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    Summary
    EudraCT Number:2020-000705-86
    Sponsor's Protocol Code Number:01-2020
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-05
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-000705-86
    A.3Full title of the trial
    Control of inflammatory parameters with omega-3 fatty acid supplementation in adult patients with parenteral nutrition and respiratory infection by SARS-CoV-2: randomized clinical trial COVID-19
    Control de parámetros inflamatorios con suplementación de ácidos grasos omega-3 en pacientes adultos con nutrición parenteral e infección respiratoria por SARS-CoV-2 : ensayo clínico aleatorizado COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Control of inflammatory parameters with fish oil in parenteral nutrition
    Control de parámetros inflamatorios con aceite de pescado en nutrición parenteral.
    A.4.1Sponsor's protocol code number01-2020
    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 SponsorVALL HEBRON UNIVERSITY HOSPITAL
    B.1.3.4CountrySpain
    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 supportVALL HEBRON UNIVERSITY HOSPITAL
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVALL HEBRON UNIVERSITY HOSPITAL
    B.5.2Functional name of contact pointDAVID BERLANA
    B.5.3 Address:
    B.5.3.1Street AddressVALL HEBRON 119
    B.5.3.2Town/ cityBARCELONA
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number+34654431619
    B.5.6E-maildberlana@vhebron.net
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 SMOFLIPID
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameTPN with emulsions enriched with omega-3 fatty acid
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNaceite de soja, triglicéridos de cadena media, aceite de oliva y aceite de pescado
    D.3.9.1CAS number 66581
    D.3.9.3Other descriptive nameLONG-CHAIN TRIGLYCERIDES
    D.3.9.4EV Substance CodeSUB192715
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 RoleComparator
    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 CLINOLEIC
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameTPN with emulsions enriched with omega-3 fatty acid
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAceite de oliva purificado y aceite de soja purificado
    D.3.9.1CAS number 66971
    D.3.9.3Other descriptive nameLONG-CHAIN TRIGLYCERIDES
    D.3.9.4EV Substance CodeSUB192715
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 RoleComparator
    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 OMEGAVEN
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameTPN with emulsions enriched with omega-3 fatty acid
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAcidos grasos omega-3
    D.3.9.3Other descriptive nameOMEGA-3-FATTY ACIDS 90
    D.3.9.4EV Substance CodeSUB33372
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 NUTRIFLEX LIPID SPECIAL
    D.2.1.1.2Name of the Marketing Authorisation holderB BRAUN
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameNUTRIFLEX LIPID SPECIAL
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSolucion de aminoacidos
    D.3.9.1CAS number 62987
    D.3.9.3Other descriptive nameESSENTIAL AMINO ACIDS
    D.3.9.4EV Substance CodeSUB170287
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number56
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSolucion de glucosa anhidra
    D.3.9.1CAS number 62987
    D.3.9.3Other descriptive nameGLUCOSE ANHYDROUS PH EUR
    D.3.9.4EV Substance CodeSUB29104
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number158
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAceite de soja refinado y MCT
    D.3.9.1CAS number 62987
    D.3.9.3Other descriptive nameLONG-CHAIN TRIGLYCERIDES
    D.3.9.4EV Substance CodeSUB192715
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 OMEGAFLEX SPECIAL
    D.2.1.1.2Name of the Marketing Authorisation holderB BRAUN
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameOMEGAFLEX SPECIAL
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSolucion de aminoacidos
    D.3.9.1CAS number 82103
    D.3.9.3Other descriptive nameESSENTIAL AMINO ACIDS
    D.3.9.4EV Substance CodeSUB170287
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSolución de glucosa anhidra
    D.3.9.1CAS number 82103
    D.3.9.3Other descriptive nameGLUCOSE ANHYDROUS PH EUR
    D.3.9.4EV Substance CodeSUB29104
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number158
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAceite de soja refinado,MCT y aceite de pescado
    D.3.9.1CAS number 82103
    D.3.9.3Other descriptive nameLONG-CHAIN TRIGLYCERIDES
    D.3.9.4EV Substance CodeSUB192715
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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: 6
    D.1.2 and D.1.3IMP RoleComparator
    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 OLIMEL N9
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER S. A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameOLIMEL N9
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSolución de aminoacidos
    D.3.9.1CAS number 62987
    D.3.9.3Other descriptive nameESSENTIAL AMINO ACIDS
    D.3.9.4EV Substance CodeSUB170287
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number57
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlucosa anhidra
    D.3.9.1CAS number 72066
    D.3.9.3Other descriptive nameGLUCOSE ANHYDROUS PH EUR
    D.3.9.4EV Substance CodeSUB29104
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAceite de oliva purificado y aceite de soja purificado
    D.3.9.1CAS number 72066
    D.3.9.3Other descriptive nameLONG-CHAIN TRIGLYCERIDES
    D.3.9.4EV Substance CodeSUB192715
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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: 7
    D.1.2 and D.1.3IMP RoleComparator
    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 SMOFKABIVEN
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameSMOFKABIVEN
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSolucion de aminoacidos
    D.3.9.1CAS number 70985
    D.3.9.3Other descriptive nameESSENTIAL AMINO ACIDS
    D.3.9.4EV Substance CodeSUB170287
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlucosa anhidra
    D.3.9.1CAS number 70985
    D.3.9.3Other descriptive nameGLUCOSE ANHYDROUS PH EUR
    D.3.9.4EV Substance CodeSUB29104
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number125 to 125
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNaceite de soja, triglicéridos de cadena media, aceite de oliva y aceite de pescado
    D.3.9.1CAS number 70895
    D.3.9.3Other descriptive nameLONG-CHAIN TRIGLYCERIDES
    D.3.9.4EV Substance CodeSUB192715
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number36
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Critically ill adult patients with parenteral nutrition and respiratory infection by SARS-COV-2
    Pacientes críticos con nutrición parenteral e infección respiratoria por SARS-COV-2
    E.1.1.1Medical condition in easily understood language
    Patients with parenteral nutrition and respiratory infection by SARS-COV-2
    Pacientes críticos con nutrición parenteral e infección respiratoria por SARS-COV-2
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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
    In critically adult patients with parenteral nutrition with liver impairment related to parenteral nutrition, the main objective is to determinate wether the change to lipidic emulsion (with a 30% omega-3 fatty acids) is effective in reducing th liver impairment, measured as gamma-glutamyl-transferase (GGT)
    En pacientes críticos adultos con nutrición parenteral con daño hepático ligado a la nutrición parenteral, el objetivo principal es determinar si el cambio de emulsión lipidica (con un 30% de acidos grasos omega-3) es efectiva en reducir el daño hepa´tico, medico como gamma-glutamil-transferasa (GGT).
