Clinical Trials Register

Summary
EudraCT Number:	2020-001765-37
Sponsor's Protocol Code Number:	PROTOCOLO/ICO/COVID20
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:	2020-04-13
Trial results	View 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

2020-001765-37

A.3

Full title of the trial

Pragmatic clinical trial to evaluate the efficacy of hydroxychloroquine in the treatment of COVID-19 infection in two cohorts: patients with oncohaematological disease and SARS-CoV-2 positive without radiological alteration and sars-cov-2 positive professionals without radiological alteration

ENSAYO CLÍNICO PRAGMATICO PARA EVALUAR LA EFICACIA DE HIDROXICLOROQUINA EN EL TRATAMIENTO DE INFECCION COVID-19 EN DOS COHORTES: PACIENTES CON ENFERMEDAD ONCOHEMATOLOGICA Y SARS-CoV-2 POSITIVOS (NIT 1 y NIT 2) SIN ALTERACIÓN RADIOLOGICA Y PROFESIONALES SARS-CoV-2 POSITIVOS SIN ALTERACIÓN RADIOLOGICA

A.3.1

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

Pragmatic clinical trial of hydroxychloroquine in the treatment of oncohematological patients and health professionals with COVID-19 infection without radiological alteration.

Ensayo clínico pragmático de hidroxicloroquina en el tratamiento de pacientes oncohematológicos y profesionales sanitarios con infección COVID-19 sin alteración radiológica.

A.4.1

Sponsor's protocol code number

PROTOCOLO/ICO/COVID20

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	Institut Català d’Oncologia
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	pending
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	Institut Català d’Oncologia
B.5.2	Functional name of contact point	Margarita García Martín
B.5.3	Address:
B.5.3.1	Street Address	Av Gran Via de l'Hospitalet 199-203
B.5.3.2	Town/ city	L´Hospitalet de Llobregat
B.5.3.3	Post code	08908
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034932607331
B.5.5	Fax number	0034932607334
B.5.6	E-mail	mgarciamartin@iconcologia.net

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.2.1.2	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	hydroxychloroquine
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	range
D.3.10.3	Concentration number	400 to 800
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

SAR COV2 virus infection, without radiological affectation.

Infección por virus SAR COV2, sin afectación radiológica.

E.1.1.1

Medical condition in easily understood language

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10051905
E.1.2	Term	Coronavirus infection
E.1.2	System Organ Class	100000004862

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	10070255
E.1.2	Term	Coronavirus test positive
E.1.2	System Organ Class	10022891 - Investigations

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 determine the efficacy of hydroxychloroquine in the treatment of SARS-COV2 infection in oncohaematological patients without radiological alteration and SARS-COV2 positive professionals without radiological alteration.

Determinar la eficacia de hidroxicloroquina en el tratamiento dela infección del SARS-COV2 en pacientes oncohematológicos (NIT1 y NIT2) sin alteración radiológica y profesionales SARS-COV2 positivos sin alteración radiológica.

E.2.2

Secondary objectives of the trial

Evaluate the toxicity profile of the treatment.

Evaluar el perfil de toxicidad del tratamiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patient Cohort
1) Patients diagnosed with onco-haematological disease
2) Age: over 18 years old.
3) ECOG performance status < 2 (Karnofsky>60%)
4) Life expectancy > 3 months for the neoplastic disease.
5) Patients with laboratory confirmed Covid-19 diagnosis (PCR)
6) Patients with clinical signs compatible with Covid-19: fever, cough, dyspnea.
7) Patients should have chest radiological imaging (plaque or CT scan) with no affectation compatible with Covid-19.
8) NIT-1-2 patients
9) Mild functional alteration of organs, defined as:
- Calculated creatinine clearance > 30 ml/min
- Bilirubin < 25 μmol/l (1.5 mg/dl)
- AST/ALT < 2.5 times upper limit of the centre's normality
- Alkaline phosphatase < 2.5 times upper limit of centre's normality
- Normal spinal function: Hematology: neutrophils > 1.0 x 109/l, lymphocytes > 0.5 x 109/l, platelets > 75 x 109/l, hemoglobin > 8 g/100ml.
-PT and PTT: normal
10) To give informed consent in accordance with current legal regulations.

Professional Cohort
1) Age: over 18 years old.
2) Diagnosis Covid-19 confirmed by laboratory (PCR)
3) They must have a chest X-ray image (plate or CT) with no Covid-19 compatible affectation.
4) Adequate organic function, defined as:
- Calculated creatinine clearance > 30 ml/min.
- Bilirubin < 25 μmol/l (1.5 mg/dl)
- AST/ALT < 2.5 times upper limit of the centre's normality
- Alkaline phosphatase < 2.5 times upper limit of centre's normality
-Normal spinal function: Hematology: neutrophils > 1.0 x 109/l, lymphocytes > 0.5 x 109/l, platelets > 75 x 109/l, hemoglobin > 8 g/100ml.
- PT and PTT: normal
5) To give informed consent in accordance with current legal regulations.

