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

RecruitingPhase 2Ages 18 Years - anyAllLorenzo delSorbo
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria 1. Age โ‰ฅ18 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 General Exclusion: 1. Inability to provide informed consent 2. Immediate need for admission to ICU 3. Immediate need for intubation 4. Imminent death 5. Clinical team refusal Randomization Exclusion 1. Patients with known contraindications to dexamethasone or tocilizumab, or any of their components 2. Allergic reaction to tocilizumab or other monoclonal antibodies 3. Patients who are using azathioprine or cyclophosphamide 4. Active tuberculosis infection 5. ALT or AST \>10x upper limit of normal 6. Neutrophil count \<1000/mcl 7. Platelet count \<50,000/mm3 8. Patients already receiving systemic steroids, monoclonal antibodies or other immunosuppressive medications at the time of presentation 9. Inability to comply with the regulations to avoid conception within 28 days after enrollment 10. 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 11. Participation in other drug clinical trials (this criterion will be discussed with the PI) 12. Reaching \>72h since hospital admission 13. Admission to ICU prior to randomization 14. Pregnancy (positive pregnancy test) or breastfeeding (which is a contraindication to tocilizumab)
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What it tests

  • Tocilizumab (Actemraยฎ)
  • Dexamethasone
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Where

1 site
Toronto General Hospital
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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