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    Summary
    EudraCT Number:2020-005759-18
    Sponsor's Protocol Code Number:CV43043
    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:2021-06-08
    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 number2020-005759-18
    A.3Full title of the trial
    A MULTICENTER, PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, OUTPATIENT STUDY TO EVALUATE THE EFFICACY, SAFETY, AND ANTIVIRAL ACTIVITY OF RO7496998 AT-527 IN PATIENTS WITH MILD OR MODERATE COVID-19
    Studio multicentrico di fase III, randomizzato, in doppio cieco, controllato con placebo per valutare l’efficacia, la sicurezza e l’attività antivirale di RO7496998 (AT-527) in pazienti non ospedalizzati con covid-19 lieve o moderato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the Efficacy, Safety, and Antiviral Activity of RO7496998 (AT-527) in Patients with Mild or Moderate COVID-19
    Studio per valutare l'efficacia, la sicurezza e l'attività antivirale di RO7496998 (AT-527) in pazienti con COVID-19 moderato o lieve
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberCV43043
    A.5.4Other Identifiers
    Name:IND NUMBERNumber:149508
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann- La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number00416168881111
    B.5.5Fax number0041616919319
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    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 No
    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 nameRO7496998 hemisulfate (AT-527)
    D.3.2Product code [RO7496998]
    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.3.9.1CAS number 2241337-84-6
    D.3.9.2Current sponsor codeRO7496998
    D.3.9.4EV Substance CodeSUB207005
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number275
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild to Moderate coronavirus disease 2019 (COVID-19)
    Malattia da coronavirus da lieve a moderata 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    COVID-19 is an infectious disease caused by coronavirus strain. Coronavirus is mainly transmitted from person to person through droplets generated when an infected person coughs, sneezes, or exhales.
    Il COVID-19 è una malattia infettiva causata da un ceppo di coronavirus. Si trasmette principalmente da persona a persona attraverso goccie quando una persona infetta tossisce, starnutisce o espira.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory 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
    To evaluate the efficacy of RO7496998 (AT-527) compared with placebo based on the time to alleviation or improvement of COVID-19 symptoms
    Valutare l’efficacia di RO7496998 (AT-527) rispetto al placebo in base al tempo di alleviamento o miglioramento dei sintomi del COVID-19
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of RO7496998 (AT-527) compared with placebo (defined as the time from randomization to the point at which the following criterion is met and maintained for at least 21.5 hours) based on:
    Time to alleviation of symptoms
    Time to one-category improvement of baseline presenting COVID-19 symptoms
    Time to alleviation of individual symptoms
    Proportion of patients requiring hospitalization for COVID-19
    Proportion of patients with >=1 COVID-19 related medically attended visit through to study end
    Duration of fever
    Frequency of COVID-19 related complications,
    Proportion of patients with any post-treatment infection
    Proportion of patients with all-cause mortality
    To evaluate the antiviral activity of RO7496998 (AT-527) compared with placebo
    To evaluate the safety of RO7496998 (AT-527) compared with placebo
    To characterize the pharmacokinetic (PK) profile of AT-511 and major metabolites in plasma
    Valutare l’efficacia di RO7496998 (AT-527) rispetto al placebo (definita come il tempo dalla randomizzazione sino al momento in cui il seguente criterio è soddisfatto e mantenuto per almeno 21,5 ore) in base a:
    Tempo all’alleviamento dei sintomi
    Tempo al miglioramento di una categoria dei sintomi del COVID-19 presenti al basale
    Tempo all’alleviamento dei singoli sintomi
    Percentuale di pazienti che richiede il ricovero per COVID-19
    Percentuale di pazienti sottoposti a >= 1 visita medica correlata al COVID-19 entro la fine dello studio
