Efficacy and Safety of Anakinra in Acute Respiratory Distress Syndrome

NCT ID: NCT05914454

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-19
• Study Completion Date: 2025-09-19

Brief 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.

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anakinra

anakinra 100 mg/day for 14 consecutive days

Group Type: EXPERIMENTAL

Anakinra 100Mg/0.67Ml Inj Syringe

Intervention Type: DRUG

anakinra 100 mg per day for 14 days

standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Anakinra 100Mg/0.67Ml Inj Syringe

anakinra 100 mg per day for 14 days

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Udine

OTHER

Sponsor Role: collaborator

Azienda Sanitaria-Universitaria Integrata di Udine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiziana Bove, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Azienda Sanitaria Universitaria Friuli Centrale

Locations

Azienda Sanitaria Universitaria

Udine, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Tiziana Bove, MD, PhD

Role: CONTACT

tiziana.bove@asufc.sanita.fvg.it

+39 0432559501

Luca Quartuccio, MD, PhD

Role: CONTACT

luca.quartuccio@asufc.sanita.fvg.it

+39 3487040396

Facility Contacts

Tiziana Quartuccio, MD, PhD

Role: primary

tiziana.bove@asufc.sanita.fvg.it

+39 0432559501

Other Identifiers

4381

Identifier Type: -

Identifier Source: org_study_id