Clinical Trials Register

Summary
EudraCT Number:	2020-001603-16
Sponsor's Protocol Code Number:	COLCHI-COVID
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
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

2020-001603-16

A.3

Full title of the trial

A RANDOMIZATION, MULTICENTRIC, OPEN-LABEL, CONTROLLED, CLINICAL TRIAL TO INVESTIGATE THE EFFECTIVENESS OF EARLY CHOLCHICINE ADMINISTRATION IN PATIENTS OVER 70 YEARS OF AGE WITH HIGH RISK OF DEVELOPING SEVERE PULMONARY COMPLICATIONS ASSOCIATED WITH CORONAVIRUS SARS-CoV2 PNEUMONIA (COVID-19)

ENSAYO CLÍNICO ALEATORIZADO, MULTICÉNTRICO, ABIERTO, CONTROLADO, PARA INVESTIGAR LA EFICACIA DE LA ADMINISTRACIÓN ANTICIPADA DE LA COLCHICINA EN PACIENTES MAYORES DE 70 AÑOS CON ALTO RIESGO DE DESARROLLAR COMPLICACIONES PULMONARES SEVERAS ASOCIADAS A LA NEUMONÍA DEL CORONAVIRUS SARS-CoV2 (COVID-19).

A.3.1

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

Ensayo clínico aleatorizado para investigar la eficacia de la administración anticipada de la colchicina en pacientes mayores de 70 años y de alto riesgo en tener complicaciones pulmonares como neumonía asociada al coronavirus.

Randomized clinical trial to investigate the efficacy of early administration of colchicine in patients over 70 years of age and at high risk of pulmonary complications such as coronavirus-associated pneumonia.

A.3.2

Name or abbreviated title of the trial where available

COLCHI-COVID

A.4.1

Sponsor's protocol code number

COLCHI-COVID

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
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	María del Mar García
B.5.3	Address:
B.5.3.1	Street Address	Avda. Valdecilla
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	COLCHICINA
D.2.1.1.2	Name of the Marketing Authorisation holder	SEID
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	COLCHICINE
D.3.9.1	CAS number	64-86-8
D.3.9.2	Current sponsor code	COLCHICINE
D.3.9.3	Other descriptive name	COLCHICINE
D.3.9.4	EV Substance Code	SUB01420MIG
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	0,5
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

Adult patients over 70 years of age diagnosed by COVID-19 with outpatient follow-up

Pacientes adultos mayores de 70 años diagnosticados por COVID-19 con seguimiento ambulatorio

E.1.1.1

Medical condition in easily understood language

Adults over 70 years old with COVID-19 coronavirus and follow up in health center

Adultos mayores de 70 años con coronavirus COVID-19 y seguimiento en centro de salud

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	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 if early treatment with colchicine reduces the rate of death and serious lung complications related to COVID-19 in patients over 70 years of age with at-risk comorbidities.

determinar si el tratamiento anticipado con colchicina reduce la tasa de muerte y las complicaciones pulmonares graves relacionadas con COVID-19 en pacientes mayores de 70 años con comorbilidades de riesgo.

E.2.2

Secondary objectives of the trial

Not applicable

No aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients of either sex who are at least 70 years old.
2. Diagnosis of COVID-19 infection within the last 24 hours and confirmed by PCR
3. The patient must be able to read and/or understand the content, read by a third party, of the information collected in the PIH.
4. Patient in outpatient follow-up (not hospitalized or under consideration) or institutionalized in senior centers/residences
5. The patient must possess at least two of the following high-risk criteria:
a. 70 years of age or older
AND
b. Any of the following: Diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥150 mm Hg), known respiratory disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, bicytopenia, pancytopenia, or the combination of a high neutrophil count and a low lymphocyte count
6. The patient must be able and willing to comply with the requirements of this study protocol.

