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    Summary
    EudraCT Number:2021-006495-16
    Sponsor's Protocol Code Number:PrEPSo
    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:2021-12-10
    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 number2021-006495-16
    A.3Full title of the trial
    Immunogenicity and safety of Sotrovimab (Vir 7831) IV as primary prophylaxis in anti-SARS-CoV-2 vaccine non responders
    Immunogenicità e sicurezza di Sotrovimab (Vir 7831) IV come profilassi primaria nei non responders al vaccino anti-SARS-CoV-2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and safety of Sotrovimab (Vir 7831) IV as primary prophylaxis in anti-SARS-CoV-2 vaccine non responders
    Immunogenicità e sicurezza di Sotrovimab (Vir 7831) IV come profilassi primaria nei non responders al vaccino anti-SARS-CoV-2
    A.3.2Name or abbreviated title of the trial where available
    PrEPSo
    PrEPSo
    A.4.1Sponsor's protocol code numberPrEPSo
    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 supportGlaxoSmithKline
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportVIR Biotechnology
    B.4.2CountryUnited States
    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 pointImmunodeficienze virali
    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.5.4Telephone number0655170546
    B.5.5Fax number0655170477
    B.5.6E-mailimmunodeficienzevirali@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 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 nameSotrovimab
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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 number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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
    Covid 19 Infection
    Infezione da Covid 19
    E.1.1.1Medical condition in easily understood language
    Covid 19 Infection
    Infezione da 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 10084458
    E.1.2Term COVID-19 prophylaxis
    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 evaluate the feasibility, safety and tolerability of VIR-7831 administered IV as Pre-Exposure Prophylaxis (PrEP) in non-responders individuals to a mRNA anti-SARS-CoV-2 vaccine, including subjects non-responders to the third dose of vaccine
    -Valutare la fattibilità, la sicurezza e la tollerabilità del VIR-7831 somministrato per via IV come profilassi pre-esposizione (PrEP) in individui non rispondenti a un vaccino mRNA anti-SARS-CoV-2, compresi i soggetti non rispondenti alla terza dose di vaccino
    E.2.2Secondary objectives of the trial
    -To evaluate the immunogenicity of VIR-7831 over time
    -To evaluate the serum pharmacokinetics (PK) of VIR-7831
    -Analysis of the viro-immunological characteristics, with particular attention to the SARS-CoV-2 sequence and the profile of immune correlates of subjects with confirmed SARS-CoV-2 infection
    -Valutare l'immunogenicità del VIR-7831 nel tempo
    -Valutare la farmacocinetica (PK) di VIR-7831
    -Analisi delle caratteristiche viro-immunologiche, con particolare attenzione alla sequenza SARS-CoV-2 e al profilo dei correlati immunitari dei soggetti con infezione confermata da SARS-COV-2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >=18 years of age at the time of obtaining informed consent.
    - Non-responders subjects (absence of antibodies response), aged 65 years or more, to a mRNA anti SARS-CoV-2 vaccination 1 month after the completion of the vaccination schedule and without an immunocompromising condition
    - Non-responders subjects (absence of antibodies response) to a mRNA anti SARS-CoV-2 vaccination 1 month after the completion of the vaccination schedule and with an immunocompromising condition, including, but not limited to, the following:

    a. Primary and secondary immunodeficiencies involving adaptive immunity
    b. Splenectomy or functional asplenia [e.g., sickle cell disease]
    c. B cell directed therapies (e.g., blocking monoclonal antibodies against CD20 or CD22, bispecific agents like blinatumomab, CD19
    or CD22-directed chimeric antigen receptor T cell [CAR-T; at least 2 weeks since the last administration] therapies, Bruton tyrosine kinase [BTK] inhibitors)
    d. T-cell-directed therapies (e.g., calcineurin inhibitors, anti-thymocyte globulin, alemtuzumab)
    e. Many chemotherapy regimens
    f. High-dose corticosteroids (=20 mg per dose or >2 mg/kg/day daily prednisone or equivalent)
    g. Hematopoietic cell transplantation (HCT), especially within the first three to six months after autologous HCT and often longer
    after allogeneic HCT
    h. Underlying aberrant immunity (e.g., graft-vs.-host disease, graft rejection, absent or incomplete immune reconstitution,
    neutropenia ANC <500/µL, lymphopenia ALC <200/µL)
    i. HIV infection
    - Persons non-responders (according to previous definition) to the third dose of a mRNA vaccine, according to national vaccine program, will be also included in the study.
    - Età >= 18 anni al momento di ottenere il consenso informato;
    - Soggetti non rispondenti (assenza di risposta anticorpale), di età pari o superiore ai 65 anni, a una vaccinazione mRNA anti SARS-CoV-2, 1 mese dopo il completamento del programma di vaccinazione e senza una condizione di immunocompromissione;
    - Soggetti non rispondenti (assenza di risposta anticorpale) ad una vaccinazione mRNA anti SARS-CoV-2 1 mese dopo il completamento del programma di vaccinazione e con una condizione di immunocompromissione, incluso, ma non solo, quanto segue:
    a. Immunodeficienze primarie e secondarie che coinvolgono l'immunità adattativa;
    b. Splenectomia o asplenia funzionale [per esempio, malattia falciforme];
    c. Terapie dirette alle cellule B (per esempio, anticorpi monoclonali bloccanti contro CD20 o CD22, agenti bispecifici come blinatumomab, CD19 o CD22-diretto da cellule T con recettore dell'antigene chimerico [CAR-T], inibitori della tirosin-chinasi di Bruton [BTK]);
    d. Terapie dirette alle cellule T (per esempio, inibitori della calcineurina, globulina anti-timociti, alemtuzumab);
    e. Numerosi regimi di chemioterapia;
    f. Corticosteroidi ad alte dosi (=20 mg per dose o >2 mg/kg/giorno di prednisone o equivalente);
    g. Trapianto di cellule emopoietiche (HCT), soprattutto entro i primi tre-sei mesi dopo un HCT autologo e spesso più a lungo dopo un HCT allogenico;
    h. Immunità anomala sottostante (per esempio, malattia dell'innesto contro l'ospite, rigetto dell'innesto, ricostituzione immunitaria assente o incompleta, neutropenia ANC <500/µL, linfopenia ALC <200/µL);
    i. Infezione da HIV;
    - Le persone non rispondenti (secondo la definizione precedente) alla terza dose di un vaccino mRNA, secondo il programma nazionale di vaccinazione, saranno anche inclusi nello studio.
