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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-002214-40
    Sponsor's Protocol Code Number:HLS-02COVID19/2020
    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:2021-10-18
    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 number2020-002214-40
    A.3Full title of the trial
    ENOXAPARIN AT PROPHYLACTIC OR THERAPEUTIC DOSES WITH MONITORING OF OUTCOMES IN SUBJECTS INFECTED WITH COVID-19: PILOT STUDY ON 300 CASES ENROLLED AT ASST FBF SACCO
    ENOXAPARINA A DOSI PROFILATTICHE O TERAPEUTICHE CON MONITORAGGIO DEGLI OUTCOMES NEI SOGGETTI INFETTI DA COVID-19: STUDIO PILOTA SU 300 CASI ARRUOLATI PRESSO ASST-FBF-SACCO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ENOXAPARIN AT PROPHYLACTIC OR THERAPEUTIC DOSES WITH MONITORING OF OUTCOMES IN SUBJECTS INFECTED WITH COVID-19
    ENOXAPARINA A DOSI PROFILATTICHE O TERAPEUTICHE CON MONITORAGGIO DEI RISULTATI NEI SOGGETTI INFETTI DA COVID-19
    A.3.2Name or abbreviated title of the trial where available
    EMOS-COVID
    EMOS-COVID
    A.4.1Sponsor's protocol code numberHLS-02COVID19/2020
    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 SponsorASST FATEBENEFRATELLI SACCO
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOSPEDALE UNIVERSITARIO LUIGI SACCO MILANO
    B.5.2Functional name of contact pointUO MEDICINA GENERALE
    B.5.3 Address:
    B.5.3.1Street AddressVIA GB GRASSI 74
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20157
    B.5.3.4CountryItaly
    B.5.4Telephone number0239042318
    B.5.5Fax number0239042566
    B.5.6E-mailarquati.massimo@gmail.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 Yes
    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 nameEnoxaparina
    D.3.2Product code [Enoxaparina]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENOXAPARINA SODICA
    D.3.9.1CAS number 679809-58-6
    D.3.9.2Current sponsor code1
    D.3.9.3Other descriptive nameenoxaparin
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000
    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) 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 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.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 Yes
    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 nameenoxaparina
    D.3.2Product code [enoxaparina]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENOXAPARINA SODICA
    D.3.9.1CAS number 679809-58-6
    D.3.9.2Current sponsor code2
    D.3.9.3Other descriptive nameenoxaparin
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000
    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) 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 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.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 Yes
    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 nameenoxaparina
    D.3.2Product code [enoxaparina]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENOXAPARINA SODICA
    D.3.9.1CAS number 679809-58-6
    D.3.9.2Current sponsor code3
    D.3.9.3Other descriptive nameenoxaparin
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000
    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) 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SARS-CoV-2 related pneumonia
    Polmonite da SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    Coranavirus related pneumonia
    Polmonite da coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the efficacy and safety of the use of enoxaparin prophylactic dose vs enoxaparin therapeutic dose in COVID-19 infected patients presenting moderate-severe respiratory failure (PaO2/FiO2<250) and/or markedly increased D-dimer levels
    Valutazione dell’efficacia e sicurezza dell’impiego di enoxaparina a dose profilattica vs enoxaparina a dose terapeutica in pazienti affetti da COVID-19 con insufficienza respiratoria moderata-grave (PaO2/FiO2<250) e/o elevati valori di D-dimero.
    E.2.2Secondary objectives of the trial
    none
    nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - COVID-19 related pneumonia associated with moderate-severe respiratory failure (PaO2/FiO2<250) and/or increased D-dimer levels (>3000 ng/mL)
    - signed informed consent
    - polmonite da COVID-19 con insufficienza respiratoria moderata-grave (PaO2/FiO2<250) e/o elevati valori di D-dimero (>3000 ng/mL)
    - consenso informato scritto valido
    E.4Principal exclusion criteria
    - age < 18 e > 80 anni
    - history of bleeding (peptic ulcer, esophageal r, cerebral aneurysm, cancer at high risk of bleeding, cirrhosi, hemorragic stroke < 1 year)
    - thrombocytopenia (<100 x109/L)
    - anemia (Hb < 8 g/dl)
    - coagulation abnormalities (PT and/or aPTT > 1.5; fibrinogen < 150 mg/dl)
    - consumption coagulopathy (ISTH criteria)
    - deep venous thrombosis and/or pulmonary embolism
    - dual antiplatelet therapy
    - anticoagulant therapy
    - LMWH allergy
    - heparin induced thrombocytopenia
    - major surgery < 1 month; neurosurgery <3 months; eye surgery <3 months
    - pregnancy
    - blood arterial hypertension (SBP>160 mm Hg; DBP>100 mm Hg)
    - renal failure (creatinine clearance < 30 ml/min
    - ICU admission or endotracheal intubation
    - PaO2/FiO2 >250
    - età < 18 e > 80 anni
    - emorragia in atto o pregressa (ulcera peptica in trattamento, varici esofagee, aneurismi cerebrali, neoplasia a rischio emorragico, cirrosi epatica, ictus emorragico < 1 anno)
    - piastrinopenia (<100 x109/L)
    - anemia (Hb < 8 g/dl)
    - alterazioni emostasi (PT e/o aPTT > 1.5; fibrinogeno < 150 mg/dl)
    - coagulopatia da consumo (criteri ISTH) [15, 16]
    - trombosi venosa profonda e/o embolia polmonare documentata all’ingresso
    - duplice terapia antiaggregante
    - terapia anticoagulante in atto
    - allergia a EBPM
    - pregressa piastrinopenia da eparina
    - chirurgia maggiore < 1 mese; neurochirurgia <3 mesi; chirurgia oculistica <3 mesi (esclusa cataratta)
    - gravidanza
    - ipertensione arteriosa non controllata (PAS>160 mm Hg; PAD>100 mm Hg)
    - insufficienza renale definita come clearance creatinina < 30 ml/min
    - ricovero in rianimazione o intubazione oro-tracheale
    - PaO2/FiO2 >250
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: motality (during hospitalization and at 1 month) and number of days with positive pressure ventilation
    Safety: major bleeding and non-major bat clinically relevant bleeding
    Efficacia: Mortalità (intraospedaliera e a 30 giorni) e numero di giorni di ventilazione a pressione positiva
    Sicurezza: emorragie maggiori e non maggiori ma clinicamente rilevanti
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoints will be evaluated during hospitalization and at 1 month
    Gli endpoints verranno valutati durante il ricovero e a 1 mese
    E.5.2Secondary end point(s)
    (PaO2/FiO2>300) i
    RR<20 breaths per min
    number of transfusions with red blood cells
    (PaO2/FiO2>300)
    FR<20 atti/min
    numero di trasfusioni con unità di globuli rossi
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 72 h and 7 days
    a 72 h e a 7 giorno
    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 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 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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    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 years1
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days36
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days36
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-10-18. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patient with cognitive impairment
    Pazienti affetti da deterioramento cognitivo
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    Clinical evaluation after the end of the follow-up period
    Visita al termine del follow-up
    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 Decision2020-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-09-30
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