Clinical Trials Register

Summary
EudraCT Number:	2020-001972-13
Sponsor's Protocol Code Number:	COVID-19HD
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:	2020-06-26
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

2020-001972-13

A.3

Full title of the trial

Randomised controlled trial comparing efficacy and safety of high versus low low-molecular weight heparin dosages in hospitalised patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD)

Studio randomizzato controllato sull’efficacia e sulla sicurezza di alte verso basse dosi di eparina a basso peso molecolare in pazienti ricoverati per grave polmonite in corso di COVID-19 e coagulopatia, e che non richiedano ventilazione meccanica invasiva. (COVID-19 HD)

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

Randomised controlled trial comparing efficacy and safety of high versus low low-molecular weight he

Studio randomizzato controllato sull’efficacia e sulla sicurezza di alte verso basse dosi di eparina

A.4.1

Sponsor's protocol code number

COVID-19HD

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 POLICLINICO DI MODENA
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	Fondo Ricerca -Emergenza COVID-19
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	Azienda Ospedaliero-Universitaria di Modena
B.5.2	Functional name of contact point	Clinical Trial Quality Team
B.5.3	Address:
B.5.3.1	Street Address	via Del Pozzo 71
B.5.3.2	Town/ city	Modena
B.5.3.3	Post code	41124
B.5.3.4	Country	Italy
B.5.4	Telephone number	0594225868
B.5.5	Fax number	0594224369
B.5.6	E-mail	mighali.pasquale@aou.mo.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	Inhixa
D.2.1.1.2	Name of the Marketing Authorisation holder	Techdow Europe AB
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	Inhixa
D.3.2	Product code	[-]
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	enoxaparina sodica
D.3.9.2	Current sponsor code	-
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	4000 to 8000
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	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

Hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation.

Pazienti ricoverati in ospedale con grave polmonite da COVID-19 e coagulopatia, che non necessitano di ventilazione meccanica invasiva

E.1.1.1

Medical condition in easily understood language

Hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation.

Pazienti ricoverati in ospedale con grave polmonite da COVID-19 e coagulopatia, che non necessitano di ventilazione meccanica invasiva

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	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10053983
E.1.2	Term	Corona virus infection
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess whether high doses of Low Molecular Weight Heparin (LMWH) (ie. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (ie, Enoxaparin 4000 IU once day) are:
a) more effective to prevent clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first, during hospital stay:
1. Death
2. Acute Myocardial Infarction [AMI]
3. Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
4. Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients who are in standard oxygen therapy by delivery interfaces at randomisation
5. Need for invasive mechanical ventilation for patients who are in non-invasive mechanical ventilation at randomisation
b) Similar in terms of major bleeding risk during hospital stay

Valutare se alte dosi di eparina a basso peso molecolare (EBPM) (ie. Enoxaparina 70 IU/kg ogni 12 ore), confrontate con le dosi standard utilizzate per la profilassi del trombembolismo venoso (ie, Enoxaparina 4000 IU una volta al dì) sono:
a) più efficaci nel prevenire il peggioramento clinico, definito come la comparsa, durante il ricovero ospedaliero, del primo fra questi eventi:
1. Morte
2. Infarto miocardico acuto (IMA)
3. Trombombolismo venoso o arterioso sintomatico, confermato da indagini strumentali
4. Necessità di ricorrere a ventilazione meccanica non invasiva - intesa come Continuous Positive Airway Pressure (Cpap), Non-Invasive Ventilation (NIV) - o invasiva per i pazienti che alla randomizzazione sono in ossigeno terapia standard
5. Necessità di ricorrere a ventilazione meccanica invasiva per i pazienti che alla randomizzazione sono in ventilazione meccanica non invasiva
b) Simili in termini di emorragia maggiore

E.2.2

Secondary objectives of the trial

To assess whether high doses of Low Molecular Weight Heparin (LMWH) (ie. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (ie, Enoxaparin 4000 IU once day) differ in terms of the following events occurring during hospital stay:
a) Laboratory parameters of disease severity, including:
1. D-dimer level
2. Plasma fibrinogen levels
3. Mean Platelet Volume
4. Lymphocyte/Neutrophil ratio
5. IL-6 plasma levels
b) Clinically relevant non-major bleeding
c) Death during hospital stay and at 30 days
d) Acute Myocardial Infarction [AMI]
e) Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
f) Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation
g) Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation

