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New drug shows promise for ARDS patients in major trial

NCT ID NCT04909697

Disease control Sponsor: Sichuan Provincial People's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This clinical trial tested a drug called sivelestat sodium in 324 adults with acute respiratory distress syndrome (ARDS) and systemic inflammation. The drug aims to block a harmful enzyme that damages lung tissue. Researchers measured whether it improved oxygen levels and reduced the need for a breathing machine.

What this could mean

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

Active substance
sivelestat sodium
What this could lead to
If it works, this could provide a new treatment option for ARDS patients, potentially improving oxygen levels and reducing time on a ventilator.
What could go wrong
This is a completed Phase 4 trial, but results are not yet widely reported. The drug may not show significant benefit over standard care, and side effects 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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

324 people

The number who actually took part.

Started

Apr 2022

Finished

Oct 2025

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 to 75 years

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: 1. Males and females \> 18 years old and \<75 years old (non-pregnant, non-lactating females). 2. Patients fulfilled the Berlin diagnostic criteria of acute respiratory distress syndrome, with a arterial oxygen partial pressure (PaO2) to fraction of inspired oxygen (FiO2) between 150 mmHg and 300 mmHg. 3. Signed written informed consent has been obtained Exclusion Criteria: 1. History of chronic respiratory disease 2. Single cardiogenic pulmonary edema 3. Apach2 score ≥21 points 4. Complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge 5. ARDS course\>3 days 6. Agranulocytosis or receiving immunosuppressive agents or high doses of corticosteroids (methylprednisolone\>40mg/day) 7. Pregnancy or breastfeeding 8. Participated in this study 9. Do not agree to participate in this experiment

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome

As listed by the trial registrant

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

Acute respiratory distress syndrome

Contacts and locations

Locations

  • Sichuan provincial people's hospital

    Chengdu, Sichuan Privince, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.