    Durata della febbre
    Frequenza delle complicanze correlate al COVID-19
    Percentuale di pazienti con qualsiasi infezione post-trattamento
    Percentuale di pazienti con mortalità per tutte le cause
    Valutare l’attività antivirale di RO7496998 (AT-527) rispetto al placebo
    Valutare la sicurezza di RO7496998 (AT-527) rispetto al placebo
    Definire il profilo farmacocinetico (PK) di AT-511 e dei principali metaboliti nel plasma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age >=18 years (regardless of weight) at the time of signing informed consent or age >=12 to <18 years (weight >=40 kilogram) at the time of signing informed consent (and assent)
    Ability to comply with all aspects of the study protocol, including providing samples for virology, in the opinion of the investigator
    At least three of the following symptoms of at least moderate (score >=2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea
    Positive severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) diagnostic test (reverse-transcriptase polymerase chain reaction [RTPCR] or validated rapid antigen test) <=72 hours prior to randomization
    Symptoms consistent with mild or moderate COVID-19, as determined by the Investigator, with onset <=5 days before randomization
    For women of childbearing potential and girls at or beyond menarche (age >=12 to <18 years): agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 30 days after the final dose of RO7496998 (AT-
    527)
    Età >= 18 anni (indipendentemente dal peso) al momento della firma del consenso informato o età da >= 12 a <18 anni (peso >= 40 chilogrammi) al momento della firma del consenso (e dell’assenso) informato
    Capacità, a giudizio dello sperimentatore, di rispettare tutti gli aspetti del protocollo dello studio, inclusa la fornitura di campioni per gli esami di virologia
    Almeno tre dei seguenti sintomi di intensità almeno moderata (punteggio >= 2 secondo il diario dei sintomi del COVID-19): congestione nasale o naso che cola, mal di gola, tosse, respiro affannoso, dolori muscolari, stanchezza, cefalea, brividi o sudorazione, sensazione di caldo o di essere febbricitante, nausea, vomito o diarrea
    Test diagnostico positivo per la sindrome respiratoria acuta grave da coronavirus-2 (SARS-CoV-2) (reazione a catena della polimerasi a trascrittasi inversa [RT-PCR] o test antigenico rapido convalidato) <= 72 ore prima della randomizzazione
    Sintomi compatibili con COVID-19 di entità lieve o moderata, in base a quanto stabilito dallo sperimentatore, con insorgenza <= 5 giorni prima della randomizzazione
    Per le donne in età fertile e le ragazze al o post-menarca (età compresa tra >= 12 e < 18 anni): consenso all’astensione (dai rapporti eterosessuali) o all’utilizzo di misure contraccettive adeguate durante il periodo di trattamento e per i 30 giorni successivi all’assunzione dell’ultima dose di RO7496998 (AT-527)
    E.4Principal exclusion criteria
    Clinical signs indicative of COVID-19 illness requiring hospitalization
    Admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to COVID-19
    In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization
    Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
    Treatment with a COVID-19 therapeutic agent against SARS-CoV-2 including, but not limited to, other direct or indirect acting antivirals, dexamethasone, interferons, convalescent plasma, monoclonal antibodies against SARS CoV-2, intravenous immunoglobulin or other emergency use authorization (EUA)-approved treatments within the last 2 weeks prior to the screening visit
    Concomitant use of P-glycoprotein (P-gp) inhibitors or inducers
    Known allergy or hypersensitivity to components of study drug
    Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of RO7496998 (AT-527)
    Abnormal laboratory test results at screening
    Requirement of any prohibited medications during the study
    Known active viral or bacterial infection at the time of screening
    Any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study
    Segni clinici indicativi di malattia da COVID-19 per cui è necessario il ricovero
    Ricovero in ospedale prima della randomizzazione o già ricoverato al momento della randomizzazione per via del COVID-19
    A giudizio dello sperimentatore, il paziente è suscettibile di essere interessato da un imminente peggioramento e necessitare di ricovero
