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Blood marker may help doctors spot and treat respiratory failure before it worsens

NCT ID NCT07334379

Disease control Sponsor: Lorenzo delSorbo 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether measuring a blood marker called interleukin-6 (IL-6) can help doctors decide when to give anti-inflammatory drugs to patients hospitalized with acute respiratory failure. Patients with high IL-6 levels will receive either standard care, a single dose of tocilizumab, or a 10-day course of dexamethasone. The goal is to see if this approach is practical and can prevent the need for intensive care.

What this could mean

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

Active substance
tocilizumab (Actemra) and dexamethasone
What this could lead to
If successful, this approach could help doctors identify high-risk patients earlier and start targeted anti-inflammatory treatment to prevent severe complications like organ failure.
What could go wrong
This is a small, early feasibility study with only 60 participants, so results may not apply broadly. The treatments also carry risks like infection or side effects from steroids.

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 60 people

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

Started

Oct 2025

Expected to finish

Feb 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: 1. Age ≥18 years 2. Presence of new onset of respiratory symptoms in the previous 14 days upon presentation at the emergency department. Respiratory symptoms are characterized by at least one of the following: cough, dyspnea, or requirement of oxygen supplementation 3. Requirement of inpatient hospital management Exclusion Criteria: 1. Inability to provide informed consent 2. Patients with known contraindications to dexamethasone or tocilizumab, or any of their components 3. Allergic reaction to tocilizumab or other monoclonal antibodies 4. Patients who are using azathioprine or cyclophosphamide 5. Active tuberculosis infection 6. Patients who have active hepatic disease or hepatic impairment 7. ALT or AST \>3x upper limit of normal 8. Neutrophil count \<1000/mcl 9. Platelet count \<50,000/mm3 10. Hemoglobin (Hb) below 8.5 g/dL, 11. White blood cell count (WBC) below 3000/mm3 12. Absolute Neutrophil Count (ANC) below 2.0 x 109/L 13. absolute lymphocyte count below 500/mm3 14. total bilirubin above ULN 15. Triglycerides (TG) above 10 mmol/L (above 900 mg/dL) 16. Serum creatinine above 1.4 mg/dL in female patients and above 1.6 mg/dL in male patients 17. Patients already receiving systemic steroids, monoclonal antibodies or other immunosuppressive medications at the time of presentation 18. Inability to comply with the regulations to avoid conception within 28 days after enrollment 19. Admission to ICU prior to randomization 20. Immediate need for intubation 21. Imminent death 22. Clinical team refusal 23. Participation in other drug clinical trials (this criterion will be discussed with the PI) 24. Reaching \>72h since hospital admission 25. Pregnancy (positive pregnancy test) or breastfeeding (which is a contraindication to tocilizumab)

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Conditions

The condition(s) this trial relates to.

acute respiratory failure respiratory failure

As listed by the trial registrant

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

Acute hypoxemic respiratory failure

How to take part

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

  1. The places running it

    1 site. 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

  • Toronto General Hospital

    RECRUITING

    Toronto, Ontario, M5G 2N2, Canada

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