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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-005226-28
    Sponsor's Protocol Code Number:D8110C00001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-23
    Trial results View 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 number2020-005226-28
    A.3Full title of the trial
    A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
    Studio di fase III, multicentrico, randomizzato, in doppio cieco, controllato con placebo, in adulti per determinare la sicurezza, l’efficacia e l’immunogenicità di AZD1222, un vaccino a vettore ChAdOx1 non replicante, per la prevenzione della COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III Double-blind, Placebo-controlled Study of AZD1222 for the
    Prevention of COVID-19 in Adults
    Studio di Fase III, in doppio cieco, controllato con placebo di AZD1222 per la prevenzione della COVID-19 negli adulti
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberD8110C00001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN89951424
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04516746
    A.5.4Other Identifiers
    Name:IND numberNumber:23522
    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 SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressSödertälje
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE-151 85
    B.5.3.4CountrySweden
    B.5.6E-mailInformation.center@astrazeneca.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 namena
    D.3.2Product code [AZD1222]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 2420395-83-9
    D.3.9.2Current sponsor codeAZD1222
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular 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 (COVID-19)
    Infezione da SARS-COV-2 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    COVID-19
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1 To estimate the efficacy of 2 IM doses of AZD1222 compared to
    placebo for the prevention of COVID-19 in adults =18years of age
    2 To assess the safety and tolerability of 2 IM doses of AZD1222
    compared to placebo in adults =18years of age
    1 Stimare l’efficacia di 2 dosi di AZD1222 per via IM rispetto al placebo per la prevenzione della COVID-19 in adulti di età = 18 anni
    2 Valutare la sicurezza e la tollerabilità di 2 dosi IM di AZD1222 rispetto al placebo in adulti di età = 18 anni.
    E.2.2Secondary objectives of the trial
    1. To estimate the efficacy of 2 IM doses of AZD1222 compared to
    placebo for the prevention of SARS-CoV-2 infection.
    2. To estimate the efficacy of 2 IM doses of AZD1222 compared to
    placebo for the prevention of symptomatic COVID-19 using CDC criteria.
    3. To estimate the efficacy of 2 IM doses of AZD1222 compared to
    placebo for the prevention of University of Oxford defined symptomatic
    COVID-19
    4. To estimate the efficacy of 2 IM doses of AZD1222 compared to
    placebo in the prevention of COVID-19 in all study participants,
    regardless of evidence of prior SARS-CoV-2 infection
    5. To estimate the efficacy of 2 IM doses of AZD1222 compared to
    placebo for the prevention of severe or critical symptomatic COVID-19.
    6. To estimate the efficacy of 2 IM doses of AZD1222 compared to
    placebo for the prevention of COVID-19-related Emergency Department
    visits.
    1 Stimare l’efficacia di 2 dosi IM di AZD1222 rispetto al placebo per la prevenzione dell’infezione da SARS-CoV-2.
    2 Stimare l’efficacia di 2 dosi IM di AZD1222 rispetto al placebo per la prevenzione della COVID-19 sintomatica in base ai criteri dei CDC.
    3 Stimare l’efficacia di 2 dosi IM di AZD1222 rispetto al placebo per la prevenzione della COVID-19 sintomatica secondo la definizione dell’Università di Oxford.
    4 Stimare l’efficacia di 2 dosi IM di AZD1222 rispetto al placebo per la prevenzione della COVID-19 in tutti i partecipanti allo studio, a prescindere dall’evidenza di pregressa infezione precedente da SARS-CoV-2.
    5 Stimare l’efficacia di 2 dosi IM di AZD1222 rispetto al placebo per la prevenzione della COVID-19 sintomatica grave o critica.
