Clinical Trials Register

Summary
EudraCT Number:	2020-001421-31
Sponsor's Protocol Code Number:	QUINAVID-19
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:	2020-04-07
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.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2020-001421-31

A.3

Full title of the trial

Clinical trial randomized, unblinded and controled for evaluation of efficacy and safety of hydroxychloroquine chemoprophylaxis against SARS-CoV-2 (COVID-19) infection in healthcare professionals.

Ensayo clínico aleatorizado controlado y abierto para la evaluación de la eficacia y seguridad de la quimioprofilaxis con hidroxicloroquina de la enfermedad infecciosa por SARS-CoV-2 (COVID-19) en los profesionales sanitarios.

A.3.1

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

Clinical trial for evaluation of efficacy and safety of hydroxychloroquine chemoprophylaxis against SARS-CoV-2 (COVID-19) infection in healthcare professionals.

Ensayo clínico para la evaluación de la eficacia y seguridad de la quimioprofilaxis con hidroxicloroquina de la enfermedad infecciosa por SARS-CoV-2 (COVID-19) en los profesionales sanitarios.

A.4.1

Sponsor's protocol code number

QUINAVID-19

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	Sociedad Española de Farmacia Hospitalaria
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	Sociedad Española de Farmacia Hospitalaria
B.4.2	Country	Spain
B.4.1	Name of organisation providing support	Instituto de Salud Carlos III
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	Delos Clinical
B.5.2	Functional name of contact point	Emilio Garcia Cabrera
B.5.3	Address:
B.5.3.1	Street Address	Calle Castilla 135 2C
B.5.3.2	Town/ city	Sevilla
B.5.3.3	Post code	41010
B.5.3.4	Country	Spain
B.5.6	E-mail	secretaria@delosclinical.com

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	Hidroxicloroquina Aristo
D.2.1.1.2	Name of the Marketing Authorisation holder	Aristo Pharma GmbH
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	Hidroxicloroquina sulfato
D.3.4	Pharmaceutical form	Coated tablet
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 SULFATE
D.3.9.1	CAS number	747-36-4
D.3.9.2	Current sponsor code	81939
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	equal
D.3.10.3	Concentration number	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.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	Hidroxicloroquina Aristo
D.2.1.1.2	Name of the Marketing Authorisation holder	Aristo Pharma GmbH
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	Hidroxicloroquina sulfato
D.3.4	Pharmaceutical form	Coated tablet
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 SULFATE
D.3.9.1	CAS number	747-36-4
D.3.9.2	Current sponsor code	81939
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	equal
D.3.10.3	Concentration number	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

SARS-CoV-2 infection

infección por SARS-CoV-2

E.1.1.1

Medical condition in easily understood language

SARS-CoV-2 COVID-19 infection

Infección por coronavirus SARS-CoV-2 COVID-19

E.1.1.2

Therapeutic area

Health Care [N] - Environment and Public Health [N06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10049924
E.1.2	Term	Infection prophylaxis
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 assess the efficacy of hydroxychloroquine as chemoprophylaxis against SARS-CoV-2 (COVID-19) infection in healthcare professionals by negative PCR.

Evaluar la eficacia de la hidroxicloroquina como quimioprofilaxis frente a la infección por SARS-CoV-2 (COVID-19) en profesionales sanitarios determinado mediante PCR.

E.2.2

Secondary objectives of the trial

To assess the safety of hydroxychloroquine as chemoprophylaxis against SARS-CoV-2 (COVID-19) infection in healthcare professionals.

To assess the efficacy of personal protective equipment against SARS-CoV-2 (COVID-19) infection in healthcare professionals

- Evaluar la seguridad de la hidroxicloroquina como quimioprofilaxis frente a la infección por SARS-CoV-2 (COVID-1).

- Evaluar la eficacia de los equipos de protección individual (EPI) como profilaxis frente a la infección por SARS-CoV-2 (COVID-19).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Absence of SARS-CoV-2 infection (COVID-19) due to the absence of a symptoms of acute respiratory infection or a diagnostic test with a negative result.

2. Men or women 18 years of age or older at the time of signing the informed consent.

3. For fertile women, negative pregnancy test and written commitment to use a reliable contraceptive method for the duration of the study and for 3 months after the end of treatment.

4. Health care workers active at the center.

5. Informed consent signed

1. Diagnóstico de ausencia de infección por SARS-CoV-2 (COVID-19) por ausencia de cuadro clínico de infección respiratoria aguda o test diagnóstico con resultado negativo.

