Clinical Trials Register

Summary
EudraCT Number:	2020-005919-51
Sponsor's Protocol Code Number:	REP0220
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-01-25
Trial results	View 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

2020-005919-51

A.3

Full title of the trial

A phase 3, double-blind, randomized, placebo-controlled, multicenter study on the efficacy and safety of Reparixin in the treatment of hospitalized patients with severe COVID-19 pneumonia.

Studio multicentrico di fase 3, in doppio cieco, randomizzato, controllato verso placebo sull'efficacia e la sicurezza di Reparixin nel trattamento di pazienti ospedalizzati con polmonite grave da COVID-19

A.3.1

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

Reparixin in COVID-19 pneumonia

Reparixin per polmonite da COVID-19

A.3.2

Name or abbreviated title of the trial where available

REPAVID-19 fase 3

A.4.1

Sponsor's protocol code number

REP0220

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	DOMPé FARMACEUTICI S.P.A.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Dompé farmaceutici 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	Dompé farmaceutici Spa
B.5.2	Functional name of contact point	Flavio Mantelli
B.5.3	Address:
B.5.3.1	Street Address	via Santa Lucia, 6
B.5.3.2	Town/ city	milano
B.5.3.3	Post code	20122
B.5.3.4	Country	Italy
B.5.4	Telephone number	02583831
B.5.5	Fax number	0258383324
B.5.6	E-mail	flavio.mantelli@dompe.com

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	No
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	Reparixin
D.3.2	Product code	[DF1681Y]
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	REPARIXIN
D.3.9.1	CAS number	266359-83-5
D.3.9.2	Current sponsor code	DF1681Y
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	600
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

COVID-19 Pneumonia

Polmonite da COVID-19

E.1.1.1

Medical condition in easily understood language

COVID-19 Pneumonia

Polmonite da 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	20.0
E.1.2	Level	HLGT
E.1.2	Classification code	10047438
E.1.2	Term	Viral infectious disorders
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Efficacy and safety of Reparixin treatment as compared to placebo (both on top of standard treatment) in adult patients with severe COVID-19 pneumonia.

Efficacia e sicurezza del trattamento con Reparixin rispetto al placebo (entrambi in aggiunta al trattamento standard) nei pazienti adulti con polmonite COVID-19 grave.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion Criteria:
1. Age 18 to 90, male and female subject of any race
2. Polymerase Chain Reaction (PCR)-confirmed COVID-19 infection based on a nasal / oropharyngeal swab within 10 days before randomization
3. At least one of the following: 1) Respiratory distress with tachypnea (RR = 24 breaths/min without oxygen); 2) Partial arterial oxygen pressure (PaO2) / Fraction of inspiration O2 (FiO2) >100 and <300 mmHg (1mmHg = 0.133kPa), 3) SpO2 = 94% while they were breathing ambient air.
4. Need of supplemental oxygen (i.e. new use of supplemental oxygen, or increased oxygen requirement if on chronic oxygen) requiring low- or high-flow oxygen devices or non-invasive mechanical ventilation (7-point WHO-OS category 4 or 5)
5. Radiological chest imaging (X-rays, CT scan) confirms lung involvement and inflammation (presence of ground-glass opacities, inter/intra lobular septal thickening, consolidations in a patchy distribution).
6. Inflammatory status as documented by at least one of the following: Lactate dehydrogenase (LDH) > normal range, C-reactive protein (CRP) = 100 mg/L or IL-6 = 40 pg/mL, serum ferritin = 900 ng/mL, XDP > 20 mcg/mL.

