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    Summary
    EudraCT Number:2021-000344-21
    Sponsor's Protocol Code Number:MP1032-CT05
    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:2021-07-27
    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 number2021-000344-21
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PROOF-OF-CONCEPT, PHASE IIA STUDY OF MP1032 PLUS STANDARD OF CARE VS STANDARD OF CARE IN THE TREATMENT OF HOSPITALIZED PATIENTS WITH MODERATE TO SEVERE COVID-19.
    STUDIO PROOF-OF-CONCEPT DI FASE IIA, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, MULTICENTRICO DI MP1032 PIÙ TERAPIA STANDARD RISPETTO ALLA TERAPIA STANDARD NEL TRATTAMENTO DI PAZIENTI RICOVERATI CON COVID-19 DI GRADO DA MODERATO A GRAVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MP1032 Treatment in Patients with Moderate to Severe COVID-19
    Trattamento con MP1032 in pazienti con malattia da COVID-19 da moderata a grave.
    A.3.2Name or abbreviated title of the trial where available
    MP1032 Treatment in Patients with Moderate to Severe COVID-19
    Trattamento con MP1032 in pazienti con malattia da COVID-19 da moderata a grave.
    A.4.1Sponsor's protocol code numberMP1032-CT05
    A.5.4Other Identifiers
    Name:INDNumber:153604
    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 SponsorMetrioPharm AG
    B.1.3.4CountrySwitzerland
    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 supportMetrioPharm AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMetrioPharm Deutschland GmbH
    B.5.2Functional name of contact pointClinical Department
    B.5.3 Address:
    B.5.3.1Street AddressAm Borsigturm 100
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13507
    B.5.3.4CountryGermany
    B.5.4Telephone number004930338439502
    B.5.5Fax number004930338439599
    B.5.6E-mailclinicaltrials@metriopharm.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.2.1.1.1Trade name NA
    D.2.1.1.2Name of the Marketing Authorisation holderNA
    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 nameMP1032 hard gelatin capsules 50 mg
    D.3.2Product code [MP1032]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 20666-12-0
    D.3.9.2Current sponsor codeMP1032
    D.3.9.3Other descriptive nameMP 1032
    D.3.9.4EV Substance CodeMP 1032
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe coronavirus disease 2019 (COVID 19)
    Malattia da COVID-19 da moderata a grave.
    E.1.1.1Medical condition in easily understood language
    Moderate to severe coronavirus disease 2019 (COVID 19)
    Malattia da COVID-19 da moderata a grave.
    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 LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084460
    E.1.2Term COVID-19 treatment
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084382
    E.1.2Term Coronavirus disease 2019
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084529
    E.1.2Term 2019 novel coronavirus infection
    E.1.2System Organ Class 100000004862
    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 this study is to measure the effect of MP1032 plus standard of care (SoC) versus placebo plus SoC on Day 14 on disease progression in patients with moderate to severe coronavirus disease 2019 (COVID-19).
    • Misurare l’effetto di MP1032 più standard di cura (Standard of Care, SoC) rispetto a placebo più SoC al Giorno 14 sulla progressione della malattia in pazienti con malattia da coronavirus 2019 (Coronavirus Disease 2019, COVID-19) da moderata a grave
    E.2.2Secondary objectives of the trial
    • To measure the effect of MP1032 plus SoC versus placebo plus SoC on
    Day 28 on disease progression in patients with moderate to severe
    COVID-19;
    • To measure the effect of MP1032 plus SoC versus placebo plus SoC on
    disease resolution on Day 14 and Day 28;
    • To measure the effect of MP1032 plus SoC versus placebo plus SoC on
    the mortality rate and other specific COVID-19 related characteristics;
    • To assess the safety of MP1032 (eg, adverse events [AEs] and
    laboratory abnormalities);
    • To assess the pharmacokinetics (PK) of MP1032 on Day 1 (single dose)
    and Day 7 (steady state) in a PK subset of patients.
    • Misurare l’effetto di MP1032 più SoC rispetto a placebo più SoC al Giorno 28 sulla progressione della malattia in pazienti con COVID-19 da moderata a grave
    • Misurare l’effetto di MP1032 più SoC rispetto a placebo più SoC sulla risoluzione della malattia al Giorno 14 e al Giorno 28
    • Misurare l’effetto di MP1032 più SoC rispetto a placebo più SoC sul tasso di mortalità e su altre caratteristiche specifiche correlate alla COVID-19
    • Valutare la sicurezza di MP1032 (per es., eventi avversi [EA] e anomalie di laboratorio)
    • Valutare la farmacocinetica (Pharmacokinetics, PK) di MP1032 al Giorno 1 (dose singola) e al Giorno 7 (stato di equilibrio) in un sottogruppo di PK di pazienti
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Optional pharmacokinetik assessments

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Studio di farmacocinetica opzionale.