    6 Stimare l’efficacia di 2 dosi IM di AZD1222 rispetto a placebo per la prevenzione di visite al pronto soccorso associate alla COVID-19.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Increased risk of SARS-CoV-2 infection, Defined as adults whose
    locations or circumstances put them at appreciable risk of exposure to
    SARS-CoV-2 and COVID-19, based on available risk assessment
    contemporaneous to enrollment (believed to be at risk/exposure)
    - Medically stable such that, according to the judgment of the
    investigator, hospitalization within the study period is not anticipated
    and the participant appears likely to be able to remain on study through
    the end of protocol-specified follow-up. A stable medical condition is
    defined as disease not requiring significant change in therapy or
    hospitalization for worsening disease during the 3 months prior to
    enrollment
    Aumento del rischio di infezione da SARS-CoV-2, definito come adulti cui luoghi o circostanze li mettono a rischio apprezzabile di esposizione a SARS-CoV-2 e COVID-19, in base alla valutazione del rischio disponibile contemporaneamente all'arruolamento (ritenuto a rischio / esposizione)
    - Medicalmente stabile tale che, secondo il giudizio del
    ricercatore, il ricovero entro il periodo di studio non è previsto
    e il partecipante sembra essere in grado di continuare lo studio fino alla fine del follow-up specificato dal protocollo. Una condizione medica stabile è definita come malattia che non richiede un cambiamento significativo nella terapia o ricovero in ospedale per peggioramento della malattia nei 3 mesi precedenti all'arruolamento
    E.4Principal exclusion criteria
    Any confirmed or suspected immunosuppressive or immunodeficient
    state, including asplenia
    - Any other significant disease, disorder, or finding that may significantly
    increase the risk to the participant because of participation in the study,
    affect the ability of the participant to participate in the study, or impair
    interpretation of the study data
    - Receipt of, or planned receipt of investigational products indicated for
    the treatment or prevention of SARS-CoV-2 or COVID-19 Note: For
    participants who become hospitalized with COVID-19, receipt of licensed
    treatment options and/orparticipation in investigational treatment
    studies is permitted
    Qualsiasi stato di immunosoppressore o immunodeficiente confermato o sospetto, inclusa l'asplenia
    - Qualsiasi altra malattia, disturbo o scoperta che può significativamente aumentare il rischio per il partecipante a causa della partecipazione allo studio, influenzare la capacità del partecipante di partecipare allo studio o compromettere interpretazione dei dati dello studio
    - Ricevimento o ricezione programmata dei prodotti in sperimentazione indicati per il trattamento o la prevenzione di SARS-CoV-2 o COVID-19 Nota: per partecipanti che vengono ricoverati in ospedale con COVID-19, ricevuta di licenza opzioni di trattamento e / o partecipazione al trattamento sperimentale sono consentiti gli studi
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the first case of SARS-CoV-2 RT-PCR-positive
    symptomatic illness occurring = 15 days post second dose of study
    intervention, in a participant with negative
    serostatus at baseline. Participants will be included in the primary
    endpoint if they have RT-PCR-confirmed SARS-CoV-2 and meet the
    following criteria at any point from their initial illness visit at the site
    (Day 1) through their second illness visit (Day 14):
    One or more Category A findings OR Two or more Category B findings
    Category A:
    -Pneumonia diagnosed by chest x-ray, or computed tomography scan
    -Oxygen saturation of = 94% on room air or requiring either new
    initiation or escalation in
    supplemental O2
    -New or worsening dyspnea/shortness of breath
    Category B:
    -Fever > 100 °F (> 37.8 °C) or feverishness
    -New or worsening cough
    -Myalgia/muscle pain
    -Fatigue that interferes with activities of daily living
    -Vomiting and/or diarrhea (only one finding to be counted toward
    endpoint definition)
    -Anosmia and/or ageusia (only one finding to be counted toward endpoint definition)
    L'endpoint primario è il primo caso di SARS-CoV-2 RT-PCR-positivo
    malattia sintomatica che si verifica = 15 giorni dopo la seconda dose dello studio
    intervento, in un partecipante con negativo
    stato sierico al basale. I partecipanti saranno inclusi nelle primarie
    endpoint se hanno SARS-CoV-2 confermato con RT-PCR e soddisfano il
    seguendo i criteri in qualsiasi momento dalla loro visita iniziale di malattia presso il sito
    (Giorno 1) attraverso la loro seconda visita di malattia (Giorno 14):
    Uno o più risultati di categoria A OPPURE due o più risultati di categoria B.
    Categoria A:
    -Polmonite diagnosticata mediante radiografia del torace o tomografia computerizzata
    -Saturazione dell'ossigeno = 94% nell'aria ambiente o che richiede uno nuovo
    iniziazione o escalation in
    O2 supplementare
    -Nuova o peggioramento della dispnea / mancanza di respiro
    Categoria B:
    -Febbre> 100 ° F (> 37,8 ° C) o febbre
    -Tosse nuova o in peggioramento
    -Mialgia / dolore muscolare
    -Fatica che interferisce con le attività della vita quotidiana
    -Vomito e / o diarrea (solo un dato da conteggiare
    definizione dell'endpoint)
    -Anosmia e / o ageusia (solo un risultato da conteggiare per la definizione dell'endpoint)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Participants are followed through Day360 for symptomatic COVID-19
    I partecipanti vengono seguiti fino al Day360 per COVID-19 sintomatico
    E.5.2Secondary end point(s)
    -The proportion of participants who have a post-treatment response (negative at baseline to positive post treatment with study intervention) for SARS-CoV-2 Nucleocapsid antibodies over time
    -The incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring = 15 days post second dose of study intervention using CDC criteria
    - The incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring = 15 days post second dose of study intervention using University of Oxford defined symptom criteria.
