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    EudraCT Number:2020-001673-75
    Sponsor's Protocol Code Number:ABX464-401
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-08-10
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001673-75
    A.3Full title of the trial
    A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing
    COVID-19 associated acute respiratory failure in patients aged = 65 and patients aged =18 with at least one additional risk factor who are infected with SARS-CoV-2. (the MiR-AGE study).
    Studio di fase 2/3, randomizzato, in doppio cieco, controllato verso placebo per valutare l’efficacia e la sicurezza di ABX464 nel trattamento dell’infiammazione e nella prevenzione dell’insufficienza respiratoria acuta associata a COVID-19 in pazienti con età = 65 anni e pazienti con età = 18 anni con almeno un fattore di rischio aggiuntivo che sono infetti da SARS-CoV-2 (Studio MiR-AGE).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2/3 study of ABX464, once daily oral capsule, in high risk patients infected by SARS-CoV-2 prior to respiratory distress.
    Studio di fase 2/3 di ABX464, in capsule da assumere per via orale una volta al giorno, in pazienti ad alto rischio con infezione da SARS-CoV-2 precedente a distress respiratorio associato a COVID-19.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberABX464-401
    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 SponsorAbivax
    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 supportabivax
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationabivax
    B.5.2Functional name of contact pointClinical operations
    B.5.3 Address:
    B.5.3.1Street Address5 rue de la baume
    B.5.3.2Town/ cityParigi
    B.5.3.3Post code75008
    B.5.4Telephone number000000000
    B.5.5Fax number000000
    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.2.1.2Country 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 name------
    D.3.2Product code [ABX464]
    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.3.9.2Current sponsor codeABX464
    D.3.9.3Other descriptive nameABX464
    D.3.9.4EV Substance CodeSUB184487
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    Infection with SARS-CoV-2 virus, COVID-19 infection
    infezione da virus SARS-CoV-2, infezione COVID-19
    E.1.1.1Medical condition in easily understood language
    The coronavirus disease 2019 (COVID-19) is an acute respiratory disease caused by a novel coronavirus, that has been exported around the globe to reach pandemic proportion
    La malattia di coronavirus 2019 (COVID-19) è una malattia respiratoria acuta causata da un nuovo coronavirus, che è stata esportata nel globo sino a raggiungere la proporzione di pandemia
    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 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 determine the efficacy of ABX464 50mg to prevent respiratory failure or death in study patients.
    L’obiettivo primario dello studio è determinare l’efficacia di ABX464 50 mg per prevenire l’insufficienza respiratoria o il decesso nei pazienti dello studio.
    E.2.2Secondary objectives of the trial
    Evaluate the proportion of patients requiring hospitalization compared to the {Standard of care + placebo} group
    Assess the proportion of patients reporting each severity rating on a 7- point ordinal scale
    Assess the time to an improvement of one category of the a 7-point on an ordinal scale from baseline
    Evaluate and compare the effect of ABX464 on immunophenotyping and cytokines levels
    Evaluate the proportion of patient requiring oxygen supplementation
    Assess the time to hospitalization
    Evaluate the time to application of invasive and non-invasive mechanical ventilation or high flow oxygen therapy
    Assess the IMV and/or NIV duration
    Assess the oxygen supplementation (>3L/min) duration
    Assess the hospital stay duration
    Evaluate the effect of ABX464 on miR-124 expression
    Assess the change in CRP, Troponin I & T and D-dimer levels
    Evaluate the prevention of Covid-19 related deaths
    Evaluate SARS-CoV-2 infection in subjects
    Evaluate the safety
    Valutare la percentuale di pazienti che necessitano di ricovero ospedaliero durante lo studio, rispetto al gruppo {Standard di cura + placebo}
    Valutare la percentuale di pazienti che indicano ciascun livello di gravità su una scala ordinale a 7 punti
    Valutare il tempo intercorrente prima di ottenere un miglioramento di una categoria a 7 punti su una scala ordinale dal basale
    Valutare e confrontare gli effetti di ABX464 sull’immunofenotipizzazione e sui livelli di citochine
    Valutare la proporzione di pazienti che richiedono integrazione di ossigeno
    Valutare il tempo di ospedalizzazione
    Valutare il tempo di applicazione della ventilazione meccanica invasiva e non invasiva o dell'ossigenoterapia ad alto flusso
    Valutare la durata di IMV e / o NIV
    Valutare la durata della supplementazione di ossigeno (>3 ml)
    Valutare la durata della degenza in ospedale
    Valurare l'effetto di ABX464 su espressione di miR-124
    Per i restanti obiettivi si faccia riferimento al protocollo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible to participate in this study if ALL the following criteria are met:
    1. Adult (= 18 years old) men or women hospitalizedor not hospitalized,diagnosed for SARS-CoV-2 infection by PCR with at least one associated risk factor.
    Considered risk factors are:
    • Age = 65 years
    • Obesity defined as BMI = 30
    • Recent histroy of uncontrolled High Blood Pressure (SBP > 150 mm Hg & DBP >100 mm Hg) according to investigator
    • Treated diabetes (type I or II)
    • History of ischemic cardiovascular disease
    2. Symptomatic patients at enrollment. Symptoms are defined as fever (body temperature = 37.8 °C oral/tympanic, or = 38.2 °C rectal) for more than 24 hours associated either with headache, sore throat, dry cough, fatigue, chest pain or choking sensation (with no associated respiratory distress), myalgia, anosmia or ageusia.
    3. Patients with pulse oximetry arterial saturation (SpO2) = 92 % on room air at enrolment.
    4. Patients with the following hematological and biochemical laboratory parameters obtained within 7 days prior to D0:
    • Hemoglobin > 9.0 g dL-1
    • Absolute Neutrophil Count = 1000 mm-3;
    • Platelets = 100,000 mm-3;
    • Creatinine clearance = 50 mL min-1 by the Cockcroft-Gault formula
    • Total serum bilirubin < 2 x ULN
    • Alkaline phosphatase< 2 x ULN, AST (SGOT) and ALT (SGPT) < 3 x ULN;
    5. Women of child bearing potential and men receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to enrolment. Women must be surgically sterile or
    if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male patients should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male patients must not donate sperm as long as contraception is required. For the purpose of this protocol, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle
    stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Finally a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
    6. Patients must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures.
    7. Patients able and willing to comply with study visits and procedures as per protocol.
    8. Patients should be affiliated to a social security regimen (for French sites only).
    Per essere idoneo/a per questo studio, un/a paziente deve soddisfare TUTTI i seguenti criteri:
    1. Uomini o donne adulti (= 18 anni), ricoverati/e in ospedale o non ricoverati/e in ospedale, con una diagnosi di infezione da SARS-CoV-2 rilevata mediante PCR, con almeno un fattore di rischio associato. I fattori di rischio considerati sono:
    • Età = 65 anni
    • Obesità definita come indice di massa corporea (IMC) = 30
    • Recente anamnesi di pressione sanguigna elevata non controllata (pressione sanguigna sistolica [Systolic Blood Pressure, SBP] > 150 mmHg e pressione sanguigna diastolica [Diastolic Blood Pressure, DBP] > 100 mmHg) secondo lo sperimentatore
    • Trattati per il diabete (di tipo I o II)
    • Anamnesi di malattia cardiovascolare ischemica
    2. Pazienti sintomatici al momento dell’arruolamento. I sintomi sono definiti come febbre (temperatura corporea orale/timpanica = 37,8 °C o rettale = 38,2 °C) per più di 24 ore associati a mal di testa, mal di gola, tosse secca, affaticamento, dolore toracico o sensazione di soffocamento (non associati a distress respiratorio), mialgia, anosmia o ageusia.