    E.3Principal inclusion criteria
    1. The patient must be willing and able to give informed consent to
    participate in the study and to adhere to the procedures stated in the
    protocol or, for adults incapable of consenting due to their medical
    condition (eg, too weak or debilitated, severe shortness of breath) or
    due to literacy issues, the patient's legally authorized representative
    must be willing and able to give informed consent on behalf of the
    patient to participate in the study as permitted by local regulatory
    authorities, institutional review boards (IRBs)/independent ethics
    committees (IECs), or local laws;
    2. The patient is male or female adult aged =18 years (as per local laws)
    at the time of giving informed consent;
    3. The patient is admitted to a hospital and has a positive SARS-CoV-2
    test by standard RT-PCR assay or equivalent test. Please note: If the
    patient has a previous confirmation of SARS-CoV-2 (within 7 days of Day
    1), the SARS-CoV-2 test at screening is not required;
    4. The patient has the presence of any symptom(s) suggestive of
    moderate or severe systemic illness with COVID-19 on Day 1, such as
    presence of fever (=38.0°C [=100.4°F] by any route), loss of smell or
    taste, cough, sore throat, malaise, headache, muscle pain,
    gastrointestinal symptoms, shortness of breath upon exertion and/or at
    rest, or respiratory distress;
    5. The patient has the presence of moderate to severe clinical signs
    indicative of moderate or severe illness with COVID-19 on Day 1:
    a) Moderate:
    i. Clinical signs suggestive of moderate illness with COVID-19, such as
    respiratory rate =20 breaths per minute, SpO2 >93% (on room air at
    sea level, if possible), heart rate =90 beats per minute
    ii. No clinical signs indicative of severe or critical COVID-19
    b) Severe:
    i. Clinical signs suggestive of severe systemic illness with COVID-19,
    such as respiratory rate =30 breaths per minute, heart rate =125 beats
    per minute, SpO2 =93% (on room air at sea level, if possible), partial
    pressure of oxygen/FiO2 <300, or diagnosed with acute respiratory
    distress syndrome (according to the Berlin definition)
    ii. No criteria met for critical COVID-19
    6. The patient does not require hemodialysis (chronic) or any renal
    replacement therapies at screening or Day 1;
    7. The patient is able to swallow the study drug (hard gelatin capsules);
    8. The patient agrees to minimize strong sun exposure (sunbathing) and
    strong ultraviolet exposure during the course of the study. Additionally,
    during the study, patients must agree to use sunscreen when spending
    an extended period outdoors
    1. Il paziente deve essere disposto e in grado di fornire il consenso informato a partecipare allo studio e ad aderire alle procedure indicate nel protocollo oppure, per soggetti adulti incapaci di fornire il consenso a causa della loro condizione medica (per es., per eccessiva debolezza o debilitazione, grave respiro affannoso) o a causa di problemi di alfabetizzazione, il rappresentante legalmente autorizzato del paziente deve essere disposto e in grado di fornire il consenso informato per conto del paziente a partecipare allo studio, come consentito dalle autorità regolatorie locali; comitati etici di revisione (Institutional Review Board, IRB)/comitati etici indipendenti (CEI); o le leggi locali.
    2. Il paziente è un soggetto adulto di sesso maschile o femminile di età =18 anni (in base alle leggi locali) al momento del rilascio del consenso informato.
    3. Il paziente viene ricoverato in ospedale e presenta un test positivo a SARS-CoV-2 mediante test standard RT-PCR o test equivalente. Tenere presente che: se il paziente ha ricevuto in precedenza una conferma di SARS-CoV-2 (entro i 7 giorni precedenti il Giorno 1), non è necessario eseguire il test per SARS-CoV-2 allo screening.
    4. Il paziente presenta un qualsiasi sintomo suggestivo di malattia sistemica moderata o grave con COVID-19 al Giorno 1, quali presenza di febbre (=38,0 °C misurata con qualsiasi modalità), perdita dell’olfatto o del gusto, tosse, mal di gola, malessere, mal di testa, dolore muscolare, sintomi gastrointestinali, respiro affannoso sotto sforzo e/o a riposo o distress respiratorio.
    5. Il paziente presenta segni clinici da moderati a gravi indicativi di malattia moderata o grave con COVID-19 al Giorno 1:
    a) Moderata:
    i. Segni clinici indicativi di malattia moderata con COVID-19, come frequenza respiratoria =20 respiri al minuto, SpO2 >93% (in aria ambiente al livello del mare, se possibile), frequenza cardiaca =90 battiti al minuto
    ii. Nessun segno clinico indicativo di COVID-19 grave o critica
    b) Grave:
    i. Segni clinici indicativi di malattia sistemica grave con COVID-19, come frequenza respiratoria =30 respiri al minuto, frequenza cardiaca =125 battiti al minuto, SpO2
    =93% (in aria ambiente al livello del mare, se possibile), pressione parziale di ossigeno/FiO2 <300 o diagnosi di sindrome da distress respiratorio acuto (secondo la definizione di Berlino)
    ii. Nessun criterio soddisfatto per COVID-19 critica
    Tenere presente che: i pazienti che ricevono ossigenoterapia al basale per una condizione cronica (per es., enfisema, malattia polmonare ostruttiva cronica, PAH, IPF, ecc.) devono essere considerati come affetti da COVID-19 grave (a meno che il paziente non soddisfi la definizione di COVID-19 critica). Per domande relative alla gravità della COVID-19, lo sperimentatore deve contattare il responsabile del monitoraggio medico.
    6. Il paziente non necessita di emodialisi (cronica) o di eventuali terapie di sostituzione renale allo screening o al Giorno 1.
    7. Il paziente è in grado di ingerire il farmaco dello studio (capsule rigide in gelatina).
    8. Il paziente accetta di ridurre al minimo l’esposizione intensa al sole (per abbronzarsi) e l’esposizione intensa ai raggi ultravioletti durante il corso dello studio. Inoltre, durante lo studio, i pazienti devono accettare di utilizzare una crema solare quando trascorrono un periodo prolungato all’aperto.
    E.4Principal exclusion criteria
    for =48 hours beyond Day 1.
    2. The patient has a diagnosis of asymptomatic COVID-19, mild COVID-
    19, or critical COVID-19 on Day 1.
    a) Asymptomatic COVID-19 is defined as a patient with a positive SARSCoV-
    2 test by standard RT-PCR assay or equivalent test but not
    experiencing symptoms.
    b) Mild COVID-19 is defined as a patient with a positive SARS-CoV-2 test
    by standard RT-PCR assay or equivalent test and experiencing symptoms
    of mild illness but no clinical signs indicative of moderate, severe, or
    critical COVID-19.
    c) Critical COVID-19 is defined as a patient with a positive SARS-CoV-2
    test by standard RT-PCR assay or equivalent test and experiencing at
    least 1 of the following: shock defined by systolic blood pressure <90
    mm Hg or diastolic blood pressure <60 mm Hg, or requiring
    vasopressors; respiratory failure requiring endotracheal intubation and
    invasive mechanical ventilation, oxygen delivered by high-flow nasal
    cannula (heated, humidified, oxygen delivered via reinforced nasal
    cannula at flow rates >20 L/min with fraction of delivered oxygen =0.5),
    non-invasive positive pressure ventilation, ECMO, or clinical diagnosis of
    respiratory failure (ie, clinical need for 1 of the preceding therapies, but
    preceding therapies not able to be administered in setting of resource
    limitation), and/or multi-organ dysfunction/failure.
    3. The patient has a Child Pugh score = C.
    4. The patient has a documented medical history of infection with
    hepatitis A, B, or C at screening or Day 1.
    5. The patient has a documented medical history of infection with human
    immunodeficiency virus and has a detectable viral load and CD4 count
    <500 cells/µL.
    6. The patient has a documented active infection with tuberculosis at
    screening or Day 1.
    7. The patient has clinically significant electrocardiogram abnormalities
    at screening.
    8. A female patient who is pregnant, planning to become pregnant
    during the study, breastfeeding, or has a positive pregnancy test at
    screening (by serum) and before dosing on Day 1 (by urine) as
    determined by human chorionic gonadotrophin tests.
    9. The patient is planning to donate or bank ova or sperm from Day 1
    until 30 days after the last dose of study drug.
    10. The patient has a known history of drug or alcohol abuse within 6
    months of study start that would interfere with the patient's
    participation in the study.
