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

NCT07334379 | Recruiting Phase 2 DMC

• 3 other identifiers: 25-5269ISRCTN46157068296418
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acute Hypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (5)

• To determine the potential recruitment rate

  From enrollment to completion of the study (in including the 6-month follow-up).

• To assess the proportion of eligible patients who do not have daily IL-6 measurement

  Baseline (Day 0) to Day 2

• To assess the proportion of eligible patients who are not randomized

  Baseline (Day 0) to Day 2

• To determine the rate of adherence to the assigned treatment strategy and any cross-overs

  Baseline to end of 28-day observation period (or hospital discharge)

• To estimate the time from hospital admission to randomization and initiation of the allocated treatment

  Baseline to Day 3

Secondary Outcomes (11)

• All cause 28-day mortality

  From enrollment to completion of the 28-day observation period (or hospital discharge).

• Sequential Organ Failure Assessment (SOFA) score increase of ≥2 or death

  From enrollment to end of 28-day observation period (or hospital discharge).

• Development of ARDS or death

  From enrollment to end of 28-day observation period (or hospital discharge).

• ICU admission or death

  From enrollment to end of 6-month follow-up period.

• Hospital length of stay

  From enrollment to end of 28-day observation period (or hospital discharge).

Other Outcomes (1)

• To assess reasons why eligible patients are not randomized

  Baseline (Day 0) to Day 2.

Study Arms (3)

Control

NO INTERVENTION

Routine care only

Tocilizumab

EXPERIMENTAL

Routine care + single intravenous infusion of tocilizumab at a dose of 4mg/kg of body weight (up to a max 400mg).

Drug: Tocilizumab (Actemra®)

Dexamethasone

EXPERIMENTAL

Routine care + a 10mg of oral dexamethasone per day for up to 10 days (or until hospital discharge).

Drug: Dexamethasone

Interventions

Tocilizumab (Actemra®) DRUG

Subjects randomized to the tocilizumab arm will receive a single intravenous (IV) infusion of tocilizumab, given over 1 hour. The tocilizumab will be given at a dosage of 4mg per kg of body weight, up to a maximum dose of 400 mg.

Tocilizumab

Dexamethasone DRUG

Subjects randomized to the dexamethasone arm will receive 6 mg of dexamethasone per day, for up to 10 days, or until discharged from the hospital. Dexamethasone will be given in tablet form orally (by mouth) or through an equivalent method.

Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• 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
• Requirement of inpatient hospital management

You may not qualify if:

• Inability to provide informed consent
• Patients with known contraindications to dexamethasone or tocilizumab, or any of their components
• Allergic reaction to tocilizumab or other monoclonal antibodies
• Patients who are using azathioprine or cyclophosphamide
• Active tuberculosis infection
• Patients who have active hepatic disease or hepatic impairment
• ALT or AST \>3x upper limit of normal
• Neutrophil count \<1000/mcl
• Platelet count \<50,000/mm3
• Hemoglobin (Hb) below 8.5 g/dL,
• White blood cell count (WBC) below 3000/mm3
• Absolute Neutrophil Count (ANC) below 2.0 x 109/L
• absolute lymphocyte count below 500/mm3
• total bilirubin above ULN
• Triglycerides (TG) above 10 mmol/L (above 900 mg/dL)

Sponsors & Collaborators

• Lorenzo delSorbo: lead
• Roche Diagnostic Ltd.: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

tocilizumab; Dexamethasone

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Critical Care Medicine Department, Toronto General Hospital

Model Details: This study is a pilot, feasibility study.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: January 12, 2026
• Study Start: October 20, 2025
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): February 26, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

CA (1)