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    Summary
    EudraCT Number:2020-001960-28
    Sponsor's Protocol Code Number:RCTVITD/SARS-CoV-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:2020-05-26
    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 number2020-001960-28
    A.3Full title of the trial
    Efficacy of vitamin D treatment in patients diagnosed with pneumonia who require hospital admission and have vitamin D deficiency and a positive diagnosis for SARS-Cov-2 (COVID-19)
    Eficacia del tratamiento con vitamina D en pacientes con diagnóstico de neumonía que precisan ingreso hospitalario y presentan déficit de vitamina D y diagnóstico positivo para SARS-Cov-2 (COVID-19)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of vitamin D treatment in patients diagnosed with pneumonia who require hospital admission and have vitamin D deficiency and a positive diagnosis for SARS-Cov-2 (COVID-19)
    ficacia del tratamiento con vitamina D en pacientes con diagnóstico de neumonía que precisan ingreso hospitalario y presentan déficit de vitamina D y diagnóstico positivo para SARS-Cov-2 (COVID-19)
    A.4.1Sponsor's protocol code numberRCTVITD/SARS-CoV-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 SponsorInvestigation Institute Bioaraba
    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 supportInvestigation Institute Bioaraba
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInvestigation Institute Bioaraba
    B.5.2Functional name of contact pointInés Pérez Francisco
    B.5.3 Address:
    B.5.3.1Street Addressc/José Atxotegui s/n
    B.5.3.2Town/ cityVitoria-Gasteiz
    B.5.3.3Post code01009
    B.5.3.4CountrySpain
    B.5.6E-mailINES.PEREZFRANCISCO@osakidetza.eus
    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 Hidroferol 0,266 mg cápsulas blandas
    D.2.1.1.2Name of the Marketing Authorisation holderFaes Farma
    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 Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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, soft
    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
    Infección por COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 infection
    Infección por COVID-19
    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
    Assess whether the group of patients receiving vitamin D supplements presents a less serious evolution of his pneumonia translated into lower mortality than patients who do not receive this supplement
    Evaluar si el grupo de pacientes que recibe suplementos de vitamina D presenta una evolución de su neumonía de menor gravedad traducida en una menor mortalidad que los pacientes que no reciben ese suplemento
    E.2.2Secondary objectives of the trial
    - Determine the number of ICU admissions in both groups
    - To determine the hospital stay (days of admission) in both study groups
    - Estimate the prevalence of vitamin D deficiency in all the patients studied and the efficacy of the supplementation strategy in correcting hypervitaminosis D with a record of episodes of hypercalcemia or hypelcalciuria
    - Request at baseline (study), 24 and 48 hours after placebo supplementation or vitamin D and at the end of the protocol, the permit for storage in the Basque Research Biobank of plasma, serum and urine samples (at -80ºC) that allows the hypotheses of interest to be evaluated a posteriori
    - Establish the final degree of complexity of both groups according to the international classification
    - Carrying out a cost-effectiveness study on the value of vitamin D treatment in these patients
    - Determinar el número de ingresos en UCI en ambos grupos
    - Determinar la estancia hospitalaria (días de ingreso) en ambos grupos a estudio
    - Estimar la prevalencia de déficit de vitamina D en todos los pacientes estudiados y la eficacia de la estrategia de suplementación en corregir la hipervitaminosis D con registro de episodios de hipercalcemia o hipelcalciuria
    - Solicitar al inicio (basal) del estudio, a las 24 y 48 horas de la suplementación con placebo o vitamina D y al finalizar el protocolo, el permiso para el almacenamiento en el Biobanco Vasco de Investigación de muestras de plasma, suero y orina (a -80ºC) que permita evaluar a posteriori las hipótesis de interés
    - Establecer el grado de complejidad final de ambos grupos de acuerdo a la clasificación internacional
    - Realización de un estudio coste-efectividad sobre el valor del tratamiento con vitamina D en estos pacientes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Older patients of both sexes
    - Admitted to the Respiratory and / or Internal Medicine Unit of the Hospital De Santiago, the OSI Araba HUA is walking due to pneumonia
    - Possibility for observation during the treatment period
    - Signature of written and, exceptionally oral, informed consent
    - Have requested the test for SARS-CoV-2 (nasopharyngeal exudate PCR) and obtain positive results
    - Having a deficiency of vitamin D (25 (OH) vitamin D), defined by blood levels below 30 mg / ml
    - Pacientes mayores de edad de ambos sexos
    - Ingresados en la Unidad Respiratoria y/o Medicina Interna del Hospital De Santiago ande la OSI Araba HUA por una neumonía
    - Posibilidad para observación durante el período de tratamiento
    - Firma del consentimiento informado escrito y, excepcionalmente oral
    - Haber solicitado el test para el SARS-CoV-2 (PCR de exudado nasofaríngeo) y obtener resultados positivos
    -Tener un Tener un déficit de vitamina D (25(OH) vitamina D), definido por niveles en sangre inferiores a 30 mg/ml
    E.4Principal exclusion criteria
    - Patients taking any type of vitamin D supplement
    - Patients with hypoparathyroidism
    - Pregnant or lactating women
    - Patients in whom vitamin D administration is formally contraindicated
    - Patients who cannot take vitamin D orally at the time of enrollment
    - Pacientes que tomen cualquier tipo de suplemento de vitamina D
    - Pacientes con hipoparatiroidismo
    - Mujeres embarazadas o en período de lactancia
    - Pacientes en quienes esté contraindicada formalmente la administración de vitamina D
    - Pacientes que en el momento de la inclusión no pueden ingerir la vitamina D por vía oral
    E.5 End points
    E.5.1Primary end point(s)
    Thus evaluating patients receiving vitamin D substitutes present a less serious evolution of respiratory syndrome compared to patients who do not receive a supplement, in terms of mortality and ICU admission
    Evaluar así los pacientes que reciben suplentes de vitamina D presentan una evolución de síndrome respiratorio de menor gravedad en comparación con los pacientes que no reciben suplemento, en términos de mortalidad y de ingreso en UCI
    E.5.1.1Timepoint(s) of evaluation of this end point
    Until the end of the study
    Hasta el final del estudio
    E.5.2Secondary end point(s)
    - Diagnosis (SARS-CoV-2 positive / negative)
    - Disease severity determined based on the categories established according to the clinic presented by the patients included in the study
    - Blood vitamin D concentration
    - Clinical symptoms
    - Days in ICU / hospital
    - Discharge date
    - Drug use (specify drugs and doses)
    - Death (Yes / No)
    - Income costs
    - Diagnóstico (SARS-CoV-2 positivo/negativo)
    - Severidad de la enfermedad determinada en base a las categorías establecidas según la clínica que presentan los pacientes incluidos en el estudio
    - Concentración de vitamina D en sangre
    - Síntomas clínicos
    - Días en la UCI/hospital
    - Fecha de alta
    - Consumo de fármacos (especificar los fármacos y las dosis)
    - Fallecimiento (Sí/No)
    - Costes del ingreso
    E.5.2.1Timepoint(s) of evaluation of this end point
    Until the end of the study
    Hasta el final del estudio
    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) 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 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
    None
    Ninguno
    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 months3
    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: 70
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 48
    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 state108
    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 Decision2020-05-25
    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 StatusOngoing
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