Trials Sponsors Conditions Drugs Pricing

Conditions

Acute respiratory distress syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Interventions

Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.Type not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
Named ingredient: Anakinra
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

Sponsors & Collaborators

Azienda Sanitaria Universitaria Friuli Centrale
Type not reportedlead

Study Sites (1)

Azienda Sanitaria Universitaria Friuli Centrale

Udine, 33100, Italy

Tiziana Bove0432559501 tiziana.bove@asufc.sanita.fvg.it

Central Study Contacts

Samantha Gomboso

0432554278 samantha.gomboso@asufc.sanita.fvg.it

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

October 14, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-518125-15-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 05:49:37 UTC

Documents

PROTOCOLLO

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

Locations