Last updated: June 13, 2023
Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Overall Status: Active - Recruiting
Phase
2
Condition
Lung Injury
Respiratory Failure
Acute Respiratory Distress Syndrome (Ards)
Treatment
Anakinra 100Mg/0.67Ml Inj Syringe
Clinical Study ID
NCT05914454
4381
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients admitted to intensive care unit diagnosed within 48 hours of moderate-severeARDS (PaO2/FiO2 < 200, PEEP ≥ 5 cmH2O) and requiring intubation and mechanicalventilation;
- Berlin clinical criteria for definition of ARDS: onset within 1 week of initial lesionor new or worsening respiratory symptoms, bilateral opacities not fully explained byeffusions, lobar or lung collapse or nodules, respiratory failure not fully explainedby heart failure or fluid overload
- ARDS-like clinical-laboratory profile, defined by at least one of the followingcriteria:
- high plasma levels of inflammatory biomarkers (e.g. IL-6 > 80 pg/ml, CRP > 250mg/l)
- dependence on vasopressors (of any type and at any dosage for at least one hourof treatment)
- reduction of bicarbonatemia (< 18 mMol/L) or hyperlactacidemia (> 4 mMol/L)
- Informed consent for participation in the study
- Negative swab for COVID-19.
Exclusion
Exclusion Criteria:
- Pregnant or lactating patients;
- Hypersensitivity to the active substance or to any of the excipients or to proteinsderived from Escherichia Coli;
- Concomitant treatment with anti-TNF-alpha or other biotechnological agent;
- Neutropenia (neutrophils < 1.5 x 109/L);
- Pre-existing malignancies;
- Moderate to severe renal insufficiency, creatinine clearance < 60 ml/minute.
Study Design
Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Anakinra 100Mg/0.67Ml Inj Syringe
Phase: 2
Study Start date:
May 19, 2023
Estimated Completion Date:
September 19, 2025
Connect with a study center
Azienda Sanitaria Universitaria
Udine, 33100
ItalyActive - Recruiting

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