    E.2.2Secondary objectives of the trial
    To analyze wether the use of PN with a 30% of omega-3 fatty acids is effective in reducing the infection rate, hyperglycemia rate, hypertrygliceridemia rate, ICU and hospital length of stay. As well as to study the differences in farnesoid-X receptor expression depending on the type of lipid received.
    Analizar si la utilización de NP con omega-3 disminuye la tasa de infección, tasa de hipertrigliceridemia e hiperglicemia, así como la estancia hospitalaria y en UCI. Otro objetivo secundario es estudiar la diferencia de expresión del receptor X-farnesoide en función del tipo de lípido.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 18 years.
    • Patients with at least 5 days of PN.
    • Baseline liver parameters before PN: GGT, alkaline phosphatase < 100 U/dL and direct bilirubin <1.2 mg/dL al inicio de NP.
    • Liver parameter alterations: GGT ≥ 300 U/dL, alkaline phosphatase ≥ 200 U/dL or direct bilirubin ≥1.8 mg/dL
    • Forseeing to receive at least 5 days of PN.
    • Admitted in the ICU of the Valle Hebron University Hospital
    • Willing to give their IC in writing for the trial and be able to do so.
    Criterios de inclusión:
    • Pacientes ≥ 18 años.
    • Que hayan recibido al menos 5 días de NP.
    • Que hayan presentado valores de GGT, fosfasa alcalina < 100 U/dL y de bilirrubina <1.2 mg/dL al inicio de NP (dentro de las 36h previas o si no hay disponibilidad 24h posteriores).
    • Presenten 2 de los siguientes valores: GGT ≥ 300 U/dL, fosfatasa alcalina ≥ 200 U/dL o valores de bilirrubina ≥1.8 mg/dL
    • Se prevea una continuación de la NP ≥ 5 días.
    • Paciente esté ingresado en la UCI del HUVH
    • Aceptación del paciente (consentimiento informado)
    E.4Principal exclusion criteria
    - Lipids administration contraindicated
    - Have a history of hypersensitivity of idiosincratic reactions to any component of intravenous lipid emulsions.
    - Home parenteral nutrition patients
    - Liver transplantation
    - Liver parameters alterations before PN: 20% above upper normal values.
    - Patients rejection to participate.
    Criterios de exclusión
    • Contraindicada la administración de lípidos.
    • Alergia a algún componente presente en la NP.
    • Paciente con NP domiciliaria
    • Trasplante hepático
    • Valores bioquímicos de parámetros hepáticos al inicio de la NP por encima del 20% del límite superior de valores normales
    • Negativa del paciente
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point is the change of liver function parameters: GGT ; from the value the day of inclusion to the end of PN.
    La variable principal es la diferencia en la evolución del parámetro bioquímico hepático GGT, entre el momento de inclusión del paciente y el final de la NP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Inclusion day and end of PN.
    Inclusión del estudio y finalización de la nutrición parenteral.
    E.5.2Secondary end point(s)
    Infection rate, hyperglycemia rate, hypertrygliceridemia rate, ICU and hospital length of stay.
    Farnesoid-X receptor expression measured as fibroblast-growth-factor-19.
    Tasa de infección, tasa de hipertrigliceridemia e hiperglicemia, así como la estancia hospitalaria y en UCI. Otro objetivo secundario es estudiar la diferencia de expresión del receptor X-farnesoide en función del tipo de lípido mediante la determinación de FGF19.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day of inclusion and end of PN
    Inclusión en el estudio hasta finalización de la nutrición parenteral.
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 trial3
    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.8.5The 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 No
    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
    End of PN
    Fin de la nutrición parenteral
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months4
    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: 117
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 117
    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 state117
    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
    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 Decision2020-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-23
    P. End of Trial
    P.End of Trial StatusOngoing
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