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    Summary
    EudraCT Number:2020-001808-42
    Sponsor's Protocol Code Number:PHM-2020-001
    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:2020-07-10
    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 number2020-001808-42
    A.3Full title of the trial
    PHASE II CLINICAL TRIAL, SINGLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED TO EXPLORE THE EFFECTIVENESS AND SAFETY OF MELATONIN I.V. IN PATIENTS WITH COVID-19 ENTERED INTO THE ICU (MELCOVID STUDY)
    ENSAYO CLÍNICO DE FASE II, UNICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO PARA EXPLORAR LA EFICACIA Y SEGURIDAD DE MELATONINA I.V. EN PACIENTES CON COVID-19 INGRESADOS EN UCI (ESTUDIO MELCOVID)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHASE II CLINICAL TRIAL, SINGLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED TO EXPLORE THE EFFECTIVENESS AND SAFETY OF MELATONIN IN PATIENTS WITH COVID-19 ENTERED INTO THE INTENSIVE CARE UNIT
    ENSAYO CLÍNICO PARA EXPLORAR LA EFICACIA Y SEGURIDAD DE MELATONINA EN PACIENTES CON COVID-19 INGRESADOS EN UNIDAD DE CUIDADOS INTENSIVOS
    A.3.2Name or abbreviated title of the trial where available
    MELCOVID
    MELCOVID
    A.4.1Sponsor's protocol code numberPHM-2020-001
    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 SponsorPharmamel S.L.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPharmamel S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro de Investigación Biomédica Universidad de Granada
    B.5.2Functional name of contact pointCatedrática de Fisiología
    B.5.3 Address:
    B.5.3.1Street AddressAvda del Conocimiento s/n
    B.5.3.2Town/ cityArmilla, Granada,
    B.5.3.3Post code18016
    B.5.3.4CountrySpain
    B.5.4Telephone number34618521646
    B.5.6E-mailgescames@ugr.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.2.5The 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 namemelatonina 6mg/ml
    D.3.2Product code melatonina 6mg/ml
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMelatonin
    D.3.9.1CAS number 73-31-4
    D.3.9.2Current sponsor codeMelatonin
    D.3.9.3Other descriptive nameMELATONIN
    D.3.9.4EV Substance CodeSUB14496MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous 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
    Infección por 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.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10084268
    E.1.2Term COVID-19
    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
    Assess whether treatment with melatonin i.v. reduces mortality
    Evaluar si el tratamiento con melatonina i.v. reduce la mortalidad.
    E.2.2Secondary objectives of the trial
    Assess whether melatonin treatment i.v .:
    - reduces the duration of admission to the ICU
    - reduces the duration of mechanical ventilation (VM).
    - It is associated with an increase in VM free days.
    - is associated with a reduction in the number of vital organ failures, according to the SOFA scale.
    -is associated with a reduction in frequency and severity of thromboembolic processes caused by COVID-19.
    - it is associated with a reduction in the systemic inflammatory response, defined by the levels of ferritin, D-dimer, C-reactive protein (PCR) or procalcitonin (PCT) and IL-6.
    - is associated with improvement of hematological, biochemical, gasometric parameters.
    Describe the events and adverse reactions that occurred during the study.
    Evaluar si el tratamiento con melatonina i.v.:
    - reduce la duración del ingreso en la U
    - reduce la duración de la ventilación mecánica (VM).
    - se asocia a un aumento de días libres de VM.
    - se asocia a una reducción del número de fallos de órganos vitales, según la escala SOFA.
    -se asocia a una reducción de frecuencia y gravedad de los procesos trombo-embólicos causados por COVID-19.
    - se asocia a una reducción de la respuesta inflamatoria sistémica, definida por los niveles de ferritina, dímero-D, proteína C reactiva (PCR) o procalcitonina (PCT) e IL-6.
    - se asocia a mejora de parámetros hematológicos, bioquímicos, gasométricos.
    Describir los acontecimientos y reacciones adversas acontecidos durante el estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Granting of informed consent by the patient, their family member or their legal representative.
    • Age equal to or greater than 18 years.
    • Presence of SARS-CoV-2 infection, with compatible symptoms and confirmation by PCR.
    • Admission to the ICU with acute hypoxemic respiratory failure attributed to SARS-CoV-2 infection
    • Have been admitted to the ICU for less than 7 days, with or without mechanical ventilation (MV) and with no signs of improvement in respiratory failure.
    • Otorgamiento de consentimiento informado por parte del paciente, su familiar o su representante legal.
    • Edad igual o superior a 18 años.
    • Presencia de infección por SARS-CoV-2, con clínica compatible y confirmación mediante PCR.
    • Ingreso en UCI con insuficiencia respiratoria aguda hipoxémica atribuidos a la infección por SARS-CoV-2
    • Llevar ingresado en UCI menos de 7 dias, con o sin ventilación mecánica (VM) y sin signos de mejoría de la insuficiencia respiratoria.
    E.4Principal exclusion criteria
    • Be included in another COVID-19 study that involves the administration of a drug in clinical development phase that lacks a prior marketing authorization.
    • Liver transaminases> 5 times the ULN.
    • Stage IV or dialysis kidney failure (GFR <30)
    • Pregnancy
    • Terminal medical or surgical illness.
    • Autoimmune disease.
    • Any condition of the patient that, in the opinion of the investigator, prevents the study procedures from being carried out.
    • Estar incluido en otro estudio de COVID-19 que implique la administración de un medicamento en fase de desarrollo clínico que carezca de una autorización de comercialización previa.
    • Transaminasas hepáticas > 5 veces el LSN.
    • Insuficiencia renal de estadio IV o en diálisis (GFR <30)
    • Embarazo
    • Enfermedad terminal médica o quirúrgica.
    • Enfermedad autoinmune.
    • Cualquier condición del paciente que en opinión del investigador impida llevar a cabo los procedimientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Mortality in each treatment group, in frequencies and in time until the event.
    Mortalidad en cada grupo de tratamiento, en frecuencias y en tiempo hasta el evento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Mortality in each treatment group, in frequencies and in time until the event.
    Mortalidad en cada grupo de tratamiento, en frecuencias y en tiempo hasta el evento.
    E.5.2Secondary end point(s)
    ICU admission time, time with mechanical ventilation and modification of the patient's state of severity with respect to baseline values
    Tiempo de ingreso en UCI, tiempo con ventilación mecánica y modificación del estado de gravedad del paciente respecto a los valores basales
    E.5.2.1Timepoint(s) of evaluation of this end point
    ICU admission time, time with mechanical ventilation and modification of the patient's state of severity with respect to baseline values
    Tiempo de ingreso en UCI, tiempo con ventilación mecánica y modificación del estado de gravedad del paciente respecto a los valores basales
    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.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
    LSLV
    Última visita del último paciente en el ensayo
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients in Intensive Care Unit
    Pacientes ingresados en Unidad de Cuidados Intensivos
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    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
    Tratamiento según práctica clínica habitual
    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 Decision2020-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-06
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