Efficacy and Safety of Anakinra in Acute Respiratory Distress Syndrome

NCT05914454 | Unknown Phase 2

• 1 other identifier: 4381
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

IL-1; anakinra; acute respiratory distress syndrome; lung

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

anakinra

EXPERIMENTAL

anakinra 100 mg/day for 14 consecutive days

Drug: Anakinra 100Mg/0.67Ml Inj Syringe

standard of care

NO INTERVENTION

Interventions

Anakinra 100Mg/0.67Ml Inj Syringe DRUG

anakinra 100 mg per day for 14 days

anakinra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead
• University of Udine: collaborator

Study Sites (1)

Azienda Sanitaria Universitaria

Udine, 33100, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Tiziana Bove, MD, PhD

  Azienda Sanitaria Universitaria Friuli Centrale

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiziana Bove, MD, PhD

CONTACT

+39 0432559501; tiziana.bove@asufc.sanita.fvg.it

Luca Quartuccio, MD, PhD

CONTACT

+39 3487040396; luca.quartuccio@asufc.sanita.fvg.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: May 19, 2023
• Primary Completion: June 19, 2025
• Study Completion: September 19, 2025
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)