Clinical Trials Register

Summary
EudraCT Number:	2020-001528-32
Sponsor's Protocol Code Number:	ARCO-Homestudy
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-06-24
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

2020-001528-32

A.3

Full title of the trial

Adaptive Randomized trial for therapy of COrona virus disease 2019 at home with oral antivirals

Studio randomizzato adattivo per la terapia della malattia da Corona virus 2019 a casa con antivirali orali

A.3.1

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

Adaptive Randomized trial for therapy of COrona virus disease 2019 at home with oral antivirals

Studio randomizzato adattivo per la terapia della malattia da Corona virus 2019 a casa con antivirali orali

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

ARCO-Homestudy

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	ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
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	Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
B.5.2	Functional name of contact point	Dipartimento di Epidemiologia Digno
B.5.3	Address:
B.5.3.1	Street Address	VIA PORTUENSE
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00149
B.5.3.4	Country	Italy
B.5.6	E-mail	simone.lanini@inmi.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	Kaletra
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie
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	Kaletra
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LOPINAVIR
D.3.9.2	Current sponsor code	-
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	200
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RITONAVIR
D.3.9.2	Current sponsor code	-
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	50
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	Yes
D.2.1.1.1	Trade name	PLAQUENIL - 200 MG COMPRESSE RIVESTITE 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS S.P.A.
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	PLAQUENIL
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IDROSSICLOROCHINA SOLFATO
D.3.9.2	Current sponsor code	-
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	200
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: 3
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	Rezolsta
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag SpA,
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	REZOLSTA
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DARUNAVIR
D.3.9.2	Current sponsor code	-
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	800
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	cobicistat
D.3.9.2	Current sponsor code	-
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	150
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: 4
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	Avigan
D.2.1.1.2	Name of the Marketing Authorisation holder	Fujifilm
D.2.1.2	Country which granted the Marketing Authorisation	Japan
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	Avigan
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Favipiravir
D.3.9.2	Current sponsor code	-
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	200
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

Coronavirus Covid 19 infection

Infezione da coronavirus Covid 19

E.1.1.1

Medical condition in easily understood language

Coronavirus Covid 19 infection

Infezione da coronavirus Covid 19

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	HLT
E.1.2	Classification code	10047468
E.1.2	Term	Viral lower respiratory tract infections
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

Evaluation of the effectiveness of therapy in reducing the proportion of subjects with who still have viruses in the upper airways after 7 days of therapy
Evaluation of the effectiveness of therapy in reducing the proportion of hospitalized subjects within 14 days of starting therapy.

Valutazione dell’efficacia della terapia nella riduzione della proporzione dei soggetti con che ancora hanno virus nelle vie aeree superiori dopo 7 giorni di terapia
Valutazione dell’efficacia della terapia nella riduzione della proporzione dei soggetti ospedalizzati entro 14 giorni dall’inizio della terapia

E.2.2

Secondary objectives of the trial

Evaluation of the effectiveness of therapy in reducing the proportion of subjects with who still have viruses in the upper airways after 14 and 28 days of therapy.
Evaluation of the effectiveness of therapy in reducing the proportion of hospitalized subjects within 7 or 28 days of starting therapy.
7, 14 and 28 day drug safety and tolerability profile
Modeling of blood and biochemical parameters between T0 and T28

Valutazione dell’efficacia della terapia nella riduzione della proporzione dei soggetti con che ancora hanno virus nelle vie aeree superiori dopo 14 e 28 giorni di terapia.
Valutazione dell’efficacia della terapia nella riduzione della proporzione dei soggetti ospedalizzati entro 7 o 28 giorni dall’inizio della terapia.
Profilo di sicurezza e tollerabilità dei farmaci a 7, 14 e 28 giorni
Modellizzazione di parametri ematochimici e biochimici tra il T0 ed il T28

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures;
2. Agrees to the collection of nasopharyngeal swabs and venous blood samples per protocol
3. Male or female adult >=18 years of age at time of enrolment;
4. Has laboratory-confirmed SARS-CoV-2 infection as determined by an approved molecular test (PCR) in Italy;
5. Being symptomatic for less than 5 days before starting therapy;
6. Do not meet criteria for immediate hospitalization (NEWS = 2).

