JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

Launched by PPD DEVELOPMENT, LP · Nov 20, 2024

Keywords

ClinConnect Summary

The JUST BREATHE trial is a research study looking into a new treatment called paridiprubart for adults with Acute Respiratory Distress Syndrome (ARDS), a serious condition that affects breathing. This study will involve several hospitals and aims to find out if this treatment is safe and effective compared to a placebo, which is an inactive substance that looks like the treatment but has no therapeutic effect. Participants will be randomly assigned to receive either paridiprubart or the placebo without knowing which one they are getting, to ensure fair results.

To qualify for the trial, participants should be hospitalized adults between the ages of 65 and 74 who have moderate to severe ARDS, determined by specific tests that measure how well they are getting oxygen. However, those who are allergic to paridiprubart or its ingredients will not be able to take part. While the trial is not yet recruiting, it promises to provide valuable information that could help improve treatments for ARDS in the future. Participants will receive close monitoring and care throughout the study, contributing to important research that could benefit many patients.

Gender

ALL

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 has a known allergy or known hypersensitivity to paridiprubart or its excipients, including polysorbate 80