Criteri di Inclusione:
1_Età compresa tra 18 e 90 anni. Soggetti maschi e femmine di qualsiasi razza
2_Infezione COVID-19 confermata dalla analisi mediante PCR (Reazione a Catena della Polimerasi, cioè una tecnica che permette di valutare la presenza molecolare del virus) basata sull’analisi di un tampone nasale/orofaringeo entro 10 giorni prima della randomizzazione (cioè il proceso si assegnazione casuale a uno dei trattamenti “con farmaco” oppure “placebo”)
3_La conferma di almeno uno dei seguenti parametri:
a) difficoltà respiratoria (detto anche distress respiratorio) con tachipnea, cioè respirazione alterata, con misurazione di 24 o più respiri al minuto senza somministrazione di ossigeno (RR = 24 respiri/min senza ossigeno);
b) Pressione arteriosa parziale dell'ossigeno (PaO2)/Frazione di inspirazione di ossigeno (FiO2)> 100 e <300 mmHg (1 mmHg = 0,133 kPa), (ovvero alterata capacità del paziente di inspirare e veicolare nel sangue il normale quantitativo di ossigeno
necessario)
c) Saturazione di ossigeno (detta anche SpO2, cioè la quantità di ossigeno disponibile nel sangue) = 94%
4_Necessità di ossigeno supplementare (ad es. nuovo uso di ossigeno supplementare, o aumento del fabbisogno di ossigeno se questo si sta assumendo in maniera continua) che richiede dispositivi di ossigeno a basso flusso o alto flusso o ventilazione meccanica non invasiva.
5_Immagini radiologiche del torace (raggi X, TAC) che confermano il coinvolgimento e l'infiammazione polmonare. In alternativa, immagini ecografiche con linee B compatte e consolidamenti (indicative delle lesioni polmonari).
6_Stato infiammatorio documentato da almeno uno dei seguenti parametri di laboratorio: lattato deidrogenasi (LDH)> intervallo normale, proteina C-reattiva (PCR) = 100 mg / L (proteina prodotta a seguito di una infiammazione) o IL-6 = 40 pg / mL (proteina prodotta dal sistema immunitario a seguito di una infiammazione), ferritina sierica =900 ng / mL, XDP> 20 mcg / mL (dimeri di fibrina, per monitorare lo stato dicoagulazione del sangue).

E.4

Principal exclusion criteria

Exclusion Criteria:
1. Cannot obtain informed consent.
2. hepatic dysfunction with Child Pugh score B or C, or ALT or AST > 5 times the upper limit;
3. renal dysfunction with estimated glomerular filtration rate (MDRD) < 50 mL/min/1.73 m2 or patient receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
4. Bacterial sepsis (besides COVID-19)
5. Positive test for influenza virus, if tested during the current illness (note: influenza testing is not required by protocol)
6. Known congenital or acquired immune deficiency,
7. Patients with hypersensitivity to ibuprofen or to more than one non-steroidal antiinflammatory drug or to more than one medication belonging to the class of sulfonamides (e.g. sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib; hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole, does not qualify for exclusion). Know allergy to any medication (either investigational or noninvestigational) planned for use in the study.
8. Patients receiving other not allowed medications (see Section: Not allowed medications)
9. Severe, active bleeding such as hemoptysis, gastrointestinal bleeding, central nervous system bleeding, and nosebleeds within 1 month before enrollment.
10. Evidence of COVID-19 disease progression during previously initiated treatment with remdesivir (alone on in any combination with other antiviral treatments), protease inhibitors (e.g. ritonavir, lopinavir, darunavir – atazanavir), tyrosine kinase
inhibitors (e.g. baricitinib, imatinib, gefitinib), convalescent plasma or intravenous immunoglobulin for COVID-19, or other investigational treatments
11. More than three infusions of remdesivir, including the loading dose, prior to randomization
12. Pregnant and lactating women.
13. Subject participating in other interventional clinical trials. Subject having received investigational therapy in the previous 3 days, or at least 5 half-lives.
14. At the time of enrollment, patients not in a clinical condition compatible with the oral administration of the study drug.