    3. Pazienti con % di pulsossimetria arteriosa (SpO2) = 92% in aria ambiente al momento dell’arruolamento.
    4. Pazienti con i seguenti parametri di laboratorio ematologici e biochimici ottenuti entro 7 giorni precedenti al G0:
    ¦ Emoglobina > 9,0 g dl-1
    ¦ Conta assoluta dei neutrofili = 1.000 mm-3;
    ¦ Piastrine = 100.000 mm-3;
    ¦ Clearance della creatinina = 50 ml min-1, calcolata mediante equazione di Cockcroft-Gault
    ¦ Bilirubina totale nel siero < 2 x ULN
    ¦ Fosfatasi alcalina < 2 x ULN, AST (Serum Glutamic Oxaloacetic Transaminase, SGOT) e ALT (Serum Glutamic Pyruvic Transaminase, SGPT) < 3 x ULN;
    5. Le donne in età fertile e gli uomini che ricevono il trattamento dello studio e le loro partner devono acconsentire a utilizzare un metodo contraccettivo altamente efficace durante lo studio e per 6 mesi (180 giorni) dopo la fine o l’interruzione anticipata dello studio. La contraccezione deve essere in atto da almeno 2 settimane prima dell’arruolamento. Le donne devono essere chirurgicamente sterili o se in età fertile devono utilizzare un metodo contraccettivo altamente efficace. Le donne in età fertile (Women Of Childbearing Potential, WOCBP) accederanno allo studio dopo la conferma del ciclo mestruale e un test di gravidanza negativo. I metodi contraccettivi altamente efficaci includono astinenza effettiva, dispositivo intrauterino (intrauterine device, IUD) o contraccezione ormonale finalizzata all’inibizione dell’ovulazione, sistema di rilascio ormonale intrauterino, legatura bilaterale delle tube, partner vasectomizzato. L’astinenza completa è definita come pratica in linea con lo stile di vita preferito e abituale del/la paziente. In ogni caso di ritardo del ciclo mestruale (oltre un mese tra le mestruazioni) è richiesta la conferma dell’assenza di gravidanza. Questa raccomandazione si applica anche alle donne WOCBP con ciclo mestruale saltuario o irregolare. I pazienti di sesso femminile e maschile non devono pianificare una gravidanza durante la sperimentazione e nei 6 mesi successivi il completamento della loro partecipazione alla sperimentazione. Inoltre, i pazienti di sesso maschile devono utilizzare un preservativo durante la sperimentazione e nei 6 mesi (180 giorni) successivi il completamento della propria partecipazione allo studio. I pazienti di sesso maschile non devono donare sperma fintantoché sarà richiesta la contraccezione. Ai fini del presente protocollo, una donna è considerata in età fertile (WOCBP), successivamente al menarca e fino all’ingresso in post-menopausa, a meno che non sia permanentemente sterile. I metodi di sterilizzazione permanente includono isterectomia, salpingectomia bilaterale e ooforectomia bilaterale. Uno stato post-menopausale è definito come assenza del ciclo mestruale da 12 mesi senza una causa medica alternativa............
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria will be excluded from the study:
    1. Patients with moderate or severe acute respiratory failure or requiring non-invasive ventilation or oxygen or with SpO2 < 92% or tachypnea (respiratory rate = 30 breaths/min).
    2. Patients treated with immunosuppressors and/or immunomodulators (cf.Appendix #2).
    3. Engrafted patients (organ and/or hematopoietic stem cells).
    4. Patients with uncontrolled auto-immune disease.
    5. Patients with known or suspected active (i.e. not controlled) bacterial, viral (excluding COVID-19) or fungal infections.
    6. Patients with preexisting, severe and not controlled organ failure.
    7. History or active malignancy requiring chemotherapy or radiation therapy (excluding 2 years disease free survivor patients).
    8. Pregnant or breast-feeding women.
    9. Illicit drug or alcohol abuse or dependence that may compromise the patient's safety or adherence to the study protocol.
    10. Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer.
    11. Hypersensitivity to ABX464 and/or its excipients.
    12. Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.
    I/Le pazienti che soddisfano uno qualsiasi dei seguenti criteri di esclusione saranno esclusi/e dallo studio:
    1. Pazienti con insufficienza respiratoria acuta moderata o grave o richiedenti ventilazione non invasiva od ossigeno o con SpO2 < 92% o tachipnea (frequenza respiratoria = 30 atti respiratori/minuto).
    2. Pazienti trattati/e con immunosoppressori e/o immunomodulatori (vedere Appendice 2).
    3. Pazienti sottoposti/e a trapianto (di organo e/o cellule staminali ematopoietiche).
    4. Pazienti con malattia autoimmune non controllata.
    5. Pazienti con infezioni attive, note o sospette (per es. non controllate), di tipo batterico, virale (esclusa la COVID-19) o micotico.
    6. Pazienti con insufficienza d’organo preesistente, grave e non controllata.
    7. Anamnesi o presenza di neoplasia attiva richiedente chemioterapia o radioterapia (ad eccezione di pazienti sopravvissuti/e con 2 anni di assenza della malattia).
