Home › Respiratory Distress Syndrome › NCT06701682
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
RecruitingPhase 2
Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Cohort A: vilobelimab (drug)
- Cohort A: placebo (drug)
Sponsor: PPD Development, LP · Participants: 200 · Started: Jun 21, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT06701682
Locations in the U.S.
| Alabama | University of Alabama Hospital, Birmingham (Not yet recruiting) |
| California | Community Regional Medical Center, Fresno
Long Beach Memorial Medical Center, Long Beach
University of California Irvine Medical Center, Orange
University of California Davis Medical Center - Pulmonary Medicine, Sacramento
Stanford Medical Center, Stanford |
| Colorado | Denver Health Hospital and Authority, Denver |
| District of Columbia | MedStar Washington Hospital Center, Washington D.C. |
| Florida | Nova Clinical Research, Bradenton
North Florida / South Georgia Veterans Health System, Gainesville
Sarasota Memorial Hospital, Sarasota |
| Idaho | St. Luke's Boise Medical Center, Boise |
| Illinois | Northshore University Healthsystem Research Institute, Evanston (Not yet recruiting)
OSF Saint Francis Medical Center-, Peoria |
| Massachusetts | Tufts Medical Center, Boston (Not yet recruiting)
Lahey Hospital and Medical Center, Burlington |
| Michigan | University of Michigan Hospital, Ann Arbor
Henry Ford Health Hospital, Detroit |
| Minnesota | Mayo Clinic, Rochester |
| New Jersey | Robert Wood Johnson Medical School, New Brunswick |
| New York | Memorial Sloan Kettering Cancer Center, New York (Not yet recruiting)
Weill Cornell Medical College, New York (Not yet recruiting)
Montefiore Hospital - Moses Campus, The Bronx
Westchester Medical Center, Valhalla (Not yet recruiting) |
| North Carolina | University of North Carolina at Chapel Hill, Chapel Hill
Duke Lung Transplant Clinic - Clinic 2F/2G - PPDS, Durham (Not yet recruiting)
Durham VA Medical Center, Durham |
| Ohio | Cleveland Clinic, Cleveland (Not yet recruiting)
University Hospitals Cleveland Medical Center, Cleveland (Not yet recruiting)
Mercy Health - St. Vincent Medical Center, Toledo |
| Oklahoma | The University of Oklahoma Health Sciences Center, Oklahoma City |
| Oregon | Oregon Health and Science University, Portland |
| South Carolina | Medical University of South Carolina (MUSC), Charleston |
| Tennessee | Vanderbilt University Medical Center, Nashville |
| Texas | Baylor All Saints Medical Center, Fort Worth
Baylor St Luke's Medical Center, Houston (Not yet recruiting)
Houston Methodist Hospital, Houston (Not yet recruiting) |
| Utah | Intermountain Medical Center, Murray |
| Virginia | University of Virginia Health System, Charlottesville (Not yet recruiting) |
| Washington | Swedish Medical Center, Seattle |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.