Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study (NCT07334379)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Toronto General Hospital โ Toronto, Ontario
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Toronto General Hospital โ Toronto, Ontario
๐ Contact the Study Coordinator
Phone: (416) 340-4800
Email: dominiquekate.abesames@uhn.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Acute Hypoxemic Respiratory Failure
- Assessment of PaO2/FiO2 Ratio Pre and POst INTubation โ Chicago, Illinois
- HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT โ Calgary, Alberta
- Adiposity Distribution in Acute Respiratory Failure โ Boston, Massachusetts
- Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients โ Chicago, Illinois
- Pressure Muscle Index and Threshold of Over-assistance During Pressure Support Ventilation โ Toronto, Ontario
- Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure โ New York, New York
Explore by condition: All Acute Hypoxemic Respiratory Failure clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.