Clinical Trials Register

Summary
EudraCT Number:	2020-001536-98
Sponsor's Protocol Code Number:	PREPSARS
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-04-20
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

2020-001536-98

A.3

Full title of the trial

Prophylaxis of COVID-19 infection with hydroxychloroquine in healthcare
personnel with high risk of infection.

Profilaxis de la infección por COVID-19 con hidroxicloroquina en personal
sanitario con elevado riesgo de contagio.

A.3.1

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

Prophylaxis of COVID-19 infection with hydroxychloroquine in healthcare
personnel with high risk of infection.

Profilaxis de la infección por COVID-19 con hidroxicloroquina en personal
sanitario con elevado riesgo de contagio.

A.4.1

Sponsor's protocol code number

PREPSARS

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	HOSPITAL UNIVERSITARI MÚTUA TERRASSA
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	HOSPITAL UNIVERSITARI MUTUA TERRASSA
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	HOSPITAL UNIVERSITARI MUTUA TERRASSA
B.5.2	Functional name of contact point	INTERNAL MEDICINE DEPARTMENT
B.5.3	Address:
B.5.3.1	Street Address	PL DR ROBERT 5
B.5.3.2	Town/ city	TERRASSA
B.5.3.3	Post code	08221
B.5.3.4	Country	Spain
B.5.6	E-mail	lboix@mutuaterrassa.cat

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	hidroxicloroquine
D.2.1.1.2	Name of the Marketing Authorisation holder	hidroxicloroquine
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	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Hydroxychloroquine
D.3.9.1	CAS number	747-42-3
D.3.9.3	Other descriptive name	HYDROXYCHLOROQUINE SULFATE
D.3.9.4	EV Substance Code	SUB02587MIG
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	5 to 200
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

COVID-19 infection

Infección por COVID-19

E.1.1.1

Medical condition in easily understood language

COVID-19 infection

Infección por COVID-19

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

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

1. Incidence of symptomatic healthcare professionals with positive PCR
between day 15 and day 30 of inclusion in the study. Health
professionals with high risk of transmission taking prophylaxis (Group
A) and the control group of high risk health professionals who decide not
to take it (Group C1) will be compared.
2. Incidence of symptomatic healthcare professionals with positive PCR
between day 15 and day 30 of inclusion in the study. Professionals with
high risk of transmission taking prophylaxis (Group A) and the control
group of professionals with low risk of transmission (Group C2) will be
compared.

1. Incidencia de profesionales sanitarios sintomáticos con PCR positiva
entre el día 15 y el día 30 de inclusión en el estudio. Se compararán los
profesionales sanitarios con alto riesgo de contagio que tomen profilaxis
(Grupo A) y el grupo control de los profesionales sanitarios de alto
riesgo que decidan no tomarla (Grupo C1).
2. Incidencia de profesionales sanitarios sintomáticos con PCR positiva
entre el día 15 y el día 30 de inclusión en el estudio. Se compararán los
profesionales con alto riesgo de contagio que tomen la profilaxis (Grupo
A) y el grupo control de los profesionales con bajo riesgo de contagio
(Grupo C2).

E.2.2

Secondary objectives of the trial

1. Incidence of cases of COVID-19 requiring hospitalization in a
conventional plant between day 15 and day 30 of inclusion in the study,
comparing the three study groups.
3. Duration of symptoms of COVID-19 in those infected with positive PCR
between day 15 and day 30 of inclusion in the study, comparing the
three study groups.
4. Incidence and severity (hospital admissions, ICU admissions) of
COVID cases in the first 15 days after enrollment in the study, comparing
the three study groups.

1. Incidencia de casos de COVID-19 que requieran hospitalización en
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planta convencional entre el día 15 y el día 30 de inclusión en el estudio,
comparando los tres grupos del estudio.
3. Duración de los síntomas de COVID-19 en los contagiados con PCR
positiva entre el día 15 y el día 30 de inclusión en el estudio,
comparando los tres grupos del estudio.
4. Incidencia y gravedad (ingresos en planta, ingresos en UCI) de casos
de COVID en los primeros 15 días tras la inclusión en el estudio,
comparando los tres grupos del estudio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Be over 18 years old and sign the informed consent.
-Not having previously presented or at the time of inclusion SARS-CoV-2
infection.
- In the case of fertile women, a written commitment to use a reliable
contraceptive method for the duration of the study and for 3 months
after the end of treatment.
- Sign the informed consent.
-Groups of patients:
1. Active treatment group (Group A): healthcare professionals with high
risk of exposure to patients with COVID-19 (ICU staff, emergency
departments, medical plants that have patients with COVID-19
hospitalized) who agree to take treatment with hydroxychloroquine. for
a month.
2. Control group 1 (Group C1): health professionals with high risk of
exposure to patients with COVID-19 (ICU staff, emergency departments,
medical plants that have patients with COVID-19 hospitalized) who do
not want to take treatment with hydroxychloroquine for one month.
3. Control group 2 (Group C2): health professionals with low risk of
exposure to patients with COVID.

