Efficacy and Safety of Anakinra in Acute Respiratory Distress Syndrome

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

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.

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
    Italy

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.