Criteri di esclusione:
1. Impossibilità di ottenere il consenso informato.
2. disfunzione epatica con punteggio Child Pugh B o C, o ALT o AST (enzimi epatici) > 5 volte il limite superiore;
3. disfunzione renale con velocità di filtrazione glomerulare stimata (MDRD) <50 mL / min / 1,73 m2 o paziente in emodialisi o dialisi peritoneale.
4. Sepsi batterica (oltre a COVID-19)
5. Test positivo per il virus dell'influenza, se testato durante la malattia in corso (nota: il test dell'influenza non è richiesto dal protocollo)
6. Immunodeficienza congenita o acquisita nota,
7. Pazienti con ipersensibilità all'ibuprofene o a più di un farmaco antinfiammatorio non steroideo o a più di un farmaco appartenente alla classe dei sulfamidici (es. Sulfametazina, sulfametossazolo, sulfasalazina, nimesulide o celecoxib; ipersensibilità
ai soli antibiotici sulfanilamide, es. sulfametossazolo, non si qualifica per l'esclusione). Nota allergia a qualsiasi farmaco (sperimentale o non sperimentale) pianificato per l'uso nello studio.
8. Pazienti che ricevono altri farmaci non consentiti dal protocollo
9. Emorragia grave e attiva come emottisi (emissione di ssangue dalle vie respiratorie), sanguinamento gastrointestinale, emorragia cerebrale e sanguinamento dal naso entro 1 mese prima dell'arruolamento.,
10. Evidenza della progressione della malattia COVID-19 durante il trattamento precedentemente iniziato con remdesivir (da solo in qualsiasi combinazione con altri trattamenti antivirali), inibitori della proteasi (ad es. Ritonavir, lopinavir, darunavir - atazanavir), inibitori della tirosin-chinasi (ad es. Baricitinib, imatinib, gefitinib), trattamento con plasma o somministrazione endovenosa di immunoglobuline per COVID-19 o altri trattamenti sperimentali
11. Più di tre infusioni di remdesivir prima della randomizzazione
12. Donne in gravidanza e in allattamento.
13. Soggetto che partecipa ad altri studi clinici interventistici. Soggetto che ha ricevuto terapia sperimentale nei 3 giorni precedenti.
14. Al momento dell'arruolamento, pazienti non in una condizione clinica compatibile con la somministrazione orale del farmaco in studio.

E.5 End points

E.5.1

Primary end point(s)

Time to the achievement of a composite endpoint based on the following occurrences, up to 28 days (time to first occurrence of any of the following): death, use of invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO), admission to intensive care unit (ICU), use of rescue therapy (see Section: Rescue therapy in thestudy protocol).

Tempo al raggiungimento di un endpoint composito basato sui seguenti eventi, fino a 28 giorni (tempo alla prima comparsa di uno qualsiasi dei seguenti): morte, uso della ventilazione meccanica invasiva o ossigenazione extracorporea a membrana (ECMO), ricovero in unità di terapia intensiva (ICU), uso della terapia di soccorso (vedere la sezione: Terapia di soccorso nel protocollo di studio).

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 28 days from the start of the treatment

Fino a 28 giorni dall'inizio del trattamento

E.5.2

Secondary end point(s)

