Evaluating a new treatment for Acute Respiratory Distress Syndrome
Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)
This study is testing a new treatment called paridiprubart to see if it can help hospitalized adults with Acute Respiratory Distress Syndrome breathe better and improve their chances of recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | PPD Development, LP Industry-sponsored |
| Locations | 40 sites (Birmingham, Alabama and 39 other locations) |
| Trial ID | NCT06701669 on ClinicalTrials.gov |
What this trial studies
This Phase 2 multicenter, randomized, double-blinded, placebo-controlled trial aims to assess the safety and efficacy of paridiprubart, a host-directed therapeutic, in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS). Participants will be randomly assigned to receive either the investigational product or a placebo while continuing standard ARDS treatments. The study will monitor various outcomes, including ventilatory status, oxygenation, and survival, over a period of approximately 90 days. Comprehensive assessments, including physical exams and laboratory tests, will be conducted to gather data on the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults with moderate to severe ARDS.
Not a fit: Patients with known allergies to paridiprubart or its components may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from ARDS.
How similar studies have performed: Other studies have shown promise with similar host-directed therapeutic approaches, but this specific treatment is being evaluated in a novel context.
Eligibility criteria
Show full inclusion / exclusion 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 has a known allergy or known hypersensitivity to paridiprubart or its excipients, including polysorbate 80
Where this trial is running
Birmingham, Alabama and 39 other locations
- University of Alabama Hospital — Birmingham, Alabama, United States (Not_yet_recruiting)
- Community Regional Medical Center — Fresno, California, United States (Recruiting)
- Long Beach Memorial Medical Center — Long Beach, California, United States (Recruiting)
- University of California Irvine Medical Center — Orange, California, United States (Recruiting)
- University of California Davis Medical Center - Pulmonary Medicine — Sacramento, California, United States (Recruiting)
- Denver Health Hospital and Authority — Denver, Colorado, United States (Recruiting)
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (Recruiting)
- Nova Clinical Research — Bradenton, Florida, United States (Recruiting)
- North Florida / South Georgia Veterans Health System — Gainesville, Florida, United States (Recruiting)
- Sarasota Memorial Hospital — Sarasota, Florida, United States (Recruiting)
- St. Luke's Boise Medical Center — Boise, Idaho, United States (Recruiting)
- Northshore University Healthsystem Research Institute — Evanston, Illinois, United States (Not_yet_recruiting)
- OSF Saint Francis Medical Center- — Peoria, Illinois, United States (Recruiting)
- Tufts Medical Center — Boston, Massachusetts, United States (Not_yet_recruiting)
- Lahey Hospital and Medical Center — Burlington, Massachusetts, United States (Recruiting)
- University of Michigan Hospital — Ann Arbor, Michigan, United States (Recruiting)
- Henry Ford Health Hospital — Detroit, Michigan, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Renown Institute for Heart & Vascular Health — Reno, Nevada, United States (Withdrawn)
- Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Not_yet_recruiting)
- Weill Cornell Medical College — New York, New York, United States (Not_yet_recruiting)
- Montefiore Hospital - Moses Campus — The Bronx, New York, United States (Recruiting)
- Westchester Medical Center — Valhalla, New York, United States (Not_yet_recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Durham VA Medical Center — Durham, North Carolina, United States (Recruiting)
- Duke Lung Transplant Clinic - Clinic 2F/2G - PPDS — Durham, North Carolina, United States (Not_yet_recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Not_yet_recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Not_yet_recruiting)
- Mercy Health - St. Vincent Medical Center — Toledo, Ohio, United States (Recruiting)
- The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Baylor All Saints Medical Center — Fort Worth, Texas, United States (Recruiting)
- Baylor St Luke's Medical Center — Houston, Texas, United States (Not_yet_recruiting)
- Houston Methodist Hospital — Houston, Texas, United States (Not_yet_recruiting)
- Intermountain Medical Center — Murray, Utah, United States (Recruiting)
- University of Virginia Health System — Charlottesville, Virginia, United States (Not_yet_recruiting)
- Swedish Medical Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Just Breathe Trial Team
- Email: crgjustbreathealerts.sm@thermofisher.com
- Phone: Please email
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.