JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
Recruiting
Phase 2
Interventional Study
Acute Respiratory Distress Syndrome (ARDS)
ARDS
ARDS (Acute Respiratory Distress Syndrome)
Acute Respiratory Distress Syndrome
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- PPD Development, LP · Industry
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About This Trial
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 proce…
Trial Locations
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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 c…
Contacts