- Ser mayores de 18 años y firmar el consentimiento informado.
-No haber presentado previamente ni en el momento de la inclusión
infección por SARS-CoV-2.
- En el caso de mujeres fértiles, compromiso por escrito a utilizar un
método anticonceptivo fiable durante la duración del estudio y durante
los 3 meses posteriores al término del tratamiento.
- Firmar el consentimiento informado.
-Grupos de pacientes:
1. Grupo de tratamiento activo (Grupo A): profesionales sanitarios con
alto riesgo de exposición a pacientes afectos de COVID-19 (personal de
UCI, urgencias, plantas médicas que tengan hospitalizados pacientes con
COVID-19) que acepten tomar el tratamiento con hidroxicloroquina
durante un mes.
2. Grupo de control 1 (Grupo C1): profesionales sanitarios con alto
riesgo de exposición a pacientes afectos de COVID-19 (personal de UCI,
urgencias, plantas médicas que tengan hospitalizados pacientes con
COVID-19) que no quieran tomar el tratamiento con hidroxicloroquina
durante un mes.
3. Grupo de control 2 (Grupo C2): profesionales sanitarios con bajo
riesgo de exposición a pacientes afectos de COVID.

E.4

Principal exclusion criteria

Group A:
- Pregnant or lactating women.
- Having previously had a positive PCR for SARS-CoV-2, presenting
positive serologies for SARS-CoV-2 or compatible clinic at the time of
inclusion.
- Long QT syndrome
- Diseases of the retina or cornea
- Glomerular filtration <30ml / min
- Severe liver dysfunction (Child Pugh 3)
- Hypersensitivity to study medication
- Greater drug interaction between your chronic medication and
hydroxychloroquine.
- Any other contraindication included in the technical sheet of the study
medication

Grupo A:
- Mujeres embarazadas o lactantes.
- Haber tenido previamente una PCR positiva por SARS-CoV-2,
presentar serologías positivas para SARS-CoV-2 o clínica compatible en
el momento de la inclusión.
- Síndrome de QT largo
- Enfermedades de la retina o de la cornea
- Filtrado glomerular < 30ml/min
- Severa disfunción hepática (Child Pugh 3)
- Hipersensibilidad a la medicación del estudio
- Interacción medicamentosa mayor entre su medicación crónica y la
hidroxicloroquina.
- Cualquier otra contraindicación recogida en la ficha técnica de la
medicación del estudio

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

Inclusion in the study: A serology of SARS-CoV-2 will be performed
before inclusion,.
Day 15 from inclusion: the incubation period of a possible infection ends
prior to the inclusion of the study. Events from now on will count for
Objectives 1-5.
Day 30 from enrollment: end of treatment period and active follow-up. A
second SARS-CoV-2 serology will be performed on all professionals.
Day 45 from inclusion: end of the study. It will be evaluated if the health
personnel have had symptoms of illness within 15 days after the end of
the treatment. The appearance of possible adverse effects will be
evaluated.

Inclusión en el estudio: Se realizará una serología de SARS-CoV-2 antes
de la inclusión, para valorar si los candidatos presentan inmunidad.
Día 15 desde la inclusión: termina el periodo de incubación de una
posible infección previa a la inclusión del estudio. Los eventos a partir de
estos momentos computarán para los Objetivos 1-5.
Día 30 desde la inclusión: finalización del periodo de tratamiento y
seguimiento activo. Se realizará una segunda serología de SARS-CoV-2 a
todos los profesionales.
Día 45 desde la inclusión: finalización del estudio. Se evaluará si el
personal sanitario ha tenido síntomas de enfermedad los 15 días
posteriores a la finalización del tratamiento. Se evaluará la aparición de
posibles efectos adversos.

E.5.2

Secondary end point(s)

1. Incidencia de casos de COVID-19 que requieran hospitalización en
planta convencional entre el día 15 y el día 30 de inclusión en el estudio,
comparando los tres grupos del estudio.
3. Duración de los síntomas de COVID-19 en los contagiados con PCR
positiva entre el día 15 y el día 30 de inclusión en el estudio,
comparando los tres grupos del estudio.
4. Incidencia y gravedad (ingresos en planta, ingresos en UCI) de casos
de COVID en los primeros 15 días tras la inclusión en el estudio,
comparando los tres grupos del estudio.

E.5.2.1

Timepoint(s) of evaluation of this end point

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

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

grupo control

control group

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

grupo control

control group

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

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

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:

300

F.1.3

Elderly (>=65 years)

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

Yes

F.3.2

Patients

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

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)

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

2020-04-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-15

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2020-04-27

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IMP with orphan designation in the indication
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