Acute hypoxemic respiratory failure Respiratory
Conditions
Interventions
Patient's blood IL-6 levels will be measured at 2 timepoints, with samples taken 24-48 hours apart. Patients will be monitored for 28 days, or until discharge from hospital, and data will be gathered
Sponsors
University Health Network
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 years 2. New onset or worsening of respiratory symptoms (cough, dyspnea, and/or requirement of oxygen supplementation) in the past 14 days 3. Requirement for inpatient hospital management
Exclusion criteria
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 72 h since hospital admission 25. Pregnancy (positive pregnancy test) or breastfeeding (which is a contraindication to tocilizumab)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Participant recruitment measured using the number of enrolled participants at study closeout. 2. Feasibility of daily IL-6 measurements measured using the number of participants who successfully completed daily IL-6 measurements at study closeout. 3. Proportion of patients meeting eligibility criteria and not randomized measured using number of eligible patients randomized compared to the number of eligible patients not randomized at study closeout. 4. Compliance with the treatment protocol measured using the number of patients who completed the study treatment a outline in the protocol and the amount of associated protocol deviations at study closeout. 5. Time from hospital admission to randomization measured for each randomized patient study closeout. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All-cause 28-day mortality measured at the end of the 28-day observation period. 2. SOFA score increase of greater than or equal to 2, or death over the 28-day observation period. 3. Development of ARDS or death recorded at the end of the 28-day observation period. 4. ICU admission or death recorded at the end of the 28-day observation period. 5. Hospital length of stay recorded at the end of the 28-day observation period. 6. ICU length of stay recorded at the end of the 28-day observation period. 7. Need for invasive mechanical ventilation or death at the end of the 28-day observation period. 8. Duration of invasive mechanical ventilation occurring from the time of enrollment to the end of the 28-day observation period. 9. Health-related quality of life measured using the 36-Item Short Form Survey (SF-36) at 6 months following the 28-day observation period or hospital discharge 10. Survival at 6 months following the 28-day observation period or hospital discharge. 11. Complications of steroids or tocilizumab measured using the number of adverse events of special interest (AESI) related to the study intervention during the 28-day observation period .These AESIs include: 11.1. Hypersensitivity or allergic reaction to tocilizumab 11.2. Nosocomial infections 11.3. Neuromuscular weakness 11.4. Gastrointestinal perforations 11.5. Hypernatremia (serum sodium >150 mmol/L) 11.6. Hyperglycemia (requiring new insulin or increased insulin dose) 11.7. Hepatic dysfunction 11.8. Demyelinating disorders 11.9. Myocardial infarction or acute coronary syndrome 11.10. Malignancies 11.11. Stroke 11.12. New delirium 11.13. Neuromuscular weakness 11.14. Clinically significant gastrointestinal bleeding (requiring transfusion or endoscopy) 11.15. Fetal and infant harm 11.16. Death | — |
Countries
Canada
Contacts
Public ContactDominique Kate Abesames
Outcome results
None listed