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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   43694   clinical trials with a EudraCT protocol, of which   7248   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    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
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-000850-24
    A.3Full 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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Echinacea and Covid-19 (Acronym: ECCO-2)
    A.4.1Sponsor's protocol code numberECCO-2
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJesús Rodríguez Requena
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNone
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCIMUS Biomedical Research Institute. University of Santiago de Compostela-IDIS
    B.5.2Functional name of contact pointJesús Rodríguez Requena
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de Barcelona s/n
    B.5.3.2Town/ citySantiago de Compostela
    B.5.3.3Post code15782
    B.5.4Telephone number34881815464
    B.Sponsor: 2
    B.1.1Name of SponsorJosé Luis Pérez Albiac
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNone
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJosé Luis Pérez Albiac
    B.5.2Functional name of contact pointJosé Luis Pérez Albiac
    B.5.3 Address:
    B.5.3.1Street AddressCentro de Salud Monzón Rural. Calle San José de Calasanz, 1
    B.5.3.2Town/ cityMonzón
    B.5.3.3Post code22400
    B.5.4Telephone number34608332686
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name EQUINÁCEA ARKOPHARMA cápsulas duras
    D. of the Marketing Authorisation holderArkopharma LABORATORIOS, S.A.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEchinacea purpurea
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameECHINACEA PURPUREA ROOT, CRYOGROUND
    D.3.9.4EV Substance CodeSUB190100
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084355
    E.1.2Term COVID-19 virus test positive
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084437
    E.1.2Term COVID-19 PCR test positive
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary 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
    -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.2.3Trial contains a sub-study No
    E.3Principal 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.4Principal 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.5.1Primary 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.5.1.1Timepoint(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.5.2Secondary end point(s)
    Adverse events
    Incidencia de efectos adversos
    E.5.2.1Timepoint(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.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women 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.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state230
    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)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-31
    P. End of Trial
    P.End of Trial StatusOngoing
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