1. pazienti che hanno firmato il consenso
2. pazienti che accettano di fare il tampone nasofaringeo e i prelievi ematici necessari
3. pazienti maschi e femmine non gravide >=18 anni;
4. pazienti con infezione da SARS-CoV-2 confermata da test (PCR);
5. pazienti con sintomi comparsi da non più di 5 gg;
6. pazienti senza una immediata necessità di ricovero in ospedale (NEWS = 2)

E.4

Principal exclusion criteria

A. Requires immediate hospitalization or mechanical ventilation and/or supplemental oxygen therapy or have a NEWS = 2;
B. Having already receive any of the trial drug less than 1 month before randomization
C. Being concurrently involved in another trial for COVID-19
D. Pregnancy (based on home test)
E. HIV infection (based on the anamnesis)
F. Use of any antiretroviral medication
G. Hypersensitivity to any of the used in the experimental compound including excipients
H. Use of medications that are contraindicated with chloroquine (Full list will be reported in the standard operative protocol to be developed in each of the five recruiting Centre).
I. Having a pacemaker and / or history or current evidence of clinically significant cardiac arrhythmia
J. Active or clinically significant cardiac disease including congestive heart failure (New York Heart Association Class III or higher)
K. Severe liver injury (Child-Pugh Class B or C);
L. Use of concomitant medications that prolong the QT/QTc interval (Full list will be reported in the standard operative protocol to be developed in each of the five recruiting Centre) [42]
M. Receiving drug that cannot be co-administered with any of the experimental compound (Full list will be reported in the standard operative protocol to be developed in each of the five recruiting Centre)
N. Autoimmune diseases receiving therapy at the time of randomization.
O. Women of childbearing potential and fertile men must agree to use at least one primary form of contraception for the duration of the study.

A. Necessità di ricovero immediato o di ventilazione meccanica e/o ossigenoterapia supplementare o NEWS = 2;
B. Precedente assunzione dei farmaci sperimentali prova meno di 1 mese prima della randomizzazione
C. Contemporanea partecipazione ad altro studio clinico per COVID-19
D. Gravidanza (in base al test a domicilio)
E. Infezione da HIV (basata sull'anamnesi)
F. Uso di qualsiasi farmaco antiretrovirale
G. Ipersensibilità a uno qualsiasi dei farmaci sperimentale, compresi gli eccipienti
H. Uso di farmaci controindicati con la clorochina (l'elenco completo sarà riportato nel protocollo operativo standard da sviluppare in ciascuno dei cinque centri di reclutamento).
I. Portatore di pacemaker e/o anamnesi o sintomi di aritmia cardiaca clinicamente significativa
J. Malattia cardiaca attiva o clinicamente significativa, compresa insufficienza cardiaca congestizia (New York Heart Association Classe III o superiore)
K. Grave insufficienza epatica (Child-Pugh classe B o C);
L. Uso di farmaci che prolungano l'intervallo QT/QTc (l'elenco completo sarà riportato nel protocollo operativo standard da sviluppare in ciascuno dei cinque centri di reclutamento)
M. Uso di farmaci controindicati con i farmaci sperimentali (l'elenco completo sarà riportato nel protocollo operativo standard da sviluppare in ciascuno dei cinque centri di reclutamento)
N. Malattie autoimmuni in terapia al momento della randomizzazione.
Le donne in età fertile debbono essere d’accordo di utilizzare un metodo contracettivo (primario, lo tradurrei efficace) per la durata dello studio

E.5 End points

E.5.1

Primary end point(s)

Virologic outcome. Proportion of participants with undetectable SARS-CoV-2 gene E and gene M at day 7 after randomization.
Clinical outcome. Proportion of participants who need not hospitalization (NEWS = 2) by day 14 after randomization.

