Clinical Trials Register

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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2020-000705-86

A.3

Full 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.3.1

Title 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.4.1

Sponsor's protocol code number

01-2020

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	VALL HEBRON UNIVERSITY HOSPITAL
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	VALL HEBRON UNIVERSITY HOSPITAL
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	VALL HEBRON UNIVERSITY HOSPITAL
B.5.2	Functional name of contact point	DAVID BERLANA
B.5.3	Address:
B.5.3.1	Street Address	VALL HEBRON 119
B.5.3.2	Town/ city	BARCELONA
B.5.3.3	Post code	08035
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34654431619
B.5.6	E-mail	dberlana@vhebron.net

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	SMOFLIPID
D.2.1.1.2	Name of the Marketing Authorisation holder	FRESENIUS KABI
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	TPN with emulsions enriched with omega-3 fatty acid
D.3.4	Pharmaceutical form	Emulsion for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	aceite de soja, triglicéridos de cadena media, aceite de oliva y aceite de pescado
D.3.9.1	CAS number	66581
D.3.9.3	Other descriptive name	LONG-CHAIN TRIGLYCERIDES
D.3.9.4	EV Substance Code	SUB192715
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	CLINOLEIC
D.2.1.1.2	Name of the Marketing Authorisation holder	BAXTER
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	TPN with emulsions enriched with omega-3 fatty acid
D.3.4	Pharmaceutical form	Emulsion for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Aceite de oliva purificado y aceite de soja purificado
D.3.9.1	CAS number	66971
D.3.9.3	Other descriptive name	LONG-CHAIN TRIGLYCERIDES
D.3.9.4	EV Substance Code	SUB192715
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	OMEGAVEN
D.2.1.1.2	Name of the Marketing Authorisation holder	FRESENIUS KABI
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	TPN with emulsions enriched with omega-3 fatty acid
D.3.4	Pharmaceutical form	Emulsion for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Acidos grasos omega-3
D.3.9.3	Other descriptive name	OMEGA-3-FATTY ACIDS 90
D.3.9.4	EV Substance Code	SUB33372
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	NUTRIFLEX LIPID SPECIAL
D.2.1.1.2	Name of the Marketing Authorisation holder	B BRAUN
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	NUTRIFLEX LIPID SPECIAL
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Solucion de aminoacidos
D.3.9.1	CAS number	62987
D.3.9.3	Other descriptive name	ESSENTIAL AMINO ACIDS
D.3.9.4	EV Substance Code	SUB170287
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	56
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Solucion de glucosa anhidra
D.3.9.1	CAS number	62987
D.3.9.3	Other descriptive name	GLUCOSE ANHYDROUS PH EUR
D.3.9.4	EV Substance Code	SUB29104
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	158
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Aceite de soja refinado y MCT
D.3.9.1	CAS number	62987
D.3.9.3	Other descriptive name	LONG-CHAIN TRIGLYCERIDES
D.3.9.4	EV Substance Code	SUB192715
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	OMEGAFLEX SPECIAL
D.2.1.1.2	Name of the Marketing Authorisation holder	B BRAUN
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	OMEGAFLEX SPECIAL
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Solucion de aminoacidos
D.3.9.1	CAS number	82103
D.3.9.3	Other descriptive name	ESSENTIAL AMINO ACIDS
D.3.9.4	EV Substance Code	SUB170287
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Solución de glucosa anhidra
D.3.9.1	CAS number	82103
D.3.9.3	Other descriptive name	GLUCOSE ANHYDROUS PH EUR
D.3.9.4	EV Substance Code	SUB29104
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	158
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Aceite de soja refinado,MCT y aceite de pescado
D.3.9.1	CAS number	82103
D.3.9.3	Other descriptive name	LONG-CHAIN TRIGLYCERIDES
D.3.9.4	EV Substance Code	SUB192715
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 6
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	OLIMEL N9
D.2.1.1.2	Name of the Marketing Authorisation holder	BAXTER S. A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	OLIMEL N9
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Solución de aminoacidos
D.3.9.1	CAS number	62987
D.3.9.3	Other descriptive name	ESSENTIAL AMINO ACIDS
D.3.9.4	EV Substance Code	SUB170287
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	57
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Glucosa anhidra
D.3.9.1	CAS number	72066
D.3.9.3	Other descriptive name	GLUCOSE ANHYDROUS PH EUR
D.3.9.4	EV Substance Code	SUB29104
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	11
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Aceite de oliva purificado y aceite de soja purificado
D.3.9.1	CAS number	72066
D.3.9.3	Other descriptive name	LONG-CHAIN TRIGLYCERIDES
D.3.9.4	EV Substance Code	SUB192715
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 7
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	SMOFKABIVEN
D.2.1.1.2	Name of the Marketing Authorisation holder	FRESENIUS KABI
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	SMOFKABIVEN
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Solucion de aminoacidos
D.3.9.1	CAS number	70985
D.3.9.3	Other descriptive name	ESSENTIAL AMINO ACIDS
D.3.9.4	EV Substance Code	SUB170287
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Glucosa anhidra
D.3.9.1	CAS number	70985
D.3.9.3	Other descriptive name	GLUCOSE ANHYDROUS PH EUR
D.3.9.4	EV Substance Code	SUB29104
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	125 to 125
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	aceite de soja, triglicéridos de cadena media, aceite de oliva y aceite de pescado
D.3.9.1	CAS number	70895
D.3.9.3	Other descriptive name	LONG-CHAIN TRIGLYCERIDES
D.3.9.4	EV Substance Code	SUB192715
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	36
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical 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.1.1.1

Medical 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.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(s) of evaluation of this end point

Inclusion day and end of PN.

Inclusión del estudio y finalización de la nutrición parenteral.

E.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

117

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

117

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

117

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-04-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-23

P. End of Trial
P.	End of Trial Status	Ongoing

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