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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   40977   clinical trials with a EudraCT protocol, of which   6698   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2020-001501-24
    Sponsor's Protocol Code Number:IRST100.47
    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: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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001501-24
    A.3Full title of the trial
    PROTECT: A randomized study with Hydroxychloroquine versus observational support for prevention or early phase treatment of Coronavirus disease (COVID-19).
    PROTECT: studio randomizzato con idrossiclorochina vs osservazione per la prevenzione e il trattamento precoce della malattia da coronavirus (COVID-19)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PROTECT: studio randomizzato con idrossiclorochina vs osservazione per la prevenzione e il trattamento precoce della malattia da coronavirus (COVID-19)
    PROTECT: studio randomizzato con idrossiclorochina vs osservazione per la prevenzione e il trattamento precoce della malattia da coronavirus (COVID-19)
    A.3.2Name or abbreviated title of the trial where available
    PROTECT
    PROTECT
    A.4.1Sponsor's protocol code numberIRST100.47
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI - IRST IRCCS - MELDOLA (FC)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI - IRST IRCCS - MELDOLA (FC)
    B.5.2Functional name of contact pointCentro di Coordinamento Studi IRST
    B.5.3 Address:
    B.5.3.1Street Addressvia Piero Maroncelli, 40
    B.5.3.2Town/ cityMeldola (FC)
    B.5.3.3Post code47014
    B.5.3.4CountryItaly
    B.5.4Telephone number0547394547
    B.5.5Fax number0544285330
    B.5.6E-mailcc.ubsc@irst.emr.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIDROSSICLOROCHINA_IRSTIRCCS
    D.3.2Product code [IDROSSICLOROCHINA_IRSTIRCCS]
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIDROSSICLOROCHINA SOLFATO
    D.3.9.1CAS number 118-42-3
    D.3.9.2Current sponsor codeIDROSSICLOROCHINA_IRSTIRCCS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    Group 1: SARS-CoV-2-exposed subjects, as household members/contacts of COVID-19 patients
    Group 2: Patients with COVID-19 asymptomatic or paucisymptomatic in home situation
    Gruppo 1: Soggetti esposti a SARS-CoV-2 come conviventi e/o contatti di pazienti con COVID-19
    Gruppo 2: Pazienti con COVID-19 confermato, asintomatici o paucisintomatici in confinamento domiciliare non in trattamento specifico per COVID-19
    E.1.1.1Medical condition in easily understood language
    Group 1: SARS-CoV-2-exposed subjects , as household members/contacts of COVID-19 patients
    Group 2: Patients with COVID-19 asymptomatic or paucisymptomatic in home situation
    Gruppo 1: Soggetti esposti a SARS-CoV-2 come conviventi e/o contatti di pazienti con COVID-19
    Gruppo 2: Pazienti con COVID-19 confermato, asintomatici o paucisintomatici in confinamento domiciliare
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Group 1: Prevention of COVID-19 or related symptoms in SARS-CoV-2-exposed subjects, as household members/contacts of COVID-19 patients within one month from randomization
    Group 2: Efficacy of Hydroxychloroquine in early phase COVID-19 within 14 days from randomization
    Gruppo 1: Prevenzione dell’insorgenza di COVID-19 o dei sintomi correlati nei membri del nucleo familiare / contatti di pazienti con COVID-19 entro un mese dalla randomizzazione
    Gruppo 2: Efficacia della idrossiclorochina nei pazienti con COVID-19 in fase precoce entro 14 giorni dalla randomizzazione
    E.2.2Secondary objectives of the trial
    To compare the efficacy of Hydroxychloroquine:
    - as prophylaxis, in prevention of COVID-19 infection in a population of SARS-CoV-2-exposed subjects (household members/contacts of COVID-19 pts) respect to observation only
    - as prophylaxis, in subgroup population (stratification factors, class of age, gender)
    - in early phase COVID-19 pts within 14 days from randomization in subgroup population (stratification factors, class of age, gender)
    - in early phase COVID-19 pts within 1 month from randomization in overall population and in subgroup population (stratification factors, class of age, gender)
    To evaluate in study groups:
    - treatment toxicity
    - QoL
    To participate in European network for meta analysis of similar studies or in data collection for identifying prediction rule of outcomes.

    Explorative: To identify biologic features that correlate with susceptibility or resistance to SARs-CoV2 infection or treatment with Hydroxychloroquine in study subgroups.
    Confrontare l'efficacia dell'idrossiclorochina:
    - come profilassi, nella prevenzione dell'infezione nella popolaz. di soggetti esposti a SARS-CoV-2 (membri della famiglia/contatti di paz. COVID-19) rispetto alla sola osservazione
    - come profilassi, nei sottogruppi della popolaz. in studio (fattori di stratificazione, età, genere)
    - nei paz. COVID-19 in fase precoce entro 14 gg dalla randomiz. nei sottogruppi di popolaz. (fattori di stratificazione, età, genere)
    - nei paz. COVID-19 in fase precoce entro 1 mese dalla randomiz. nella popolaz. generale e nei sottogruppi (fattori di stratificazione, età, genere)
    Valutare nei 2 gruppi:
    - tossicità
    - QoL
    Partecipare alla rete europea per la meta analisi di studi simili o alla raccolta di dati per identificare la regola predittiva degli outcomes.

