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    Summary
    EudraCT Number:2020-002274-28
    Sponsor's Protocol Code Number:COVID-VIT-D
    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:2020-05-21
    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 number2020-002274-28
    A.3Full title of the trial
    Usefulness of vitamin D on morbidity and mortality of SARS-COV-2 virus infection (Covid-19) at the Central University Hospital of Asturias
    Estudio destinado a valorar la utilidad de vitamina D sobre morbilidad y mortalidad de la infección por virus SARS-COV-2 (Covid-19) en el Hospital Universitario Central de Asturias
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the likely beneficial effects of vitamin D on infection with coronavirus.
    Evaluación de los probables efectos beneficiosos de la vitamina D en la infección por coronavirus.
    A.3.2Name or abbreviated title of the trial where available
    Vitamin D and COVID-19
    Vitamin D y COVID-19
    A.4.1Sponsor's protocol code numberCOVID-VIT-D
    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 y la Innovación Biosanitaria del Principado de Asturias (FINBA)
    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 y la Innovación Biosanitaria del Principado de Asturias (FINBA)
    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 y la Innovación Biosanitaria del Principado de Asturias (FINBA)
    B.5.2Functional name of contact pointManaging director
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Hospital Universitario s/n
    B.5.3.2Town/ cityOviedo
    B.5.3.3Post code33011
    B.5.3.4CountrySpain
    B.5.4Telephone number3498510 99 05
    B.5.6E-mailenrique.caso@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Videsil 100.000 UI
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Gebro Pharma, S.A.
    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.3.4Pharmaceutical form Oral solution in sachet
    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 INNCOLECALCIFEROL
    D.3.9.1CAS number 67-97-0
    D.3.9.3Other descriptive nameVITAMIN D3
    D.3.9.4EV Substance CodeSUB06794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100.000
    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
    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
    Infección por SARS-COV-2
    E.1.1.1Medical condition in easily understood language
    COVID-19 disease
    Enfermedad 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 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
    The objective of the study is to analyze if the administration of a single dose of native vitamin D (100,000 IU of Colecalciferol) (1 ampoule of 100,000) has an influence on the evolution of clinical and biochemical parameters of the disease.
    El objetivo del estudio es analizar si la administración de una dosis única de vitamina D nativa (100.000 UI de Colecalciferol) (1 ampolla bebida de 100.000) tiene influencia sobre la evolución de parámetros clínicos y bioquímicos de la enfermedad.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients treated in the ER or admitted to the HUCA Hospitalization unit.
    • Diagnosis of COVID19 demonstrated by positive PCR for SARS COV2 prior to randomization.
    • Age> = 18 years.
    • That they have accepted to participate in the study through informed consent.
    • Pacientes atendidos en Urgencias o ingresados en unidad de Hospitalización del HUCA
    • Diagnóstico de COVID19 demostrado por PCR positiva para SARS COV2 previo a la aleatorización.
    • Edad >=18 años
    • Que hayan aceptado participar en estudio a través del consentimiento Informado
    E.4Principal exclusion criteria
    • When discharge or a fatal outcome is expected within the next 48 hours.
    • Obvious cognitive impairment (inability to communicate).
    • PCR for SARS-COV 2 negative despite radiological, analytical and clinical findings compatible with this type of infection.
    • Allergy to vitamin D.
    • Patients who are receiving, or have received in the past 3 months, any form of vitamin D
    • Pregnant women
    • Cuando se prevea el alta o un desenlace fatal en las siguientes 48 horas.
    • Deterioro cognitivo evidente (imposibilidad para la comunicación)
    • PCR para SARS-COV 2 negativa a pesar de hallazgos radiológicos, analíticos y clínicos compatibles con este tipo de infección.
    • Alergia a la vitamina D.
    • Pacientes que estén recibiendo, o hayan recibido durante los 3 últimos meses, cualquier forma de vitamina D.
    • Mujeres embarazadas
    E.5 End points
    E.5.1Primary end point(s)
    • Percentage and time of patients who have a negative SARS-CoV-2 viral load
    • Clinical symptoms and time during hospitalization
    • Improvement of biochemical and molecular parameters of inflammation
    • Overall mean hospital stay
    • Percentage of patients requiring transfer to the ICU
    • Average stay in ICU
    • Mortality during follow-up
    • Porcentaje y tiempo de pacientes que pasan a tener carga viral SARS-CoV-2 negativa
    • Sintomatología clínica y tiempo de la misma durante la hospitalización
    • Mejoría de parámetros bioquímicos y moleculares de inflamación
    • Mejoría de parámetros bioquímicos y moleculares de inflamación
    • Estancia media global de hospitalización
    • Porcentaje de pacientes que precisan traslado a la UCI
    • Estancia Media en UCI
    • Mortalidad durante el seguimiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 and 21 days or until a negative SARS-CoV-2 test every 7 days.
    14 y 21 días o hasta resultado negativo de SARS-CoV-2 cada 7 días.
    E.5.2Secondary end point(s)
    N/A
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    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 Yes
    E.6.4Safety Yes
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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
    One month after last COVID 19 patients is discharged
    Un mes despues que el último paciente con COVID 19 es dado de alta
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months4
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    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)
    N/A
    N/A
    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 Decision2020-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-23
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