Efficacy and safety of anakinra in non-COVID-19 related ARDS. ESKA study.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Sanitaria Universitaria Friuli Centrale

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2024-11-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518125-15-00

EudraCT number

2021-006644-27

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The main aim of this study is to evaluate ventilation-free days.

Secondary objectives 1

1. The secondary aims of this study are as follows: - 28-day mortality; - ICU mortality; - In-hospital mortality; - Improved PaO2/FiO2 ratio (measurement at day 0 and day 28); - Driving pressure reduction (measurement at day 0 and day 28); - Reduction peak pressure (measurement at day 0 and day 28); - Reduction plateau pressure (measurement at day 0 and day 28); - Days free from multi-organ damage calculated by Sequential Organ Failure Assessment methodology (SOFA) score (SOFA score <2) at day 28 or last day of ICU admission if discharge occurs earlier, or at patient's death; - Days free from renal function replacement treatment; - Peak creatininemia; - Peak AST/ALT/bilirubin; - Days free from vasoactive support; - Inpatient days after discharge from ICU; - ICU Inpatient Days; - Intrahospital inpatient days; - Cumulative dose of corticosteroids.

Conditions and MedDRA coding

Acute respiratory distress syndrome (ARDS)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Age ≥ 18 years; 2. Any male and female; 3. Patients admitted to the ICU with a diagnosis within 48 hours of moderate-severe ARDS (PaO2/FiO2 < 200, PEEP ≥ 5 cmH2O) and needing intubation and mechanical ventilation; 4. Berlin clinical criteria for definition of ARDS: onset within 1 week of initial injury or of new or worsening respiratory symptoms, bilateral opacities not fully explained by effusion, lobar or pulmonary collapse or nodules, respiratory failure not fully explained by heart failure or fluid overload 5. ARDS-like clinical-laboratory profile, defined by at least one of the following criteria: a. high plasma levels of inflammatory biomarkers (e.g., IL-6 > 80 pg/ml, PCR > 250 mg/l) b. dependence on vasopressors (of any type and at any dosage for at least one hour of treatment) c. decreased bicarbonatemia (< 18 mMol/L) or hyperlactacidemia (> 4 mMol/L) 6. Informed consent for participation in the study; 7. Negative swab for COVID-19.

Exclusion criteria 1

1. 1. Age < 18 years; 2. Pregnant or lactating patients; 3. Hypersensitivitỳ to the active ingredient or any of the excipients or to proteins derived from Escherichia coli; 4. Concomitant treatment with anti TNF-alpha; 5. Neutropenia (neutrophils <1.5 x 109/L); 6. Pre-existing malignancies; 7. Moderate-severe renal failure, creatinine CL <60 mL/minute.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The main aim of this study is to evaluate ventilation-free days.

Secondary endpoints 1

1. - 28-day mortality; - ICU mortality; - In-hospital mortality; - Improved PaO2/FiO2 ratio (measurement at day 0 and day 28); - Driving pressure reduction (measurement at day 0 and day 28); - Reduction peak pressure (measurement at day 0 and day 28); - Reduction plateau pressure (measurement at day 0 and day 28); - Days free from multi-organ damage calculated by Sequential Organ Failure Assessment methodology (SOFA) score (SOFA score <2) at day 28

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Sanitaria Universitaria Friuli Centrale

Sponsor organisation

Azienda Sanitaria Universitaria Friuli Centrale

Address

Piazzale Santa Maria Della Misericordia 15

City

Udine

Postcode

33100

Country

Italy

Scientific contact point

Organisation

Azienda Sanitaria Universitaria Friuli Centrale

Contact name

Luca Quartuccio

Public contact point

Organisation

Azienda Sanitaria Universitaria Friuli Centrale

Contact name

Samantha Gomboso

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications