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    Summary
    EudraCT Number:2022-002827-36
    Sponsor's Protocol Code Number:C4671042
    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:2022-11-25
    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 number2022-002827-36
    A.3Full title of the trial
    AN INTERVENTIONAL, EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE A REPEAT 5-DAY COURSE OF NIRMATRELVIR/RITONAVIR COMPARED TO PLACEBO/RITONAVIR IN PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH REBOUND OF COVID-19
    SYMPTOMS AND RAPID ANTIGEN TEST POSITIVITY
    UNO STUDIO DI FASE 2, INTERVENTISTICO, RANDOMIZZATO, IN DOPPIO CIECO, A DUE BRACCI, PER VALUTARE L’EFFICACIA E LA SICUREZZA DI UN CICLO RIPETUTO DI 5 GIORNI DI NIRMATRELVIR/RITONAVIR RISPETTO A PLACEBO/RITONAVIR IN PARTECIPANTI DI ALMENO 12 ANNI DI ETÀ CON RICOMPARSA DEI SINTOMI DI COVID-19 E POSITIVITÀ AL TEST ANTIGENICO RAPIDO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Learn About a Repeat 5-Day Treatment with Nirmatrelvir/Ritonavir in People with Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment with Nirmatrelvir/Ritonavir
    Uno studio per acquisire maggiori informazioni su un ciclo ripetuto di 5 giorni con nirmatrelvir/ritonavir in persone con ricomparsa dei sintomi di COVID-19 e positività al SARS-CoV-2 dopo aver terminato il trattamento con nirmatrelvir/ritonavir
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberC4671042
    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 SponsorPFIZER INC
    B.1.3.4CountryUnited States
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 nameNirmatrelvir
    D.3.2Product code [PF-07321332]
    D.3.4Pharmaceutical form Film-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 INNNirmatrelvir
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB220919
    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: 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 RITONAVIR
    D.2.1.1.2Name of the Marketing Authorisation holderCamber Pharmaceuticals, Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameRitonavir
    D.3.2Product code [Ritonavir]
    D.3.4Pharmaceutical form Capsule
    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 INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboFilm-coated tablet
    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
    SARS-CoV-2 Infection
    Infezione da SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    COVID-19
    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 23.1
    E.1.2Level PT
    E.1.2Classification code 10084460
    E.1.2Term COVID-19 treatment
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of nirmatrelvir/ritonavir to placebo/ritonavir on viral RNA level in NP swabs in participants with mild-to-moderate COVID-19.
    Confrontare l’effetto di nirmatrelvir/ritonavir con placebo/ritonavir sul livello di RNA virale nei tamponi nasofaringei in partecipanti con COVID-19 da lieve a moderato.
    E.2.2Secondary objectives of the trial
    - To compare the effect of nirmatrelvir/ritonavir to placebo/ritonavir on the duration of viral shedding.
    - To compare the effect of nirmatrelvir/ritonavir to placebo/ritonavir on the duration and severity of signs and symptoms in participants with mild-to-moderate COVID-19.
    - To describe the safety and tolerability of nirmatrelvir/ritonavir in participants with mild-tomoderate
    COVID-19.
    • Confrontare l’effetto di nirmatrelvir/ritonavir con placebo/ritonavir sulla durata dello shedding virale.
    • Confrontare l’effetto di nirmatrelvir/ritonavir con placebo/ritonavir sulla durata e gravità dei segni e sintomi nei partecipanti con COVID-19 da lieve a moderato.
    • Descrivere la sicurezza e la tollerabilità di nirmatrelvir/ritonavir nei partecipanti con COVID-19 da lieve a moderato.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants aged 12 years or older and weighing =40 kg at screening.
    2. Participants must have written documentation with patient-reported 100% compliance (ie, completed a 5 day course of nirmatrelvir/ritonavir). They must have symptom alleviation or
    resolution in COVID-19 signs/symptoms followed by a worsening (rebound) of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir based on the judgement of both the participant and investigator.
    3. The onset of rebound in COVID-19 symptoms must occur within 2 weeks (14 days) after the completion of the initial 5-day course of nirmatrelvir/ritonavir.
    4. Onset of rebound in signs/symptoms attributable to COVID-19 within 48 hours prior to randomization and =1 sign/symptom attributable to COVID-19 present on the day of randomization.
    5. SARS-CoV-2 infection as determined by rapid antigen testing in any specimen collected within 24 hours prior to randomization and collected within 2 weeks (14 days) after the completion of the initial 5-day treatment course of nirmatrelvir/ritonavir.
    6. Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19.
    1. Partecipanti di età pari o superiore a 12 anni e di peso =40 kg allo screening.
    2. I partecipanti devono disporre di documentazione scritta e riferire una compliance del 100% al trattamento (ovvero, di aver completato un ciclo di 5 giorni con nirmatrelvir/ritonavir). Devono manifestare un’attenuazione o una risoluzione dei segni/sintomi dei COVID-19 seguita da un peggioramento (una ricomparsa) dei segni/sintomi dopo aver completato un ciclo iniziale di 5 giorni con nirmatrelvir/ritonavir sulla base del giudizio sia del partecipante sia dello
    sperimentatore.
