Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05075161 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Pirfenidone to Prevent Fibrosis in Ards.

Study acronym: PIONEER
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 8, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 2025 to Jun 2026
    • Study completion date: Dec 2025 to Dec 2026
    v10
  2. Study sites: 10 to 17
    • Primary completion date: Jun 2025 to Dec 2025
    • Study completion date: Oct 2025 to Dec 2025
    v9
  3. Study sites: 2 to 10v8
  4. Primary completion date: Oct 2024 to Jun 2025v7
  5. 2 versions Re-verified since Dec 23, 2022, no change to tracked fieldsv5-v6
Show 3 earlier versionsHide 3 earlier versions
  1. Start date changed from estimate of Jun 2022 to Jun 1, 2022v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2022 to Jun 2022
    • Study sites: 1 to 2
    v3
  3. Start date: Oct 2021 to Jan 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 affects ARDS patients even years after acute phase resolution. Pirfenidone is an oral anti-fibrotic drug, approved and largely used for treatment of idiopathic pulmonary fibrosis (IPF). The effect of Pirfenidone in ARDS has been evaluated only in animal models. This is a randomized controlled study to evaluate for the first time the efficacy of Pirfenidone in ARDS.
Trial Details
NCT Number NCT05075161
Lead Sponsor Università Vita-Salute San Raffaele
Conditions
(from sponsor)		 Acute Respiratory Distress Syndrome (ARDS)
Related terms Pulmonary Fibrosis, Respiratory Distress Syndrome
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov