Clinical Trials Register

Summary
EudraCT Number:	2021-000850-24
Sponsor's Protocol Code Number:	ECCO-2
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:	2021-09-01
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

2021-000850-24

A.3

Full title of the trial

A study on the effect of an Echinacea formulation on the clinical manifestations and evolution of Covid-19.

Estudio sobre el efecto de un preparado de Equinácea sobre las manifestaciones clínicas y evolución de Covid-19

A.3.1

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

Echinacea and Covid-19 (Acronym: ECCO-2)

A.4.1

Sponsor's protocol code number

ECCO-2

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	Jesús Rodríguez Requena
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	None
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	CIMUS Biomedical Research Institute. University of Santiago de Compostela-IDIS
B.5.2	Functional name of contact point	Jesús Rodríguez Requena
B.5.3	Address:
B.5.3.1	Street Address	Avenida de Barcelona s/n
B.5.3.2	Town/ city	Santiago de Compostela
B.5.3.3	Post code	15782
B.5.3.4	Country	Spain
B.5.4	Telephone number	34881815464
B.5.6	E-mail	jesus.requena@usc.es
B.Sponsor: 2
B.1.1	Name of Sponsor	José Luis Pérez Albiac
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	None
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	José Luis Pérez Albiac
B.5.2	Functional name of contact point	José Luis Pérez Albiac
B.5.3	Address:
B.5.3.1	Street Address	Centro de Salud Monzón Rural. Calle San José de Calasanz, 1
B.5.3.2	Town/ city	Monzón
B.5.3.3	Post code	22400
B.5.3.4	Country	Spain
B.5.4	Telephone number	34608332686
B.5.6	E-mail	jlperezalbiac@salud.aragon.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	EQUINÁCEA ARKOPHARMA cápsulas duras
D.2.1.1.2	Name of the Marketing Authorisation holder	Arkopharma LABORATORIOS, S.A.U.
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	Echinacea purpurea
D.3.4	Pharmaceutical form	Capsule, hard
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	ECHINACEA PURPUREA ROOT, CRYOGROUND
D.3.9.3	Other descriptive name	ECHINACEA PURPUREA ROOT, CRYOGROUND
D.3.9.4	EV Substance Code	SUB190100
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	250
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Capsule, hard
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

COVID-19

E.1.1.1

Medical condition in easily understood language

COVID-19

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	LLT
E.1.2	Classification code	10084355
E.1.2	Term	COVID-19 virus test positive
E.1.2	System Organ Class	100000004848

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	LLT
E.1.2	Classification code	10084437
E.1.2	Term	COVID-19 PCR test positive
E.1.2	System Organ Class	100000004848

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 demonstrate whether the drug "Equinacea Arkopharma", consisting of root of Echinacea purpurea, diminishes symptoms and improves disease course in covid-19 positive patients when administered along the standard treatment of the disease.

Objetivo de eficacia:
Demostrar si en pacientes covid-19 disminuye la sintomatología de forma más eficaz, si al tratamiento estándar se le pauta EQUINÁCEA ARKOPHARMA cápsulas duras según ficha técnica en comparación al tratamiento estándar.

Objetivo de seguridad:
Determinar que la incidencia de efectos adversos no es superior al tratamiento estándar que se utilice en cada caso.

E.2.2

Secondary objectives of the trial

To determine that incidence of adverse effects is not higher than those associated to the standard treatment.

Determinar y calcular si existen diferencias significativas entre grupos:
-días de fiebre
-días de disnea subjetiva
-días de desaturación
-días de enfermedad
-% de hospitalizaciones
-días de duración de hospitalizaciones
-días de duración de baja laboral
-% de visitas a urgencias en el brazo de Atención
-% de ingreso en UCI
-% de fallecimientos
Estudiar:
-apreciación subjetiva de utilidad del producto en la mejoría de la evolucion
-apreciación subjetiva de utilidad del producto en la mejoría de la evolucion
-incidencia de afección respiratoria en ambos brazos y % de abandonos por este motivo.
-incidencia de desaturación por debajo de 96% y % de abandonos por este motivo.
-aparición de palpitaciones en ambos brazos y % de abandonos por este motivo
-incidencia de elevación de transaminasas y % de abandonos por este motivo
-aparición de dolores de cabeza
-aparición de molestias estomacales
-incidencia de insomnio y nerviosismo y % de abandonos por este motivo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Age between 18 and 99. Capacity to provide informed consent.
• Presentation with a predominantly respiratory involvement.
• Body temperature of 37ºC, at some point in the course of the disease,
• Being between days 1 and 8 of disease course, counted from inception of symptoms
• Npt being vaccinated against SARS_COV-2.
• Being able to complete the treatment, in particular, swallowing the caplets.

• Edad entre 18 y 99 años . Capacidad de dar su consentimiento informado.
• Clínica predominantemente respiratoria. No se excluye al paciente si además tiene clínica menor de tipo digestivo, neurológico etc.
• Temperatura termometrada axilar mayor o igual a 37ºC, en algún momento de la enfermedad, en su evolución previa a la captación, o en el mismo momento de la captación.
• Estar entre los días 1 y 8 de evolución de la enfermedad, ambos inclusive, contada desde el día de inicio de los síntomas.
• No haber recibido dosis alguna de ninguna vacuna contra el SARS_COV-2 de las existentes.
• Tener capacidad de completar correctamente el tratamiento en lo relativo a la deglución o a cualquier aspecto físico que le incapacite para llevar a cabo un tratamiento con cápsulas

E.4

Principal exclusion criteria

• Patients without a PCR or antigen test-based diagnosis.
• Asymptomatic patients.
• Patients with a disease course of more than 9 days
• Patients with a predominantly digestive presentation.
• Patients with a formal counterindication to take echinacea.
• Patients that have previously received oxygen therapy.
• Non collaborative patients, patients under 18, or unable to provide informed consent

de exclusión:
• Pacientes no diagnosticados por PCR o test de antígenos.
• Pacientes asintomáticos.
• Pacientes con una evolución superior a 9 días desde el inicio de síntomas
• Pacientes con sintomatología predominantemente digestiva.
• Pacientes con contraindicación formal a la toma de equinácea.
• Pacientes con oxigenoterapia domiciliaria previa.
• Pacientes no colaboradores, menores de 18 años, sin capacidad para dar su consentimiento informado.

E.5 End points

E.5.1

Primary end point(s)

The main variable is the number of days of fever (temperature equal to or greater than 37ºC at some point during the day).

La variable principal es el número de días de fiebre (temperatura igual o superior a 37ºC en algún momento del día).

E.5.1.1

Timepoint(s) of evaluation of this end point

Over the study, and reported on Visits at 7 days, 12 days y 28 days

Durante todo el estudio, y recogido en las Visitas a lo 7, 12 y 28 días

E.5.2

Secondary end point(s)

Adverse events

Incidencia de efectos adversos

E.5.2.1

Timepoint(s) of evaluation of this end point

Over the study, and reported on Visits at 7 days, 12 days y 28 days

Durante todo el estudio, y recogido en las Visitas a lo 7, 12 y 28 días

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)

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

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

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

Las visit of the last subject (LVLS)

Útima visita del último sujeto

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:

140

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-09-01.

Yes

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

230

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

2021-06-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-31

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

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