Clinical Trials Register

Summary
EudraCT Number:	2021-006644-27
Sponsor's Protocol Code Number:	CARR-ARDS-2021
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-08-26
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-006644-27

A.3

Full title of the trial

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

Efficacia e sicurezza di anakinra nella ARDS non-COVID-19 relata. Studio ESKA.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Efficacia e sicurezza di anakinra nella ARDS non-COVID-19 relata. Studio ESKA.

A.3.2

Name or abbreviated title of the trial where available

ESKA

A.4.1

Sponsor's protocol code number

CARR-ARDS-2021

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AZIENDA OSPEDALIERO-UNIVERSITARIA UDINE
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Azienda Ospedaliero Universitaria Udine
B.5.2	Functional name of contact point	Clinica di Reumatologia - Azienda O
B.5.3	Address:
B.5.3.1	Street Address	Piazzale Santa Maria della Misericordia, 15
B.5.3.2	Town/ city	Udine
B.5.3.3	Post code	33100
B.5.3.4	Country	Italy
B.5.6	E-mail	studiclinici.reumatologia@asufc.sanita.fvg.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	kineret
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	anakinra
D.3.2	Product code	[L04AC03]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	anakinra
D.3.9.2	Current sponsor code	IMP 1
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acute respiratory distress syndrome (ARDS)

Sindrome da distress respiratorio acuto

E.1.1.1

Medical condition in easily understood language

Acute respiratory failure with hypoxemia, non-cardiogenic or non-fluid overload pulmonary edema, diffuse bilateral opacities on chest X-ray in the presence of a predisposing factor.

Insufficienza respiratoria acuta con ipossiemia, edema polmonare non cardiogeno o non da sovraccarico fluidico, opacità diffuse bilaterali agli rx del torace in presenza di un fattore predisponente

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10003083
E.1.2	Term	ARDS
E.1.2	System Organ Class	100000004855

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to evaluate a composite outcome of mortality at 28 days and ventilation-free days. The calculation will take place from the day of extubation to the 28th day of hospitalization. Patients who died prior to respiratory weaning will be considered as having 0 days free of ventilation.

L'obiettivo principale di questo studio è la valutazione di un outcome composito di mortalità a 28 giorni e giorni liberi da ventilazione. Il calcolo avverrà dal giorno dell’estubazione al 28° giorno di ricovero. I pazienti deceduti prima dello svezzamento respiratorio verranno considerati come con 0 giorni liberi di ventilazione.

E.2.2

Secondary objectives of the trial

The secondary objectives of this study are to evaluate:
- Days free from ventilation;
- Mortality in IT;
- In-hospital mortality;
- PaO2 / FiO2 ratio improvement;
- Driving pressure reduction;
- Reduction of peak pressure;
- Reduction of plateau pressure;
- Days free from multi-organ damage calculated using Sequential Organ Failure Assessment methodology (SOFA) score (SOFA score <2) on the 28th day or on the last day of hospitalization in the ICU if discharge occurs earlier, or on the death of the patient;
- Days free from renal replacement treatment;
- Peak blood creatinine;
- AST / ALT / bilirubin peak;
- Days free from vasoactive support;
- Days of hospitalization after discharge from intensive care;
- Days of Hospitalization in IT;
- Days of hospitalization in hospital;
- Cumulative dose of corticosteroids.

Gli obiettivi secondari di questo studio sono valutare:
- Giorni liberi da ventilazione;
- Mortalità in TI;
- Mortalità intraospedaliera;
- Miglioramento rapporto PaO2/FiO2;
- Riduzione driving pressure;
- Riduzione pressione di picco;
- Riduzione pressione di plateau;
- Giorni liberi da danno multiorgano calcolato tramite Sequential Organ Failure Assessment methodology (SOFA) score (SOFA score <2) al 28° giorno o all’ultimo giorno di ricovero in TI se la dimissione avviene prima, o alla morte del paziente;
- Giorni liberi da trattamento sostitutivo della funzione renale;
- Picco di creatininemia;
- Picco di AST/ALT/bilirubina;
- Giorni liberi da supporto vasoattivo;
- Giorni di ricovero dopo dimissione dalla terapia intensiva;
- Giorni di Degenza in TI;
- Giorni di degenza intraospedaliera;
- Dose cumulativa di corticosteroidi.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age = 18 years;
Any gender;
Patients admitted to the ICU with a diagnosis of moderate-severe ARDS according to the Berlin criteria and with the need for intubation and mechanical ventilation;
Informed consent for participation in the study;
Negative swab for COVID-19.

Età = 18 anni;
Qualsiasi sesso;
Pazienti ammessi in terapia intensiva con diagnosi di ARDS moderata-severa secondo i criteri di Berlino e con necessità di intubazione e ventilazione meccanica;
Consenso informato per la partecipazione allo studio;
Tampone negativo per COVID-19.

E.4

Principal exclusion criteria

¿ Age <18 years;
¿ Pregnant or breastfeeding patients;
¿ Hypersensitivit¿ 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 malignant neoplasms;
¿ Moderate to severe renal insufficiency, CL creatinine <60 ml / minute.

¿ Età < 18 anni;
¿ Pazienti in stato di gravidanza o in allattamento;
¿ Ipersensibilità` al principio attivo o ad uno qualsiasi degli eccipienti o a proteine derivate da Escherichia Coli;
¿ Trattamento concomitante con anti TNF-alfa o altro agente biotecnologico;
¿ Neutropenia (neutrofili <1,5 x 109/L);
¿ Neoplasie maligne preesistenti;
¿ Insufficienza renale moderata-severa, CL creatinina <60 ml/minuto.

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

28 DAYS

28 GIORNI

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

corticosteroide

corticosteroids

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

28th day or last day of hospitalization in ICU if discharge occurs earlier, or upon death of the patient

28° giorno o ultimo giorno di ricovero in TI se la dimissione avviene prima, o alla morte del paziente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-08-26.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Patient unable to understand or unconscious patient

Paziente non in grado di comprendere o paziente incosciente

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients will be managed according to normal clinical standard of care of ARDS

I pazienti verranno gestiti in base alla normale pratica clinica per il trattamento dell’ARDS

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-10-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-02-28

P. End of Trial
P.	End of Trial Status	Ongoing

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