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    Summary
    EudraCT Number:2020-005315-44
    Sponsor's Protocol Code Number:D8851C00001
    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:2021-02-02
    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 number2020-005315-44
    A.3Full title of the trial
    A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults
    Studio di fase III, randomizzato, multicentrico in doppio cieco, controllato con placebo, per determinare la sicurezza e l’efficacia di AZD7442 per il trattamento di pazienti adulti affetti da COVID-19 non ospedalizzati
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3, Double-blind, Placebo-controlled Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults
    Studio di fase III, in doppio cieco, controllato con placebo di AZD7442 per il trattamento dei pazienti adulti affetti da COVID 19 in regime ambulatoriale
    A.3.2Name or abbreviated title of the trial where available
    TACKLE
    TACKLE
    A.4.1Sponsor's protocol code numberD8851C00001
    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
    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 pointClinical Study Information 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 [AZD8895]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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.3.8INN - Proposed INNACIDO ACETILSALICILICO
    D.3.9.1CAS number 2420564-02-7
    D.3.9.2Current sponsor codeAZD8895
    D.3.9.3Other descriptive namemonoclonal antibody (mAb)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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.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 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 [AZD1061]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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.3.8INN - Proposed INNACIDO ACETILSALICILICO
    D.3.9.1CAS number 2420563-99-9
    D.3.9.2Current sponsor codeAZD1061
    D.3.9.3Other descriptive namemonoclonal antibody (mAb)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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/infusion
    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
    COVID-19 (Coronavirus Disease 2019)
    COVID-19 (Malattia da Coronavirus 2019)
    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
    Efficacy of AZD7442 in the prevention of the composite endpoint of either severe COVID-19 or death from any cause through study Day 29.
    Efficacia di AZD7442 nella prevenzione dell’endpoint combinato di COVID-19 grave o decesso per qualsiasi causa durante lo studio fino al Giorno 29
    E.2.2Secondary objectives of the trial
    Efficacy of AZD7442 in the prevention of the composite endpoint of either death or hospitalization for COVID-19 complications or sequelae through Day 169.
    Efficacia di AZD7442 nella prevenzione dell'endpoint combinato di morte o ospedalizzazione per complicanze o sequele da COVID-19 fino al giorno 169
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant has a documented laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (eg, oropharyngeal, NP, or nasal swab, or saliva) collected = 3 days prior to Day 1.
    2. WHO Clinical Progression Scale score > 0 and < 4.
    3. Participant must be dosed with IMP no more than 7 days from selfreported onset of COVID-19-related symptoms (mild to moderate COVID-19) or measured fever, defined as the self-reported date of first
    reported sign/symptom.
    4. One or more of the following signs/symptoms must be present within 24 hours prior to Day1: Cough, Sore throat, Shortness of breath or difficulty breathing at rest or with activity, Body pain or muscle pain/aches, Fatigue, Headache, Chills, Nasal obstruction or congestion, Nasal discharge, Nausea or vomiting, Diarrhea, New loss of taste or smell.
    5. Oxygenation saturation of = 92% obtained at rest by study staff within 24 hours prior to Day 1 (unless participant regularly receives chronic supplementary oxygen for an underlying lung condition).
    6. Participant agrees not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days after entry into the study (whichever is earliest).
    7. Participant must be = 18 years of age, provide informed consent and is able to comply with study requirements/procedures.
    1. Il partecipante è affetto da infezione da SARS-CoV-2 documentata e confermata in laboratorio, come determinato da un test molecolare (antigene o acido nucleico) da qualsiasi campione del tratto respiratorio (p. es., orofaringeo, NP o nasale tampone o saliva) raccolti < 3 giorni (compreso) prima del Giorno 1.
    2. Punteggio della scala di progressione clinica dell'OMS > 0 e < 4.
    3. Il partecipante deve ricevere la dose di IMP non oltre i 7 giorni dall'autocertificazione di insorgenza dei sintomi correlati a COVID-19 (COVID-19 da lieve a moderata) o febbre misurata, definita come la data auto-riportata del primo segno / sintomo segnalato.
    4. Uno o più dei seguenti segni / sintomi devono essere presenti nelle 24 ore prima del Giorno 1: tosse, mal di gola, mancanza di respiro o difficoltà a respirare a riposo o durante l'attività, dolore al corpo o ai muscoli, affaticamento, mal di testa, brividi, ostruzione o congestione nasale, secrezioni nasali, nausea o vomito, diarrea, nuova perdita del gusto o olfatto.
