Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07334379

Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study

Led by Lorenzo delSorbo · Updated on 2026-01-12

60

Participants Needed

1

Research Sites

70 weeks

Total Duration

On this page

Sponsors

L

Lorenzo delSorbo

Lead Sponsor

R

Roche Diagnostic Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Acute hypoxemic respiratory failure (AHRF) happens when the lungs are unable to absorb enough oxygen. The bloodstream is deprived of oxygen which can eventually lead to more severe conditions like multi-organ failure (MOF) and death. AHRF accounts for over 30% of patients to critical care units, thus novel treatments are sorely needed. Research has shown that blood levels of the inflammatory biomarker Interleukin-6 (IL-6) may be a reliable marker for predicting which patients with AHRF will progress into requiring intensive care unit (ICU) admission, MOF, and eventually death. IL-6 levels were shown to reliably peak several days before MOF, ICU admission, and death. Thus, the investigators believe that by identifying patients before the peak of their IL-6 levels, they will be able to administer early treatment to prevent the patient's condition from worsening. The aim of this study is to test the feasibility of a treatment strategy for AHRF based on IL-6 measurement in patients who are admitted to hospital care with AHRF. Patients who are eligible for the study will have their plasma IL-6 levels measured over 2 days. Patients with elevated IL-6 levels will be randomized into 1 of 3 treatment groups: standard of care only, standard of care plus a single IV infusion of Tocilizumab, or standard of care plus treatment with oral Dexamethasone for 10 days. Patients will then be observed till discharge or up to 28 days, and a follow-up phone interview will be conducted 6 months of the end of the observation period.

CONDITIONS

Official Title

Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • New onset of respiratory symptoms (cough, shortness of breath, or need for oxygen) within 14 days before emergency department presentation
  • Requires inpatient hospital management
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Known contraindications or allergies to dexamethasone, tocilizumab, or their components
  • Use of azathioprine or cyclophosphamide
  • Active tuberculosis infection
  • Active liver disease or liver impairment
  • Elevated liver enzymes (ALT or AST >3 times upper limit of normal)
  • Low neutrophil count (<1000/mcl)
  • Low platelet count (<50,000/mm3)
  • Hemoglobin below 8.5 g/dL
  • Low white blood cell count (<3000/mm3)
  • Low absolute neutrophil count (<2.0 x 10^9/L)
  • Low absolute lymphocyte count (<500/mm3)
  • Elevated total bilirubin above normal
  • Very high triglycerides (>10 mmol/L or 900 mg/dL)
  • High serum creatinine (above 1.4 mg/dL in females, 1.6 mg/dL in males)
  • Already receiving systemic steroids, monoclonal antibodies, or immunosuppressive medications at presentation
  • Cannot comply with pregnancy prevention rules for 28 days after enrollment
  • Already admitted to ICU before randomization
  • Immediate need for intubation
  • Imminent death
  • Refusal by clinical team
  • Participation in other drug clinical trials (to be discussed with investigator)
  • More than 72 hours since hospital admission
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2N2

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study | DecenTrialz