Esito virologico: percentuale di pazienti con SARS-CoV-2 gene E and gene M non rilevabile 7 giorni dopo la randomizzazione
Esito clinico: percentuale di pazienti che non necessitano di ospedalizzazione (NEWS = 2) 14 giorni dopo la randomizzazione.

E.5.1.1

Timepoint(s) of evaluation of this end point

7 days
14 days

7 giorni
14 giorni

E.5.2

Secondary end point(s)

Proportion of participants with undetectable SARS-CoV-2 gene E and gene M at day 14 after randomization, by arm.
Proportion of participants with undetectable SARS-CoV-2 gene E and gene M at day 28 after randomization, by arm.
Proportion of participants who need not hospitalization (NEWS = 2) by day 7 and 28 after randomization, by arm.
Proportion of patients in each category at point N at time 0, 7, 14 and 28, by arm
Mean value of category at point N by arm at time 0,7,14 and 28
Proportion of participants with any adverse event (grade = 2 according to CTCAE) at day 7, 14 and 28, by arm.
Proportion of participants with severe adverse events (grade = 3 according to CTCAE) at day 7, 14 and 28, by arm.
Mean variation of value of biomarker parameters reported in end point section (point I to M) from base line to day 7, 14 and 28 after randomization, by arm.

¿ % di pazienti con geni SARS-CoV-2 E e M non rilevabili al giorno 14 dopo la randomizzazione
¿ % di pazienti con geni SARS-CoV-2 E e M non rilevabili al giorno 28 dopo la randomizzazione
¿ % di pazienti che non necessitano di ricovero in ospedale (NEWS = 2) entro il giorno 7 dopo la randomizzazione.
¿ % di pazienti che non necessitano di ricovero in ospedale (NEWS = 2) entro il giorno 28 dopo la randomizzazione.
¿ % di pazienti con qualsiasi evento avverso (grado = 2 secondo CTCAE) al giorno 7
¿ % di pazienti con qualsiasi evento avverso (grado = 2 secondo CTCAE) al giorno 14
¿ % di pazienti con qualsiasi evento avverso (grado = 2 secondo CTCAE) al giorno 28
¿ % di pazienti con eventi avversi gravi (grado = 3 secondo CTCAE) al giorno 7.
¿ % di pazienti con eventi avversi gravi (grado = 3 secondo CTCAE) al giorno 14
¿ % di pazienti con eventi avversi gravi (grado = 3 secondo al CTCAE) al giorno 28
¿ % di pazienti i ricoverati in terapia intensiva al giorno 7 dopo la randomizzazione
¿ % di pazienti ricoverati in terapia intensiva al 14° giorno dopo la randomizzazione
¿ % di pazienti ricoverati in terapia intensiva al giorno 28 dopo la randomizzazione
¿ % di pazienti sopravvissuti al giorno 7 dopo la randomizzazione
¿ % di pazienti sopravvissuti al giorno 14 dopo la randomizzazione
¿ % di pazienti sopravvissuti al giorno 28 dopo la randomizzazione
¿ Emocromo completo con formula ai giorni 0, 7 14 e 28
¿ Funzione epatica ALT, AST e bilirubina ai giorni 0, 7 14 e 28
¿ Coagulazione complete PT, aPTT and INR ai giorni 0,7,14 e 28
¿ Altri marcatori D-dimero CPK ed LDH ai giorni 0, 7, 14 e 28

E.5.2.1

Timepoint(s) of evaluation of this end point

To see the study protocol

Vedere il protocollo di studio

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

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

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

Yes

E.8.2.3.1

Comparator description

Braccio di controllo. Nessun trattamento antivirale

Control arm. No specific antiviral treatment.

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:

261

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

174

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

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

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

435

F.4.2

For a multinational trial

F.4.2.1

In the EEA

435

F.4.2.2

In the whole clinical trial

435

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)

At the end of the study, if necessary, patients will be followed according to normal clinical practice.

Al termine dello studio, se necessario, i pazienti saranno seguiti secondo la normale pratica clinica.

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

2020-05-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-04

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
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