Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

The primary outcome of this clinical trial is to document an increase in the number of ventilator free days (VFD) at day 28 in the Pirfenidone group when compared to the placebo group.

Secondary Outcomes (11)

Increase in ICU-free days at day 28
Increase in cumulative SOFA-free score at day 28
Reduction in hospital length of stay
Reduction in fibroproliferative changes on high-resolution CT performed at ICU discharge, according to specific interpretation guidelines
Mortality at ICU/hospital discharge
+6 more secondary outcomes

Interventions

SODIO CLORURO 0,9% BAXTER Soluzione per infusioneType not reported

Esbriet 267 mg film-coated tabletsType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Esbriet 267 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Esbriet 267 mg film-coated tablets
Named ingredient: pirfenidone
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

ARDS (moderate and severe) based on the Berlin definition
Inflammatory ARDS phenotype as defined by at least one of the following: 1) High plasma levels of inflammatory biomarkers (e.g. IL-6 > 80 pg/ml, PCR > 250 mg/l); 2) Vasopressor dependence (any vasoconstrictor at any dosage for at least 1 hour); 3) Low serum bicarbonate (< 18 mmol/l) or increased serum lactate (>4 mmol/l)

Sponsors & Collaborators

Ospedale San Raffaele S.r.l.
Type not reportedlead

Study Sites (30)

Azienda Ospedaliera Universitaria Gaetano Martino Messina

Messina, 98124, Italy

Alberto Noto3471981248 alberto.noto@unime.it

Centro Cardiologico Monzino S.p.A.

Milan, 20138, Italy

Andrea Ballotta3669801356 andrea.ballotta@cardiologicomonzino.it

Ospedale Uboldo - ASST Melegnano e Martesana

Cernusco sul Naviglio (MI), 20063, Italy

Massimo Zambon0292360336

Central Study Contacts

Giacomo Monti

0226432222 monti.giacomo@hsr.it

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

December 6, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-514355-16-01
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 05:10:46 UTC

Documents

D1_Protocol_2024-514355-16-01_for pubblication

PIrfenidone to prevent fibrOsis in ARDS. A RaNdomizEd controllEd tRial - PIONEER

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (30)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (30)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations