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RecruitingPhase 2

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

PPD Development, LP · with Biomedical Advanced Research and Development Authority, InflaRx GmbH · NCT06701682

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
200
US sites recruiting
28
Study start
June 21, 2025
Record last updated
July 31, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Cohort A: vilobelimab; Cohort A: placebo

Conditions: Acute Respiratory Distress Syndrome (ARDS); ARDS; ARDS (Acute Respiratory Distress Syndrome); Acute Respiratory Distress Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 with established cirrhosis and a modified Child-Pugh Score of 12 or greater

Recruiting US locations

Study contacts (from the official record)

  • Just Breathe Trial Team · Please email · crgjustbreathealerts.sm@thermofisher.com
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS-… (NCT06701682) | Bored Studies