    3. L’inizio della ricomparsa dei sintomi di COVID-19 deve verificarsi entro 2 settimane (14 giorni) dopo il completamento del ciclo iniziale di 5 giorni con nirmatrelvir/ritonavir.
    4. Ricomparsa di segni/sintomi attribuibili al COVID-19 entro 48 ore prima della randomizzazione e =1 segno/sintomo attribuibile al COVID-19 presente il giorno della randomizzazione.
    5. Infezione da SARS-CoV-2 determinata mediante test antigenico rapido in qualsiasi campione raccolto entro 24 ore prima della randomizzazione ed entro 2 settimane (14 giorni) dal completamento del ciclo di trattamento iniziale di 5 giorni con nirmatrelvir/ritonavir.
    6. Presenta almeno 1 condizione medica caratteristica o sottostante associata ad un aumentato rischio di sviluppare una malattia severa da COVID-19.
    E.4Principal exclusion criteria
    1. Current need for hospitalization, hospitalized for the index COVID-19 infection, or anticipated need for hospitalization within 24h after randomization in the clinical
    opinion of the site investigator.
    2. History of severe chronic liver disease (eg, jaundice, ascites, hepatic encephalopathy, history of bleeding esophageal or gastric varices). No laboratory testing is needed.
    3. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator.
    4. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
    5. Receiving dialysis or eGFR <30 mL/min/1.73m2 (for adults) or eCrCl <30 mL/min (for adolescents) at screening using creatinine point of care device.
    6. Oxygen saturation of <92% on room air obtained at rest within 24 hours prior to randomization.
    7. Immunocompromised.
    8. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
    9. Current use of any prohibited concomitant medication(s).
    10. COVID-19 vaccination within 14 days prior to study entry or anticipated COVID-19 vaccination through Day 34.
    11. Receiving other COVID-19 specific treatments within 30 days of randomization and through Day 34, excluding the initial course of nirmatrelvir/ritonavir as well as blinded study medication.
    12. Prior participation in this trial.
    13. Current or previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study
    intervention used in this study (whichever is longer).
    14. Females who are pregnant up to 14 weeks gestation. Pregnancy =14 weeks is not exclusionary.
    15. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
    1. Partecipanti che necessitano di ricovero o che sono ricoverati per l’infezione iniziale da COVID-19 o per i quali si prevede la necessità di ricovero entro 24 ore dalla randomizzazione secondo il parere clinico dello sperimentatore del centro.
    2. Storia di grave epatopatia cronica (ad es., ittero, ascite, encefalopatia epatica, storia di
    sanguinamento da varici esofagee o gastriche). Non sono necessari esami di laboratorio.
    3. Storia di ipersensibilità o altra controindicazione a uno qualsiasi dei componenti degli
    interventi dello studio, come stabilito dallo sperimentatore.
    4. Infezione sistemica attiva sospetta o confermata concomitante diversa da COVID-19 che può interferire con la valutazione della risposta all’intervento dello studio.
    5. In dialisi o con eGFR <30 mL/min/1,73 m2 (per gli adulti) o eCrCl <30 mL/min (per gli adolescenti) allo screening utilizzando un dispositivo POC (point of care) per la creatinina.
    6. Saturazione di ossigeno <92% nell’aria ambiente ottenuta a riposo nelle 24 ore precedenti la randomizzazione.
    7. Paziente immunocompromesso.
    8. Altre condizioni mediche o psichiatriche, tra cui idee/comportamenti suicidari recenti (nell’ultimo anno) o attivi o valori anomali di laboratorio che possono aumentare il rischio della partecipazione allo studio o, a giudizio dello sperimentatore, rendere il partecipante non idoneo allo studio.
    9. Uso attuale di farmaci concomitanti vietati.
    10. Vaccinazione contro il COVID-19 nei 14 giorni precedenti l’ingresso nello studio o vaccinazione contro il COVID-19 prevista entro il giorno 34.
    11. Ricezione di altri trattamenti specifici per COVID-19 entro 30 giorni dalla randomizzazione e fino al giorno 34, escluso il ciclo iniziale di nirmatrelvir/ritonavir e il farmaco in studio in cieco.
    12. Precedente partecipazione a questa sperimentazione.
    13. Somministrazione in corso o precedente di un prodotto sperimentale (farmaco o vaccino) entro 30 giorni (o come previsto dai requisiti locali) o 5 emivite precedenti la prima dose dell’intervento utilizzato nel presente studio (a seconda di quale sia il periodo più lungo).
    14. Donne in gravidanza fino a 14 settimane di gestazione. Una gravidanza =14 settimane non è motivo di esclusione.
    15. Personale del centro di sperimentazione direttamente coinvolto nella conduzione dello studio e loro familiari, personale del centro altrimenti supervisionato dallo sperimentatore e dipendenti dello sponsor e del delegato dello sponsor, direttamente coinvolti nella conduzione dello studio e relativi familiari.
