JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab

NCT06701656 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: BP-ARDS-P2-001 (bevacizumab)75A50124C00001
• Study Type: interventional
• Target: 200
• 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. Cohort C: Participants will be randomized to receive either a placebo or bevacizumab. This record describes the default procedures and analyses for Cohort C. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.

Conditions

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

  Time Frame: 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 (2)

Cohort C: bevacizumab

EXPERIMENTAL

Drug: Cohort C: bevacizumab

Cohort C: placebo

PLACEBO COMPARATOR

Drug: Cohort C: placebo

Interventions

Cohort C: placebo DRUG

Administered as a single IV dose of placebo on Day 1

Cohort C: placebo

Cohort C: bevacizumab DRUG

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

Cohort C: bevacizumab

Eligibility Criteria

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

You may not qualify if:

• ARDS Severity of mild, moderate or severe, based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization.
• Participant has a known allergy or hypersensitivity to the active substance/excipients, or Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies
• Participant with established cirrhosis and Child-Pugh Score of 7 or greater
• Participant was dialysis-dependent prior to hospitalization. Participant must have a urine dipstick for proteinuria \< 2+
• The hospitalized participant has a history or currently experiencing the following:
• Participant must not have an international normalized ratio (INR) \>1.5 and/or aPTT \>1.5 × upper limit of normal (ULN) within 7 days prior to initiation of study treatment for participants not receiving anticoagulation. For participants on full dose oral or parenteral anticoagulants for therapeutic purposes the INR and/or activated partial thromboplastin time (aPTT) must be within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the participant on a stable dose of anticoagulants for ≥ 2 weeks prior to initiation of study treatment.
• Participant with recent serious hemorrhage or history of recent hemoptysis \> 2 episodes (defined as ≥2.5 mL of bright red blood per episode) within 1 month of screening.
• Participant with inadequately controlled hypertension (defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg). Antihypertensive therapy is permitted to achieve these parameters.
• Participant with a history of hypertensive crisis or hypertensive encephalopathy.
• Participant with a history of Grade ≥ 4 venous thromboembolisms.
• Participant with significant vascular disease (eg, aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 3 months of study drug treatment.
• Participant with history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months of study drug treatment.
• Participant with serious, non-healing wound, active ulcer, or untreated bone fracture.
• Participant with history or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (ie, in the absence of therapeutic anticoagulation).
• Participant with clinically significant cardiovascular disease including cerebrovascular accident or myocardial infarction within previous 6 months, unstable angina, congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication.

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

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

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 22, 2024
• Study Start: October 28, 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)