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    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001528-32
    A.3Full 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.3.1Title 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.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberARCO-Homestudy
    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 NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
    B.5.2Functional name of contact pointDipartimento di Epidemiologia Digno
    B.5.3 Address:
    B.5.3.1Street AddressVIA PORTUENSE
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00149
    B.5.3.4CountryItaly
    B.5.6E-mailsimone.lanini@inmi.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.2.1.1.1Trade name Kaletra
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie
    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 nameKaletra
    D.3.2Product code [-]
    D.3.4Pharmaceutical form 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 INNLOPINAVIR
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITONAVIR
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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.2.1.1.1Trade name PLAQUENIL - 200 MG COMPRESSE RIVESTITE 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS S.P.A.
    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 namePLAQUENIL
    D.3.2Product code [-]
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor code-
    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.IMP: 3
    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.2.1.1.1Trade name Rezolsta
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag SpA,
    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 nameREZOLSTA
    D.3.2Product code [-]
    D.3.4Pharmaceutical form 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 INNDARUNAVIR
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcobicistat
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.IMP: 4
    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.2.1.1.1Trade name Avigan
    D.2.1.1.2Name of the Marketing Authorisation holderFujifilm
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameAvigan
    D.3.2Product code [-]
    D.3.4Pharmaceutical form 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 INNFavipiravir
    D.3.9.2Current sponsor code-
    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
    Coronavirus Covid 19 infection
    Infezione da coronavirus Covid 19
    E.1.1.1Medical condition in easily understood language
    Coronavirus Covid 19 infection
    Infezione da coronavirus Covid 19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level HLT
    E.1.2Classification code 10047468
    E.1.2Term Viral lower respiratory tract infections
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary 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.2.3Trial contains a sub-study No
    E.3Principal 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.4Principal 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.5.1Primary 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.5.1.1Timepoint(s) of evaluation of this end point
    7 days
    14 days
    7 giorni
    14 giorni
    E.5.2Secondary 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.5.2.1Timepoint(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.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Braccio di controllo. Nessun trattamento antivirale
    Control arm. No specific antiviral treatment.
    E.8.2.4Number of treatment arms in the trial5
    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 concerned5
    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 months3
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days10
    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: 261
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 174
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    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 state435
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 435
    F.4.2.2In 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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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