    E.4Principal exclusion criteria
    - History of prior positive SARS-CoV-2 RT-PCR or antigen test or history of positive SARS-CoV-2 serology test including during screening.
    - Febrile illness with or without respiratory symptoms (e.g., cough, nasal congestion) within 7 days prior to randomization
    - Unstable medical condition and not expected to survive for the duration of study participation as judged by the investigator
    - Known hypersensitivity to any constituent present in the investigational product
    - Previous anaphylaxis or hypersensitivity to a monoclonal antibody
    - Contemporary CAR-T treatment
    - Anti-S Ab the day of vaccination
    - Storia di un precedente test RT-PCR o antigene positivo per la SARS-CoV-2 o storia di un test sierologico positivo per la SARS-CoV-2, anche durante lo screening.
    - Malattia febbrile con o senza sintomi respiratori (ad esempio, tosse, congestione nasale) entro 7 giorni prima della randomizzazione
    - Condizioni mediche instabili e con una ridotta sopravvivenza per la durata della partecipazione allo studio, come giudicato dallo sperimentatore
    - Il partecipante ha qualsiasi condizione che, a giudizio dello sperimentatore, proibirebbe di ricevere iniezioni intramuscolari, come disturbi della coagulazione, diatesi emorragica o trombocitopenia
    - Ipersensibilità nota a qualsiasi componente presente nel prodotto in sperimentazione
    - Precedenti anafilassi o ipersensibilità a un anticorpo monoclonale
    - Trattamento CAR-T contemporaneo
    - Anti-S Ab il giorno della vaccinazione
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
    - Proportion of participants who have a detectable IgG anti-RBD at day 29, 85 and 180 after the Vir-7831 administration and magnitude of this titres
    - Analysis of the cell-mediated response to the Spike antigen (cytokine release test after specific stimulation, flow cytofluorimetry) at day 29, 85 and 180 after the Vir-7831 administration
    - Serum PK of VIR-7831 administered IV (PK parameters) at day of infusion [End-of-Infusion (EOI)], Day 8, Day 29, and Day 85 +/- 3 days window
    - Incidence of anti-N IgG serum conversions on the day of administration and subsequently at 1 month, 3 e 6 months
    - Number of symptomatic participants with a positive molecular test for SARS-CoV-2 (according to NIH criteria) at day 29, 85 and 180
    - Death associated with COVID-19 at day 29, 85 and 180 after
    - All-cause mortality
    - Incidenza di eventi avversi (AE), eventi avversi seri (SAE), ed eventi avversi di particolare interesse (AESIs), comprese le reazioni al sito di iniezione (ISRs);
    - Percentuale di partecipanti che hanno un IgG anti-RBD rilevabile ai giorni 29, 85 e 180 dalla somministrazione di Vir-7831 e grandezza di questo titolo;
    - Analisi della risposta cellulo-mediata all'antigene Spike (test di rilascio di citochine dopo stimolazione specifica, citofluorimetria a flusso) ai giorni 29,85 e 180;
    - PK di VIR-7831 somministrato per via endovenosa IV (parametri PK) al giorno dell'infusione [End-of-Infusion (EOI)], giorno 8, 29, e giorno 85 (con una finestra di +/- 3 giorni);
    - Incidenza di conversioni sieriche anti-N IgG il giorno della somministrazione e successivamente a 1 mese, 3 e 6 mesi
    - Numero di partecipanti sintomatici con un test molecolare positivo per SARS-CoV-2 (secondo i criteri NIH) ai giorni 29,85 e 180;
    - Morte associata a COVID-19 ai giorni 29,85 e 180;
    - Mortalità per tutte le cause
    E.5.1.1Timepoint(s) of evaluation of this end point
    - In each period of the study;
    - on days 29, 85 and 180 from the administration of Vir-7831;
    - on days 29.85 and 180;
    - day 8, 29, and day 85 (with a window of +/- 3 days);
    - on the day of administration and after 1 month, 3 and 6 months
    - on days 29.85 and 180;
    - on days 29.85 and 180;
    - In each period of the study
    - In ogni periodo dello studio;
    - ai giorni 29, 85 e 180 dalla somministrazione di Vir-7831;
    - ai giorni 29,85 e 180;
    - giorno 8, 29, e giorno 85 (con una finestra di +/- 3 giorni);
    - il giorno della somministrazione e successivamente a 1 mese, 3 e 6 mesi
    - ai giorni 29,85 e 180;
    - ai giorni 29,85 e 180;
    - In ogni periodo dello 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS e chiusura dei centri clinici
    LVLS e chiusura dei centri clinici
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    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 months0
    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: 50
    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 Yes
    F.3.2Patients No
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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, patients will be treated with the procedures required by normal clinical practice
    Al termine dello studio i pazienti saranno trattati con le procedure previste dalla 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 Decision2022-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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