    8. Donne in gravidanza o che stanno allattando al seno.
    9. Abuso di o dipendenza da sostanze stupefacenti o alcolici che possa compromettere la sicurezza del/la paziente o la relativa aderenza al protocollo dello studio.
    10. Utilizzo di qualsiasi prodotto sperimentale o non registrato entro 3 mesi o entro 5 emivite precedenti il basale, a seconda di quale periodo sia più lungo.
    11. Ipersensibilità a ABX464 e/o ai suoi eccipienti.
    12. Qualsiasi condizione, che, a parere dello sperimentatore, possa compromettere la sicurezza del/la paziente o la relativa aderenza al protocollo dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of patients with no invasive or non-invasive mechanical ventilation (IMV and NIV, respectively), but excluding simple nasal/mask oxygen supplementation, and who are alive at the end of the 28 days period.
    Il tasso di pazienti non richiedenti l’utilizzo di ventilazione obbligatoria intermittente [invasive mechanical ventilation, IMV] e ventilazione meccanica non invasiva [non-invasive ventilation, NIV], rispettivamente) ma escluso la semplice supplementazione di ossigeno nasale / maschera e che sono vivi alla fine del periodo di 28 giorni.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    Giorno 28
    E.5.2Secondary end point(s)
    1.Rate of patients hospitalized in both treatment groups
    2. Percentage of patients reporting each severity rating on a 7-point ordinal scale at each study visit (i.e. Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO;Death);
    3.Mean change in the ranking on an ordinal scale from baseline to days 7, 14, 21, and 28
    4.Change from enrolment in inflammatory markers in plasma (i.e. MCP1, MIP-1 a, G-CSF, IL-1b, IL-2, IL-6, IL-7, IL-10, IL-17, INFg and TNFa) and in immune phenotype and assessment of cell-activation markers in PBMCs at D14, D28 for hospitalized patients only.
    5.Rate of patients requiring oxygen supplementation in both treatment groups.
    6.Time to hospitalization (log rank) from baseline in both treatment groups.
    7.Time to assisted ventilation and oxygen supplementation (log rank) from baseline in both treatment groups.
    8.Number of days of assisted ventilation in both treatment groups.
    9.Number of days of oxygen supplementation in both treatment groups.
    10.Number of days at the hospital from admission to discharge in both treatment groups.
    11.Change from baseline in microRNA-124 levels in total blood (PAXgene®) at D0, D7 and D28 in both treatment groups.
    12.AUC and % of change from enrolment in CRP, Troponin I & T and Ddimer levels in both treatment groups.
    13.Time to death (log rank) and mortality rate (all causes, and Covid-19 related) in both treatment groups.
    14.SARS-CoV-2 virus in nasopharyngeal sample and/or in blood at Day 0, 7, 14, 21, and 28.
    15 Number and rates of participants with Treatment Emergent Adverse Event
    16.Cumulative incidence of serious adverse events (SAEs) - 28 days
    17.Cumulative incidence of Grade 3 and 4 adverse events (AEs) - 28 days
    18.Number of participants with a discontinuation or temporary suspension of study drugs (for any reason) - 28 days.
    19.Central blinded review of the hospitalization discharge CT-Scans for descriptive analysis with regards to the disease severity and outcomes.
    1 Tasso di pazienti ricoverati/e in ospedale in entrambi i gruppi di trattamento
    2 Percentuale di pazienti che indicano ciascun livello di gravità su una scala ordinale a 7 punti, in occasione di ciascuna visita dello studio (per es. non ricoverato/a in ospedale, senza limitazione delle attività; non ricoverato/a in ospedale, con limitazione delle attività; ricoverato/a in ospedale, non richiedente ossigenoterapia; ricoverato/a in ospedale, richiedente ossigeno supplementare; ricoverato/a in ospedale, in trattamento con dispositivi di alimentazione di ossigeno mediante ventilazione non invasiva o ad alto flusso; ricoverato/a in ospedale, in trattamento con ventilazione meccanica invasiva od ossigenazione extracorporea a membrana [ExtraCorporeal Membrane Oxygenation, ECMO]; decesso);
    3 Variazione media nella classificazione su una scala ordinale dal basale ai Giorni 7, 14, 21 e 28
    4 Variazione dal momento dell’arruolamento dei marcatori infiammatori nel plasma (per es. MCP-1, MlP-1 a, G-CSF, IL-1b, IL-2, IL-6, IL-7, IL-10, IL-17, INFg e TNFa) e nel fenotipo immunologico, nonché valutazione dei marcatori di attivazione cellulare nelle cellule immunitarie nel sangue periferico (peripheral blood mononuclear cells, PBMC) il G14 e il G28 solo nei/nelle pazienti ricoverati/e in ospedale.