    Trattamento con un farmaco sperimentale entro 5 emivite o 30 giorni (a seconda di quale sia il più lungo) dalla randomizzazione
    Trattamento con un agente terapeutico per COVID-19 anti-SARS-CoV-2 tra cui, ma senza limitazioni, altri antivirali ad azione diretta o indiretta, desametasone, interferoni, plasma di pazienti guariti, anticorpi monoclonali anti-SARS CoV-2, immunoglobuline per somministrazione endovenosa o altri trattamenti autorizzati/approvati in caso di emergenza (Emergency Use Authorization, EUA negli Stati Uniti) nelle ultime 2 settimane antecedenti la visita di screening
    Uso concomitante di inibitori o induttori della glicoproteina P (P-gp)
    Allergia o ipersensibilità nota ai componenti del farmaco in studio
    Gravidanza o allattamento al seno o intenzione di rimanere incinta durante lo studio o entro 30 giorni dall’assunzione dell’ultima dose di RO7496998 (AT-527)
    Risultati anomali degli esami di laboratorio allo screening
    Necessità di assumere farmaci vietati durante lo studio
    Infezione virale o batterica attiva nota al momento dello screening
    Qualsiasi condizione medica clinicamente significativa o valori anomali di laboratorio che, a giudizio dello sperimentatore, comprometterebbero la sicurezza del paziente o influirebbero sul rispetto da parte sua del protocollo o sulle osservazioni in merito a sicurezza/efficacia durante lo studio
    E.5 End points
    E.5.1Primary end point(s)
    Time to alleviation or improvement of COVID-19 symptoms (Items 1-12 of the COVID-19 symptom diary) maintained for a duration of 21.5 hours
    Tempo per alleviare o migliorare i sintomi COVID-19 (Articoli 1-12 del diario dei sintomi COVID-19) mantenuto per una durata di 21,5 ore
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Day 1 to day 29
    1. Dal giorno 1 al giorno 29
    E.5.2Secondary end point(s)
    Time to alleviation of symptoms defined as the time from randomization to the point at which the following criterion is met and maintained for at least 21.5 hours: Score of 0 or 1 for Items 1-12 of the COVID-19
    Symptom Diary
    Time to one-category improvement of baseline presenting COVID-19 symptoms maintained for a duration of 21.5 hours defined as time from randomization to when the symptoms have improved by at least one category from baseline on the Likert scale
    Time to alleviation of individual symptoms, defined as the time from randomization to the point at which the following criterion is met and maintained (for each individual symptom) for at least 21.5 hours: Score of 0 or 1 for Items 1-14 of the COVID-19 Symptom Diary
    Percentage of patients requiring hospitalization for COVID-19
    Percentage of patients with >=1 COVID-19 related medically attended visit through to study end (defined as hospitalization, emergency room [ER] visit, urgent care visit, physician's office visit, or telemedicine visit, with the primary reason for the visit being COVID-19)
    Duration of fever (time to return to afebrile state [temperature <=37.5 degrees celsius] and remaining so for at least 21.5 hours)
    Frequency of COVID-19 related complications
    Percentage of patients with any post-treatment infection
    Percentage of patients with all-cause mortality
    Change from baseline in amount of SARS-CoV-2 virus RNA, as measured by (reverse-transcriptase quantitative polymerase chain reaction) RTqPCR at each timepoint
    Time to cessation of SARS-CoV-2 viral shedding, as measured by RTqPCR
    Percentage of patients positive for SARS-Cov-2 virus RNA, as measured by RT-qPCR at specified timepoints
    Area under the curve in the amount of SARS-CoV-2 virus RNA, as measured by RT-qPCR
    Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0
    Change from baseline in vital signs, including peripheral capillary oxygen saturation (SpO^2)
    Change from baseline in targeted clinical laboratory test results
    Plasma concentration of AT-511 (the free base form of RO7496998 [AT- 527]), AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010) at specified timepoints
    Tempo all’alleviamento dei sintomi definito come il tempo dalla randomizzazione al momento in cui il seguente criterio è soddisfatto e mantenuto per almeno 21,5 ore: punteggio di 0 o 1 per le voci 1-12 del Diario dei sintomi del COVID-19