    Obiettivo esplorativo: Identificare le caratteristiche biologiche correlate alla suscettibilità o alla resistenza all'infezione o al trattamento con idrossiclorochina nei sottogruppi in studio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or Female, aged >= 18 years
    2) SARS-CoV-2-exposed subjects, as household members and/or contacts of COVID-19 patients (GROUP 1). In this group are included Health care professionals in contact with COVID-19 patients. or
    3) COVID-19 patients, asymptomatic or paucisymptomatic in home situation who are not in treatment with any anti COVID-19 medication (GROUP 2)
    4) Absence of any COVID-19 symptom in last week before randomization (fever >37.5°C, cough, dyspnea) (only for GROUP 1 subjects)
    5) Paracetamol treatment is accepted only for GROUP 2.
    6) Participant is willing and able to give informed consent for participation in the study (either recorded during a telephonic interview or signed in person) and agrees with the study and its conduct.
    1) Maschi o femmine con età >= 18 anni
    2) Soggetti esposti a SARS-CoV-2, come conviventi e / o contatti di pazienti con COVID-19 (GRUPPO 1). In questo gruppo sono inclusi gli operatori sanitari a contatto con pazienti con COVID-19
    Oppure
    3) Pazienti con COVID-19 asintomatici o paucisintomatici in confinamento domiciliare, che non sono in trattamento con alcun farmaco anti COVID-19 (GRUPPO 2)
    4) Assenza di qualsiasi sintomo compatibile con COVID-19 nell'ultima settimana prima della randomizzazione (febbre>37,5 °C, tosse, dispnea) (solo per soggetti del GRUPPO 1)
    5) Il trattamento con paracetamolo è accettato solo per i soggetti del GRUPPO 2.
    6) Il soggetto è in grado di fornire il consenso informato per la partecipazione allo studio (registrato durante un colloquio telefonico o firmato di persona) e accetta di seguire le procedure dello studio.
    E.4Principal exclusion criteria
    1) Reported anamnesis for:
    a. Intolerance or previous toxicity for hydroxychloroquine/chloroquine
    b. Bradycardia or reduction rhythm of heart with arrythmias
    c. Ischemic heart disease
    d. Retinopathy
    e. Congestive heart failure under/with use of diuretics
    f. Favism or glucose-6-phosphate dehydrogenase (G6PD) deficiency
    g. Diabetes type 1
    h. Major comorbidities like advanced chronic kidney disease or dialysis therapy, known history of ventricular arrhythmias, any oncologic/hematologic malignancy.
    i. Severe neurological and mental illness
    2) Any other contraindication to take hydroxychloroquine
    3) Already taking chloroquine, hydroxychloroquine or analogous during the past 3 weeks
    4) Use of other antiviral agents in the last 3 weeks
    5) Known positiveness for HIV, active HCV, HBV infection
    6) Subject with a positive test for SARS-CoV-2 (for Group 1)
    7) Pregnant or lactating
    8) Current use of medications with known significant drug-drug interactions: digoxin, hypoglycemic agents, anticonvulsant, Cyclosporine, Phenylbutazone, drugs that inhibit CYP2D6
    9) Known prolonged QT syndrome or current use of drugs with known QT prolungation
    10) Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
    1) Anamnesi segnalata per:
    a. Intolleranza o tossicità per idrossiclorochina / clorochina
    b. Bradicardia o riduzione del ritmo cardiaco con aritmie
    c. Cardiopatia ischemica
    d. Retinopatia
    e. Insufficienza cardiaca congestizia sotto/con uso di diuretici
    f. Favismo o carenza di glucosio-6-fosfato deidrogenasi (G6PD)
    g. Diabete di tipo 1
    h. Comorbidità maggiori come malattia renale cronica avanzata o terapia dialitica, anamnesi nota di aritmie ventricolari, qualsiasi neoplasia oncoematologica
    i. Grave malattia neurologica e mentale
    2) Qualsiasi altra controindicazione all'assunzione di idrossiclorochina
    3) Assunzione di clorochina, idrossiclorochina o analogo nelle ultime 3 settimane
    4) Uso di altri agenti antivirali nelle ultime 3 settimane
    5) Positività nota per l'infezione da HIV, HCV attiva, HBV
    6) Soggetto con un test positivo per SARS-CoV-2 (per il GRUPPO 1)
    7) Donne in gravidanza o in allattamento
    8) Assunzione di farmaci con note e significative interazioni farmacologiche: digossina, agenti ipoglicemizzanti, anticonvulsivanti, Ciclosporina, Fenilbutazone, farmaci che inibiscono il CYP2D6
    9) Nota Sindrome del QT lungo o assunzione di farmaci che prolungano il QT
    10) Partecipazione a un'altra sperimentazione clinica con agenti sperimentali entro 30 giorni dallo screening dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Group 1: the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization
    Group 2: the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization
    Gruppo 1: la percentuale di soggetti del Gruppo 1, che diventano sintomatici e / o positivi in ciascun braccio entro 1 mese dalla randomizzazione.
