Recruiting PHASE2 Acute Respiratory Distress Syndrome (ARDS)

New treatment option for Acute Respiratory Distress Syndrome (ARDS)

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

ClinicalTrials.gov ID: NCT06701682

What this study is testing

What is Cohort A: vilobelimab?

Cohort A: vilobelimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute respiratory distress syndrome (ards).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • The following are in addition to the

You likely can't join if

  • 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:
  • No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol NCT06703073.

The study team makes the final eligibility decision.

Where it's taking place

  • Birmingham, Alabama, United States
  • Fresno, California, United States
  • Long Beach, California, United States
  • Orange, California, United States
  • Sacramento, California, United States
  • Denver, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Bradenton, Florida, United States
  • Gainesville, Florida, United States
  • Sarasota, Florida, United States
  • Boise, Idaho, United States
  • Evanston, Illinois, United States
  • Peoria, Illinois, United States
  • Boston, Massachusetts, United States
  • Burlington, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Detroit, Michigan, United States
  • Rochester, Minnesota, United States
  • Reno, Nevada, United States
  • New Brunswick, New Jersey, United States

+ 16 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Birmingham, Alabama, United States; Fresno, California, United States; Long Beach, California, United States; Orange, California, United States; Sacramento, California, United States; Denver, Colorado, United States and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.