Clinical Trials Register

Summary
EudraCT Number:	2020-001704-42
Sponsor's Protocol Code Number:	SANsinCOVID
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:	2020-05-21
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

2020-001704-42

A.3

Full title of the trial

Controlled and randomised trial to assess the safety and efficacy of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in hospital healthcare personnel (Sanitarios sin COVID-19 -SANsinCOVID-19).

Ensayo controlado y aleatorizado para evaluar la seguridad y eficacia de la quimioprofilaxis con hidroxicloroquina en la infección por SARS CoV2 en personal sanitario del ámbito hospitalario (Sanitarios sin COVID-19 -SANsinCOVID-19).

A.3.1

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

Controlled and randomised trial to assess the safety and efficacy of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in hospital healthcare personnel (Sanitarios sin COVID-19).

A.3.2

Name or abbreviated title of the trial where available

Sanitarios sin COVID -SANsinCOVID-

A.4.1

Sponsor's protocol code number

SANsinCOVID

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	Hidroxicloroquina
D.2.1.1.2	Name of the Marketing Authorisation holder	EFG
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	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
D.3.9.1	CAS number	118-42-3
D.3.9.4	EV Substance Code	SUB08077MIG
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

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 prophylaxis with Hydroxychloroquine for 2 months versus placebo in the prevention and reduction of symptomatic and asymptomatic CoV-2 SARS infection in healthcare personnel.

Evaluar la eficacia de la profilaxis con Hidroxicloroquina durante 2 meses frente al placebo en la prevención y disminución de la infección sintomática y asintomática por SARS CoV-2 en el personal sanitario.

E.2.2

Secondary objectives of the trial

1) To evaluate the safety of HCQ during 2 months in the healthcare personnel.
2) To evaluate the number of working days lost as a result of symptomatic or asymptomatic infection by COVID19.
3) To analyse the percentage of severe respiratory illness due to COVID-19 in healthcare personnel.
4) To define the incidence, prevalence and severity of SARS CoV-2 infection in healthcare personnel in the hospital setting.

1) Evaluar la seguridad de HCQ durante 2 meses en el personal sanitario.
2) Evaluar el número de días laborales perdidos como consecuencia de la infección sintomática o asintomática por COVID19.
3) Analizar el porcentaje de enfermedad respiratoria grave por COVID-19 en el personal sanitario.
4) Definir la incidencia, prevalencia y severidad de la infección por SARS CoV-2 en personal sanitario del ámbito hospitalario.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Healthcare professional aged between 18 and 65 (inclusive) at the time of the first selection visit.
2) Must provide a signed written informed consent and agree to adhere to the study protocol.
3) Active work in high exposure areas during the last two weeks and during the following weeks.

1) Profesional sanitario con edad comprendida entre los 18 y los 65 años (inclusive) en el momento de la primera visita de selección.
2) Deben proporcionar un consentimiento informado por escrito firmado y aceptar cumplir con el protocolo del estudio.
3) Trabajo activo en áreas de alta exposición durante las dos últimas semanas y durante las siguientes semanas.

E.4

Principal exclusion criteria

1) Previous infection by SARS CoV2 (positive coronavirus PCR or positive IgG serology with negative SARS Cov2 PCR and absence of symptoms).
2) Current treatment with HCQ or chloroquine
3) Contraindication for taking HCQ (known epilepsy, porphyria, recent ischemic heart disease).
4) Previous or current treatment with tamoxifen or raloxifene.
5) Previous eye disease, especially maculopathy.
6) Known heart failure (Grade III-IV of the New York Heart Association classification) or prolonged QTc.
7) Any type of cancer (except basal cell) in the last 5 years.
6) Refusal to give informed consent.
8) Signs of any other untreated, unstable or clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplasic or psychiatric disease.
9) Positive antibodies to human immunodeficiency virus .
10) Significant kidney or liver disease.
11) Pregnancy or lactation
12) Hypersensitivity or allergy to HCQ, or any contraindication in Summary of Product Characteristics to HCQ intake.

1) Infección previa por SARS CoV2 (PCR coronavirus positiva o Serología IgG positiva con PCR SARS Cov2 negativa y ausencia de sintomatología).
2) Tratamiento actual con HCQ o cloroquina.
3) Contraindicación para la toma de HCQ (epilepsia conocida, porfiria, cardiopatía isquémica reciente).
4) Tratamiento previo o actual con tamoxifeno o raloxifeno.
5) Enfermedad ocular previa, especialmente maculopatía.
6) Insuficiencia cardíaca conocida (Grado III a IV de la clasificación de la Asociación de Cardiología de Nueva York [New York Heart Association) o QTc prolongado.
7) Cualquier tipo de cáncer (excepto basocelular) en los últimos 5 años.
6) Negativa a dar el consentimiento informado.
8) Indicios de cualquier otra enfermedad inmunológica, endocrina, hematológica, gastrointestinal, neurológica, neoplásica o psiquiátrica inestable o clínicamente significativa sin tratar.
9) Anticuerpos positivos para el virus de la inmunodeficiencia humana.
10) Enfermedad renal o hepática significativas.
11) Embarazo o lactancia;
12) Hipersensibilidad o alergia a la HCQ, o cualquier contraindicación en ficha técnica a la toma de HCQ

E.5 End points

E.5.1

Primary end point(s)

- Number of healthcare professionals with symptomatic or asymptomatic SARS-CoV2 infection.
- Severity of the infection.

- Número de profesionales sanitarios con infección sintomática o asintomática por SARS-CoV2.
- Gravedad de la infección.

E.5.1.1

Timepoint(s) of evaluation of this end point

2 months

2 meses

E.5.2

Secondary end point(s)

- Adverse effects of medication
- Number of working days lost to infection
- Incidence, prevalence and severity of SARS CoV-2 infection in healthcare professionals.

- Efectos adversos de la medicación.
- Número de días laborales perdidos por la infección.
- Incidencia, prevalencia y gravedad e la infección por SARS CoV-2 en los profesionales sanitarios

E.5.2.1

Timepoint(s) of evaluation of this end point

2 months

2 meses

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

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

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

Yes

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

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:

450

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

Yes

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

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

450

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

2020-05-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-14

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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