2. Hombres o mujeres de edad igual o mayor a 18 años en el momento de firma del consentimiento informado.

3. En el caso de mujeres fértiles, prueba de embarazo negativa y compromiso por escrito a utilizar un método anticonceptivo fiable durante la duración del estudio y durante los 3 meses posteriores al término del tratamiento. Se define a una mujer fértil como toda aquella capaz fisiológicamente de quedarse embarazada, incluyendo a las mujeres cuya trayectoria, estilo de vida u orientación sexual excluya el coito con un varón, o cuyas parejas hayan sido esterilizados con vasectomía u otros métodos. Se considera un método anticonceptivo fiable la abstinencia completa de coito sexual, la esterilización quirúrgica propia (ligadura de trompas) y de la pareja masculina (vasectomía), los anticonceptivos hormonales orales, inyectables o implantados (DIU) y los métodos barrera con espermicida.

4. Profesional sanitario que ejerza en el centro.

5. Firma y fecha del consentimiento informado antes de cualquier actividad relacionada con el estudio, incluidas las evaluaciones necesarias para la selección.

E.4

Principal exclusion criteria

1. Health care workers previously treated with hydroxycloroquine in the 60 days before.

2. Health care workers participating in another clinical study where they received an investigational drug in the 24 weeks before to signing the informed consent.

3. Pregnant or lactating women.

4. Postmenopausal women

5. Psoriasis.

6. Retinopathy, maculopathy or changes in the visual field, regardless of its origin.

7. Neurogenic hearing impairment.

8. Myasthenia gravis.

9. Disease of the hematopoietic system.

10. Glucose-6-phosphate dehydrogenase deficiency (eg hemolytic anemia or favism).

11. Hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives.

12. Inability to take oral medication.

13. Diagnosis of any other pathology that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the objectives of the study.

14. Consumption of alcohol or any other drug that could disable him in the judgment of the investigator to participate in the study.

15. Other circumstances or difficulties that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the study's objectives.

1. Tratamiento previo de hidroxicloroquina en los 60 días anteriores a la firma del consentimiento informado.

2. Participación en otro estudio clínico donde hayan recibido un fármaco en investigación en las 24 semanas anteriores a la firma del consentimiento informado.

3. Mujeres embarazadas o en periodo de lactancia.

4. Mujeres posmenopáusicas de menos de 2 años en el momento d

5. Psoriasis.

6. Retinopatía, maculopatía o cambios en el campo visual, independientemente de su origen.

7. Deficiencia auditiva neurogénica.

8. Miastenia gravis.

9. Enfermedad del sistema hematopoyético.

10. Deficiencia de glucosa-6-fosfato deshidrogenasa (ej. anemia hemolítica o favismo).

11. Hipersensibilidad a la hidroxicloroquina o derivados de la 4-aminoquinolina.

12. Incapacidad de ingesta de medicación por vía oral.

13. Diagnóstico de cualquier otra patología que a juicio del investigador pueda incrementar el riesgo del sujeto o reducir las posibilidades de obtener datos satisfactorios para lograr los objetivos del estudio.

14. Consumo de alcohol o cualquier otra droga que pudiera incapacitarlo a juicio del investigador para participar en el estudio.

15. Otras circunstancias o dificultades que a juicio del investigador pueda incrementar el riesgo del sujeto o reducir las posibilidades de obtener datos satisfactorios para lograr los objetivos del estudio.

E.5 End points

E.5.1

Primary end point(s)

Diagnosis of SARS-CoV-2 COVID-19 infection

Diagnóstico de infección por SARS-CoV-2 COVID-19

E.5.1.1

Timepoint(s) of evaluation of this end point

- At the end of prophylaxis treatment
- Fourteen days after the last dose of treatment

- A la finalización del tratamiento profilactico
- 14 días de seguimiento tras la finalización del tratamiento

E.5.2

Secondary end point(s)

- Adverse event reported
- Diagnosis of SARS-CoV-2 COVID-19 infection

- Acontecimientos adversos detectados
- Diagnóstico de infección por SARS-CoV-2 COVID-19

E.5.2.1

Timepoint(s) of evaluation of this end point

- At the end of prophylaxis treatment
- Fourteen days after the last dose of treatment

- A la finalización del tratamiento profilactico
- 14 días de seguimiento tras la finalización del tratamiento

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Otro régimen de dosificación

Other doses regimen

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

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

Ultima visita del último paciente incluido

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:

2163

F.1.3

Elderly (>=65 years)

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

F.3.3

Specific vulnerable populations

Yes

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

HEalth care workers

Trabajadores sanitarios

F.4 Planned number of subjects to be included

F.4.1

In the member state

1530

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

1530

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

Ninguno

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

2020-04-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-04

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials