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    Summary
    EudraCT Number:2020-001994-66
    Sponsor's Protocol Code Number:ECIT-PRO19
    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:2020-05-08
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-001994-66
    A.3Full title of the trial
    Ramdomised clinical trial of ivermectin for treatment and prophylaxis of COVID-19
    ENSAYO CLINICO CON IVERMECTINA PARA EL TRATAMIENTO Y LA PROFILAXIS DEL COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the efficacy of ivermectin in the treatment and prevention of COVID-19
    Estudio de la eficacia de ivermectina en el tratamiento y la prevención de COVID-19
    A.4.1Sponsor's protocol code numberECIT-PRO19
    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 SponsorFundació Assistencial Mútua Terrassa
    B.1.3.4CountrySpain
    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 supportFundació Docència i Recerca Mútua Terrassa
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Assistencial Mútua Terrassa
    B.5.2Functional name of contact pointClinical trial
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Olabarria s/n
    B.5.3.2Town/ cityValldoreix
    B.5.3.3Post code08197
    B.5.3.4CountrySpain
    B.5.4Telephone number0034644460736
    B.5.6E-mailtomas.perez.porcuna@gmail.com
    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.2.1.1.1Trade name STROMECTOL 3 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMSD France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameSTROMECTOL 3 mg
    D.3.2Product code 34009 352 388 5 6
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 No
    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 placeboTablet
    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
    SARS COVID-19
    SARS COVID-19
    E.1.1.1Medical condition in easily understood language
    Coronavirus infection
    Infección por coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the effectiveness of Ivermectin in the prophylaxis and treatment of COVID-19
    Demostrar la efectividad de la Ivermectina en la profilaxis y tratamiento de la COVID-19
    E.2.2Secondary objectives of the trial
    not applicable
    not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study 1:
    Tittle:Demonstrate the Efficacy of Ivermectin in the treatment of SARS-CoV-2
    Specific Objective:. Compare the viral clearance in SARS-CoV-2 patients treated with Ivermectin and placebo.
    Secondary objective: Compare the clinical evolution and complications between COVID-19 patients receiving Ivermectin and placebo

    Sub-study 2:
    Tittle: Demonstrate Ivermectin efficacy in contact prophylaxis
    Specific objective: Compare the contagion rate between home contacts of patients with COVID-19 + receiving prophylaxis with Ivermectin and placebo
    Secondary objective: Compare the clinical evolution and complications between home contacts of COVID-19 + patients receiving Ivermectin and Placebo prophylaxis.
    Subestudio 1:
    Título: Demostrar la Eficacia de la Ivermectina en el tratamiento del SARS-CoV-2
    Objectivo específico:Comparar el viral clearance en pacientes de SARS-CoV-2 en tratamiento con Ivermectina y placebo.
    Objetivo secundario: Comparar la evolución clínica y complicaciones entre pacientes de COVID-19 en tratamiento con Ivermectina y placebo

    Subestudio 2:
    Título: Demostrar eficacia Ivermectina en la profilaxis de los contactos
    Objetivo específico: Comparar la tasa de contagio entre contactos domiciliarios de pacientes con COVID-19+ que reciban profilaxis con Ivermectina y placebo
    Objetivo secundario: Comparar la evolución clínica y complicaciones entre contactos domiciliarios de pacientes COVID-19+ que reciban profilaxis con Ivermectina y Placebo.
    E.3Principal inclusion criteria
    Sub-study 1:
    1. Symptomatic (respiratory) patients with a positive PCR-RT test for COVID-19 and a clinical condition of less than 5 days of evolution.
    2. ≥18 years old.
    3. In women of childbearing age, negative pregnancy test and use of contraceptive method during the study period.
    4. Accept to take the medication and the complementary test procedures during the study, including analysis and nasal sampling.
    5. Able to provide informed consent (oral or written).

    Sub-study 2:
    1. Contacts of symptomatic (respiratory) patients with a positive PCR-RT test for COVID-19 and a diagnosis of less than 5 days of evolution.
    2. Of legal age.
    3. In women of childbearing age, negative pregnancy test and use of contraceptive method during the study period.
    4. Accept to take the medication and the complementary test procedures during the study, including analysis and nasal sampling.
    5. Able to provide informed consent (oral or written).
    Subestudio 1
    1. Pacientes sintomáticos (respiratorios) con test PCR-RT positive por COVID-19 y clínica inferior a 5 días de evolución.
    2. Mayores de edad (≥18 años).
    3. En mujeres en edad fértil prueba de embarazo negativo y uso de método anticonceptivo durante el periodo de estudio.
    4. Aceptar tomar la medicación y los procedimientos de pruebas complementarias durante el estudio incluido analítica y toma de muestras nasales.
    5. Capaz de proveer consentimiento informado (oral o escrito).

    Subestudio 2
    1. Contactos de pacientes sintomáticos (respiratorios) con test PCR-RT positiva por COVID-19 y diagnóstico inferior a 5 días de evolución.
    2. Mayores de edad.
    3. En mujeres en edad fértil prueba de embarazo negativo y uso de método anticonceptivo durante el periodo de estudio.
    4. Aceptar tomar la medicación y los procedimientos de pruebas complementarias durante el estudio incluido analítica y toma de muestras nasales.
    5. Capaz de proveer consentimiento informado (oral o escrito).
    E.4Principal exclusion criteria
    Sub-study 1
    1. Moderate or severe forms of infection requiring hospital admission
    a.-Respiratory distress with respiratory rate> = 30 breaths / min
    b.-Oxygen saturation ≤93% at rest
    c.- Kirby index:(PaO2) /(FIO2)) ≤300mmHg.
    2. Participants taking medications that may interfere with the study medication such as anticoagulants.
    3. Inability to take oral medication.
    4. Severe liver disorders (Child Pugh C).
    5. Impairment of severe renal function (with GFR ≤30 mL / min / 1.73 m2) or requiring dialysis.
    6. Participants with coagulation disorders.
    7. Individuals with severe neurological or mental impairment.
    8. Pregnant or lactating women.
    9. Unable to consent to the study protocol.
    10. People with known hypersensitivity to Ivermectin.
    11. People who have been treated in any other study in the previous 30 days.
    12. Concomitant administration of enzyme inducers (such as carbamazepine) that could affect the effectiveness of the drug and those receiving CYP3A4 substrates (such as statins) due to the risk of increased toxicity.
    13. Any other contraindication according to the technical sheet for Ivermectin.

    Sub-study 2
    1. Participants taking medications that may interfere with study medication.
    2. Inability to take oral medication.
    3. Severe liver disorders (Child Pugh C) or alcoholism.
    4. Impaired severe renal function (with GFR ≤30 mL / min / 1.73 m2) or requiring dialysis.
    5. Participants with coagulation disorders.
    6. Individuals with severe neurological or mental impairment.
    7. Pregnant or lactating women.
    8. Unable to consent to study protocol.
    9. People with known hypersensitivity to Ivermectin.
    10. People who have been treated in any other study in the previous 30 days.
    11. Concomitant administration of enzyme inducers (such as carbamazepine) that could affect the effectiveness of the drug and those receiving CYP3A4 substrates (such as statins) due to the risk of increased toxicity.
    12. Any other contraindication according to the technical data sheet for Ivermectin.
    Subestudio 1
    1. Formas moderadas o graves de la infección que requieran ingreso hospitalario
    a.-Distrés respiratorio con frecuencia respiratoria >=30 respiraciones/min
    b.-Saturación de oxígeno ≤93% en reposo
    c.-Índice PAFI (Presión arterial de oxígeno (PaO2)/ fracción inspirada de oxígeno (FIO2) ) ≤300mmHg.
    2. Participantes que tomen medicaciones que puedan interferir con la medicación del estudio como los anticuagulantes.
    3. Incapacidad de tomar medicación oral.
    4. Alteraciones hepáticas severas (Child Pugh C).
    5. Afectación de la función renal grave (con FG ≤30 mL/min/1.73 m2) o que requiera diálisis.
    6. Participantes con alteraciones de la coagulación.
    7. Individuos con afectación neurológica o mental grave.
    8. Mujeres embarazadas o en periodo de lactancia.
    9. Incapaz de dar consentimiento al protocolo de estudio.
    10. Personas con hipersensibilidad conocida a la Ivermectina.
    11. Personas que hayan sido tratadas en cualquier otro estudio en los 30 días previos.
    12. Administración concomitante de inductores enzimáticos (como la carbamazepina) que podrían afectar la efectividad del medicamento y aquellos que reciben sustratos de CYP3A4 (como estatinas) debido al riesgo de aumento de la toxicidad.
    13. Cualquier otra contraindicación según ficha técnica para la Ivermectina.

    Subestudio 2

    1. Participantes que tomen medicaciones que puedan interferir con la medicación del estudio.
    2. Incapacidad de tomar medicación oral.
    3. Alteraciones hepáticas severas (Child Pugh C) o alcoholismo.
    4. Afectación de la función renal grave (con FG ≤30 mL/min/1.73 m2) o que requiera diálisis.
    5. Participantes con alteraciones de la coagulación.
    6. Individuos con afectación neurológica o mental grave.
    7. Mujeres embarazadas o en periodo de lactancia.
    8. Incapaz de dar consentimiento al protocolo de estudio.
    9. Personas con hipersensibilidad conocida a la Ivermectina.
    10. Personas que hayan sido tratadas en cualquier otro estudio en los 30 días previos.
    11. Administración concomitante de inductores enzimáticos (como la carbamazepina) que podrían afectar la efectividad del medicamento y aquellos que reciben sustratos de CYP3A4 (como estatinas) debido al riesgo de aumento de la toxicidad.
    12. Cualquier otra contraindicación según ficha técnica para la Ivermectina.
    E.5 End points
    E.5.1Primary end point(s)
    Sub-study 1
    Virological clearence at 3, 6, 9 and 12 days after starting treatment with Ivermectin

    Sub-study 2
    Incidence of secondary cases diagnosed by molecular biology and serology on the 7th, 14th, 21st day after starting prophylaxis with Ivermectin and with placebo
    Subestudio 1
    Presencia / ausencia de carga viral al 3, 6, 9 i 12 día después de iniciar el tratamiento con Ivermectina (virological clearance)

    Subestudio 2
    Incidencia de casos secundarios mediada a través de diagnóstico por biología molecular y serología al 7, 14, 21º día después de iniciar la profilaxis con Ivermectina y con placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Sub-study 1
    Day 3rd, 6th, 9th and 12th after starting treatment

    Sub-study 2
    Day 7th, 14, 21th after starting treatment
    Subestudio 1
    Dia 3, 6, 9, 12 después de iniciar tratamiento

    Subestudio 2
    Dia 7, 14, 21 después de iniciar el tratamiento
    E.5.2Secondary end point(s)
    Sub-study 1
    1. Viral load at 3, 6, 9 and 12 days after starting treatment with Ivermectin and placebo (virological clearance).
    2. Serological response at 6 and 14 days
    3. Morbidity and Mortality at 14 days
    4. Incidence of infection between household contacts
    5. Analytical values ​​at 0 (baseline), 6 and 12 days
    6. Proportion of participants leaving the study
    7. Proportion of participants not complying with the study protocol

    Sub-study 2
    1. Morbidity and mortality at 28 days
    2. Analytical values ​​at 0 (baseline), 7, 12 and 21 days
    Subestudio 1
    1. Carga viral al 3, 6, 9 i 12 día después de iniciar el tratamiento con Ivermectina y placebo (virological clearance).
    2. Respuesta serológica a los 6 y 14 días
    3. Morbilidad y Mortalidad a los 14 días
    4. Incidencia de infección entre contactos domiciliares
    5. Valores analíticos a los 0 (basal), 6 y 12 días
    6. Proporción de participantes que abandonan estudio
    7. Proporción de participantes que no cumplen protocolo del estudio

    Subestudio 2
    1. Morbilidad y mortalidad a los 28 días
    2. Valores analíticos a los 0 (basal), 7, 12 y 21 días
    E.5.2.1Timepoint(s) of evaluation of this end point
    Sub-study 1
    Day 3rd, 6th, 9th, 12th and 14 after starting treatment

    Sub-study 2
    Day 0, 7th, 12, 21th and 28th after starting treatment
    Subestudio 1
    Dia 3, 6, 9, 12 y 14 después de iniciar tratamiento

    Subestudio 2
    Dia 0, 7, 12, 21 y 28 después de iniciar el tratamiento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    ültima visita, 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 months
    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: 266
    F.1.3Elderly (>=65 years) No
    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 No
    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 state266
    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)
    The expected normal tratment of patients with SARS COVID-19
    El tratamiento esperado para los pacientes con SARS COVID19
    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 Decision2020-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-12-31
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