JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)
NCT ID: NCT06703073
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
600 participants
INTERVENTIONAL
2025-06-10
2028-09-30
Brief Summary
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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.
Detailed Description
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Outcome data will be assembled for each patient over time (such as ventilatory status, oxygenation, and survival). Functional status using the WHO Ordinal scale and Karnofsky scale will be collected. Resource utilization will be calculated (length of stay in a critical care setting, days intubated, and survival).
All participants will undergo a series of physical exams, laboratory assessments/biomarker collections, ECG, Chest X-ray or CT scan, and questionnaires through Day 90. Exploratory biomarkers will be evaluated over time to facilitate clinical learning.
For information specific to each intervention included in this platform trial, please refer to the below corresponding, separate, clinicaltrials.gov records:
Vilobelimab NCT06701682 ; Paridiprubart NCT06701669 ; Bevacizumab NCT06701656
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
* 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.
Study Groups
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Cohort A: vilobelimab
Cohort A: vilobelimab
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: placebo
Cohort A: placebo
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 B: paridiprubart
Cohort B: paridiprubart
Administered as a single IV dose of 15 mg/kg up to maximum of 1440 mg on Day 1
Cohort B: placebo
Cohort B: placebo
Administered as a single IV dose of placebo on Day 1
Cohort C: bevacizumab
Cohort C: bevacizumab
Administered as a single IV dose of 500 mg on Day 1
Cohort C: placebo
Cohort C: placebo
Administered as a single IV dose of placebo on Day 1
Interventions
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Cohort A: vilobelimab
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: placebo
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 B: paridiprubart
Administered as a single IV dose of 15 mg/kg up to maximum of 1440 mg on Day 1
Cohort B: placebo
Administered as a single IV dose of placebo on Day 1
Cohort C: bevacizumab
Administered as a single IV dose of 500 mg on Day 1
Cohort C: placebo
Administered as a single IV dose of placebo on Day 1
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
* Participant received treatment with an investigational immunomodulator or immunosuppressant drugs within 5 half-lives or 30 days (whichever is longer) before randomization.
* Participant with concurrent infections or history of the following:
1. Known active tuberculosis,
2. Known active Hepatitis B, or
3. HIV and a CD4 count less than 50 or a detectable viral load of \>200 copies/mL HIV RNA.
* Participant received treatment with any other investigational drugs within 30 days prior to consent.
* Participant had a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 28 days of screening or inadequate wound healing secondary to major thoracoabdominal surgery at the time of screening.
* Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Participant may have additional cohort-specific requirements.
18 Years
ALL
No
Sponsors
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Biomedical Advanced Research and Development Authority
FED
InflaRx GmbH
INDUSTRY
Edesa Biotech Inc.
INDUSTRY
Genentech, Inc.
INDUSTRY
PPD Development, LP
INDUSTRY
Responsible Party
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Locations
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Community Regional Medical Center
Fresno, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
University of California Irvine Medical Center
Orange, California, United States
University of California Davis Medical Center - Pulmonary Medicine
Sacramento, California, United States
Denver Health Hospital and Authority
Denver, Colorado, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Nova Clinical Research
Bradenton, Florida, United States
North Florida / South Georgia Veterans Health System
Gainesville, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
St. Luke's Boise Medical Center
Boise, Idaho, United States
OSF Saint Francis Medical Center-
Peoria, Illinois, United States
Tufts Medical Center
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Henry Ford Health Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Renown Institute for Heart & Vascular Health
Reno, Nevada, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Montefiore Hospital - Moses Campus
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Durham VA Medical Center
Durham, North Carolina, United States
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor All Saints Medical Center
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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Central Contacts
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References
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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.
Other Identifiers
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75A50124C00001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BP-ARDS-P2-001 (Master Record)
Identifier Type: -
Identifier Source: org_study_id