Dexamethasone or Tocilizumab for Respiratory Impairment
(IDENTIFY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults over 18 who've been hospitalized with new respiratory symptoms like coughing, shortness of breath, or needing extra oxygen within the last two weeks. It's not suitable for those who don't require inpatient care.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care, with some receiving additional treatment with Tocilizumab or Dexamethasone based on IL-6 levels
Observation
Participants are observed until discharge or up to 28 days to monitor treatment effects and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a follow-up phone interview
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Tocilizumab
Trial Overview
The study tests if monitoring Interleukin-6 levels can guide treatment with Dexamethasone or Tocilizumab to prevent worsening conditions in patients with acute hypoxemic respiratory failure. Participants are divided into three groups: standard care, standard plus Tocilizumab, and standard plus Dexamethasone.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Routine care + single intravenous infusion of tocilizumab at a dose of 4mg/kg of body weight (up to a max 400mg).
Routine care + a 10mg of oral dexamethasone per day for up to 10 days (or until hospital discharge).
Routine care only
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lorenzo delSorbo
Lead Sponsor
Roche Diagnostic Ltd.
Industry Sponsor
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