

OSF Saint Francis Medical Center-

Peoria, Illinois, 61637-0001, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

NOT YET RECRUITING

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805-0001, United States

RECRUITING

University of Michigan Hospital

Ann Arbor, Michigan, 48109-5000, United States

RECRUITING

Henry Ford Health Hospital

Detroit, Michigan, 48202-2608, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905-0001, United States

RECRUITING

Renown Institute for Heart & Vascular Health

Reno, Nevada, 89502-1576, United States

WITHDRAWN

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901-1928, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065-6007, United States

NOT YET RECRUITING

Montefiore Hospital - Moses Campus

The Bronx, New York, 10467, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-0001, United States

RECRUITING

Durham VA Medical Center

Durham, North Carolina, 27705-3875, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-1716, United States

NOT YET RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, 43608-2603, United States

RECRUITING

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104-3609, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239-3011, United States

RECRUITING

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425-8908, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-0004, United States

RECRUITING

Baylor All Saints Medical Center

Fort Worth, Texas, 76104-4110, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

NOT YET RECRUITING

Intermountain Medical Center

Murray, Utah, 84107-5701, United States

RECRUITING

University of Virginia Health System

Charlottesville, Virginia, 22908-0816, United States

NOT YET RECRUITING

Swedish Medical Center

Seattle, Washington, 98122-4379, United States

RECRUITING

Related Publications (1)

• Truwit JD, Fleming K, Nanchal RS. Empowering Respiratory Therapists to Restrict Nebulized 3% Saline and N-Acetylcysteine During Mechanical Ventilation. Respir Care. 2025 Aug;70(8):937-945. doi: 10.1089/respcare.12586. Epub 2025 Feb 24.

  PMID: 40028879 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Central Study Contacts

Just Breathe Trial Team

CONTACT

Please email; crgjustbreathealerts.sm@thermofisher.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The overall 2-step randomization scheme will be implemented. * Randomization Level 1 will be open-label, assigning an eligible patient to one of the available treatment cohorts. * Randomization Level 2 will be double-blinded and will randomize participants at a 1:1 ratio to receive either IP or placebo within a specific cohort. Thus, the PPD blinded team, site blinded staff members, and participants/legal authorized representative will be considered blinded to study treatment assignment (either IP or placebo) throughout the course of the study. To preserve the integrity of the study blind, an unblinded pharmacist at each site will be responsible for the reconstitution and dispensation of all study drugs and placebos and will endeavor to ensure that there are no observable differences between the treatment groups (IP or placebo) when dispensing the study materials.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: June 10, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-02

Locations

US (36)