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    Summary
    EudraCT Number:2020-001530-35
    Sponsor's Protocol Code Number:MeCOVID
    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:2020-04-13
    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 number2020-001530-35
    A.3Full title of the trial
    Randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts. COVID-19
    Ensayo clínico multicéntrico aleatorizado para evaluar la eficacia de melatonina en la profilaxis de la infección por SARS-CoV-2 en contactos de alto riesgo. COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to avoid infection by SARS-CoV-2 in high-risk population. COVID-19
    Ensayo clínico para evitar el contagio por SARS-CoV-2 en población de alto riesgo. COVID-19
    A.4.1Sponsor's protocol code numberMeCOVID
    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 SponsorFundación para la Investigación Biomédica del Hospital La Paz (FIBHULP)
    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 supportFundación para la Investigación Biomédica del Hospital La Paz (FIBHULP)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación Biomédica del Hospital La Paz (FIBHULP)
    B.5.2Functional name of contact pointAlberto Borobia
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number34912071466
    B.5.5Fax number34912071466
    B.5.6E-mailalberto.borobia@salud.madrid.org
    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 CIRCADIN 2 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRAD Neurim Pharmaceuticals EEC SARL
    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 nameCIRCADIN 2mg
    D.3.2Product code EMEA/H/C/000695
    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 INNCIRCADIN
    D.3.9.1CAS number 73-31-4
    D.3.9.3Other descriptive nameMELATONIN
    D.3.9.4EV Substance CodeSUB14496MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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-CoV-2 infection in high-risk contacts
    Infección por SARS-CoV-2 en contactos de alto riesgo
    E.1.1.1Medical condition in easily understood language
    SARS-CoV-2 infection in high-risk contacts
    Infección por SARS-CoV-2 en contactos de alto riesgo
    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
    The main objective is to evaluate the efficacy of melatonin in the prevention of SARS-CoV-2 infection in healthcare personnel with high-risk contacts.
    El objetivo principal es evaluar la eficacia de melatonina en la prevención de la infección por SARS-CoV-2 en personal sanitario con contactos de alto riesgo.
    E.2.2Secondary objectives of the trial
    o Evaluate the efficacy of melatonin in the prevention of asymptomatic SARS-CoV-2 infections (COVID-19).
    o To evaluate the efficacy of melatonin in preventing the development of severe COVID-19 in participants who acquire the infection during the development of the study.
    o Assess the duration of symptoms of COVID-19 infection in participants receiving melatonin.
    o Assess IgM / IgG seroconversion from symptom detection
    o Evaluar la eficacia de melatonina en la prevención de infecciones asintomáticas por SARS-CoV-2 (COVID-19).
    o Evaluar la eficacia de melatonina en la prevención del desarrollo de COVID-19 grave en participantes que adquieran la infección durante el desarrollo del estudio.
    o Evaluar la duración de los síntomas de la infección por COVID-19 en participantes que recibieron melatonina.
    o Evaluar la seroconversión de IgM/IgG desde la detección de síntomas
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    InmunoCOVID. v1.0 31/03/2020
    InmunoCOVID. v1.0 31/03/2020
    E.3Principal inclusion criteria
    · Men and women aged between 18 and 65 years.
    · They are part of the health personnel of public or private hospitals of the Spanish hospital network in an area with risk of transmission of SARS-CoV-2.
    · Not having been previously diagnosed with SARS-CoV-2 (COVID-19) infection.
    · Have not exhibited symptoms consistent with SARS-CoV-2 (COVID-19) infection from March 1, 2020 until entry into the trial.
    · Understand the purpose of the study and have NOT taken any medications such as PrEP against SARS-CoV-2 from March 1, 2020 until trial entry (also includes PrEP for HIV).
    · Have a negative PCR for SARS-CoV-2 at the entrance.
    Negative urine pregnancy test performed in the 7 days prior to the start of study treatment in pre-menopausal women or <2 years after menopause.
    · Women of childbearing potential and men of childbearing potential should commit to using a highly effective method of contraception (such as surgical sterilization, double barrier method, oral contraceptives or hormonal contraceptive implants) and to continue using them until the day of the last dose. of treatment.
    · Hombre y mujeres con edad entre 18 y 65 años.
    · Forman parte del personal sanitario de hospitales públicos o privados de la red hospitalaria española en una zona con riesgo de transmisión de SARS-CoV-2.
    · No haber sido diagnosticado previamente de infección por SARS-CoV-2 (COVID-19).
