Phase 3 Interstitial Lung Disease Trial, Recruiting NCT05075161 Sponsor: Università Vita-Salute San Raffaele Condition: Interstitial Lung Disease
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Phase 3 Interstitial Lung Disease Trial, Recruiting

NCT05075161
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are at least 18 years old
  • You developed serious breathing problems (a condition called ARDS, which is moderate or severe) within the last week, caused by a known illness or injury
  • A chest X-ray shows cloudiness or shadows in both lungs that cannot be fully explained by fluid, collapsed lung tissue, or nodules
  • Your breathing failure is not mainly caused by a heart problem or too much fluid in the body
  • Your oxygen levels are significantly low even while on a breathing machine
  • You show signs that your ARDS involves a high level of inflammation in the body — this could mean high levels of certain proteins in the blood that signal inflammation, a need for medications to keep your blood pressure up, or certain abnormal results in your blood tests (confirm with trial site)
  • You (or your legal representative) are able to give consent to take part in the trial

Who may not be able to join:

  • You have been on a breathing machine (through a tube in your throat or a tracheostomy) for more than 7 days before being considered for the trial
  • Your moderate or severe breathing problems have been going on for more than 36 hours
  • Your breathing failure is mainly caused by an untreated blood clot in the lungs, fluid around the lungs, or a collapsed lung
  • Your breathing failure is fully explained by heart failure or too much fluid in the body
  • You have refused to give consent
  • You have a serious long-term lung disease that already requires you to use a breathing machine at home
  • There is reason to believe you have a significant long-term condition that causes stiff or scarred lungs (confirm with trial site)
  • You are pregnant, or you are a woman who could become pregnant and are sexually active
  • You have a known allergy to a medication called pirfenidone
  • You are currently taking a medication called fluvoxamine
  • You have known severe liver failure
  • You have known severe kidney failure, or you need dialysis for a reason not related to your current illness
  • Your overall health condition is assessed as very critical, with a low chance of survival based on a specific medical scoring system (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Giovanni Landoni, Professor, Università Vita-Salute San Raffaele

Phone: +39022643

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Università Vita-Salute San Raffaele
Registry
ClinicalTrials.gov
Start date
1 June 2022
Est. completion
1 June 2026

Where this trial is recruiting

🇮🇹 Italy 🇰🇿 Kazakhstan

Primary endpoints

The number of ventilator free days (VFD) at day 28.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov