Efficacy and Safety of Anakinra in Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

— ESKA  

Official title:

Efficacy and Safety of Anakinra in Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914454
• Other study ID #: 4381
• Status: Recruiting
• Phase: Phase 2
• Start date: May 19, 2023
• Est. completion date: September 19, 2025

Study information

• Verified date: June 2023
• Source: Azienda Sanitaria-Universitaria Integrata di Udine
• Contact: Tiziana Bove, MD, PhD
• Phone: +39 0432559501
• Email: tiziana.bove[@]asufc.sanita.fvg.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute Respiratory Distress Syndrome (ARDS) is a life-threatening condition characterized by acute respiratory failure with hypoxemia, noncardiogenic or non-fluid overload pulmonary edema, bilateral diffuse opacities on chest radiograph in the presence of a predisposing factor.

In ARDS there is activation of the inflammatory cascade which is very intense and persistent in the severe types. It was highlighted that the inflammatory cytokines in patients with ARDS or sepsis is similar to that observed in COVID-19 positive patients.

Emerging therapies include immunomodulation and the administration of mesenchymal stem cells for the modulation of lung repair through the release of cytokines and growth factors that modulate the local inflammatory response.

Regardless of the cause of ARDS, the severity of the inflammatory state and fibroproliferative evolution have been shown to be independent predictors of survival and ventilator dependence. Patients suffering from severe forms of ARDS in fact require prolonged mechanical ventilation, which exposes them to ventilator-associated pneumonia (VAP) and the onset of multiorgan insufficiency. The hyperinflammatory state underlying ARDS predisposes to pulmonary fibroproliferation, which in turn increases susceptibility to ventilator dependence and increases the risk of MOF and death. For this reason, the rationale in the use of anakinra is to limit the inflammatory process of ARDS as early as possible, avoiding the progression of lung damage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 19, 2025
• Est. primary completion date: June 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted to intensive care unit diagnosed within 48 hours of moderate-severe ARDS (PaO2/FiO2 < 200, PEEP = 5 cmH2O) and requiring intubation and mechanical ventilation;

• Berlin clinical criteria for definition of ARDS: onset within 1 week of initial lesion or new or worsening respiratory symptoms, bilateral opacities not fully explained by effusions, lobar or lung collapse or nodules, respiratory failure not fully explained by heart failure or fluid overload

• ARDS-like clinical-laboratory profile, defined by at least one of the following criteria:

• high plasma levels of inflammatory biomarkers (e.g. IL-6 > 80 pg/ml, CRP > 250 mg/l)

• dependence on vasopressors (of any type and at any dosage for at least one hour of 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 Criteria:

• Pregnant or lactating patients;

• Hypersensitivity to the active substance or to any of the excipients or to proteins derived 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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• Anakinra 100Mg/0.67Ml Inj Syringe
anakinra 100 mg per day for 14 days

Locations

Country	Name	City	State
Italy	Azienda Sanitaria Universitaria	Udine

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Sanitaria-Universitaria Integrata di Udine	University of Udine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of ventilation-free days	The calculation will take place from the day of extubation to the 28th day of hospitalization. Patients who die before ventilator weaning will be considered as having 0 days off ventilation. The calculation of the days free from ventilation will be calculated as follows: 28 - number of days of ventilation.	28 days