    · No haber presentado síntomas compatibles con infección por SARS-CoV-2 (COVID-19) desde el 1 de marzo de 2020 hasta la entrada en el ensayo.
    · Entender el propósito del estudio y NO haber tomado ninguna medicación como PrEP frente a SARS-CoV-2 desde el 1 de marzo de 2020 hasta la entrada en el ensayo (también incluye PrEP para el VIH).
    · Tener una PCR negativa para SARS-CoV-2 a la entrada.
    · Prueba de embarazo en orina negativa realizada en los 7 días anteriores al comienzo del tratamiento en estudio en mujeres pre-menopáusicas o < 2 años después de la menopausia.
    · Las mujeres en edad fértil y los varones con pareja en edad fértil deben comprometerse a utilizar un método anticonceptivo de gran eficacia (como esterilización quirúrgica, método de doble barrera, anticonceptivos orales o implantes hormonales anticonceptivos) ya continuar utilizándolos hasta el día de la última dosis de tratamiento.
    E.4Principal exclusion criteria
    • HIV infection.
    • Active infection with hepatitis B virus.
    • Kidney failure (creatinine clearance <60 ml / min / 1.72 m2) and participants on hemodialysis.
    • Osteoporosis.
    • Myasthenia gravis.
    • Pre-existing maculopathy of the eye.
    • Retinitis pigmentosa.
    • Bradycardia <50 beats / minute.
    • Weight <40 Kg.
    • Participants with immunosuppressive or hematological disease.
    • Treatment in the last month before randomization and for more than 7 days, with drugs that can prolong the QT interval including: azithromycin, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone , pentamidine, procaine quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone.
    • Participants with hereditary galactose intolerance, Lapp lactase deficiency, or glucose or galactose malabsorption.
    • Fluvoxamine treatment.
    • Treatment with benzodiazepines or non-benzodiazepine hypnotics, such as zaleplon, zolpidem, and zopiclone.
    • Pregnancy or planning to become pregnant during the course of the study. Lactation
    • Participants with a history of potentially immune-mediated or inflammatory diseases: systemic lupus erythematosus, Crohn's, ulcerative colitis, vasculitis, rheumatoid arthritis.
    • Hypersensitivity to the active substance or to any of the excipients.
    • Paarticipants who for any reason should not be included in the study according to the evaluation of the research team.
    • Infección por el VIH.
    • Infección activa por virus de la hepatitis B.
    • Insuficiencia renal (aclaramiento de creatinina < 60 ml/min/1.72 m2) y participantes en hemodiálisis.
    • Osteoporosis.
    • Miastenia gravis.
    • Maculopatía preexistente del ojo.
    • Retinitis pigmentosa.
    • Bradicardia < 50 latidos/minuto.
    • Peso < 40 Kg.
    • Participantes con enfermedad inmunosupresora o hematológica.
    • Tratamiento en el último mes antes de la aleatorización y durante más de 7 días, con fármacos que pueden prolongar el intervalo QT incluidos: azitromicina, clorpromazina, cisaprida, claritromicina, domperidona, droperidol, eritromicina, halofantrina, haloperidol, lumefantrina, mefloquina, metadona, pentamidina, procaina quinidina, quinina, sotalol, esparfloxacina, tioridazina, amiodarona.
    • Los participantes que presenten intolerancia hereditaria a la galactosa, de insuficiencia de lactasa de Lapp o malabsorción de glucosa o galactosa.
    • Tratamiento con fluvoxamina.
    • Tratamiento con benzodiacepinas o hipnóticos no benzodiacepínicos, tales como el zaleplón, el zolpidem y la zopiclona.
    • Embarazo o planificación de quedarse embarazada durante el transcurso del estudio. Lactancia
    • Participantes con historia de enfermedades potencialmente mediadas por el sistema inmune o enfermedades inflamatorias: lupus eritematoso sistémico, Crohn, colitis ulcerosa, vasculitis, artritis reumatoide.
    • Hipersensibilidad al principio activo o a alguno de los excipientes.
    • Participantes que por cualquier motivo no deberían ser incluidos en el estudio según evaluación del equipo investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Number of symptomatic infections confirmed by SARS-CoV-2 (COVID-19)
    Número de infecciones sintomáticas confirmadas por SARS-CoV-2 (COVID-19)
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    16 semanas
    E.5.2Secondary end point(s)
    • Number of asymptomatic infections confirmed by SARS-CoV-2 (COVID-19) measured by serology.
