Recruiting
Phase 2

Tocilizumab & Dexamethasone

Sponsor:

Lorenzo delSorbo

Code:

NCT07334379

Conditions

Acute Hypoxemic Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tocilizumab (Actemra®)

Dexamethasone

Study Details

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 ID

NCT07334379

Start date

Oct 20, 2025

Status verified date

Jan, 2026

Completion date

Feb 26, 2027

Anticipated

Primary completion date

Oct 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Control

Routine care only

experimental: Tocilizumab

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

experimental: Dexamethasone

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

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.

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.

Primary outcome measure

  • To determine the potential recruitment rate [ Time Frame: 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 [ Time Frame: Baseline (Day 0) to Day 2 ]
  • To assess the proportion of eligible patients who are not randomized [ Time Frame: Baseline (Day 0) to Day 2 ]
  • To determine the rate of adherence to the assigned treatment strategy and any cross-overs [ Time Frame: 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 [ Time Frame: Baseline to Day 3 ]

Central Contacts and Locations

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Dominique Kate Abesames

416-340-4800dominiquekate.abesames@uhn.ca

Principal Investigator:

Lorenzo MD Del Sorbo

More Information

Sponsor

Lorenzo delSorbo

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lorenzo delSorbo on 2026-01-12.