1. Pacientes de ambos sexos con al menos 70 años de edad.
2. Diagnóstico de infección por COVID-19 en las últimas 24 horas y haberse confirmado por PCR
3. El paciente debe poder leer y/o comprender el contenido, leído por un tercero, de la información recogida en la HIP.
4. Paciente en seguimiento ambulatorio (no hospitalizado o bajo consideración) o institucionalizado en centros/residencias para mayores
5. El paciente debe poseer al menos dos de los siguientes criterios de alto riesgo:
a. 70 años o más de edad
Y
b. Alguno de los siguientes: Diabetes mellitus, hipertensión no controlada (presión arterial sistólica ≥150 mm Hg), enfermedad respiratoria conocida (incluido asma o enfermedad pulmonar obstructiva crónica), insuficiencia cardíaca conocida, enfermedad coronaria conocida, bicitopenia, pancitopenia o la combinación de un alto recuento de neutrófilos y un bajo recuento de linfocitos
6. El paciente debe ser capaz y estar dispuesto a cumplir con los requisitos de este protocolo de estudio.

E.4

Principal exclusion criteria

1. Inpatient or under immediate consideration of doing
2. Patient with an inability to read and/or understand the content, read by a third party, of the information collected in the PIH.
3. Patient in a state of shock or with hemodynamic instability;
4. Patient taking colchicine for other indications
5. Patient with history of allergic reaction or sensitivity to colchicine
6. Patient with severe gastrointestinal disorders such as inflammatory bowel disease, gastric ulcer, chronic diarrhea a or malabsorption
7. Patient with pre-existing progressive neuromuscular disease
8. Patient with renal damage and estimated glomerular filtrate rate <30 ml/m at 1732
9. Patient with a history of cirrhosis, chronic active hepatitis or severe liver disease
10. Patient undergoing chemotherapy for cancer.
11. Patient with hematological disorders, such as blood dyscrasias
12. Patients being treated with CYP3A4 and/or P-glycoprotein inhibitor drugs.
13. If the investigator considers you, for any reason, to be an unsuitable candidate.

1. Paciente hospitalizado o bajo consideración inmediata de hacerlo
7. Paciente con incapacidad para poder leer y/o comprender el contenido, leído por un tercero, de la información recogida en la HIP.
2. Paciente en estado de shock o con inestabilidad hemodinámica;
3. Paciente que toma colchicina para otras indicaciones
4. Paciente con antecedentes de reacción alérgica o sensibilidad a la colchicina
5. Paciente con trastornos gastrointestinales graves como enfermedad inflamatoria intestinal, úlcera gástrica, diarrea crónica o malabsorción
6. Paciente con enfermedad neuromuscular progresiva preexistente
7. Paciente con daño renal y tasa de filtrado glomerular estimada <30 ml/m en/1.732
8. Paciente con antecedentes de cirrosis, hepatitis activa crónica o enfermedad hepática grave
9. Paciente sometido a quimioterapia para el cáncer.
10. Paciente con alteraciones hematológicas, como discrasias sanguíneas
11. Pacientes que estén siendo tratados con fármacos inhibidores del CYP3A4 y/o de la glicoproteina P.
12. Si el investigador lo considera, por cualquier motivo, candidato inadecuado.

E.5 End points

E.5.1

Primary end point(s)

Number of participants who die or require hospitalization due to 19-COVID infection within 30 days of randomization

Número de participantes que mueren o requieren hospitalización debido a la infección por COVID-19 en los 30 días después de la aleatorización

E.5.1.1

Timepoint(s) of evaluation of this end point

1 months

1 mes

E.5.2

Secondary end point(s)

-Number of participants requiring mechanical ventilation within 30 days of randomization
-Number of patients with Adverse Events/Serious Adverse Reactions during treatment

-Número de participantes que requieren ventilación mecánica en los 30 días siguientes a la aleatorización.
-Número de pacientes con Acontecimientos Adversos/Reacciones Adversas Graves durante el tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

1 month for the first secondary target and two months for the second secondary target

1 mes para el primer objetivo secundario y dos meses para el segundo objetivo secundario

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)

Yes

E.7.4

Therapeutic use (Phase IV)

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

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)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

1024

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

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

1024

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

2020-05-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-05

P. End of Trial
P.	End of Trial Status	Completed

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