Key Secondary Endpoints:
- Time to death
- Incidence of ICU admission
- Time to recovery (category 1 - 2 - 3 of the 7-point WHO Ordinal Scale of clinical improvement (WHO-OS); Additional Secondary Endpoints:
o Proportion of subjects achieving the composite endpoint (same as described for the primary end-point) at fixed time-points: days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) after randomization (randomization = day 1),
o Mean changes in clinical severity score based on the 7-point WHO-OS
o Time to clinical improvement 1 (decline of 1 category in the 7-point WHO-OS)
o Time to clinical improvement 2 (decline of 2 categories in the 7-point WHO-OS)
o Time to discharge from hospital (up to day 28)
o Clinical status at days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) - 60 (±2) either in hospital or at home (7-point WHO-OS). When patient is at home, his/her clinical status can be assessed by phone
o Dyspnea severity (Likert scale and VAS scale) at days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge
o Duration of supplemental oxygen treatment (days)
o Incidence of invasive mechanical ventilation use, or ECMO
o Duration of invasive mechanical ventilation, or ECMO (days)
o Duration of non-invasive mechanical ventilation (days)
o Duration of ICU admission (days)
o Duration of hospitalization since randomization (days)
o Partial pressure of oxygen (PaO2): change from baseline to the firstly available daily value at days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge
o Pulse oximetry by measurement of peripheral arterial oxygen saturation (SpO2)
o P/F ratio [partial arteriolar oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio] from baseline to days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge
o Hs-CRP: change from baseline to days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge (alternatively, CRP); Exploratory Endpoints:
o Time between onset of symptoms and initiation of the investigational treatment (days)
o Time between hospitalization and initiation of the investigational treatment (days)
o Concomitant, off-label, use of other specific COVID-19 treatments [for example: remdesivir (± baricitinib), hydroxychloroquine, protease inhibitors (e.g. lopinavir / ritonavir, darunavir – atazanavir), tyrosine kinase inhibitors (e.g. baricitinib,
imatinib, gefitinib), convalescent plasma or intravenous immunoglobulin].
o Cytokine profile (IL-1, IL-6, IL-8) measured at baseline and at days 3 and 7 (±1)
o Concentration of Reparixin in serum measured immediately before and one hour (± 15 min) after first dosing at day 3.
o SARS-CoV-2 viral burden (quantitative PCR) tested on a nasopharyngeal swab upon discharge from hospital; Safety Endpoints:
o Incidence of Adverse Events (AEs)
o Incidence of Serious Adverse Events (SAEs)
o Incidence of bacterial infections
o Main hematology / biochemistry test values at baseline and at days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge; additional biochemistry at day 21 (±2)
o Changes in neutrophil counts from baseline to days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge
o Changes in estimated Glomerular Filtration Rate (eGFR; MDRD formula) from baseline to days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge
o Changes in serum creatinine from baseline to days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge
o Changes in Alanine Transaminase (ALT) from baseline to days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge
o Changes in Aspartate Transaminase (AST) from baseline to days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge
o Changes in total bilirubin from baseline to days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge
o Clinically significant ECG changes
o Changes in blood pressure, heart rate