Valutare se alte dosi di eparina a basso peso molecolare(EBPM)(ie. Enoxaparina 70 IU/kg ogni 12 ore),confrontate con le dosi standard utilizzate per la profilassi del trombembolismo venoso(ie,Enoxaparina 4000 IU una volta al dì)differiscono in termini di incidenza durante ricovero ospedaliero dei seguenti eventi:
a) Variazioni dei parametri di lab.indicatori della gravità di malattia,quali:
1. Livelli plasmatici di D-dimero
2. Livelli plasmatici di fibrinogeno
3. Volume Medio Piastrinico
4. Rapporto Linfociti/neutrofili
5. Livelli plasmatici di IL-6
b) Emorragia non maggiore,clinicamente rilevante
c) Morte intraospedaliera e a 30 g
d) Infarto Miocardico Acuto
e)Tromboembolismo venoso o arterioso sintomatico
f) Necessità di ricorrere a ventilazione meccanica non invasiva o invasiva per i pz. che alla randomizzazione sono in ossigeno terapia standard
g) Necessità di ricorrere a ventilazione meccanica invasiva per i pz. che alla randomizzazione sono in ventilazione meccanica non invasiva

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients admitted to the hospital with COVID-19 confirmed by PCR test on throat swab samples, and with severe pneumonia plus coagulopathy, defined as the presence of at least one clinical and one laboratory criteria.
Clinical criteria (at least one)
1) Respiratory Rate = 25 breaths /min
2) Arterial oxygen saturation = 93% at rest in room air
3) PaO2/FiO2 = 300 mmHg
Laboratory criteria and SIC score (at least one )
1) D-dimer > 4 times the upper level of normal reference range
2) Sepsis-Induced Coagulopathy (SIC) score > 4

Pazienti ricoverati in ospedale con COVID-19 confermato da PCR su tampone naso-faringeo, con polmonite grave e coagulopatia, definite come la presenza di almeno un criterio clinico ed uno di laboratorio, che non necessitano di ventilazione meccanica invasiva
Criteri Clinici (almeno uno)
1) Frequenza Respiratoria =25 atti/min
2) Saturazione arteriosa di ossigeno =93% a riposo in aria ambiente
3) PaO2/FiO2 =300 mmHg
Criteri dl laboratorio e SIC score (almeno uno)
1) D-dimero >4 volte il limite superiore di riferimento del laboratorio
2) Sepsis-Induced Coagulopathy (SIC) score >4

E.4

Principal exclusion criteria

1. Age < 18 and > 80 years
2. Invasive ventilation
3. Thrombocytopenia (platelet count < 80.000 mm3)
4. Coagulopathy: INR >1.5, aPTT ratio >1.4
5. Impaired renal function (eGFR by CKD-EPI Creatinine equation < 30 ml/min)
6. Known hypersensitivity to enoxaparin
7. History of heparin induced thrombocytopenia
8. Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignant tumors at high risk of haemorrhages, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations)
9. Concomitant anticoagulant treatment for other indications (e.g. atrial fibrillation, venous thromboembolism, prosthetic heart valves)
10. Concomitant double antiplatelet therapy
11. Administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization; prophylactic doses are allowed
12. Pregnancy or breastfeeding or positive pregnancy test
13. Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition)
14. Lack or withdrawal of informed consent

1. Eta <18 e > 80 anni
2. Ventilazione meccanica invasiva
3. Piastrinopenia (conta piastrinica < 80.000 mm3)
4. Coagulopatia: INR >1.5, aPTT ratio >1.4
5. Insufficienza renale (eGFR secondo l’equazione CKD-EPI Creatinina <30 ml/min)
6. Allergia nota ad Enoxaparina
7. Storia di piastrinopenia da eparina
8. Presenza di sanguinamento attivo, o di una condizione ad alto rischio di sanguinamento in presenza di terapie anticoagulanti (ad esempio: recente ictus emorragico, ulcera peptica, neoplasie maligne ad alto rischio emorragico, recente intervento di neurochirurgia o chirurgia endooculare, aneurismi vascolari, malformazioni arterovenose)
9. Terapie anticoagulanti in atto per altre indicazioni (ad es: fibrillazione atriale, tromboembolismo venoso, protesi valvolari cardiache meccaniche)
10. Concomitante doppia terapia antiaggregante
11. Somministrazione di dosi terapeutiche di eparina non frazionata, EBPM o fondaparinux per più di 72 ore precedenti la randomizzazione. Sono concesse dosi profilattiche degli stessi farmaci
12. Gravidanza o allattamento
13. Presenza di patologie gravi che determinano aspettativa di vita < 28 giorni
14. Rifiuto a firmare il consenso informato, o revoca dello stesso.

