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New drug trial aims to tame deadly lung condition ARDS

NCT ID NCT06564207

Disease control Sponsor: Inova Health Care Services 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 the drug fostamatinib can safely help adults hospitalized with acute respiratory distress syndrome (ARDS), a severe lung injury. About 40 participants will receive either the drug or a placebo, and researchers will track serious side effects for 30 days. The goal is to see if fostamatinib can control the disease and improve outcomes.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

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: * Age ≥ 18 years old. * Subject (or legal representative) provides informed consent to study participation. * Subject (or legal representative) understands and agrees to comply with planned study procedures. * Hospitalized with acute respiratory failure from ARDS with ratio of partial pressure of arterial oxygen to fraction of inspired oxygen PaO2/FiO2 of 200 mm of Hg or less with positive end expiratory pressure (PEEP) equal to or higher than 5 cm of H2O and requiring invasive mechanical ventilation or extracorporeal support. * Functional respiratory imaging (FRI) compatible CT scan of the chest within the prior 7 days. * Duration of invasive mechanical ventilation \< 10 days. * Females of childbearing potential must agree to be abstinent or seek a highly effective form of contraception from the time of enrollment through 30 days after the last day of study drug. Exclusion Criteria: * Severe hepatic impairment (Child-Pugh Class C). * Abnormal liver function tests (AST or ALT \> 3x ULN or AST or ALT \> 3x ULN) * Pregnant or nursing. * Participation in any other clinical trial, or receipt of an investigational medicinal product within 30 days prior. * Known concomitant life-threatening disease with a life expectancy \< 6 months. * Known hypersensitivity to fostamatinib. * Uncontrolled hypertension (Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg). * Neutrophil count \< 1000/uL * Death expected within 72 hours * Received a live vaccine in the last 30 days * Those who were cognitively impaired or mentally disabled prior to acute illness * Patients with acute coronary syndrome, ejection fraction \<30%, or active unstable arrhythmias

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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 ARDS

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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