    5. Saturazione dell'ossigenazione maggiore o uguale a 92% misurata a riposo dal personale dello studio entro 24 ore prima del Giorno 1 (a meno che il partecipante non riceva regolarmente ossigeno supplementare in cronico per una condizione polmonare sottostante).
    6. Il partecipante accetta di non partecipare a un'altra sperimentazione clinica per trattamento di COVID-19 o SARS-CoV-2 durante il periodo di studio fino al raggiungimento del ricovero in ospedale o 28 giorni dopo l'ingresso nello studio (a seconda di quale avviene per primo).
    7. Il partecipante deve avere un’età maggiore o uguale a 18 anni, dare il proprio consenso informato ed essere in grado di soddisfare i requisiti/procedure dello studio.
    E.4Principal exclusion criteria
    1. History or current hospitalization for COVID-19.
    2. Need for hospitalization/immediate medical attention in a clinic/emergency room service
    3. Previous adverse reaction to any monoclonal antibodies or known allergy to components of the IMP or placebo.
    4. Receipt of any investigational or licensed vaccine for prevention of COVID-19 at any time prior to entry into this study.
    5. Requirement or anticipated impending need for mechanical ventilation.
    6. Any significant disease, disorder or finding that may increase risk to the participant that might affect his/her ability to participate in this study.
    7. Received convalescent COVID-19 plasma treatment any time prior to entry into this study.
    8. Pregnant or breastfeeding women.
    9. Receipt of any IMP in the previous 90 days or 5 half lives (whichever is longer), or expected receipt of IMP during the study follow-up period, or concurrent participation in another interventional study.
    1. Anamnesi o attuale ricovero per COVID-19.
    2. Necessità di ricovero / cure mediche immediate in una clinica/pronto soccorso.
    3. Precedente reazione avversa a qualsiasi anticorpo monoclonale o nota allergia ai componenti dell'IMP o al placebo.
    4. Ricezione di qualsiasi vaccino sperimentale o autorizzato per la prevenzione di COVID-19 in qualsiasi momento prima dell'ingresso in questo studio.
    5. Necessità o necessità imminente anticipata di ventilazione meccanica.
    6. Qualsiasi malattia significativa, disturbo o scoperta che può aumentare il rischio del partecipante che potrebbe influenzare la sua capacità di partecipare a questo studio.
    7. Ricevuto un trattamento con plasma da convalescenti al COVID-19 in qualsiasi momento prima dell’ingresso in questo studio.
    8. Donne incinte o che allattano.
    9. Ricezione di qualsiasi IMP nei 90 giorni precedenti o 5 emivite (a seconda di quale è più lungo), o la ricezione prevista di IMP durante il periodo di follow-up dello studio, o partecipazione simultanea a un altro studio interventistico.
    E.5 End points
    E.5.1Primary end point(s)
    A composite of either severe COVID-19 or death from any cause through Day 29.
    Un endpoint combinato di COVID-19 grave o morte per qualsiasi causa al Giorno 29
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 29
    Giorno 29
    E.5.2Secondary end point(s)
    A composite of either death from any cause or hospitalization for COVID-19 complications or sequelae during the 168-day post-dose period (Day 1 to Day 169).
    Un endpoint combinato di morte per qualsiasi causa o ospedalizzazione per complicazioni o sequele da COVID-19 durante il giorno 168 del periodo post-dose (da Giorno 1 a Giorno 169).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 169
    Da Giorno 1 a Giorno 169
    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 Yes
    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 EEA30
    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
    Japan
    Mexico
    Russian Federation
    United States
    Germany
    Hungary
    Italy
    Spain
    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
    Last Subject Last Visit
    LSLV
    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 months4
    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 months4
    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: 1700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1020
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Ensure that participants who are considered by the investigator clinically unable to consent at screening and who are entered into the study by the consent of a legally acceptable representative show evidence of assent, as applicable in accordance wi
    Assicurarsi che i partecipanti che sono considerati dallo sperimentatore clinicamente incapaci di dare il consenso allo screening e che sono entrati nello studio con il consenso di un rappresentante legalmente riconosciuto mostrino prove di assenso,
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1040
    F.4.2.2In the whole clinical trial 1700
    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)
    na
    na
    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 Decision2021-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-09
    P. End of Trial
    P.End of Trial StatusOngoing
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