Cohorte de pacientes
1) Pacientes diagnosticados de enfermedad onco-hematológica.
2) Edad: mayores de 18 años.
3) ECOG performance status < 2 (Karnofsky>60%)
4) Esperanza de vida > 3 meses por su enfermedad neoplásica.
5) Pacientes con diagnóstico Covid-19 confirmado por laboratorio (PCR)
6) Pacientes que presentan clínica compatible con Covid-19: fiebre, tos, disnea.
7) Los pacientes deben tener imagen radiológica de tórax (placa o TAC) sin afectación compatible con Covid-19.
8) Pacientes NIT-1-2
9) Alteración funcional de órganos leve, definida como:
- Aclaramiento calculado de creatinina > 30 ml/min.
- Bilirrubina < 25 μmol/l (1.5 mg/dl)
- AST/ALT < 2.5 veces el límite superior de la normalidad del centro
- Fosfatasa alcalina < 2.5 veces el límite superior de la normalidad del centro
- Función medular normal: Hematología: neutrófilos> 1.0 x 109/l, linfocitos > 0.5 x 109/l, plaquetas > 75 x 109/l, hemoglobina > 8 g/100ml.
- PT and PTT: normales
10) Otorgar consentimiento informado de acuerdo con la normativa legal vigente.

Cohorte de profesionales
1) Edad: mayores de 18 años.
2) Diagnóstico Covid-19 confirmado por laboratorio (PCR)
3) Deben tener imagen radiológica de tórax (placa o TAC) sin afectación compatible con Covid-19.
4) Adecuada función orgánica, definida como:
- Aclaramiento calculado de creatinina > 30 ml/min.
- Bilirrubina < 25 μmol/l (1.5 mg/dl)
- AST/ALT < 2.5 veces el límite superior de la normalidad del centro
- Fosfatasa alcalina < 2.5 veces el límite superior de la normalidad del centro
- Función medular normal: Hematología: neutrófilos> 1.0 x 109/l, linfocitos > 0.5 x 109/l, plaquetas > 75 x 109/l, hemoglobina > 8 g/100ml.
- PT and PTT: normales
5) Otorgar consentimiento informado de acuerdo con la normativa legal vigente.

E.4

Principal exclusion criteria

Patient cohort and professional cohort
● Uncontrolled intercurrent disease including infections other than CoVID19, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric or social disorder that may limit study requirements
● To be receiving any other drug or product under study
● Allergy to one or more of the medications in the trial
● Chronic concomitant immunosuppressive medication

Cohorte de pacientes y cohorte de profesionales
● Enfermedad intercurrente no controlada incluyendo infecciones diferentes de CoVID19, insuficiencia cardiaca sintomática, angina pectoris inestable, arritmia cardiaca, trastorno psiquiátrico o social que puede limitar los requerimientos del estudio.
● Estar recibiendo cualquier otro fármaco o producto en estudio
● Alergia a uno o más de las medicaciones presentes en el ensayo
● Medicación crónica inmunosupresora concomitante

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients (cohort A) and professionals (cohort B) who achieve control of the disease without symptoms in 14 days, assessed by chest radiography without pneumonia.

Porcentaje de pacientes (cohorte A) y profesionales (cohorte B) que consiguen el control de la enfermedad sin presencia de síntomas en 14 días, evaluado mediante radiografía de tórax sin neumonía.

E.5.1.1

Timepoint(s) of evaluation of this end point

14 days after treatment initiation

14 dias despues de iniciar tratamiento

E.5.2

Secondary end point(s)

Safety endpoints.

Variables de seguridad.

E.5.2.1

Timepoint(s) of evaluation of this end point

Throughout the study.

Durante todo el estudio.

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

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

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

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

The study will end when the evaluation of the last patient included in
the study "Last visit last patient"

El estudio finalizará cuando finalice la evaluación del último paciente
incluido en el estudio "Last Patient-Last Visit"

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:

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

Yes

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

103

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)

Patients who complete their participation in this study will continue with the medical tests and treatments prescribed by their doctor according to their usual practice.

Los pacientes que finalicen su participación en este estudio, continuarán con las pruebas médicas y tratamientos que les prescriba
su médico de acuerdo a su práctica clínica habitual.

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

2020-04-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-10

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2020-06-26

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