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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2020-001474-29
    Sponsor's Protocol Code Number:SAINT
    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 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.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-001474-29
    A.3Full title of the trial
    Pilot study to evaluate the potential of ivermectin to reduce COVID-19 transmission
    Estudio piloto para evaluar el potencial de la ivermectina para disminuir la transmisión del COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study to evaluate the potential of ivermectin to reduce COVID-19 transmission
    Estudio piloto para evaluar el potencial de la ivermectina para disminuir la transmisión del COVID-19
    A.4.1Sponsor's protocol code numberSAINT
    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 SponsorClínica Universidad de Navarra/Universidad de Navarra
    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 supportPending
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinica Universidad de Navarra
    B.5.2Functional name of contact pointUCEC
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Pío XII, 36
    B.5.3.2Town/ cityPamplona
    B.5.3.3Post code31008
    B.5.3.4CountrySpain
    B.5.4Telephone number9482554002717
    B.5.5Fax number948296667
    B.5.6E-mailucicec@unav.es
    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
    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 nameIvermectina
    D.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INNIvermectin
    D.3.9.1CAS number 70288-86-7
    D.3.9.3Other descriptive nameIVERMECTIN
    D.3.9.4EV Substance CodeSUB12089MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 Yes
    D.3.11.13.1Other medicinal product typeSemisynthetic
    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
    COVID-19
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of a single dose of ivermectin, administered to low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset to reduce the proportion of patients with detectable SARS-CoV-2 RNA by PCR from nasopharyngeal swab at day seven post-treatment.
    Determinar la eficacia de la ivermectina en dosis única, administrada a pacientes de COVID-19 con bajo riesgo de progresión a enfermedad grave, en las primeras 48 horas desde el inicio de los síntomas, para reducir la proporción de pacientes con PCR positiva para SARS-CoV-2 en el hisopado naso-faríngeo a los siete días desde el tratamiento.
    E.2.2Secondary objectives of the trial
    1. To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab at day seven post treatment
    2. To assess the efficacy of ivermectin to improve symptom progression in treated patients
    3. To assess the proportion of seroconversions at day 21 in treated patients
    4. To assess the safety of ivermectin at the proposed dose
    5. To determine the magnitude of immune response against SARS-CoV-2
    6. To assess the early kinetics of immunity against SARS-CoV-2
    1. Determinar la eficacia de la ivermectina en la reducción del transporte viral nasal de SARS-CoV-2 a los siete días desde el tratamiento
    2. Determinar la eficacia de la ivermectina en la mejora de la progression de los sintomas en pacientes tratados
    3. Determinar la proporcion de seroconversion en el dia 21 de los pacientes tratados.
    4. Determinar la seguridad de la ivermectina a dosis propuesta.
    5. Determinar la magnitude de respuesta immune frente al SARS-CoV-2
    6. Determinar la cinética inmonologica inicial frente al SARS-CoV-2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra with a positive SARS-CoV-2 PCR.
    -Residents of the Pamplona basin (“Cuenca de Pamplona”)
    -The patient should be between the ages of 18 and 60 years of age
    -Negative pregnancy test for women of child bearing age*
    -The patient or his/her representative, have given consent to participate in the study.
    -The patient should, in the investigator's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation)

    *Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards. A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study).
    -Pacientes diagnosticados con COVID-19 en Urgencias de la Clinica Universidad de Navarra, dando resultado positive con PCR SARS-CoV-2.
    -Residentes en la cuenca de Pamplona.
    -Pacientes con edades entre los 18 y los 60 años.
    -Test de embarazo negativo en mujeres en edad fértil.*
    -Paciente o representante, deben dar su consentimiento en la participación en el estudio
    -El paciente debe, según la opinión del investigador, debe ser apto o capaz de cumplir todos los requisitos del ensayo clínico (incluyendo el seguimiento en el hogar, durante el periodo de aislamiento)
    *Las mujeres en edad fértil, pueden participar en el ensayo, si usan un método anticonceptivo seguro, durante el periodo del ensayo y hasta al menos un mes después del ensayo. Una mujer esta considerada como no fértil si es postmenopausica (un minimo de 2 años sin menstruación) o ha sido sometida a una esterilización quirúrgica (al menos un mes antes del estudio).
    E.4Principal exclusion criteria
    - Known history of Ivermectin allergy
    -Hypersensitivity to any component of Stromectol®
    -COVID-19 Pneumonia Diagnosed by the attending physician Identified in a chest X-ray
    -Fever or cough present for more than 48 hours
    -Positive IgG against SARS-CoV-2 by rapid test
    -Age under 18 or
    -over 60 years
    -Immunosuppression
    -Chronic Obstructive Pulmonary Disease
    -Diabetes
    -Hypertension
    -Obesity
    -Acute or chronic renal failure
    -History of coronary disease
    -History of cerebrovascular disease
    -Current neoplasm
    -Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan)
    -Current use of CYP 3A4 or P-gp inhibitor drugs (such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.)
    - Hipersensibilidad conocidas con la Ivermectina
    - Hipersensibilidad a cualquiera de los componentes del Stromectol®
    - Neumonía: definida por el médico urgencias y/o con una radiografía de tórax
    - Fiebre o tos desde hace más de 48 horas
    - IgG positiva frente al SARS-CoV-2 por detección rápida
    - Menos de 18 años
    - Edad superior a 60 años
    - Inmunodepresión
    - EPOC
    - Diabetes
    - Hipertensión
    - Obesidad
    - Fallo renal crónico o agudo
    - Antecedentes de enfermedad coronaria
    - Historia de la enfermedad cerebrovascular
    - Neoplasia actual
    - Historia de viaje reciente a países endémicos para Loa loa
    - Uso actual de medicamentos inhibidores del CYP 3A4 o la P-gp
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab
    Proporción de participantes con PCR positiva para SARS-CoV-2 en el hisopado nasofaríngeo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7 post-treatment
    A los 7 días del tratamiento
    E.5.2Secondary end point(s)
    1. Mean viral load as determined by PCR cycle threshold (Ct).
    2. Proportion of patients with fever and cough, as well as proportion of patients progressing to severe disease or death.
    3. Proportion of patients with seroconversion.
    4. Proportion of drug-related adverse events
    5. Levels of IgG, IgM, IgA measured by Luminex, frequencies of innate and SARS-CoV-2-specific T cells assessed by flow cytometry, levels of inflammatory and activation markers measured by Luminex and transcriptomics.
    6. Kinetics of IgG, IgM, IgA levels
    1. Carga viral media determinada por PCR en el ciclo umbral (Ct).
    2. Proporción de pacientes con fiebre y tos, así como la proporción de pacientes que progresan a enfermedad severa o mueren.
    3. Proporción de pacientes con seroconversión.
    4. Proporción de efectos adversos relacionados con el medicamento.
    5. Niveles de IgG, IgM, IgA medido por Luminex, frecuencias de respuesta innata y SARS-CoV-2-specifica evaluada por citrometria de flujo, niveles de marcadores de inflamación y activación medidos con Luminex y transcriptómica.
    6. Cinética de los niveles IgG, IgM, IgA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 4, 7, 14, 21 and 28
    Días 4, 7, 14, 21 y 28
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Última 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 months1
    E.8.9.1In the Member State concerned days7
    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: 24
    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 state24
    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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-10
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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