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    Summary
    EudraCT Number:2020-002312-43
    Sponsor's Protocol Code Number:01052020
    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:2020-05-31
    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 number2020-002312-43
    A.3Full title of the trial
    Clinical trial, PHASE III, randomized, open-label, to evaluate the efficacy of administering high-dose cholecalciferol orally alongside standard therapy in patients with COVID-19 pneumonia (COVID-19 HUSO).
    Ensayo clínico aleatorizado, FASE III, abierto, para evaluar la eficacia de la administración de colecalciferol a altas dosis por vía oral junto a tratamiento estándar en pacientes con neumonía por COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial, randomized, open-label, to evaluate the efficacy of high-dose vitamin D in patients with COVID-19 pneumonia
    Ensayo clínico aleatorizado, abierto, para evaluar la eficacia de la administrar dosis altas de vitamina D en pacientes con neumonía por COVID-19
    A.3.2Name or abbreviated title of the trial where available
    Efficacy of high dose vitamin D in COVID-19 pneumonia
    Eficacia de altas dosis de vitamina D en neumonia por COVID-19
    A.4.1Sponsor's protocol code number01052020
    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 SponsorMiguel Cervero Jiménez, servicio de Medicina Interna, Hospital Universitario Severo Ochoa
    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 supportMiguel Cervero Jiménez, servicio de Medicina Interna, Hospital Universitario Severo Ochoa
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMiguel Cervero Jiménez, servicio de Medicina Interna, Hospital Universitario Severo Ochoa
    B.5.2Functional name of contact pointMiguel Cervero
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Orellana S/N
    B.5.3.2Town/ cityLeganés
    B.5.3.3Post code28911
    B.5.3.4CountrySpain
    B.5.4Telephone number00349148180008338
    B.5.6E-mailmcerveroj@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 Thorens 25000 UI
    D.2.1.1.2Name of the Marketing Authorisation holderAEMPS
    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 nameVitamina D
    D.3.2Product code A11CC05
    D.3.4Pharmaceutical form Oral solution
    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.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameCOLECALCIFEROL CONCENTRATE (OILY FORM)
    D.3.9.4EV Substance CodeSUB20705
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25.000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    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 PNEUMONIA
    NEUMONIA POR COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 PNEUMONIA
    NEUMONIA 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
    The aim of this trial is to provide estimates of increased levels of 25-hydroxyvitamin D3 on days 7 and 14 after high-dose vitamin D treatment (10. 000 IU/d) Thorens@ 25000 IU single-dose vials oral solution 2.5 ml=1ml/day on admission (maximum 14 days) compared with conventional dosing (2,000 IU/d) Thorens@ 25000 IU single-dose vials oral solution 2.5 ml=0.2 ml/day on admission (maximum 14 days)
    El objetivo de este ensayo es proporcionar estimaciones del incremento de los niveles de 25-hidroxivitamina D3 en los días 7 y 14 días tras tratamiento con altas dosis de vitamina D (10.000 UI/día) Thorens@ 25000 UI frascos unidosis solución oral 2,5 ml=1ml/día durante el ingreso (máximo 14 días) en comparación con dosis habituales convencionales (2.000 UI/d) Thorens@ 25000 UI frascos unidosis solución oral 2,5 ml=0,2 ml/día durante el ingreso (máximo 14 días).
    E.2.2Secondary objectives of the trial
    1.Assess the safety and tolerability of both treatment guidelines.
    2. Comparison of secondary efficacy parameters between the two treatment guidelines on days 7 and 14 of treatment initiation: no progression to respiratory failure, no increased oxygen requirements; need for mechanical ventilation; reduction of analytical parameters associated with poor prognosis; radiological progression of the disease; average hospital stay; intensification treatments such as steroid boluses, Tocilizumab or Anakinra; ICU admission and % mortality at end of follow-up.
    3. Evolution of the analytical parameters on the 7th and 14th days of treatment
    3.1 Haematological.
    3.2 Biochemicals
    3.3. Phospho-calcium metabolism.
    4. Immunological study:
    Comparison of the immunological parameters on days 7 and 14 of the beginning of the treatment of IL1b, IL2r, IL6, IL8, IL10, TNF alpha, MIP-1 alpha, CD14, GM-CSF, IFN alpha, IFN beta and IFN gamma.


    .