    E.5 End points
    E.5.1Primary end point(s)
    The difference in mean change of SARS-CoV-2 RNA level in NP swabs from baseline to Day 5 between nirmatrelvir/ritonavir and placebo/ritonavir group in participants with a rebound in COVID-19
    symptoms and a positive rapid antigen test within 2 weeks following completion of an initial 5- day treatment course ,who have a positive rapid antigen test result at baseline. This will be estimated without regard to study treatment discontinuation and without regard to prohibited therapies.
    La differenza nella variazione media del livello di RNA di SARS-CoV-2 nei tamponi nasofaringei dal basale al giorno 5 tra il gruppo nirmatrelvir/ritonavir e il gruppo placebo/ritonavir nei partecipanti con ricomparsa dei sintomi di COVID-19 e un test antigenico rapido positivo entro 2 settimane dal completamento di un ciclo di trattamento iniziale di 5 giorni, che risultano positivi al test antigenico rapido al basale. Questo sarà valutato indipendentemente dall’interruzione del trattamento in studio e dalle terapie vietate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The difference in mean change of SARS-CoV-2 RNA level in NP swabs from baseline to Day 5 between nirmatrelvir/ritonavir and placebo/ritonavir group in participants with a rebound in COVID-19
    symptoms and a positive rapid antigen test within 2 weeks following completion of an initial 5-day treatment course ,who have a positive rapid antigen test result at baseline.
    This will be estimated without regard to study treatment discontinuation and without regard to prohibited therapies.
    La differenza nella variazione media del livello di RNA di SARS-CoV-2 nei tamponi nasofaringei dal basale al giorno 5 tra il gruppo nirmatrelvir/ritonavir e il gruppo placebo/ritonavir nei partecipanti con ricomparsa dei sintomi di COVID-19 e un test antigenico rapido positivo entro 2 settimane dal completamento di un ciclo di trattamento iniziale di 5 giorni, che risultano positivi al test antigenico rapido al basale. Questo sarà valutato indipendentemente dall’interruzione del trattamento in studio e dalle terapie vietate.
    E.5.2Secondary end point(s)
    - Time to 2 consecutive negative rapid antigen test results obtained at least 24 (-2) h apart through Day 28.
    - Time (days) to sustained alleviation of all targeted signs and symptoms through Day 28 where sustained alleviation is defined as the first of 2 consecutive days when any symptoms scored as moderate or severe at baseline are scored as mild or absent and any symptoms scored as mild or absent at baseline are scored as absent.
    - Incidence of TEAEs. Incidence of SAEs and AEs leading to discontinuation.
    - Tempo a 2 risultati negativi consecutivi del test antigenico rapido ottenuti a distanza di almeno 24(-2) ore fino al giorno 28.
    - Tempo (giorni) all’attenuazione mantenuta di tutti i segni e sintomi specifici fino al giorno 28, dove attenuazione mantenuta è definita come il primo di 2 giorni consecutivi in cui tutti i sintomi classificati come moderati o severi al basale vengono classificati come lievi o assenti e tutti i sintomi classificati come lievi o assenti al basale sono classificati come
    assenti.
    - Incidenza dei TEAE. Incidenza di SAE e AE che comportano l’interruzione del trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The hazard ratio for time to 2 consecutive negative rapid antigen test results obtained at least 24 (-2) h apart through Day 28 between nirmatrelvir/ritonavir and placebo/ritonavir group in participants with rebound in COVID-19 symptoms and a positive rapid antigen test within 2 weeks following completion of an initial 5-day treatment course, who have a positive rapid antigen test result at baseline. This will be estimated without regard to study treatment discontinuation and without regard to prohibited therapies.
    L’hazard ratio per il tempo a 2 risultati negativi consecutivi del test antigenico rapido ottenuti a distanza di almeno 24 (-2) ore fino al giorno 28 tra il gruppo nirmatrelvir/ritonavir e il gruppo placebo/ritonavir nei partecipanti con ricomparsa dei sintomi di COVID-19 e
    un test antigenico rapido positivo entro 2 settimane dal completamento di un ciclo di trattamento iniziale di 5 giorni, che risultano positivi al test antigenico rapido al basale. Questo sarà valutato indipendentemente dall’interruzione del trattamento in studio e dalle terapie vietate.
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Taiwan
    United States
    Germany
    Greece
    Italy
    United Kingdom
    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
    LSLV
    LSLV
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 351
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 411
    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)
    No study intervention will be provided to participants at the end of their study participation. It is expected that participants will be treated as required with standard-of-care treatments, as advised by their usual care physician.
    Nessun intervento di studio sarà fornito ai partecipanti al termine della loro partecipazione allo studio. Si prevede che i partecipanti saranno trattati come richiesto con trattamenti standard di cura, come consigliato dal loro medico abituale.
    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 Decision2023-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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