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NCT Number: NCT07334379

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

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.

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Key information

Conditions

Acute Hypoxemic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location status: Recruiting

Location contact

Dominique Kate Abesames

CONTACT

[email protected]

416-340-4800 ext. x6056

Lorenzo MD Del Sorbo

PRINCIPAL_INVESTIGATOR

Martin MD Urner

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • Serum creatinine above 1.4 mg/dL in female patients and above 1.6 mg/dL in male patients
  • Patients already receiving systemic steroids, monoclonal antibodies or other immunosuppressive medications at the time of presentation
  • Inability to comply with the regulations to avoid conception within 28 days after enrollment
  • Admission to ICU prior to randomization
  • Immediate need for intubation
  • Imminent death
  • Clinical team refusal
  • Participation in other drug clinical trials (this criterion will be discussed with the PI)
  • Reaching >72h since hospital admission
  • Pregnancy (positive pregnancy test) or breastfeeding (which is a contraindication to tocilizumab)

Treatment and study plan

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.

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.

Primary outcomes

  1. To determine the potential recruitment rate

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

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

    Time frame: Baseline (Day 0) to Day 2

  3. To assess the proportion of eligible patients who are not randomized

    Time frame: Baseline (Day 0) to Day 2

  4. 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)

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

    Time frame: Baseline to Day 3

Secondary outcomes

  1. All cause 28-day mortality

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

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

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

    The SOFA (Sequential Organ Failure Assessment) scale is used to assess a patient's organ function. The SOFA score is based on 6 different systems: respiratory, cardiovascular, hepatic, coagulation, renal, and neurological. Each system is given a score from 0 (best) to 4 (worst). Total SOFA score is calculated by adding the scores for each system, with a lower total SOFA scores generally denote better overall organ function.

  3. Development of ARDS or death

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

  4. ICU admission or death

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

  5. Hospital length of stay

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

  6. ICU length of stay

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

  7. Need for invasive mechanical ventilation or death

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

  8. Duration of invasive mechanical ventilation

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

  9. Health related quality of life at 6 months assessed using the 36-Item Short Form Survey (SF-36)

    Time frame: From enrollment to 6 months after the end of 28-day observation period (or hospital discharge)

    The SF-36 is a 36-item survey that scores patients on eight health scales: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The SF-36 is structured so higher scores on each scale generally denote a more favorable health outcome. It also includes a single item that provides an indication of perceived change in health.

  10. Survival at 6 months

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

  11. Complications of steroids or tocilizumab including

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

    Complications including: Hypersensitivity or allergic reaction to tocilizumab, Nosocomial infections, Neuromuscular weakness, Gastrointestinal perforations.=, Hypernatremia (serum sodium >150 mmol/L), Hyperglycemia (requiring new insulin or increased insulin dose), Hepatic dysfunction, Demyelinating disorders, Myocardial infarction or acute coronary syndrome, Malignancies, Stroke, New delirium, Neuromuscular weakness, Clinically significant gastrointestinal bleeding (requiring transfusion or endoscopy), Fetal and infant harm, and Death

Other outcomes

  1. To assess reasons why eligible patients are not randomized

    Time frame: Baseline (Day 0) to Day 2.

    In addition to primary outcome #3: To assess the proportion of eligible patients who are not randomized, the reasons why eligible patients are not randomized will also be recorded.

Sponsors and collaborators

Lead sponsor

Lorenzo delSorbo

Other

Collaborators

  • Roche Diagnostic Ltd.

Registry information

Acronym: IDENTIFY

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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