    5 Tasso di pazienti che necessitano di supplementazione di ossigeno in entrambi i gruppi di trattamento
    6 Tempo intercorrente prima del ricovero (log ranki) rispetto al basale in entrambi i gruppi di trattamento.
    7 Tempo intercorrente prima della ventilazione assistita e della supplementazione di ossigeno (log rank) rispetto al basale in entrambi i gruppi di trattamento.
    8 Numero di giorni di ventilazione assistita in entrambi i gruppi di trattamento
    9 Numero di giorni di supplementazione di ossigeno in entrambi i gruppi di trattamento.
    10 Numero di giorni di degenza in ospedale dal ricovero alla dimissione in entrambi i gruppi di trattamento.
    11 Variazione rispetto al basale dei livelli di microRNA-124 nel sangue totale (PAXgene®) a D0, D7 e D28 in entrambi i gruppi di trattamento.
    12 AUC e % di variazione rispetto all'arruolamento nei livelli di CRP, Troponina I & T e D Dimero in entrambi i gruppi di trattamento
    13 Tempo al decesso (log rank) e tasso di mortalità (per tutte le cause e correlate a Covid-19) in entrambi i gruppi di trattamento.
    14 SARS-CoV-2 virus nel campione rinofaringeo e / o nel sangue al giorno 0, 7, 14, 21 e 28
    15 Numero e tasso dei partecipanti con eventi avversi emergenti correlati al trattamento
    16 Incidenza cumulativa di eventi avversi gravi (SAE) - 28 giorni
    17 Incidenza cumulativa di eventi avversi di Grado 3 e 4 ( AEs) - 28 giorni
    18 Numero di partecipanti con interruzione o interruzione temporanea del farmaco in studio (per qualsiasi motivo) - 28 giorni
    19 Revisione centralizzata in cieco delle scansioni CT alla dimissione dall'ospedale per le analisi descrittive per quanto riguarda la gravità e gli esiti della malattia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. During the course of the study
    2. During the course of the study
    3. Days 7, 14, 21 and 28 from baseline
    4. Days 14 and 28
    5. During the course of the study
    6. During the course of the study
    7. During the course of the study
    8. During the course of the study
    9. During the course of the study
    10. During the course of the study
    11. Days 0, 7 and 28
    12. During the course of the study
    13. During the course of the study
    14. Days 0, 7, 14, 21 and 28
    15. During the course of the study
    16. Day 28
    17. Day 28
    18. Day 28
    19. During the course of the study
    1 Durante lo studio
    2 Durante lo studio
    3 Giorni 7,14, 21 e 28 dal basale
    4 Giorni 14 e 28
    5 Durante lo studio
    6 Durante lo studio
    7 Durante lo studio
    8 Durante lo studio
    9.Durante lo studio
    10.Durante lo studio
    11.Giorni 0,7 e 28
    12 Durante lo studio
    13 Durante lo studio
    14 Giorni 0,7, 14, 21 e 28
    15 Durante lo studio
    16 Giorno 28
    17 Giorno 28
    18 Giorno 28
    19 Durante lo studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    The study will end once all the recruited patients have performed their safety follow-up and the End of Study visit, and all the data have been analyzed and computed in the clinical study report (CSR).
    Lo studio terminerà quando tutti i pazienti reclutati avranno eseguito il loro follow-up sulla sicurezza e la visita di fine studio, e tutti i dati sono stati analizzati e calcolati nel rapporto dello studio clinico (CSR).
    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 months7
    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 months7
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 634
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state225
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1034
    F.4.2.2In the whole clinical trial 1034
    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)
    Standard of care
    Standard of care
    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 Decision2020-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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