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    Summary
    EudraCT Number:2021-004035-88
    Sponsor's Protocol Code Number:AntiCov
    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:2021-08-26
    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 number2021-004035-88
    A.3Full title of the trial
    A randomized, open-label, active controlled, parallel group, multicenter phase 3 study to evaluate the efficacy and tolerability of Bamlanivimab and Etesevimab, Casirivimab and Imdevimab, and Sotrovimab versus Standard of Care in patients with mild to moderate COVID-19 disease (AntiCov)
    A randomized, open-label, active controlled, parallel group, multicenter phase 3 study to evaluate the efficacy and tolerability of Bamlanivimab and Etesevimab, Casirivimab and Imdevimab, and Sotrovimab versus Standard of Care in patients with mild to moderate COVID-19 disease (AntiCov)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III clinical trial with monoclonal antibodies versus standard of care for the treatment of early-stage COVID-19
    Studio clinico di fase III con anticorpi monoclonali contro lo standard di cura per il trattamento della COVID-19 allo stadio iniziale
    A.3.2Name or abbreviated title of the trial where available
    AntiCov
    AntiCov
    A.4.1Sponsor's protocol code numberAntiCov
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    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 supportAIFA - Italian Medicines Agency
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE POLICLINICO UNIOVERSITARIO AGOSTINO GEMELLI UNIVERSITA CATTOLICA DEL SACRO CUORE
    B.5.2Functional name of contact pointU.O.C PNEUMOLOGIA
    B.5.3 Address:
    B.5.3.1Street AddressVIA LARGO FRANCESCO VITO 1
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number+390630155701
    B.5.5Fax number+390630155701
    B.5.6E-mailluca.richeldi@policlinicogemelli.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.2.1.1.1Trade name SOTROVIMAB
    D.2.1.1.2Name of the Marketing Authorisation holderSOTROVIMAB
    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 [SOTROVIMAB]
    D.3.4Pharmaceutical form Solution for 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 codeSOTROVIMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62
    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 nameBAMLANIVIMAB
    D.3.2Product code [BAMLANIVIMAB]
    D.3.4Pharmaceutical form Solution for 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 codeBamlanivimab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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: 3
    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 nameimdevimab
    D.3.2Product code [imdevimab]
    D.3.4Pharmaceutical form Solution for 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 codeimdevimab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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: 4
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameEtesevimab
    D.3.2Product code [Etesevimab]
    D.3.4Pharmaceutical form Concentrate for solution for 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 codeEtesevimab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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: 5
    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 namecasirivimab
    D.3.2Product code [casirivimab]
    D.3.4Pharmaceutical form Solution for 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 codeCasirivimab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with mild to moderate SARS-COV-2 infection.
    Pazienti affetti da infezione SARS-COV-2 da lieve a moderata.
    E.1.1.1Medical condition in easily understood language
    Use of monoclonal antibodies vs standard of care for the treatment of early stage SARS-COV-2 infection at high risk of progression to severe COVID-19 (according to AIFA criteria).
    Uso di anticorpi monoclonali vs lo standard of care per il trattamento dell'infezione da SARS-COV-2 in fase precoce, ad alto rischio di progressione a COVID-19 severa (secondo criteri AIFA)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    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
    The primary objective of the study is:
    - To assess the efficacy of monoclonal antibodies (Bamlanivimab/Etesevimab, Casirivimab/Imdevimab, Sotrovimab) in patients with COVID-19 by looking at disease progression in terms of hospitalization in intensive care unit, oxygen desaturation =4% and peripheral oxygen saturation =92% during the follow-up period (30 days).
    L'Obiettivo primario dello studio è il seguente:
    - valutare l'efficacia degli anticorpi monoclonali (Bamlanivimab/Etesevimab, Casirivimab/Imdevimab, Sotrovimab) in pazienti affetti da COVID-19, osservando la progressione della malattia in termini di ospedalizzazioni nelle unità di terapia intensiva, desaturazione dell'ossigeno =4% e saturazione dell'ossigeno =92% durante il periodo di follow-up (30 giorni)
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    - To assess the impact of experimental drugs on safety and tolerability during the 30-day follow-up period,
    - To assess the impact of experimental drugs on survival during the 30-day follow-up period.
    Gli Obiettivi Secondari dello studio sono:
    - Valutare sicurezza e tollerabilità dei trattamenti di studio nel periodo di follow-up (30 giorni)
    - Verificare la riduzione della mortalità a 30 giorni dalla positività per SARS-Cov-2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed Informed Consent Form
    2. Men or non-pregnant women =12 years of age at the time of randomization
    3. Agree to the collection of nasopharyngeal swabs
    4. Patients currently not hospitalized
    5. Have one or more mild or moderate COVID-19 symptoms such as fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath
    6. Must have sample collection for first positive SARS-CoV-2 viral infection
    7. High risk for severe COVID-19 disease defined as the presence of one or more of the following conditions: age=65 years, BMI=30 kg/m2, chronic kidney disease, chronic lung diseases, including COPD (chronic obstructive pulmonary disease), asthma (moderate-to-severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension, diabetes, heart conditions (such as heart failure, coronary artery disease, cardiomyopathies or hypertension), immunocompromised state, liver disease, stroke or cerebrovascular disease.
