Actively Recruiting
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
18 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
Researchers are studying acute hypoxemic respiratory failure (AHRF), a condition where the lungs cannot absorb enough oxygen, leading to serious complications like multi-organ failure and death. This study aims to test a treatment approach guided by measuring blood levels of the inflammatory marker Interleukin-6 (IL-6) in patients admitted with AHRF. Elevated IL-6 levels may predict worsening conditions, enabling early intervention to potentially prevent severe outcomes. Participants will have their plasma IL-6 measured over two days. Those with high IL-6 will be randomly assigned to one of three groups: standard care alone; standard care plus a single intravenous infusion of Tocilizumab; or standard care plus daily oral Dexamethasone for up to 10 days or until hospital discharge. Patients will be observed until discharge or for 28 days, followed by a phone interview six months later. During the study, researchers will measure recruitment rates, adherence to treatment, time to treatment initiation, and other clinical outcomes like mortality, organ failure, ICU admission, mechanical ventilation need, hospital stay length, and quality of life at six months. Safety monitoring for complications related to steroids or Tocilizumab is included. The total participation spans from enrollment through a 28-day observation and a six-month follow-up.
CONDITIONS
Brief Title
Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- New respiratory symptoms within the last 14 days, such as cough, shortness of breath, or need for oxygen
- Requires inpatient hospital management
You will not qualify if you...
- Unable to provide informed consent
- Known contraindications or allergies to dexamethasone, tocilizumab, or their components
- Current use of azathioprine or cyclophosphamide
- Active tuberculosis infection
- Active liver disease or impairment, or abnormal liver function tests (ALT or AST >3x upper limit)
- Low blood cell counts including neutrophils, platelets, hemoglobin, white blood cells, lymphocytes
- High bilirubin or triglycerides levels
- High serum creatinine (above 1.4 mg/dL for females, 1.6 mg/dL for males)
- Already receiving systemic steroids, monoclonal antibodies, or immunosuppressive medications
- Cannot comply with pregnancy prevention rules for 28 days after enrollment
- Admitted to ICU before randomization
- Immediate need for intubation or imminent death
- Refusal by clinical team
- Participation in other drug trials (discussed with principal investigator)
- More than 72 hours since hospital admission
- Pregnancy or breastfeeding (contraindication to tocilizumab)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 10 days or until hospital discharge
Participants receive either a single intravenous infusion of tocilizumab or daily oral dexamethasone for up to 10 days or until hospital discharge. Participants in the control group receive routine care only.
Daily visits while hospitalized for treatment and monitoring
Duration - Up to 6 months after treatment ends
Participants are monitored for safety, health status, and quality of life for up to 6 months after treatment.
Periodic follow-up visits up to 6 months
Trial Site Locations
Total: 1 location
1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
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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