IL-6 guided dexamethasone or tocilizumab treatment for hospitalized acute hypoxemic respiratory failure
Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
This study will test whether measuring IL-6 to guide early treatment with dexamethasone or tocilizumab helps adults hospitalized with new acute hypoxemic respiratory failure.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | tocilizumab, cyclophosphamide |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07334379 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older who present within 14 days of new respiratory symptoms, require inpatient hospital management for acute hypoxemic respiratory failure, and can provide informed consent are the intended participants.
Not a fit: Patients with contraindications to dexamethasone or tocilizumab, active tuberculosis, significant liver disease, severe cytopenias, or other listed exclusions are unlikely to benefit or be eligible for this approach.
Why it matters
Potential benefit: If successful, this approach could enable earlier, targeted anti-inflammatory treatment that prevents worsening respiratory failure and reduces ICU admissions and organ failure.
How similar studies have performed: Corticosteroids and tocilizumab have shown benefit in severe inflammatory respiratory illnesses such as COVID-19, but using serial IL-6 measurements to guide early therapy is a relatively novel and less tested strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Toronto, Ontario
- Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.