Acute Hypoxemic Respiratory FailurePhase 2IDENTIFYNCT07334379
Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
A Phase 2 study testing Tocilizumab (Actemra®) and Dexamethasone in people with Acute Hypoxemic Respiratory Failure, run by Lorenzo delSorbo at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- Tocilizumab (Actemra®) and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2025to 26 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- General Exclusion:
- Inability to provide informed consent
- Immediate need for admission to ICU
- Immediate need for intubation
- Imminent death
- Clinical team refusal
Show all 21Show fewer
- Randomization Exclusion
- 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
- ALT or AST >10x upper limit of normal
- Neutrophil count <1000/mcl
- Platelet count <50,000/mm3
- 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
- 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
- Participation in other drug clinical trials (this criterion will be discussed with the PI)
- Reaching >72h since hospital admission
- Admission to ICU prior to randomization
- Pregnancy (positive pregnancy test) or breastfeeding (which is a contraindication to tocilizumab)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Dominique Kate Abesames, 416-340-4800 ext. x6056, dominiquekate.abesames@uhn.ca
Lorenzo MD Del Sorbo
About this 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.
This study has two phases: 1) observational and 2) interventional.
Read more
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
- Being tested
- Tocilizumab (Actemra®), Dexamethasone
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
DexamethasoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Tocilizumab (Actemra®) |
| Dexamethasone | Experimental | Routine care + a 10mg of oral dexamethasone per day for up to 10 days (or until hospital discharge). Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the potential recruitment rate
Measured: 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
Measured: Baseline (Day 0) to Day 2
To assess the proportion of eligible patients who are not randomized
Measured: Baseline (Day 0) to Day 2
To determine the rate of adherence to the assigned treatment strategy and any cross-overs
Measured: 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
Measured: Baseline to Day 3
Secondary outcomes (11)
All cause 28-day mortality
Measured: From enrollment to completion of the 28-day observation period (or hospital discharge).
Sequential Organ Failure Assessment (SOFA) score increase of ≥2 or death
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.
Measured: From enrollment to end of 28-day observation period (or hospital discharge).
Development of ARDS or death
Measured: From enrollment to end of 28-day observation period (or hospital discharge).
ICU admission or death
Measured: From enrollment to end of 6-month follow-up period.
Hospital length of stay
Measured: From enrollment to end of 28-day observation period (or hospital discharge).
ICU length of stay
Measured: From enrollment to end of 28-day observation period (or hospital discharge).
Need for invasive mechanical ventilation or death
Measured: From enrollment to end of 28-day observation period (or hospital discharge).
Duration of invasive mechanical ventilation
Measured: From enrollment to end of 28-day observation period (or hospital discharge).
Health related quality of life at 6 months assessed using the 36-Item Short Form Survey (SF-36)
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.
Measured: From enrollment to 6 months after the end of 28-day observation period (or hospital discharge)
Survival at 6 months
Measured: From enrollment to end of 6-month follow-up period.
Complications of steroids or tocilizumab including
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
Measured: From enrollment to end of 28-day observation period (or hospital discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start20 Oct 2025
- Primary completion20 Feb 2027 (estimated)
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a pilot, feasibility stud with 2 phases: 1) observational and 2) interventional.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lorenzo delSorbo
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostic Ltd.
- Responsible party
- Sponsor-investigator, Lorenzo delSorbo, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334379
- Sponsor's protocol ID
- 25-5269
- Other IDs
- ISRCTN46157068, 296418
- Acronym
- IDENTIFY
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
- ClinicalTrials.gov ID
- NCT07334379
- Acronym / sponsor ID
- IDENTIFY / 25-5269
- Conditions
- Acute Hypoxemic Respiratory Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lorenzo delSorboUniversity, hospital or other
- Collaborators
- Roche Diagnostic Ltd.
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a pilot, feasibility stud with 2 phases: 1) observational and 2) interventional.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Routine care only |
| Tocilizumab | Experimental | Drug: Tocilizumab (Actemra®)Routine care + single intravenous infusion of tocilizumab at a dose of 4mg/kg of body weight (up to a max 400mg). |
| Dexamethasone | Experimental | Drug: DexamethasoneRoutine care + a 10mg of oral dexamethasone per day for up to 10 days (or until hospital discharge). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (21 listed)
- Inability to provide informed consent
- Immediate need for admission to ICU
- Immediate need for intubation
- Imminent death
- Clinical team refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Tocilizumab |
| DexamethasoneSubjects 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. | Drug | Dexamethasone |
Primary outcome
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
11 secondary outcomes
All cause 28-day mortality
Time frame: From enrollment to completion of the 28-day observation period (or hospital discharge).
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).
Development of ARDS or death
Time frame: From enrollment to end of 28-day observation period (or hospital discharge).
ICU admission or death
Time frame: From enrollment to end of 6-month follow-up period.
Hospital length of stay
Time frame: From enrollment to end of 28-day observation period (or hospital discharge).
ICU length of stay
Time frame: From enrollment to end of 28-day observation period (or hospital discharge).
Need for invasive mechanical ventilation or death
Time frame: From enrollment to end of 28-day observation period (or hospital discharge).
Duration of invasive mechanical ventilation
Time frame: From enrollment to end of 28-day observation period (or hospital discharge).
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)
Survival at 6 months
Time frame: From enrollment to end of 6-month follow-up period.
Complications of steroids or tocilizumab including
Time frame: From enrollment to end of 28-day observation period (or hospital discharge).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocilizumab (Actemra®) and Dexamethasone in people with Acute Hypoxemic Respiratory Failure, run by Lorenzo delSorbo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.