IL-6 guided dexamethasone or tocilizumab treatment for hospitalized acute hypoxemic respiratory failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 feasibility effort enrolls adults admitted with new respiratory symptoms and acute hypoxemic respiratory failure and uses serial blood IL-6 measurements to trigger early anti-inflammatory therapy. Patients who meet predefined IL-6 thresholds may receive dexamethasone or the anti-IL-6 receptor antibody tocilizumab according to the protocol, while investigators collect data on timing, safety, and operational feasibility. The aim is to identify patients before IL-6 peaks and intervene to prevent progression to ICU admission, multi-organ failure, or death. Feasibility outcomes, safety events, and preliminary clinical signals will be used to design larger definitive trials.

Why it matters

Who can join: the full rules

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

General Exclusion:

1. Inability to provide informed consent
2. Immediate need for admission to ICU
3. Immediate need for intubation
4. Imminent death
5. Clinical team refusal

Randomization Exclusion

1. Patients with known contraindications to dexamethasone or tocilizumab, or any of their components
2. Allergic reaction to tocilizumab or other monoclonal antibodies
3. Patients who are using azathioprine or cyclophosphamide
4. Active tuberculosis infection
5. ALT or AST \>10x upper limit of normal
6. Neutrophil count \<1000/mcl
7. Platelet count \<50,000/mm3
8. Patients already receiving systemic steroids, monoclonal antibodies or other immunosuppressive medications at the time of presentation
9. Inability to comply with the regulations to avoid conception within 28 days after enrollment
10. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
11. Participation in other drug clinical trials (this criterion will be discussed with the PI)
12. Reaching \>72h since hospital admission
13. Admission to ICU prior to randomization
14. Pregnancy (positive pregnancy test) or breastfeeding (which is a contraindication to tocilizumab)

Where it's running

• Toronto General Hospital
  Toronto, Ontario, Canada Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.