Evaluating a new treatment for Acute Respiratory Distress Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• 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
• Stanford Medical Center
  Stanford, California, United States Recruiting
• Denver Health Hospital and Authority
  Denver, Colorado, United States Recruiting

Study contacts

• Study coordinator: Just Breathe Trial Team
• Email: crgjustbreathealerts.sm@thermofisher.com
• Phone: Please email

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Innovative therapies for Acute Respiratory Distress Syndrome

  This study is testing new treatments for adults in the hospital with Acute Respiratory Distress Syndrome to see if they can improve breathing and overall recovery compared to a placebo.

  Recruiting at 27 sites Phase 2 PPD Development, LP · Birmingham, Alabama and 40 other locations · NCT06703073

• Evaluating vilobelimab for treating Acute Respiratory Distress Syndrome

  This study is testing if vilobelimab can help hospitalized adults with Acute Respiratory Distress Syndrome feel better and improve their chances of recovery compared to a placebo.

  Recruiting at 28 sites Phase 2 PPD Development, LP · Birmingham, Alabama and 40 other locations · NCT06701682

• Evaluating Bevacizumab for Acute Respiratory Distress Syndrome

  This study is testing whether a medication called bevacizumab can help hospitalized adults with Acute Respiratory Distress Syndrome breathe better and improve their chances of recovery.

  Recruiting at 28 sites Phase 2 PPD Development, LP · Birmingham, Alabama and 40 other locations · NCT06701656

• Treatment for Acute Respiratory Distress Syndrome using Extracellular Vesicles

  This study is testing a new treatment called ExoFlo to see if it can help hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome breathe better and improve their overall health.

  Recruiting at 31 sites Phase 3 Direct Biologics, LLC · Phoenix, Arizona and 31 other locations · NCT05354141

• Pulse Wave vs Saline Bolus EIT to measure lung perfusion in ARDS

  This study tests whether pulse wave EIT or saline bolus EIT can best show lung blood flow in ARDS patients on mechanical ventilation.

  Recruiting Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07908368

• Multicenter group study of sepsis and ARDS in China

  This study tests how sepsis and ARDS differ among adults across several Chinese hospitals and builds a biobank to understand why some patients do better or worse.

  Recruiting at 24 sites Shanghai Zhongshan Hospital · Xiamen, Fujian and 23 other locations · NCT07863908

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.