NCT07334379 Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
| NCT ID | NCT07334379 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Lorenzo delSorbo |
| Condition | Acute Hypoxemic Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-20 |
| Primary Completion | 2026-10-20 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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. 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.
Eligibility Criteria
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: 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 \<1000/mcl 9. Platelet count \<50,000/mm3 10. Hemoglobin (Hb) below 8.5 g/dL, 11. White blood cell count (WBC) below 3000/mm3 12. Absolute Neutrophil Count (ANC) below 2.0 x 109/L 13. absolute lymphocyte count below 5