    1.Evaluar la seguridad y tolerabilidad
    2. Comparación de parámetros secundarios de eficacia en los días 7 y 14 de iniciado el tratamiento: ausencia de progresión a insuficiencia respiratoria, ausencia de mayores requerimientos de oxígeno; necesidad de ventilación mecánica; reducción de parámetros analíticos asociados a mal pronóstico; progresión radiológica de la enfermedad; estancia media hospitalaria; tratamientos de intensificación, como bolos de esteroides, Tocilizumab o Anakinra, ingreso en UCI, % de mortalidad a final de seguimiento.
    3. Evolución de los parámetros analíticos en los días 7 y 14
    3.1 Hematológicos
    3.2 Bioquímicos: Función renal, función hepática, proteína C reactiva (PCR), procalcitonina (PCT), troponina, pro-BNP, CPK, albumina y glucosa
    3.3. Metabolismo fosfo-cálcico: calcio, PTHi, fósforo y magnesio
    4. Estudio inmunológico:
    Comparación de los parámetros inmunológicos en los días 7 y 14 de IL1b, IL2r, IL6, IL8, IL10, TNF, MIP-1, CD14, GM-CSF, IFN
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    No es aplicable
    E.3Principal inclusion criteria
    - 25-hydroxyvitamin D3 levels < 30 ng/mL
    - To agree to participate in the study by signing the informed consent.
    - Men and women aged ≥18 and ≤85.
    - Patients admitted with a diagnosis of pneumonia based on clinical-radiological criteria or confirmed by COVID-19 microbiology, who have had > 7 days of symptoms (cough or fever) and whose oxygen saturation is less than 94%.
    - Men and women with reproductive capacity should agree to use
    contraceptives in the study and within 30 days of the last visit.
    - In addition, women in the study with reproductive capacity should
    have a negative pregnancy test at the time of inclusion.
    • Niveles de 25-hidroxivitamina D3 < 30 ng/mL
    • Que acepte participar en el estudio firmando el consentimiento informado.
    • Hombre y mujeres con edad ≥18 años y ≤85 años.
    • Pacientes ingresados con diagnóstico de neumonía en base a criterios clínico-radiológicos o confirmado por microbiología de COVID-19, que hayan trascurrido > 7 días de síntomas (tos o fiebre) y la saturación de oxígeno sea menor del 94%.
    • Los hombres y mujeres con capacidad reproductiva deben acceder a usar métodos
    anticonceptivos en el estudio y en los 30 días siguientes a la última visita.
    • Además, las mujeres participantes en el estudio con capacidad reproductiva deben
    tener una prueba de embarazo negativa en el momento de la inclusión.
    E.4Principal exclusion criteria
    - Patients participating in any other clinical trials with drugs with potential
    antiviral action for COVID-19
    - They are already being treated with vitamin D.
    - Evidence of multiorgan failure.
    - Patients requiring mechanical ventilation at the time of inclusion.
    - Patients with hypersensitivity to the active ingredient cholecalciferol or to refined olive oil excipient
    - Patients with hypercalcemia or hypercalciuria
    - Kidney stones (nephrolithiasis, nephrocalcinosis) in patients with chronic hypercalcemia.
    - Patients with severe renal failure. (stage 4, eGF < 30)
    - Patients being treated with digoxin.
    - Patients with a diagnosis of hereditary fructose intolerance, malabsorption of glucose-galactose or sucrose insufficiency.
    - Gestation or lactation
    - Sarcoidosis
    - Hyperparathyroidism
    - Patients who for any reason should not be included in the study according to
    evaluation of the investigation team.
    - Subjects who are not capable of understanding the information sheet and unable to
    sign the informed consent.
    - Patients who are expected to be transferred to another facility within 96 hours.
    - Patients who are expected to die within the next 24-48 hours




    .
    • Pacientes participando en algún otro ensayo clínico con fármacos con potencial
    acción antiviral para COVID-19
    • Reciben ya tratamiento con vitamina D.
    • Evidencia de fallo multiorgánico.
    • Pacientes que requieran ventilación mecánica en el momento de inclusión.
    • Pacientes con hipersensibilidad al principio activo colecalciferol o a excipiente aceite de oliva refinado
    • Pacientes con hipercalcemia o hipercalciuria
    • Cálculos renales (nefrolitiasis, nefrocalcinosis) en pacientes con hipercalcemia crónica.
    • Pacientes con insuficiencia renal severa (estadio 4, FGe < 30).
    • Pacientes en tratamiento con digoxina.
    • Pacientes con diagnóstico de intolerancia hereditaria a la fructosa, malabsorción de glucosa-galactosa o insuficiencia de sacarosa.
    • Gestación o lactancia
    • Sarcoidosis
    • Hiperparatiroidismo
    • Pacientes que por cualquier motivo no deberán ser incluidos en el estudio según
    evaluación del equipo investigador.