    11. The patient has a history of sensitivity to any of the study
    medications, components thereof (eg, mannitol or gelatin), or a history
    of drug or other allergy that, in the opinion of the investigator or medical
    monitor, would contraindicate their participation.
    12. The patient has participated in and/or plans to participate in another
    clinical study using an investigational product within the following
    period before the first dosing day in the current study: 30 days, 5 halflives,
    or twice the duration of the biological effect of the investigational
    product (whichever is longer).
    1. Il paziente, a giudizio dello sperimentatore, non ha probabilità di sopravvivere per =48 ore dopo il Giorno 1.
    2. Il paziente presenta una diagnosi di COVID-19 asintomatica, COVID-19 lieve o COVID-19 critica al Giorno 1.
    a) La COVID-19 viene definita asintomatica in un paziente con un test positivo a SARS-CoV-2 mediante test standard RT-PCR o test equivalente, ma che non manifesta sintomi.
    b) La COVID-19 viene definita lieve in un paziente con un test positivo a SARS-CoV-2 mediante test standard RT-PCR o test equivalente e che manifesta sintomi di malattia lieve, ma nessun segno clinico indicativo di COVID-19 moderata, grave o critica.
    c) La COVID-19 viene definita critica in un paziente con un test positivo a SARS-CoV-2 mediante test standard RT-PCR o test equivalente e che presenta almeno 1 dei seguenti sintomi: shock definito da pressione arteriosa sistolica <90 mmHg o pressione arteriosa diastolica <60 mmHg, o che richiede vasopressori; insufficienza respiratoria che richiede intubazione endotracheale e ventilazione meccanica invasiva, ossigeno erogato da una cannula nasale ad alto flusso (ossigeno riscaldato, umidificato, erogato tramite cannula nasale rinforzata a portate >20 l/min con frazione di ossigeno erogato =0,5), ventilazione a pressione positiva non invasiva, ECMO o diagnosi clinica di insufficienza respiratoria (ovvero, necessità clinica di 1 delle terapie precedenti, ma le precedenti terapie non possono essere somministrate in un contesto di limitazione delle risorse), e/o disfunzione/insufficienza multiorgano.
    Tenere presente che: i pazienti che ricevono ossigenoterapia al basale per una condizione cronica (per es., enfisema, malattia polmonare ostruttiva cronica, PAH, IPF, ecc.) devono essere considerati come affetti da COVID-19 grave (a meno che il paziente non soddisfi la definizione di COVID-19 critica). Per domande relative alla gravità della COVID-19, lo sperimentatore deve contattare il responsabile del monitoraggio medico.
    3. Il paziente ha un punteggio Child-Pugh = C.
    4. Il paziente presenta un’anamnesi medica documentata di infezione da epatite A, B o C allo screening o al Giorno 1.
    5. Il paziente presenta un’anamnesi medica documentata di infezione da virus dell’immunodeficienza umana e presenta una carica virale rilevabile e una conta dei CD4 <500 cellule/µl.
    6. Il paziente presenta un’infezione attiva documentata da tubercolosi allo screening o al Giorno 1.
    7. Il paziente presenta allo screening anomalie clinicamente significative nell’elettrocardiogramma.
    8. Paziente di sesso femminile in gravidanza, che prevede di rimanere incinta durante lo studio, che allatta al seno o che risulta positiva al test di gravidanza allo screening (su siero) e prima della somministrazione al Giorno 1 (sulle urine), come determinato dai test della gonadotropina corionica umana.
    9. Il paziente ha in programma di donare o conservare gli ovuli o il liquido seminale dal Giorno 1 fino a 30 giorni dopo l’ultima dose del farmaco dello studio.
    10. Il paziente presenta un’anamnesi nota di abuso di droghe o alcol entro 6 mesi dall’inizio dello studio che interferirebbe con la partecipazione del paziente allo studio.
    11. Il paziente presenta un’anamnesi di sensibilità a uno qualsiasi dei farmaci dello studio, a componenti dello stesso (per es., mannitolo o gelatina) o un’anamnesi di allergia a farmaci o di altro tipo, che, a giudizio dello sperimentatore o del responsabile del monitoraggio medico, potrebbe rappresentare una controindicazione per la sua partecipazione.
