RECRUITING

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)

Quick Facts

Study Start:2025-02-13
Study Completion:2028-02-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06701682

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization
  1. * No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol NCT06703073.

Contacts and Locations

Study Contact

Just Breathe Trial Team
CONTACT
Please email
JustBreatheCT.gov_StudyInquiry@ppd.com

Study Locations (Sites)

St. Luke's Boise Medical Center
Boise, Idaho, 83712-6241
United States
Renown Institute for Heart & Vascular Health
Reno, Nevada, 89502-1576
United States

Collaborators and Investigators

Sponsor: PPD DEVELOPMENT, LP

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-13
Study Completion Date2028-02-08

Study Record Updates

Study Start Date2025-02-13
Study Completion Date2028-02-08

Terms related to this study

Keywords Provided by Researchers

  • BARDA
  • JUST BREATHE
  • ARDS
  • Acute Respiratory Distress Syndrome
  • Acute Respiratory Failure

Additional Relevant MeSH Terms

  • Acute Respiratory Distress Syndrome (ARDS)
  • ARDS
  • ARDS (Acute Respiratory Distress Syndrome)
  • Acute Respiratory Distress Syndrome