    Tempo al miglioramento di una categoria dei sintomi del COVID-19 presenti al basale mantenuto per una durata di 21,5 ore definito come il tempo dalla randomizzazione fino al miglioramento di almeno una categoria rispetto al basale sulla scala Likert
    Tempo all’alleviamento di singoli sintomi definito come il tempo dalla randomizzazione fino al momento in cui il seguente criterio è soddisfatto e mantenuto (per ogni singolo sintomo) per almeno 21,5 ore: punteggio di 0 o 1 per le voci 1-14 del Diario dei sintomi del COVID-19
    Percentuale di pazienti che richiede il ricovero per COVID-19
    Percentuale di pazienti sottoposti a >= 1 visita medica correlata sotto il profilo medico al COVID-19 entro la fine dello studio (definita come ricovero in ospedale, accesso al pronto soccorso, visita d’urgenza, visita ambulatoriale o in telemedicina, aventi come motivazione principale il COVID-19)
    Durata della febbre (tempo al ritorno allo stato di assenza di febbre [temperatura <= 37,5 gradi Celsius] e permanenza in questa condizione per almeno 21,5 ore)
    Frequenza delle complicanze correlate al COVID-19
    Percentuale di pazienti con qualsiasi infezione post-trattamento
    Percentuale di pazienti con mortalità per tutte le cause
    Variazione rispetto al basale della quantità di RNA del virus SARS-CoV-2, misurata mediante RT-qPCR (reazione a catena della polimerasi quantitativa a trascrittasi inversa) a ciascuna rilevazione
    Tempo alla cessazione della propagazione del virus di SARS-CoV-2, misurata mediante RT-qPCR
    Percentuale di pazienti positivi alla presenza dell’RNA del virus di SARS-Cov-2, misurata mediante RT-qPCR a specifiche rilevazioni
    Area sotto la curva nella quantità di RNA del virus di SARS-CoV-2, misurata mediante RT-qPCR
    Incidenza e gravità, determinata secondo i criteri NCI CTCAE v5.0, degli eventi avversi
    Variazione rispetto al basale dei segni vitali, tra cui la saturazione in ossigeno (SpO^2) del sangue capillare a livello periferico
    Variazione rispetto al basale dei risultati degli esami clinici di laboratorio mirati
    Concentrazione plasmatica di AT-511 (la forma di base libera di RO7496998 [AT-527]), AT-551, AT-229 e AT-273 (un surrogato della concentrazione intracellulare del metabolita trifosfato attivo AT-9010) a determinate rilevazioni
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. Day 1 to day 29
    4-5. Up to day 33
    6. Day 1 to day 29
    7-9. Up to day 33
    10-13. Day 1 to day 14
    14. Up to day 33
    15. Screening (Day -2 to -1) to day 14
    16. Screening (Day -2 to -1) and day 5
    17. At Days 1, 5 and 7
    1-3. Dal giorno 1 al giorno 29
    4-5. Fino al giorno 33
    6. Dal giorno 1 al giorno 29
    7-9. Fino al giorno 33
    10-13. Dal giorno 1 al giorno 14
    14. Fino al giorno 33
    15. Screening (dal giorno -2 al giorno -1) al giorno 14
    16. Screening (dal giorno -2 al giorno -1) e il giorno 5
    17. Nei giorni 1, 5 e 7
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA115
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Belgium
    Brazil
    Colombia
    Denmark
    France
    Germany
    Hungary
    Italy
    Japan
    Mexico
    Peru
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    Switzerland
    Turkey
    Ukraine
    United States
    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
    LPLV
    LPLV
    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 months5
    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 months5
    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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 150
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1236
    F.1.3Elderly (>=65 years) No
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 1386
    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)
    A follow up , observational study (CV43140) is planned to roll over patients in this study to collect labs and monitor safety.
    È previsto uno studio osservazionale di follow-up (CV43140) a cui prenderanno parte i pazienti in questo studio che avrà la finalità di raccogliere analisi di laboratorio e monitorare la sicurezza.
    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 Decision2021-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-24
    P. End of Trial
    P.End of Trial StatusOngoing
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