    12. Il paziente ha partecipato e/o prevede di partecipare a un altro studio clinico che utilizza un prodotto sperimentale nel periodo precedente il primo giorno di somministrazione nello studio attuale: 30 giorni, 5 emivite o il doppio della durata dell’effetto biologico del prodotto sperimentale (a seconda di quale periodo sia più lungo).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is the proportion of patients with disease progression on Day 14. Disease progression is defined as the proportion of patients who are not alive or who have respiratory failure. Respiratory failure is defined as patients who have a score of 2, 3, or 4 on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale.
    • Percentuale di pazienti con progressione della malattia al Giorno 14. La progressione della malattia è definita come la percentuale di pazienti che non sono in vita o che presentano insufficienza respiratoria. L’insufficienza respiratoria è definita come pazienti che presentano un punteggio di 2, 3 o 4 sulla scala ordinale a 8 punti del National Institute of Allergy and Infectious Diseases (NIAID) (vedere di seguito).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    Giorno 14
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints of this study are:
    • Proportion of patients with disease progression on Day 28. Disease
    progression is defined as the proportion of patients who are not alive or
    who have respiratory failure. Respiratory failure is defined as patients
    who have a score of 2, 3, or 4 on the NIAID 8-point ordinal scale.
    • Proportion of patients with disease resolution on Day 28. Disease
    resolution is defined as patients who are alive and have a score of 6, 7,
    or 8 on the NIAID 8-point ordinal scale.
    • All-cause mortality rate at Day 28
    • Change of clinical status related to COVID-19 on Day 28 compared with
    baseline according to the following NIAID 8-point ordinal scale:
    1. Death;
    2. Hospitalized, on invasive ventilation (mechanical ventilator and/or
    extracorporeal membrane oxygenation [ECMO]);
    3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices;
    4. Hospitalized, requiring supplemental oxygen;
    5. Hospitalized, not requiring supplemental oxygen, but requiring
    ongoing medical care (COVID-19 related or otherwise);
    6. Hospitalized, not requiring supplemental oxygen and no longer
    requires ongoing medical care (used if hospitalization was extended for
    infection-control reasons);
    7. Not hospitalized, limitation on activities, and/or requiring home
    oxygen;
    8. Not hospitalized, no limitations on activities.
    • Percentuale di pazienti con progressione della malattia al Giorno 28. La progressione della malattia è definita come la percentuale di pazienti che non sono in vita o che presentano insufficienza respiratoria. L’insufficienza respiratoria è definita come pazienti che presentano un punteggio di 2, 3 o 4 sulla scala ordinale a 8 punti NIAID (vedere di seguito).
    • Percentuale di pazienti con risoluzione della malattia al Giorno 28. La risoluzione della malattia è definita come pazienti in vita con un punteggio di 6, 7 o 8 sulla scala ordinale a 8 punti NIAID.
    • Tasso di mortalità per qualsiasi causa al Giorno 28
    • Variazione dello stato clinico correlato alla COVID-19 al Giorno 28 rispetto al basale secondo la seguente scala ordinale a 8 punti NIAID:
    1. Decesso
    2. Ricoverato in ospedale, con ventilazione invasiva (ventilatore meccanico e/o ossigenazione extracorporea a membrana [Extracorporeal Membrane Oxygenation, ECMO])
    3. Ricoverato in ospedale, con ventilazione non invasiva o dispositivi ad alto flusso di ossigeno
    4. Ricoverato in ospedale, con necessità di ossigeno supplementare
    5. Ricoverato in ospedale, senza necessità di ossigeno supplementare, ma con necessità di cure mediche continue (correlate o meno alla COVID-19)
    6. Ricoverato in ospedale, senza necessità di ossigeno supplementare e senza necessità di cure mediche continue (utilizzato se il ricovero è stato esteso per motivi di controllo dell’infezione)
    7. Non ricoverato in ospedale, limitazione delle attività e/o necessità di ossigeno a domicilio
    8. Non ricoverato in ospedale, nessuna limitazione delle attività
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified within the list of endpoints
    Specificato nella lista degli endpoints
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Verifica teorica
    Proof of concept
    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 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
    Ultima visita dell'ultimo soggetto
    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 months5
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days9
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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
    Hospitalized patients with moderate to severe coronavirus disease 2019 (COVID-19) will be enrolled: there is a possibility to enroll adults incapable of consenting due to their medical condition or due to literacy issues.
    Saranno arruolati pazienti ricoverati con malattia da COVID-19 da moderata a grave: è possibile anche arruolare adulti incapaci di dare il proprio consenso a causa delle proprie condizioni mediche.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 Decision2021-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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