    -The incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring = 15 days post second dose of study intervention regardless of evidence of prior SARS-CoV-2 infection
    -The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring = 15 days post second dose of study intervention
    -The incidence of COVID-19-related Emergency Department visits occurring = 15 days post second dose of study intervention
    -Post-treatment GMTs and GMFRs from day of dosing baseline value to 28 days post each dose in SARS-CoV-2 S, RBD antibodies (MSD serology assay)
    - The proportion of participants who have a post-treatment seroresponse (= 4-fold rise in titers from day of dosing baseline value to 28 days post
    each dose) to the S, RBD antigens of AZD1222 (MSD serology assay)
    - Post-treatment GMTs and GMFRs from day of dosing baseline value to 28 days post each dose in SARS-CoV-2 neutralizing antibodies (wild-type
    assay or pseudo-neutralization assay)
    -Proportion of participants who have a post-treatment seroresponse (= 4-fold rise in titers from day of dosing baseline value to 28 days post
    each dose) to AZD1222 as measured by SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay)= 15 days
    post second dose of study intervention
    La percentuale di partecipanti che hanno una risposta post-trattamento
    (da negativo al basale a positivo dopo il trattamento con l'intervento in studio)
    per gli anticorpi SARS-CoV-2 Nucleocapsid nel tempo
    -L'incidenza del primo caso di SARS-CoV-2 RT-PCR positivo
    malattia sintomatica che si verifica = 15 giorni dopo la seconda dose dello studio
    intervento utilizzando criteri CDC
    - L'incidenza del primo caso di SARS-CoV-2 RT-PCR positivo
    malattia sintomatica che si verifica = 15 giorni dopo la seconda dose dello studio
    intervento utilizzando i criteri dei sintomi definiti dall'Università di Oxford.
    -L'incidenza del primo caso di SARS-CoV-2 RT-PCR positivo
    malattia sintomatica che si verifica = 15 giorni dopo la seconda dose dello studio
    intervento indipendentemente dall'evidenza di una precedente infezione da SARS-CoV-2
    -L'incidenza di SARS-CoV-2 RT-PCR-positiva grave o critica malattia sintomatica che si verifica = 15 giorni dopo la seconda dose dello studio intervento
    -L'incidenza delle visite al Pronto Soccorso correlate a COVID-19 che si verificano = 15 giorni dopo la seconda dose dell'intervento in studio
    - GMT e GMFR post-trattamento dal giorno del valore basale di dosaggio a 28 giorni dopo ogni dose di anticorpi SARS-CoV-2 S, RBD (sierologia MSD
    saggio)
    - La percentuale di partecipanti che hanno una sierisposta post-trattamento (Aumento = 4 volte dei titoli dal giorno della somministrazione del valore basale a 28 giorni dopo ogni dose) agli antigeni S, RBD di AZD1222 (dosaggio sierologico MSD)
    - GMT e GMFR post-trattamento dal giorno della somministrazione del valore basale a 28 giorni dopo ogni dose di anticorpi neutralizzanti SARS-CoV-2 (wild-type
    saggio o saggio di pseudo neutralizzazione)
    -Proporzione di partecipanti che hanno una sierorisposta post-trattamento (=
    Aumento di 4 volte dei titoli dal giorno della somministrazione del valore basale a 28 giorni dopo
    ogni dose) ad AZD1222 misurata mediante neutralizzazione di SARS-CoV-2
    anticorpi (test wild-type o test di pseudo neutralizzazione) = 15 giorni
    dopo la seconda dose dell'intervento in studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints vary for each endpoint.
    Tempi di rilevazone diversi per ciascun endpoint
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy 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 Yes
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Chile
    Colombia
    Czechia
    France
    Germany
    India
    Italy
    Netherlands
    Peru
    Spain
    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
    LSLV
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 30000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10000
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Participants or their legally authorized representative will be required
    to sign a statement of informed consent that meets the requirements of
    Regulations stated in Informed consent form and Appendix A of the
    study Protocol.
    I partecipanti o il loro rappresentante legalmente autorizzato dovranno firmare una dichiarazione di consenso informato che soddisfi i requisiti dei Regolamenti indicati nel modulo di consenso informato e nell'appendice A del protocollo di studio.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6000
    F.4.2.2In the whole clinical trial 40000
    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)
    none
    nessuno
    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 Decision2020-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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