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New treatment option for Acute Hypoxemic Respiratory Failure
Official title Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
ClinicalTrials.gov ID: NCT07334379
What this study is testing
What is Tocilizumab (Actemra®)?
Tocilizumab (Actemra®) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute hypoxemic respiratory failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Presence of new onset of respiratory symptoms in the previous 14 days upon presentation at the emergency department. Respiratory symptoms are...
- Requirement of inpatient hospital management
You likely can't join if
- 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
See the full eligibility 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 inpatient hospital management
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.