    Gruppo 2: la percentuale di soggetti del Gruppo 2 che diventano negativi al tampone in ciascun braccio entro 14 giorni dalla randomizzazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 months
    4 mesi
    E.5.2Secondary end point(s)
    Variation in Quality of Life scores in different time points (weekly) respect to baseline values in both Group 1 and Group 2 populations.; Absolute and relative frequencies of Serious Adverse Events (CTCAE version 5.0) in both arms for the Group 1 and Group 2.; To participate in European network for meta-analysis of similar studies or in data collection for identifying prediction rule of outcomes.; Explorative Objective; To identify biologic features that correlate with susceptibility or resistance to SARS-CoV-2 infection or treatment with Hydroxychloroquine in a subgroup of household members/contacts of COVID-19 patients or COVID-19 patients enrolled.; The proportion of subjects with positive swabs in randomized population of SARS-CoV-2-exposed subjects (Group 1) within 1 month from randomization in both arms.; The proportion of subjects of Group 1 who become symptomatic in each arm within 1 month from randomization, in subgroup population identified by stratification factors, class of age and gender.; The proportion of subjects of Group 2 who become swab negative in each arm within within 14 days from randomization, in subgroup population identified by stratification factors, class of age and gender.; The proportion of subjects of Group 2 who become swab negative in each arm within 1 month from randomization in overall population and in subgroup population identified by stratification factors, class of age and gender.
    Variazione dei punteggi di qualità della vita in diversi punti temporali (settimanali) rispetto ai valori basali nelle popolazioni del gruppo 1 e del gruppo 2.; Frequenze assolute e relative di eventi avversi gravi (CTCAE versione 5.0) in entrambi i bracci per la popolazione globale (gruppo 1 e 2); Partecipare alla rete europea per la meta analisi di studi simili o alla raccolta di dati per identificare la regola predittiva degli outcomes.; Obiettivo esplorativo: Identificare le caratteristiche biologiche correlate alla suscettibilità o alla resistenza all'infezione o al trattamento con idrossiclorochina in un sottogruppo di membri della famiglia/ contatti di pazienti COVID-19 o pazienti COVID-19 arruolati.; La proporzione di soggetti con tampone positivo nella popolazione randomizzata di soggetti esposti a SARS-CoV-2 (Gruppo 1) entro 1 mese dalla randomizzazione in entrambi i bracci.; La proporzione di soggetti del Gruppo 1 che diventano sintomatici in ciascun braccio di trattamento entro 1 mese dalla randomizzazione nei sottogruppi di popolazione identificati dai fattori di stratificazione, classe di età, genere.; La proporzione di soggetti del Gruppo 2 che diventano negativi al tampone in ciascun braccio entro 14 giorni dalla randomizzazione, nella popolazione di sottogruppi identificata da fattori di stratificazione, classe di età e genere.; La proporzione di soggetti del Gruppo 2 che diventano negativi al tampone in ¿¿ciascun braccio entro 1 mese dalla randomizzazione nella popolazione complessiva e nei sottogruppi di popolazione identificati dai fattori di stratificazione, classe di età e genere.
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 months; 10 months; 10 months; 10 months; 4 monts; 4 monts; 4 monts; 4 months
    10 mesi; 10 mesi; 10 mesi; 10 mesi; 4 mesi; 4 mesi; 4 mesi; 4 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    Qualità della vita
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Osservazione
    Observation
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2300
    F.4.2.2In the whole clinical trial 2300
    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)
    Telephonic interviews every 4 weeks for up to 6 months, to register:
    - changes in body temperature
    - general health state
    - onset (Group 1) or change (Group 2) of any symptom compatible with COVID-19
    - date and result of rhino/oro-pharyngeal swab (if performed)
    - any adverse event occurred within one after treatment stop;
    - any contact with COVID-19 patient (other than the cohabitant for group 1) or any risk situation
    - Quality of Life Questionnaires
    - concomitant medications
    Interviste telefoniche ogni 4 settimane per 6 mesi, per registrare:
    - variazioni della temperatura corporea
    - stato di salute
    - insorgenza (GRUPPO 1) o modifica (GRUPPO 2) di sintomi compatibili con COVID-19
    - data e esito dell’eventuale tampone rino/oro-faringeo
    - eventi avversi verificati entro un mese dopo l'ultimo trattamento
    - qualsiasi contatto con paz. COVID-19 (diverso dal convivente per il GRUPPO 1) o situazioni di rischio
    - Questionari sulla qualità della vita
    - farmaci concomitanti
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-20
    P. End of Trial
    P.End of Trial StatusOngoing
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