Pirfenidone to Prevent Fibrosis in Ards.
Recruiting
Phase 3
Interventional Study
Acute Respiratory Distress Syndrome (ARDS)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
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 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 130 (estimated)
- Sponsor
- Università Vita-Salute San Raffaele · Other
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About This Trial
Acute respiratory distress syndrome (ARDS) is a severe form of acute lung injury and a major cause of Intensive Care Unit (ICU) admission worldwide. Despite a large number of randomized clinical trials, a specific and effective pharmacological approach for patients with ARDS is still lacking.
Fibroproliferation is a crucial part of the host defence response, and severe fibrotic lung disease affec…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Concomitant presence of:
* ARDS (moderate and severe) - Berlin definition
1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms
2. Bilateral opacities on CXR which are not fully explained by effusions, lobar/lung collapse or nodules
3. Resp…
Contacts