E.5 End points

E.5.1

Primary end point(s)

Primary Efficacy Endpoint:
Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first:
• Death
• Acute Myocardial Infarction [AMI]
• Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
• Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation
• Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation

Primary safety endpoint:
Major bleeding, defined as an acute clinically overt bleeding associated with one or more of the following:
• Decrease in hemoglobin of 2 g/dl or more;
• Transfusion of 2 or more units of packed red blood cells;
• Bleeding that occurs in at least one of the following critical sites [intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal];
• Bleeding that is fatal (defined as a bleeding event that was the primary cause of death or contributed directly to death);
• Bleeding that necessitates surgical intervention

Endpoint primario di Efficacia
Peggioramento clinico, definito come la comparsa, durante il ricovero ospedaliero, del primo fra questi eventi:
1. Morte
2. Infarto miocardico acuto (IMA)
3. Trombombolismo venoso o arterioso sintomatico,obiettivamente confermato
4. Ventilazione Meccanica non invasiva -intesa come Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - o invasiva per i pazienti che alla randomizzazione sono in ossigeno terapia standard
5. Ventilazione meccanica invasiva per i pazienti che alla randomizzazione sono in ventilazione meccanica non invasiva

Endpoint primario di sicurezza:
Sanguinamento maggiore, definito come sanguinamento clinicamente evidente acuto associato a uno o più dei seguenti:
• Diminuzione dell'emoglobina pari o superiore a 2 g / dl;
• Trasfusione di 2 o più unità di packed red blood cells;
• Sanguinamento che si verifica in almeno uno dei seguenti siti critici (intracranico, intraspinale, intraoculare (all'interno del corpo dell'occhio; pertanto, un sanguinamento congiuntivale non è un sanguinamento intraoculare), pericardico, intra-articolare, intramuscolare con sindrome compartimentale, o retroperitoneale];
• Sanguinamento che è fatale (definito come un evento sanguinante che è stata la principale causa di morte o ha contribuito direttamente alla morte);
• Sanguinamento che richiede un intervento chirurgico

E.5.1.1

Timepoint(s) of evaluation of this end point

occurrence of at least one of the events during hospitalization time

verificarsi di almeno uno degli eventi durante il tempo di ospitalizzazione.

E.5.2

Secondary end point(s)

Secondary Efficacy Endpoints:
Any of the following events:
- Death
- Acute Myocardial Infarction [AMI]
- Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
- Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation
- Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation
- Improvement of laboratory parameters of disease severity, including:
o D-dimer level
o Plasma fibrinogen levels
o Mean Platelet Volume
o Lymphocyte/Neutrophil ratio
o IL-6 plasma levels

Secondary safety endpoint:
Clinically Relevant non-major bleeding, defined as an acute clinically overt bleeding that does not meet the criteria for major and consists of:
• Any bleeding compromising hemodynamics;
• Spontaneous hematoma larger than 25 cm2, or 100 cm2 if there was a traumatic cause;
• Intramuscular hematoma documented by ultrasonography;
• Epistaxis or gingival bleeding requiring tamponade or other medical intervention;
• Bleeding from venipuncture for >5 minutes;
• Hematuria that was macroscopic and was spontaneous or lasted for more than 24 hours after invasive procedures;
• Hemoptysis, hematemesis or spontaneous rectal bleeding requiring endoscopy or other medical intervention;
• or any other bleeding requiring temporary cessation of a study drug.

Endpoint secondari di efficacia:
Uno dei seguenti eventi:
- Morte
- Infarto miocardico acuto (IMA)
- Trombombolismo venoso o arterioso sintomatico,obiettivamente confermato
- Ventilazione Meccanica non invasiva -intesa come Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - o invasiva per i pazienti che alla randomizzazione sono in ossigeno terapia standard
- Ventilazione meccanica invasiva per i pazienti che alla randomizzazione sono in ventilazione meccanica non invasiva
- Miglioramento dei parametri di laboratorio della gravità della malattia, tra cui:
o livello D-dimero
o Livelli di fibrinogeno plasmatico
o Volume piastrinico medio
o Rapporto linfociti / neutrofili
o livello di IL-6
o mortalità a 30 giorni

Endpoint secondario di sicurezza :
Sanguinamento clinicamente rilevante non maggiore, definito come sanguinamento clinicamente evidente acuto che non soddisfa i criteri principali e consiste in:
• Qualsiasi sanguinamento che compromette l'emodinamica;
• Ematoma spontaneo maggiore di 25 cm2 o 100 cm2 se ciò è stato una causa traumatica;
• Ematoma intramuscolare documentato mediante ecografia;
• Epistassi o sanguinamento gengivale che richiedono tamponamento o altri interventi medici;
• Sanguinamento dalla venipuntura per> 5 minuti;
• Ematuria macroscopica, spontanea o durata per più di 24 ore dopo procedure invasive;
• Emottisi, ematemesi o sanguinamento rettale spontaneo che richiede endoscopia o altri interventi medici;
• o qualsiasi altro sanguinamento che richiede l'interruzione temporanea di un farmaco in studio.

E.5.2.1

Timepoint(s) of evaluation of this end point

these outcomes will be collected during the hospitalization period and for the death event even 30 days after randomization. They will be analyzed both as binary outcomes and as survival data

questi esiti saranno raccolti durante il periodo di ospedalizzazione e per l'evento morte anche a 30 giorni dalla randomizzazione. Saranno analizzati sia come outcome binari sia come dati di sopravvivenza

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

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:

150

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

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

300

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

300

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)

best therapy available at the moment

miglior terapia disponibile al momento

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

2020-05-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-21

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-12-31

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