Dexamethasone or Tocilizumab for Acute Respiratory Failure
Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
Recruiting
Phase 2Interventional Study
Acute Hypoxemic Respiratory Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Other
Participants needed
60 (estimated)
Sponsor
Lorenzo delSorbo · Other
Who this trial is looking for
This trial is looking for adults who have recently developed breathing problems and need to be hospitalized. Participants will have their blood tested for a specific marker and may receive treatment to help improve their condition.
Are You a Good Fit for This Trial?
Must not be takingAzathioprineCyclophosphamide
Rules you outActive tuberculosisSevere liver disease
You may be able to join if
I am 18 years or older
I have new breathing problems that started in the past 14 days
I need to be admitted to the hospital
You may not be able to join if
I cannot give permission to participate in the trial
I have known allergies to the study drugs
I have active tuberculosis
I have serious liver disease
I have had my blood tests show very high liver enzymes
I have a low blood cell count
I am pregnant or breastfeeding
I have been admitted to ICU before being randomized
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 bioma…
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.
Trial Locations
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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. Requireme…
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 500/mm3
14. total bilirubin above ULN
15. Triglycerides (TG) above 10 mmol/L (above 900 mg/dL)
16. Serum creatinine above 1.4 mg/dL in female patients and above 1.6 mg/dL in male patients
17. Patients already receiving systemic steroids, monoclonal antibodies or other immunosuppressive medications at the time of presentation
18. Inability to comply with the regulations to avoid conception within 28 days after enrollment
19. Admission to ICU prior to randomization
20. Immediate need for intubation
21. Imminent death
22. Clinical team refusal
23. Participation in other drug clinical trials (this criterion will be discussed with the PI)
24. Reaching \>72h since hospital admission
25. Pregnancy (positive pregnancy test) or breastfeeding (which is a contraindication to tocilizumab)
Contacts
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