    • Severity of SARS-CoV-2 (COVID-19) infection measured in relation to the following:
    o Asymptomatic
    o Mild symptoms defined as general malaise, fever, cough, arthromyalgia
    o Moderate symptoms. The above plus moderate respiratory distress requiring hospital admission.
    o Serious symptoms. The above plus frank respiratory distress requiring ICU measures
    • Duration of symptoms of COVID-19 coronavirus infection measured in days.
    o Fever, myalgia, asthenia, respiratory distress
    • Relationship between the duration in days of treatment and the appearance of symptoms.
    • Relationship between the duration in days of treatment and the duration of symptoms.
    • Assess IgM / IgG seroconversion from symptom detection.
    • Time to positive PCR for SARS-CoV-2
    • Time (days) until appearance of symptoms compatible with COVID-19.
    In those participants who throughout the study show positive PCR for SARSCoV:
    • Need for hospital admission
    • Duration in days of hospital stay.
    • Time (days) until hospital discharge or until obtaining a score on the NEWS scale (Annex 1) ≤2 maintained for 24 hours, whichever occurs earlier.
    • Difference in the score on the NEWS scale between day 1 and days 3, 5, 8, 11, 15 and 29 of admission.
    • Percentage of participants requiring oxygen therapy.
    • Percentage of participants requiring non-invasive mechanical ventilation
    • Percentage of participants requiring invasive mechanical ventilation.
    • Percentage of participants requiring intensive care.
    • Average stay in ICU (days)
    • Mortality from any cause.
    • Progression to severe COVID (any of the following): 1) Radiological progression OR 2) Needs for ventilatory support 3) Syndrome of acute respiratory distress. 4) Admission to UVI, or 5) Death due to COVID-19.
    Other variables of interest:
    • Percentage of men and women with PCR positivity for SARS-CoV-2 throughout the study.
    • Percentage of men and women with severe COVID-19 development.
    • Número de infecciones asintomáticas confirmadas por SARS-CoV-2 (COVID-19) medidas por serología.
    • Gravedad de la infección por SARS-CoV-2 (COVID-19) medida en relación con lo siguiente:
    o Asintomático
    o Síntomas leves definidos como malestar general, fiebre, tos, artromialgias
    o Síntomas moderados. Los anteriores más dificultad respiratoria moderada que requiera ingreso hospitalario.
    o Síntomas graves. Los anteriores más dificultad respiratoria franca que precise medidas de UCI
    • Duración de los síntomas de la infección por coronavirus COVID-19 medida en días.
    o Fiebre, mialgia, astenia, dificultad respiratoria
    • Relación entre la duración en días del tratamiento y la aparición de síntomas.
    • Relación entre la duración en días del tratamiento y la duración de síntomas.
    • Evaluar la seroconversión de IgM/IgG desde la detección de síntomas.
    • Tiempo hasta PCR positiva para SARS-CoV-2
    • Tiempo (días) hasta aparición de sintomatología compatible con COVID-19.
    En aquellos participantes que a lo largo del estudio presentan PCR positiva para SARSCoV:
    • Necesidad de ingreso hospitalario
    • Duración en días de la estancia hospitalaria.
    • Tiempo (días) hasta alta hospitalaria o hasta obtención de una puntuación en la escala NEWS (Anexo 1) ≤2 mantenido durante 24 horas, lo que ocurra antes.
    • Diferencia en la puntuación en la escala NEWS entre el día 1 y los días 3, 5, 8, 11, 15 y 29 de ingreso.
    • Porcentaje de participantes que requieren Oxígenoterapia.
    • Porcentaje de participantes que requieren ventilación mecánica no invasiva
    • Porcentaje de participantes que requieren ventilación mecánica invasiva.
    • Porcentaje de participantes que requieren cuidados intensivos.
    • Estancia media en UCI (días)
    • Mortalidad por cualquier causa.
    • Progresión a COVID grave (alguna de las siguientes): 1) Progresión radiológica O 2) Necesidades de soporte ventilatorio 3) Síndorme de distrés respiratorio agudo. 4) Ingreso en UVI, o 5) Fallecimiento por COVID-19.
    Otras variables de interés:
    • Porcentaje de hombres y mujeres con positivización de la PCR para SARS-CoV-2 a lo largo del estudio.
    • Porcentaje de hombres y mujeres con desarrollo de COVID-19 grave.
    E.5.2.1Timepoint(s) of evaluation of this end point
    16 weeks
    16 semanas
    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 No
    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) 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 concerned8
    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
    Ultima visita del ultimo paciente
    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 months8
    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: 450
    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 Yes
    F.3.2Patients No
    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 state450
    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 Decision2020-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-12-29
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