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    Summary
    EudraCT Number:2020-001308-40
    Sponsor's Protocol Code Number:INHIXACOVID19
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-06-24
    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 number2020-001308-40
    A.3Full title of the trial
    Intermediate dose enoxaparin in hospitalized patients with moderate-severe COVID-19: a pilot phase II single-arm study, INHIXACOVID19
    Intermediate dose enoxaparin in hospitalized patients with moderate-severe COVID19: a pilot phase II single-arm study, INHIXACOVID19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exoxaparin in hospitalized patients with moderate-severe COVID19
    Enoxaparina nei pazienti ospedalizzato per infezione da COVID-19 da moderata a severa
    A.3.2Name or abbreviated title of the trial where available
    INHIXACOVID19
    INHIXACOVID19
    A.4.1Sponsor's protocol code numberINHIXACOVID19
    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 SponsorALMA MATER STUDIORUM UNIVERSITà DI BOLOGNA
    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 organisationUniversità di Bologna
    B.5.2Functional name of contact pointInfectious Diseases Unit, Departmen
    B.5.3 Address:
    B.5.3.1Street AddressVia Massarenti, 11
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.4Telephone number2143353
    B.5.6E-mailpierluigi.viale@unibo.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 Yes
    D.2.1.1.1Trade name Inhixa
    D.2.1.1.2Name of the Marketing Authorisation holderTechdow Pharma Netherlands B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameInhixa 2,000 IU (20 mg)/0.2 mL
    D.3.2Product code [inhixa]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPParenteral use (Noncurrent)
    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 codeIMP
    D.3.9.3Other descriptive namebiosimilar low molecular weight heparin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number60 to 100
    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
    Hospitalized adult patients with microbiologically confirmed moderate-severe COVID-19 infection
    Hospitalized adult patients with microbiologically confirmed moderate-severe COVID-19 infection
    E.1.1.1Medical condition in easily understood language
    Hospitalized adult patients with COVID-19 infection
    Hospitalized adult patients with COVID-19 infection
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 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.1.2 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
    To investigate the efficacy of enoxaparin in improving the clinical outcome of hospitalized patients with moderate-severe COVID-19.
    To investigate the efficacy of enoxaparin in improving the clinical outcome of hospitalized patients with moderate-severe COVID-19.
    E.2.2Secondary objectives of the trial
    To analyse the safety of enoxaparin in hospitalized patients with with moderate-severe COVID-19.
    To analyse the safety of enoxaparin in hospitalized patients with with moderate-severe COVID-19.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >=18 y
    - Microbiologically confirmed COVID-19 infection
    - Patients with moderate-severe disease according to study definitions (see below)
    - Informed consent
    - Age >=18 y
    - Microbiologically confirmed COVID-19 infection
    - Patients with moderate-severe disease according to study definitions (see below)
    - Informed consent
    E.4Principal exclusion criteria
    • Thrombocytopenia (platelet count < 50.000 mm3)
    • Coagulopathy: INR >1.5, aPTT ratio >1.4
    • Impaired renal function (clearance to creatinine less than 15 ml/min)
    • Known hypersensitivity to heparin
    • History of heparin induced thrombocytopenia
    • Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignat tumors at hig risk of haemorrahges, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations)
    • Body weight <45 or > 150 kg
    • Concomitant anticoagulant treatment for other indications ( eg atrial fibrillation, venous thromboembolism , prosthetic heart valves).
    • Dual antiplatelet therapy
    • Pregnant or breastfeeding women
    • Thrombocytopenia (platelet count < 50.000 mm3)
    • Coagulopathy: INR >1.5, aPTT ratio >1.4
    • Impaired renal function (clearance to creatinine less than 15 ml/min)
    • Known hypersensitivity to heparin
    • History of heparin induced thrombocytopenia
    • Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignat tumors at hig risk of haemorrahges, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations)
    • Body weight <45 or > 150 kg
    • Concomitant anticoagulant treatment for other indications ( eg atrial fibrillation, venous thromboembolism , prosthetic heart valves).
    • Dual antiplatelet therapy
    • Pregnant or breastfeeding women
    E.5 End points
    E.5.1Primary end point(s)
    • All-cause in-hospital, 30-day and 90-day mortality rates.
    • Evolution of the clinical severity during treatment.
    • ICU admission and length of ICU stay.
    • Length of hospital stay.
    • All-cause in-hospital, 30-day and 90-day mortality rates.
    • Evolution of the clinical severity during treatment.
    • ICU admission and length of ICU stay.
    • Length of hospital stay.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 day and 90 day
    30 day and 90 day
    E.5.2Secondary end point(s)
    • Proportion of patients in the severe or critical stage of disease at the end of treatment
    • Proportion of patients who develop major and non-major bleeding events
    • Time to first negative RT-PCR on nasofaringeal swab
    • Reduction of viral load in blood
    • Proportion of patients in the severe or critical stage of disease at the end of treatment
    • Proportion of patients who develop major and non-major bleeding events
    • Time to first negative RT-PCR on nasofaringeal swab
    • Reduction of viral load in blood
    E.5.2.1Timepoint(s) of evaluation of this end point
    90 day
    90 day
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    phase II single-arm interventional prospective study
    a phase II single-arm interventional prospective study including all patients treated with the study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned12
    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 years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    Patients will be followed-up to 90 days after study drug initiation. Follow-up information will be collected via telephone calls, patient medical records and/or clinical visits according to clinical evolution.
    Patients will be followed-up to 90 days after study drug initiation. Follow-up information will be collected via telephone calls, patient medical records and/or clinical visits according to clinical evolution.
    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 Decision2020-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-26
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