Clinical Trials Register

Summary
EudraCT Number:	2020-001934-37
Sponsor's Protocol Code Number:	GLUCOCOVID
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:	2020-05-08
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

2020-001934-37

A.3

Full title of the trial

USE OF CORTICOSTEROIDS IN PATIENTS WITH SARS-COV2 CORONAVIRUS INFECTION (GLUCOCOVID). Pragmatic trial inserted in real practice during a pandemic COVID-19

USO DE CORTICOIDES EN PACIENTES CON INFECCION POR CORONAVIRUS SARS-COV2 (GLUCOCOVID). Ensayo pragmático insertado en práctica real durante pandemia COVID-19

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

USE OF CORTICOSTEROIDS IN PATIENTS WITH SARS-COV2 CORONAVIRUS INFECTION

USO DE CORTICOIDES EN PACIENTES CON INFECCION POR CORONAVIRUS SARS-COV2

A.3.2

Name or abbreviated title of the trial where available

USE OF CORTICOSTEROIDS IN PATIENTS WITH SARS-COV2 CORONAVIRUS INFECTION

USO DE CORTICOIDES EN PACIENTES CON INFECCION POR CORONAVIRUS SARS-COV2

A.4.1

Sponsor's protocol code number

GLUCOCOVID

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	IDIVAL Instituto de Investigación Sanitaria Valdecilla
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	IDIVAL
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	IDIVAL
B.5.2	Functional name of contact point	Mar García Sáiz
B.5.3	Address:
B.5.3.1	Street Address	Avenida de Valdecilla s/n
B.5.3.2	Town/ city	Santander
B.5.3.3	Post code	39008
B.5.3.4	Country	Spain
B.5.4	Telephone number	34942203333
B.5.5	Fax number	34942315455
B.5.6	E-mail	mmar.garcia@scsalud.es

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
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	Urbason/Metilprednisolona
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Aventis/Normon
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.3.4	Pharmaceutical form	Powder and solvent for solution for injection
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	METHYLPREDNISOLONE
D.3.9.1	CAS number	83-43-2
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	METHYLPREDNISOLONE
D.3.9.4	EV Substance Code	SUB08872MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	20 to 40
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

SARS-CoV-2 infection (COVID-19)

Infección por SARS-CoV-2 (COVID-19)

E.1.1.1

Medical condition in easily understood language

SARS-CoV-2 infection (COVID-19)

Infección por SARS-CoV-2 (COVID-19)

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	PT
E.1.2	Classification code	10051905
E.1.2	Term	Coronavirus infection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of early anti-inflammatory treatment with corticosteroids in patients who are in a phase of the disease in which viral replication has already been limited, but there is a marked systemic inflammatory response.

Evaluar la eficacia del tratamiento anti-inflamatorio precoz con corticoides en los pacientes que se encuentran en una fase de la enfermedad en la que se ha limitado ya la replicación viral, pero existe una marcada respuesta inflamatoria sistémica.

E.2.2

Secondary objectives of the trial

To evaluate the safety of early anti-inflammatory treatment with corticosteroids

Evaluar la seguridad del tratamiento antiinflamatorio precoz con corticoides

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients admitted to hospital with Covid-19, confirmed by microbiological tests or compatible clinical manifestations, with exclusion of other infections.
- Age: 18-85 years old.
- Time of evolution: more than 7 days since the beginning of symptoms.
- Evidence of inflammation, defined by: Lung infiltrates + Gas exchange disturbance: PaO2 < 65 or Sat<93% (breathing air), or PAFI <300, or SAFI <440, or BCRSS ≥2 + Elevated biomarkers: PCR >15, or DD>800, or Ferritin >1000, or IL6>20
- Absence of bacterial infection or other disease that explains the lung disorder.
- Verbal informed consent, which will be recorded in history.

- Pacientes ingresados en el hospital con Covid-19, confirmada mediante tests microbiológicos o cuadro clínico compatible, con exclusión de otras infecciones.
- Edad: 18-85 años.
- Tiempo de evolución: más de 7 días desde inicio de síntomas
- Evidencia de inflamación, definida por: Infiltrados pulmonares + Alteración del intercambio gaseoso: PaO2 < 65 o Sat<93% (respirando aire), o PAFI <300, o SAFI <440, o BCRSS ≥2 + Biomarcadores elevados: PCR >15, o DD>800, o ferritina >1000, o IL6>20
- Ausencia de infección bacteriana u otra enfermedad que explique el trastorno pulmonar.
- Consentimiento informado verbal, que se anotará en historia.

E.4

Principal exclusion criteria

- Refusal to participate
- Pregnancy
- Established indication for mechanical ventilation, non-invasive ventilation or ICU admission
- Immunosuppression
- Chronic renal failure on dialysis

- Negativa a participar
- Embarazo
- Indicación establecida para ventilación mecánica, ventilación no invasiva o ingreso en UCI
- Inmunosupresión
- Insuficiencia renal crónica en diálisis

E.5 End points

E.5.1

Primary end point(s)

Combination of death, ICU stay or non-invasive ventilation (NIV).

Combinación de muerte, estancia en UCI o Ventilación no invasiva (VNI).

E.5.1.1

Timepoint(s) of evaluation of this end point

At the time of discharge or death

En el momento del alta hospitalaria o muerte.

E.5.2

Secondary end point(s)

- Individual components of the primary variable.
- Clinical-gasometric impairment after the test intervention (defined as: (a) PaO2/FIO2<250; or (b) shock); or (c) worsening of qSOFA or BCRSS indices).
- Change in SOFA score (comparison at time of inclusion and at 4 days).
- Length of hospital stay.
- Use of biological anti-inflammatories.

- Componentes individuales de la variable primaria
- Deterioro clínico-gasométrico tras la intervención en estudio [definido como: a) PaO2/FIO2<250; o b) shock); o c)empeoramiento de índices qSOFA o BCRSS]
- Cambio en SOFA score (comparación en el momento de la inclusión y a los 4 días)
- Duración de estancia hospitalaria
- Uso de antiinflamatorios biológicos.

E.5.2.1

Timepoint(s) of evaluation of this end point

At the time of discharge or death

En el momento del alta hospitalaria o muerte.

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

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Cohorte exhaustiva

Comprehensive cohort design

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Tratamiento estándar (según protocolos de cada centro)

Standard treatment (according to each center's protocols)

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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

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

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 years

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:

120

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

F.3.3.1

Women 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 2020-05-08.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

200

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)

The expected normal treatment of that condition

EL tratamiento habitual en estos pacientes

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

2020-05-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-06

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

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