Clinical Trials in the USA / NCT06701669
Recruiting
Phase 2
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart
NCT06701669 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Acute Respiratory Distress Syndrome (ARDS)ARDSARDS (Acute Respiratory Distress Syndrome)Acute Respiratory Distress Syndrome
Investigational drug(s) / intervention(s)
Cohort B: paridiprubart →Cohort B: placebo
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
Study 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 B: Participants will be randomized to receive either a placebo or paridiprubart.
This record describes the default procedures and analyses for Cohort B. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.
Eligibility
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 has a known allergy or known hypersensitivity to paridiprubart or its excipients, including polysorbate 80
* Participant with established cirrhosis and a modified Child-Pugh Score of 12 or greater
Primary outcome measure(s)
- All-cause mortality (ACM) rate at Day 28 — Day 28
Trial sites (41)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama Hospital | Birmingham | Alabama | Not Yet Recruiting |
| Community Regional Medical Center | Fresno | California | Recruiting |
| Long Beach Memorial Medical Center | Long Beach | California | Recruiting |
| University of California Irvine Medical Center | Orange | California | Recruiting |
| University of California Davis Medical Center - Pulmonary Medicine | Sacramento | California | Recruiting |
| Stanford Medical Center | Stanford | California | Recruiting |
| Denver Health Hospital and Authority | Denver | Colorado | Recruiting |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | Recruiting |
| Nova Clinical Research | Bradenton | Florida | Recruiting |
| North Florida / South Georgia Veterans Health System | Gainesville | Florida | Recruiting |
| Sarasota Memorial Hospital | Sarasota | Florida | Recruiting |
| St. Luke's Boise Medical Center | Boise | Idaho | Recruiting |
| Northshore University Healthsystem Research Institute | Evanston | Illinois | Not Yet Recruiting |
| OSF Saint Francis Medical Center- | Peoria | Illinois | Recruiting |
| Tufts Medical Center | Boston | Massachusetts | Not Yet Recruiting |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | Recruiting |
| University of Michigan Hospital | Ann Arbor | Michigan | Recruiting |
| Henry Ford Health Hospital | Detroit | Michigan | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| Renown Institute for Heart & Vascular Health | Reno | Nevada | Withdrawn |
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Not Yet Recruiting |
| Weill Cornell Medical College | New York | New York | Not Yet Recruiting |
| Montefiore Hospital - Moses Campus | The Bronx | New York | Recruiting |
| Westchester Medical Center | Valhalla | New York | Not Yet Recruiting |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | Recruiting |
| Durham VA Medical Center | Durham | North Carolina | Recruiting |
| Duke Lung Transplant Clinic - Clinic 2F/2G - PPDS | Durham | North Carolina | Not Yet Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Not Yet Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Not Yet Recruiting |
| Mercy Health - St. Vincent Medical Center | Toledo | Ohio | Recruiting |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | Recruiting |
| Oregon Health and Science University | Portland | Oregon | Recruiting |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Recruiting |
| Baylor All Saints Medical Center | Fort Worth | Texas | Recruiting |
| Baylor St Luke's Medical Center | Houston | Texas | Not Yet Recruiting |
| Houston Methodist Hospital | Houston | Texas | Not Yet Recruiting |
| Intermountain Medical Center | Murray | Utah | Recruiting |
| University of Virginia Health System | Charlottesville | Virginia | Not Yet Recruiting |
+ 1 more sites — see the full list on the official registry below.
More PPD Development, LP trials in the USA
Other trials for the same condition
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06701669 on ClinicalTrials.gov ↗ ← All trials in the USA