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

NCT ID: NCT07334379

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-20
• Study Completion Date: 2027-02-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control

Routine care only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Tocilizumab

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

Group Type: EXPERIMENTAL

Tocilizumab (Actemra®)

Intervention Type: 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.

Dexamethasone

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

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: 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.

Interventions

Tocilizumab (Actemra®)

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.

Intervention Type: DRUG

Dexamethasone

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.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Diagnostic Ltd.

INDUSTRY

Sponsor Role: collaborator

Lorenzo delSorbo

OTHER

Sponsor Role: lead

Responsible Party

Lorenzo delSorbo

MD, Critical Care Medicine Department, Toronto General Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Toronto General Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Dominique Kate Abesames

Role: primary

dominiquekate.abesames@uhn.ca

416-340-4800 ext. x6056

Other Identifiers

ISRCTN46157068

Identifier Type: REGISTRY

Identifier Source: secondary_id

296418

Identifier Type: OTHER

Identifier Source: secondary_id

25-5269

Identifier Type: -

Identifier Source: org_study_id