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Could a lung scarring drug help ARDS patients breathe easier?

NCT ID NCT05075161

Disease control Sponsor: Università Vita-Salute San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether pirfenidone, a drug already used for a different lung disease, can prevent scarring in patients with severe acute respiratory distress syndrome (ARDS). About 130 people on ventilators will receive either pirfenidone or a placebo through a feeding tube. The goal is to see if the drug helps them spend fewer days on a ventilator and improves recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pirfenidone
What this could lead to
If it works, this could provide a new treatment to prevent long-term lung damage in patients with severe respiratory failure.
What could go wrong
This is an early test in humans for ARDS, so the drug may not work as hoped. Side effects from pirfenidone, like nausea or liver issues, are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. Respiratory failure not fully explained by cardiac failure or fluid overload 4. PaO2/FiO2\<200 mmHg with PEEP\<=5 cmH2O (invasive mechanical ventilation) * Inflammatory ARDS phenotype (28), defined by at least one of the following: 1. High plasma levels of inflammatory biomarkers 2. Vasopressor dependence 3. Lower serum bicarbonate or increased serum lactate * Informed consent expressed by the patient or by legal representative or on the Ethical Committee indication. * Age \>=18 years Exclusion Criteria: * Intubated and mechanically ventilated via an endotracheal or tracheostomy tube (\>7 days) up to the time of randomization * ARDS severe or moderate for more than 36 hours * Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of ARF * ARF fully explained by left ventricular failure or fluid overload * Consent declined * Severe chronic respiratory disease requiring domiciliary ventilation * Clinical suspicion for significant restrictive lung disease * Pregnant women or women of childbearing potential who are sexually active * Known allergy to pirfenidone * Concomitant use of fluvoxamine * Known severe hepatic failure * Known severe renal failure or necessity of dialysis not related to acute disease * Little chance of survival (SAPS II score\>75)

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute respiratory distress syndrome (ARDS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O.R San Carlo

    RECRUITING

    Potenza, Italy

  • AOU Città della Salute e della Scienza

    RECRUITING

    Torino, 10126, Italy

  • AOU Pisana

    RECRUITING

    Pisa, Italy

  • AOU Policlinico Paolo Giaccone

    RECRUITING

    Palermo, Italy

  • ASST Spedali Civili di Brescia

    RECRUITING

    Brescia, 25123, Italy

  • Astana Medical University

    RECRUITING

    Astana, 010000, Kazakhstan

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, 56126, Italy

  • Azienda Ospedaliero Universitaria Senese

    RECRUITING

    Siena, 53100, Italy

  • Azienda Sanitaria Universitaria Integrata di Udine

    RECRUITING

    Udine, 33100, Italy

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, Italy

  • Fondazione PTV - Policlinico Tor Vergata

    RECRUITING

    Rome, 00133, Italy

  • IRCCS San Raffaele Scientific Institute

    RECRUITING

    Milan, MI, 20132, Italy

  • Ospedale Cesare Arrigo

    RECRUITING

    Alessandria, Piedmont, 15121, Italy

  • Ospedale San Giovanni di Dio - Azienda Ospedaliera Universitaria di Cagliari

    RECRUITING

    Cagliari, 09123, Italy

  • Ospedale Santa Maria

    RECRUITING

    Bari, Italy

  • Ospedale Uboldo di Cernusco sul Naviglio

    RECRUITING

    Milan, 20070, Italy

  • Ospedale di Merano

    RECRUITING

    Merano, Italy

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