Endpoint secondari chiave:
- Tempo alla morte per qualsiasi causa
- Incidenza del ricovero in terapia intensiva
- Tempo al recupero (categoria 1 - 2 - 3 della scala ordinale dell'OMS a 7 punti del miglioramento clinico (WHO-OS); Endpoint secondari aggiuntivi:
o Proporzione di soggetti che raggiungono l'endpoint composito (uguale a quello descritto per l'endpoint primario) a intervalli di tempo fissi: giorni 3 - 7 (± 1) - 14 (± 2) - 21 (± 2) - 28 (± 2 ) dopo la randomizzazione (randomizzazione = giorno 1),
o Variazioni medie del punteggio di gravità clinica basato su 7 punti WHO-OS o Tempo per il miglioramento clinico 1 (declino di 1 categoria nel 7 punti WHO-OS)
o Tempo per il miglioramento clinico 2 (declino di 2 categorie nel 7 punti WHO-OS)
o Tempo di dimissione dall'ospedale (fino al giorno 28)
o Stato clinico ai giorni 3 - 7 (± 1) - 14 (± 2) - 21 (± 2) - 28 (± 2) - 60 (± 2) in ospedale oa casa (OS-OMS a 7 punti) . Quando il paziente è a casa, il suo stato clinico può essere valutato telefonicamente
o Gravità della dispnea (scala Likert e scala VAS) ai giorni 3 - 7 (± 1) - 14 (± 2) - 21 (± 2) - 28 (± 2) o fino alla dimissione
o Durata del trattamento con ossigeno supplementare (giorni)
o Incidenza dell'uso della ventilazione meccanica invasiva o ECMO
o Durata della ventilazione meccanica invasiva o ECMO (giorni)
o Durata della ventilazione meccanica non invasiva (giorni)
o Durata del ricovero in terapia intensiva (giorni)
o Durata del ricovero dalla randomizzazione (giorni)
o Pressione parziale dell'ossigeno (PaO2): cambiamento dal valore basale al primo valore giornaliero disponibile nei giorni 3 - 7 (± 1) - 14 (± 2) - 21 (± 2) - 28 (± 2)
o fino alla scarica
o Pulsossimetria mediante misurazione della saturazione di ossigeno arterioso periferico (SpO2)
o Rapporto P / F [rapporto tra pressione arteriolare parziale dell'ossigeno (PaO2) e frazione di inspirazione O2 (FiO2)] dal basale ai giorni 3-7 (± 1) - 14 (± 2) - 21 (± 2) - 28 (± 2) o fino alla dimissione
o Hs-CRP: variazione dal basale ai giorni 3-7 (± 1) - 14 (± 2) - 21 (± 2) - 28 (± 2) o fino alla dimissione (in alternativa, CRP); Endpoint esplorativi:
o Tempo tra la comparsa dei sintomi e l'inizio del trattamento sperimentale (giorni)
o Tempo tra il ricovero e l'inizio del trattamento sperimentale (giorni)
o Uso concomitante, off-label, di altri trattamenti COVID-19 specifici [ad esempio: remdesivir (± baricitinib), idrossiclorochina, inibitori della proteasi (ad esempio lopinavir / ritonavir, darunavir - atazanavir), inibitori della tirosin-chinasi (ad
esempio baricitinib, imatinib, gefitinib ), plasma convalescente o immunoglobulina endovenosa].
o Profilo delle citochine (IL-1, IL-6, IL-8) misurato al basale e ai giorni 3 e 7 (±1)
o Concentrazione di Reparixin nel siero misurata immediatamente prima e un'ora (± 15 min) dopo la prima somministrazione al giorno 3.
o Carico virale SARS-CoV-2 (PCR quantitativa) testato su tampone nasofaringeo alla dimissione dall'ospedale; Endpoint di sicurezza:
o Incidenza di eventi avversi (EA)
o Incidenza di eventi avversi gravi (SAE)
o Incidenza di infezioni batteriche
o Principali valori dei test ematologici / biochimici al basale e ai giorni 3 - 7 (± 1) - 14 (± 2) - 21 (± 2) - 28 (± 2) o fino alla dimissione; in aggiunta la biochimica al giorno 21 (± 2)
o Cambiamenti nella conta dei neutrofili dal basale ai giorni 3 - 7 (± 1) - 14 (± 2) - 21 (± 2) - 28 (± 2) o fino alla dimissione
o Variazioni della velocità di filtrazione glomerulare stimata (eGFR; formula MDRD) dal basale ai giorni 3-7 (± 1) - 14 (± 2) - 21 (± 2) - 28 (± 2) o fino alla dimissione
o Variazioni della creatinina sierica dal basale ai giorni 3-7 (± 1) - 14 (± 2) - 21 (± 2) - 28 (± 2) o fino alla dimissione
o Modifiche dell'alanina transaminasi (ALT) dal basale ai giorni 3-7 (± 1) - 14 (± 2) - 21 (± 2) - 28 (± 2) o fino alla dimissione
o Variazioni dell'aspartato transaminasi (AST) dal basale ai giorni 3-7 (± 1) - 14 (± 2) - 21 (± 2) - 28 (± 2) o fino alla dimissione
o Variazioni della bilirubina totale dal basale ai giorni 3-7 (± 1) - 14 (± 2) - 21 (± 2) - 28 (± 2) o fino alla dimissione
o Cambiamenti ECG clinicamente significativi
o Cambiamenti nella pressione sanguigna, frequenza cardiaca

E.5.2.1

Timepoint(s) of evaluation of this end point

At each available time points throughout the study; As described in the endpoint or, if not specified, at each available time points throughout the study; As decribed in each endpoint. Concomitant medication will be evaluated at each available time points throughout the study.; As described in the endpoint or, if not specified, at each available time points throughout the study

In ogni momento disponibile durante lo studio; Ai tempi descritti nel endpoint oppure, se non specificato, in ogni moment disponibile durante lo studio; Come descritto in ogni endpoint. La somministrazione concomitante di farmaci sarà valutata in ogni momento disponibile durante lo studio.; Ai tempi descritti nel endpoint oppure, se non specificato, in ogni momento disponibile durante lo 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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

103

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

303

F.4.2

For a multinational trial

F.4.2.1

In the EEA

303

F.4.2.2

In the whole clinical trial

303

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, if necessary, will be followed up according to their clinical needs by the referring physician.

I pazienti, nel caso avessero necessità, verranno seguiti a seconda delle loro esigenze cliniche dal medico di riferimento.

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

2021-01-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-18

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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