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    Summary
    EudraCT Number:2020-001194-69
    Sponsor's Protocol Code Number:MEFLOCOVID-19
    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:2020-04-07
    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 number2020-001194-69
    A.3Full title of the trial
    Pilot study to evaluate the efficacy and safety of mefloquine as prophylaxis in people exposed to the disease caused by the SARS-CoV-2 coronavirus (COVID-19)
    Estudio piloto para evaluar la eficacia y seguridad de la mefloquina como profilaxis en personas expuestas a la enfermedad producida por coronavirus SARS-CoV-2 (COVID-19)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study to evaluate the efficacy and safety of mefloquine as prophylaxis in people exposed to the disease caused by the new SARS-CoV-2 coronavirus (COVID-19)
    Estudio para evaluar la eficacia y seguridad de la mefloquina como profilaxis en personas expuestas a la enfermedad producida por el nuevo coronavirus SARS-CoV-2 (COVID-19)
    A.3.2Name or abbreviated title of the trial where available
    MEFLOCOVID-19
    MEFLOCOVID-19
    A.4.1Sponsor's protocol code numberMEFLOCOVID-19
    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 SponsorFélix Gutiérrez Rodero
    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 supportFISABIO
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFISABIO
    B.5.2Functional name of contact pointUnidad de Enfermedades Infecciosas
    B.5.3 Address:
    B.5.3.1Street AddressCamino de la Almazara 11
    B.5.3.2Town/ cityElche
    B.5.3.3Post code03203
    B.5.3.4CountrySpain
    B.5.4Telephone number34966616234
    B.5.6E-mailgutierrez_fel@gva.es
    B.Sponsor: 2
    B.1.1Name of SponsorMar Masiá Canuto
    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 supportFISABIO
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFISABIO
    B.5.2Functional name of contact pointUnidad de Enfermedades Infecciosas
    B.5.3 Address:
    B.5.3.1Street AddressCamino de la Almazara 11
    B.5.3.2Town/ cityElche
    B.5.3.4CountrySpain
    B.5.4Telephone number34966616234
    B.5.6E-mailmasia_marcana@gva.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 Lariam
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE PRODUCTS LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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.3.8INN - Proposed INNMEFLOQUINE
    D.3.9.1CAS number 53230-10-7
    D.3.9.4EV Substance CodeSUB08709MIG
    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 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 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
    COVID-19 infection is being spread around the world with more than 400.000 cases. The spred of the disease is being a world health problem.
    La infección por COVID-19 se está extendiendo por todo el mundo con más de 400,000 casos. La velocidad del contagio de la enfermedad está siendo un problema de salud mundial.
    E.1.1.1Medical condition in easily understood language
    COVID-19 infection is being spread around the world with more than 400.000 cases. The spred of the disease is being a world health problem.
    La infección por COVID-19 se está extendiendo por todo el mundo con más de 400,000 casos. La velocidad del contagio de la enfermedad está siendo un problema de salud mundial.
    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
    To determine the protective efficacy of mefloquine prophylaxis against placebo in close contacts of people with COVID-19.
    Examinar la eficacia protectora de la profilaxis con mefloquina frente a placebo en contactos estrechos de personas con COVID-19.
    E.2.2Secondary objectives of the trial
    -Establish if the preventive administration of mefloquine attenuates the clinical manifestations of COVID-19 in people who become infected.
    -Evaluate the safety of prophylactic mefloquine in this setting.
    -Establecer si la administración preventiva de mefloquina atenúa las manifestaciones clínicas de la COVID-19 en las personas que se infectan.
    -Evaluar la seguridad de la mefloquina profiláctica en este escenario.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    People in close contact with adults diagnosed with COVID-19 who sign the informed consent. Close contact is defined as those who live at home with an infected person, who have had intimate relationships or whose job is less than two meters from the infected person.
    -Personas en contacto estrecho con adultos diagnosticados de COVID-19 que firmen el consentimiento informado. Se define como contacto estrecho aquellos que conviven en el domicilio con una persona infectada, que han mantenido relaciones íntimas o cuyo puesto de trabajo se encuentra a menos de dos metros del de la persona infectada.
    E.4Principal exclusion criteria
    -Patients <18 years.
    -Patients with symptoms suggestive of SARS-CoV-2 infection.
    -Women who are pregnant or who intend to become pregnant for the next three months after taking the drug.
    -Patients allergic to mefloquine or other quinine or quinidine-type medications.
    -Patients with a neurological history (seizures, epilepsy, etc.).
    -Patients with a previous history of psychiatric illnesses (depression, anxiety, suicide attempt).
    -Patients with cardiac pathologies or relevant chronic diseases that in the judgment of the clinician recommend the non-inclusion of the patient in the study.
    -Patients in treatment with other medications such as valproic acid, antiarrhythmics, antihistamines H1, beta-blockers, calcium channel blockers, chloroquine, halofantrine, phenothiazines, quinidine and quinine.
    -Pacientes <18 años.
    -Pacientes que presenten síntomas sugestivos de infección por SARS-CoV-2.
    -Mujeres embarazadas o que pretendan quedarse embarazadas durante los siguientes tres meses tras la toma del fármaco.
    -Pacientes alérgicos a la mefloquina o a otros medicamentos del tipo quinina o quinidina.
    -Pacientes con antecedentes neurológicos (convulsiones, epilepsia, etc.).
    -Pacientes con historial previo de enfermedades psiquiátricas (depresión, ansiedad, intento de suicido).
    -Pacientes con patologías cardíacas o enfermedades crónicas relevantes que a juicio del clínico recomienden la no inclusión del paciente en el estudio.
    -Pacientes en tratamiento con otros medicamentos como ácido valproico, antiarrítmicos, antihistamínicos H1, betabloqueantes, bloqueantes de los canales del calcio, cloroquina, halofantrina, fenotiazinas, quinidina y quinina.
    E.5 End points
    E.5.1Primary end point(s)
    COVID-19 infection.
    Infección por COVID-19.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The patient will be evaluated weekly for 30 days from enrollment in the study to rule out / confirm COVID-19 infection.
    El paciente será evaluado semanalmente durante 30 días desde su inclusión en el estudio para descartar/confirmar la infección por COVID-19.
    E.5.2Secondary end point(s)
    Mortality, gravity of COVID-19 infection
    Mortalidad, gravedad de la infección por COVID-19.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The patient will be evaluated weekly for 30 days from enrollment in the study to rule out / confirm COVID-19 infection and effects
    El paciente será evaluado semanalmente durante 30 días desde la inscripción en el estudio para descartar / confirmar la infección y los efectos de COVID-19
    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 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.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 Yes
    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
    LVLP
    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 months6
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state200
    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 patient will continue to be under the control of normal clinical practice, having the possibility of contacting the study promoters at any time.
    El paciente seguirá bajo control de la práctica clínica habitual, teniendo la posibilidad de contactar con los promotores del estudio en cualquier momento.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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