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

RecruitingPhase 2Ages 18 Years - anyAllPPD Development, LP
NCT06701682 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073. * ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization Exclusion Criteria: The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073. * Participant with established cirrhosis and a modified Child-Pugh Score of 12 or greater
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What it tests

  • Cohort A: vilobelimab
  • Cohort A: placebo
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Where

41 sites
University of Alabama Hospital
Birmingham, United States
Community Regional Medical Center
Fresno, United States
Long Beach Memorial Medical Center
Long Beach, United States
University of California Irvine Medical Center
Orange, United States
University of California Davis Medical Center - Pulmonary Medicine
Sacramento, United States
Stanford Medical Center
Stanford, United States
Denver Health Hospital and Authority
Denver, United States
MedStar Washington Hospital Center
Washington D.C., United States

…and 33 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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