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.

This study has two phases: 1) observational and 2) interventional.

In the observational phase 1, patients who meet the inclusion and a general exclusion criteria are eligible for participation. In the observational phase, patients will have their plasma IL-6 levels measured over 2 days. Patients' clinical condition will be observed till discharge or up to 28 days of admission, and data will be collected from their medical charts.

Patients participating in the observational phase 1 will be considered eligible to join the interventional phase 2 if: they are found to have elevated IL-6 levels, and they meet additional randomization exclusion criteria. In the interventional phase, patients 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' clinical condition will be observed till discharge or up to 28 days of admission, and data will be collected from their medical charts. A follow-up phone interview will be conducted 6 months of the end of the observation period.

Patients participating in the observational phase 1 who are not eligible to participate in the interventional phase 2 will continue in the observational phase 1 only. These patients will not be randomized to a group, receive any study medications, or be contacted for the 6-month follow-up.

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

Feb 20, 2027

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

General Exclusion:

1. Inability to provide informed consent
2. Immediate need for admission to ICU
3. Immediate need for intubation
4. Imminent death
5. Clinical team refusal

Randomization Exclusion

1. Patients with known contraindications to dexamethasone or tocilizumab, or any of their components
2. Allergic reaction to tocilizumab or other monoclonal antibodies
3. Patients who are using azathioprine or cyclophosphamide
4. Active tuberculosis infection
5. ALT or AST >10x upper limit of normal
6. Neutrophil count <1000/mcl
7. Platelet count <50,000/mm3
8. Patients already receiving systemic steroids, monoclonal antibodies or other immunosuppressive medications at the time of presentation
9. Inability to comply with the regulations to avoid conception within 28 days after enrollment
10. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
11. Participation in other drug clinical trials (this criterion will be discussed with the PI)
12. Reaching >72h since hospital admission
13. Admission to ICU prior to randomization
14. 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

Oct 9, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Lorenzo delSorbo on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.