    • Sujetos que no sean capaces de comprender la hoja de información e incapaces de
    firmar el consentimiento informado.
    • Pacientes a los que se prevea su traslado a otro centro en las siguientes 96 horas.
    • Pacientes a los que se prevea fallecimiento en las próximas 24-48 horas
    E.5 End points
    E.5.1Primary end point(s)
    Increased levels of 25-hydroxyvitamin D3 will be determined on days 7,
    and 14 after initiation of treatment
    Se determinará el incremento de los niveles de 25-hidroxivitamina D3 en los días 7 y 14 después de haber iniciado el tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    IT will be determined on days 7 and 14
    Se determinará en los días 7 y 14
    E.5.2Secondary end point(s)
    1.Assess the safety and tolerability of both treatment guidelines.
    2. Comparison of secondary efficacy parameters between the two treatment guidelines on days 7 and 14 of treatment initiation: no progression to respiratory failure, no increased oxygen requirements; need for mechanical ventilation; reduction of analytical parameters associated with poor prognosis; radiological progression of the disease; average hospital stay; intensification treatments such as steroid boluses, Tocilizumab or Anakinra, ICU admission, % mortality at end of follow-up.
    3. Evolution of the analytical parameters on the 7th and 14th days of treatment
    3.1 Haematological: Haemogram, differential count, D-dimer, coagulation study, fibrinogen.
    3.2 Biochemicals: Renal function (creatinine, urea, and electrolytes), liver function (AST, ALT, total and fractionated bilirubin, GGT, LDH), C-reactive protein (PCR), procalcitonin (PCT), troponin, pro-BNP, CPK, albumin, total proteins, uric acid, cholesterol, triglycerides, and glucose
    3.3. Phospho-calcium metabolism: calcium, PTHi, phosphorus and magnesium
    4. Immunological study:
    Comparison of the immunological parameters on days 7 and 14 of the beginning of the treatment of IL1b, IL2r, IL6, IL8, IL10, TNF alpha, MIP-1 alpha, MIP-1 beta, CD14, GM-CSF, IFN alpha, IFN beta y IFN gamma.
    5) Viral load evolution, if available.





    .
    1.Evaluar la seguridad y tolerabilidad de ambas pautas de tratamiento.
    2. Comparación de parámetros secundarios de eficacia entre las 2 pautas de tratamiento en los días 7 y 14 de iniciado el tratamiento: ausencia de progresión a insuficiencia respiratoria, ausencia de mayores requerimientos de oxígeno; necesidad de ventilación mecánica; reducción de parámetros analíticos asociados a mal pronóstico; progresión radiológica de la enfermedad; estancia media hospitalaria; tratamientos de intensificación, como bolos de esteroides, Tocilizumab o Anakinra, ingreso en UCI, % de mortalidad a final de seguimiento.
    3. Evolución de los parámetros analíticos en los días 7 y 14 de iniciado el tratamiento:
    3.1 Hematológicos: Hemograma, recuento diferencial, D- dímero, estudio de coagulación, fibrinógeno.
    3.2 Bioquímicos: Función renal (creatinina, urea, y electrolitos), función hepática (AST, ALT, bilirrubina total y fraccionada, GGT, LDH), proteína C reactiva (PCR), procalcitonina (PCT), troponina, pro-BNP, CPK, albumina, proteínas totales, ácido úrico, colesterol, triglicéridos y glucosa
    3.3. Metabolismo fosfo-cálcico: calcio, PTHi, fósforo y magnesio
    4. Estudio inmunológico:
    Comparación de los parámetros inmunológicos en los días 7 y 14 de iniciado el tratamiento de IL1b, IL2r, IL6, IL8, IL10, TNF alfa, MIP-1 beta, CD14, GM-CSF, IFN alfa, IFN beta, IFN gamma.
    5) Evolución de carga viral, si disponible.
    E.5.2.1Timepoint(s) of evaluation of this end point
    IT will be determined on days 7 and 14
    Se determinará en los días 7 y 14
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immune response
    Respuesta inmunológica
    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 Yes
    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) Yes
    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
    The study will be completed (end of study) on the 28th day after the start of the study medication of the last patient who started the treatment.
    El estudio se terminará (fin del estudio) el día 28 tras el inicio de la medicación de estudio del último paciente que inició el tratamiento.
    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 months
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-05-31. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state82
    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 Decision2020-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-21
    P. End of Trial
    P.End of Trial StatusOngoing
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