Clinical Trials Register

Summary
EudraCT Number:	2018-003047-32
Sponsor's Protocol Code Number:	IRFMN-7557
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:	2021-05-20
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

2018-003047-32

A.3

Full title of the trial

CardioPulmonary resuscitation with Argon (CPAr) trial

Rianimazione CardioPolmonare con Argon – Studio CPAr

A.3.1

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

CardioPulmonary resuscitation with Argon (CPAr) trial

Rianimazione CardioPolmonare con Argon – Studio CPAr

A.3.2

Name or abbreviated title of the trial where available

CPAR Trial

CPAr Trial

A.4.1

Sponsor's protocol code number

IRFMN-7557

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	IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
B.1.3.4	Country
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	Società Italiana Acetilene e Derivati S.I.A.D spa
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IRCCS Istituto di Ricerche Farmacologiche Mario Negri IRCCS
B.5.2	Functional name of contact point	Dipartimento di Ricerca Cardiovasco
B.5.3	Address:
B.5.3.1	Street Address	Via La Masa, 19
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20156
B.5.3.4	Country	Italy
B.5.4	Telephone number	0239014613
B.5.5	Fax number	0233200049
B.5.6	E-mail	giuseppe.ristagno@marionegri.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Ossigeno
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	Aria + Ossigeno ad arrivare al 30%
D.3.2	Product code	[V03AN01]
D.3.4	Pharmaceutical form	Medicinal gas, compressed
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	7782-44-7
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Oxygen
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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.IMP: 2
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	No
D.2.1.1.1	Trade name	NA
D.2.1.1.2	Name of the Marketing Authorisation holder	NA
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	Argon 70%mol/mol + Ossigeno 30% mol/mol
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Medicinal gas, compressed
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ARGON
D.3.9.1	CAS number	7440-37-1
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Argon
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	70
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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

Cardiac Arrest

Arresto cardiaco

E.1.1.1

Medical condition in easily understood language

Cardiac Arrest

Arresto cardiaco

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10019249
E.1.2	Term	Heart arrest
E.1.2	System Organ Class	100000004849

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 objective of the CPAr trial is to evaluate feasibility and safety of Ar 70%/O2 30% ventilation in patients resuscitated from OHCA.

Lo studio CPAr è uno studio controllato randomizzato di fase I open label, finalizzato alla valutazione della fattibilità e sicurezza dell’implementazione nella pratica clinica della ventilazione polmonare con una miscela di gas Argon (Ar) e ossigeno (O2).
I pazienti comatosi ammessi in terapia intensiva dopo rianimazione da arresto cardiaco extra-ospedaliero saranno randomizzati per ricevere o meno la ventilazione con Ar/O2 in aggiunta alle cure post-rianimatorie standard.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) witnessed non-traumatic OHCA of presumably cardiac etiology with a presenting shockable rhythm; (2) age = 18 years; (3) unconsciousness after return of spontaneous circulation (ROSC); (4) duration of CPR = 30 mins; (5) initiation of study intervention = 3 hrs from ROSC; (6) stable SaO2 = 94%, with a FiO2 of 30%.

pazienti adulti (= 18 anni) rianimati da arresto cardiaco extra-ospedaliero non traumatico a presunta eziologia cardiaca, con ritmo di presentazione defibrillabile; stato di incoscienza dopo recupero di circolazione spontanea (ROSC); RCP di durata inferiore o uguale a 30 minuti; arruolamento nello studio entro 3 ore dal ROSC; saturazione arteriosa d’ossigeno (SaO2) = 94 con FiO2 30%.

E.4

Principal exclusion criteria

(1) age < 18 years; (2) non-witnessed CA; (3) CA of traumatic origin; (4) non-presumably cardiac cause; (5) non-shockable presenting rhythm (pulseless electrical activity and asystole); (6) pregnancy; (7) known terminal illness; (8) pre-CA cerebral performance category (CPC) = 3; (9) initiation of the study intervention > 3 hrs from ROSC; (10) partecipation to another clinical trial;

arresto cardiaco non testimoniato; arresto cardiaco traumatico o da presunta eziologia diversa da quella cardiaca; arresto cardiaco con ritmo di presentazione non defibrillabile (asistolia e attività elettrica senza polso/PEA); stato di gravidanza; stadio terminale di malattia all’inizio dell’ALS; arruolamento in altro trial nei precedenti 30 giorni; cerebral performance category (CPC) score = 3 precedentemente all’arresto cardiaco; partecipazione ad un altro studio clinico;

E.5 End points

E.5.1

Primary end point(s)

a. The incidence, the timing, and the duration of the need to stop Ar 70% treatment in order to maintain the recommended SaO2.
b. The incidence of potentially Ar-attributable hemodynamic adverse events (i.e. arterial hypotension not responsive to fluids and/or vasoactive/inotropic drugs).

a. Incidenza, timing e durata della necessità di sospendere la ventilazione con Ar/O2 a causa di desaturazione
b. Incidenza di eventi avversi emodinamici potenzialmente attribuibili ad Ar (ipotensione arteriosa non responsiva ai fluidi e/o ad agenti vasocotrittori/inotropi.

E.5.1.1

Timepoint(s) of evaluation of this end point

1 MONTHS

1 MESE

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

E.6.4

Safety

Yes

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

Yes

E.6.13.1

Other scope of the trial description

FEASIBILITY

FATTIBILITA'

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

Yes

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

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

Yes

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

LVLS

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

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)

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

2020-12-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-21

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

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Orphan Designation Number:
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