Using Anakinra to treat Acute Respiratory Distress Syndrome

Efficacy and Safety of Anakinra in Acute Respiratory Distress Syndrome

This study is testing if a medication called Anakinra can help people with moderate to severe Acute Respiratory Distress Syndrome recover better while they are on a ventilator in the ICU.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine (Academic / other)
• Locations: 1 site (Udine)
• Trial ID: NCT05914454 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of Anakinra, an interleukin-1 receptor antagonist, in patients diagnosed with moderate to severe Acute Respiratory Distress Syndrome (ARDS). The study focuses on patients admitted to intensive care units who require intubation and mechanical ventilation, aiming to modulate the inflammatory response associated with ARDS. Participants will receive Anakinra within 48 hours of diagnosis, and their outcomes will be monitored to assess improvements in respiratory function and overall survival. The trial seeks to provide insights into the potential benefits of immunomodulation in severe ARDS cases.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with moderate to severe ARDS requiring mechanical ventilation within 48 hours of admission.

Not a fit: Patients who are pregnant, lactating, or have a confirmed COVID-19 infection may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and recovery times for patients suffering from severe ARDS.

How similar studies have performed: While the use of immunomodulation in ARDS is an emerging field, similar approaches have shown promise in other inflammatory conditions, suggesting potential for success in this trial.

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.

Where this trial is running

Udine

• Azienda Sanitaria Universitaria — Udine, Italy (Recruiting)

Study contacts

• Principal investigator: Tiziana Bove, MD, PhD — Azienda Sanitaria Universitaria Friuli Centrale
• Study coordinator: Tiziana Bove, MD, PhD

Conditions Acute Respiratory Distress Syndrome; IL-1; anakinra; acute respiratory distress syndrome; lung