    1. Adulti e adolescenti di età pari o superiore a 12 anni che non necessitano di ossigenoterapia supplementare per COVID-19 e che sono ad alto rischio di progressione a COVID-19 severa definito dalla presenza di almeno uno dei seguenti criteri:
    2. Aver firmato il Consenso informato
    3. Uomini o Donne non in stato di gravidanza, di età =12 anni
    4. Acconsentire alla raccolta di un campione tramite tampone noasofaringeo
    5. Pazienti non ospedalizzati
    7. Avere uno o più sintomi COVID-1, di entità lieve o moderata, quali febbre, tosse, mal di gola, malessere, mal di testa, dolori muscolari, sintomi di natura gastointestinale, o respiro corto
    6. Avere un campione di positività per l’infezione virale SARS-CoV-2
    7. Essere ad alto rischio di sindrome COVID-19 severa, definita con la presenza di una o più delle condizioni che seguono: età =65 anni; BMI=30 kg/m2; malattia renale cronica; malattia polmonare cronica, che include BPCO (BroncoPneumopatia Cronica Ostruttiva), asma (moderata o severa), interstiziopatia polmonare, fibrosi cistica, ipertensione polmonare; diabete; problemi cardiaci (come insufficienza cardiaca, coronaropatia, cardiomiopatie o ipertensione), stato di immunocompromissione; malattie epatiche; ictus o malattie cerebrovascolari.
    E.4Principal exclusion criteria
    1. Have SpO2 =92% on room air at sea level or PaO2/FiO2 <300
    2. Respiratory rate =30 per minute
    3. Heart rate =125 per minute
    4. Hospitalized for COVID-19 disease
    5. Respiratory failure secondary to COVID-19 disease
    6. Have known allergies to any of the components used in the formulation of the interventions
    7. Have hemodynamic instability
    8. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
    9. Have any comorbidity requiring surgery within 7 days, or that is considered life-threatening within 29 days
    10. Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study
    11. Have a history of a positive SARS-CoV-2 serology test
    12. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing (Anti-COVID-19 vaccines are allowed)
    13. Have received treatment with a SARS-CoV-2 specific monoclonal antibody
    14. Have a history of convalescent COVID-19 plasma treatment
    15. Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
    16. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
    17. Are pregnant or breast feeding.
    1. Avere una saturazione SpO2 =92% o PaO2/FiO2 <300
    2. Frequenza respiratoria =30 al minuto
    3. Frequenza cardiaca =125 al minuto
    4. Ricovero in ospedale per malattia COVID-19
    5. Insufficienza respiratoria secondaria dovuta al COVID-19
    6. Avere note allergie ad uno qualsiasi dei componenti utilizzati nella formulazione degli interventi
    7. instabilità emodinamica
    8. Sospetta o dimostrata grave infezione batterica, fungina, virale o di altro tipo (oltre a COVID-19) che a parere dello sperimentatore potrebbe costituire un rischio durante l'intervento
    9. Avere qualsiasi comorbilità che richieda un intervento chirurgico entro 7 giorni o che sia considerata pericolosa per la vita entro 29 giorni
    10. Avere qualsiasi malattia, condizione o disturbo sistemico concomitante grave che, a parere dello sperimentatore, dovrebbe precludere la partecipazione a questo studio
    11. Avere nel passato un test sierologico SARS-CoV-2 positivo
    12. Aver ricevuto un intervento sperimentale per la profilassi SARS-CoV-2 entro 30 giorni prima della somministrazione (sono consentiti i vaccini anti-COVID-19)
    13. Aver ricevuto un trattamento con un anticorpo monoclonale specifico per SARS-CoV-2
    14. Avere una storia di trattamento al plasma COVID-19 convalescente
    15. Aver partecipato, negli ultimi 30 giorni, a uno studio clinico che prevedesse un intervento sperimentale. Se il precedente intervento sperimentale ha una lunga emivita, pari a 5 emivite o 30 giorni, a seconda di quale sia più lungo, dovrebbe essere trascorso il tempo necessario
    16. Sono contemporaneamente iscritti a qualsiasi altro tipo di ricerca medica giudicata compatibile a livello medico o scientifico con questo studio
    17. Donna incinta o in allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is:
    - Disease progression defined as: hospitalization in intensive care unit, oxygen desaturation =4% and peripheral oxygen saturation =92% during the follow-up period (30 days).
    Endpoint Primario:
    - Progressione della malattia definita come: ricovero in unità di terapia intensiva, desaturazione di ossigeno =4% e saturazione di ossigeno periferica =92% durante il periodo di follow-up (30 giorni).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint are reported within the endpoint list
    Tempi di rilevazione indicati all'interno dei punti finali
    E.5.2Secondary end point(s)
    The secondary endpoints of the study are:
    - Incidence and severity of adverse events, with severity determined according to the 5-point severity scale (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 [NCI CTCAE, v.5.0]) during the follow-up period (30 days).
    - Proportion of patients admitted to the Emergency Department for COVID-19 disease during the follow-up period.
    - All-cause mortality due to COVID-19 disease.
    Endpoint Secondari:
    - Incidenza e gravità degli eventi avversi (AE), con gravità determinata secondo la scala di gravità a 5 punti (National Cancer Institute Common Terminology Criteria for Adverse Events, Versione 5.0 [NCI CTCAE, v.5.0]) durante il periodo di follow-up (30 giorni)
    - Percentuale di pazienti ricoverati in Pronto Soccorso per malattia COVID-19 durante il periodo di follow-up
    Mortalità per tutte le cause a causa della malattia COVID-19
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint are reported within the endpoint list
    Tempi di rilevazione indicati all'interno dei punti finali
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    tollerabilità
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    SOC (standard di cura) quali paracetamolo o FANS, per la gestione domiciliare del COVID-19
    SOC (standard of care) as Paracetamol or FANS for home management of COVID-19
    E.8.2.4Number of treatment arms in the trial4
    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 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 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
    LVLS
    LVLS
    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 years0
    E.8.9.2In all countries concerned by the trial months8
    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: 400
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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)
    not expected
    non previsto
    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 Decision2021-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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