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    Summary
    EudraCT Number:2021-001416-29
    Sponsor's Protocol Code Number:PREDEXACOV
    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:2021-05-26
    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 number2021-001416-29
    A.3Full title of the trial
    EARLY TREATMENT STRATEGY WITH HIGH-DOSE VERSUS STANDARD-DOSE DEXAMETHASONE IN PATIENTS WITH SARS-COV-2 PNEUMONIA (COVID-19).
    ESTRATEGIA DE TRATAMIENTO PRECOZ CON DEXAMETASONA A DOSIS ALTAS FRENTE A DOSIS ESTÁNDAR EN PACIENTES CON NEUMONÍA POR SARS-COV-2 (COVID-19).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    High-dose dexamethasone treatment for SARS-COV-2
    Tratamiento con dexametasona en dosis altas para SARS-COV-2
    A.3.2Name or abbreviated title of the trial where available
    PREDEXACOV-01
    PREDEXACOV-01
    A.4.1Sponsor's protocol code numberPREDEXACOV
    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 e Innovación Biomédica (FIIB) del Hospital Universitario Infanta Leonor y Hospital Unive
    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 supportERN
    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 e Innovación Biomédica (FIIB) del Hospital Universitario Infanta Leonor
    B.5.2Functional name of contact pointÁngel Pueyo
    B.5.3 Address:
    B.5.3.1Street AddressCalle Puerto de Lumbreras, 5
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28031
    B.5.3.4CountrySpain
    B.5.4Telephone number+34911919855
    B.5.5Fax number+34911919855
    B.5.6E-mailpueyo.angel@investiganet.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.2.1.1.1Trade name Dexamethasone 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderERN
    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 nameDexamethasone
    D.3.2Product code SUB07017MIG
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor codeSUB07017MIG
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Adult patients with SARS-CoV-2 infection (COVID19) requiring hospital admission for pneumonia. Who present pcr ≥ 66 mg/L and ≤150 mg/L at inclusion or Pandemic score [13] on admission > 200 with pcr 9.7-149 mg/L at inclusion. WHO scale level 4 [14], with need for oxygen therapy in NG ≥ 1 lpm to maintain saturation ≥ 94%.
    Pacientes adultos con infección por SARS-CoV-2 (COVID19) que requieren ingreso hospitalario por neumonía. Que presentan pcr ≥ 66 mg/L y ≤150 mg/L en el momento de la inclusión o Pandemic score [13] al ingreso > 200 con pcr 9.7-149 mg/L en el momento de la inclusión. Nivel 4 de la escala de la OMS [14], con necesidad de oxigenoterapia en GN ≥ 1 lpm para mantener saturación ≥ 94%.
    E.1.1.1Medical condition in easily understood language
    Adult patients with COVID19 infection requiring hospital admission for pneumonia
    Pacientes adultos con infección por COVID19 que requieren ingreso hospitalario por neumonía
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    To evaluate whether there is a decrease in the proportion of patients who develop respiratory distress requiring NIV/MIV/OCNAF (measured group and individually by respiratory therapies).
    To assess whether there is an impact of such a strategy on the number of days of hospitalization.
    Evaluar si hay una disminución de la proporción de pacientes que desarrollan distrés respiratorio con necesidad de VMNI/VMI/OCNAF (medidos grupal e individualmente por terapias respiratorias)
    Evaluar si hay un impacto de dicha estrategia sobre el número de días de hospitalización
    E.2.2Secondary objectives of the trial
    To evaluate whether there is a decrease in NIV/MIV/OCNAF therapy days.
    Evaluate whether there is a decrease in 30-, 60-, and 90-day, all-cause mortality.
    Safety: related short- and long-term adverse events.
    Evaluar si hay una disminución de los días de terapia VMNI/VMI/OCNAF
    Evaluar si hay una disminución de mortalidad a 30, 60 y 90 días, por todas las causas
    Seguridad: eventos adversos a corto y largo plazo relacionados
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients admitted with SARS-CoV-2 pneumonia (COVID19) confirmed by antigenic test or PCR Age ≥ 18 years.
    presents with a pcr ≥ 66 mg/L and ≤150 mg/L at inclusion or Pandemic score [13] at admission > 200 with pcr 9.7-149 mg/L at inclusion
    WHO scale level 4 [14], with need for oxygen therapy in NG ≥ 1 lpm to maintain saturation ≥ 94%.
    Onset of symptoms ≤ 10 days before the date of inclusion.
    Pacientes ingresados con neumonía por SARS-CoV-2 (COVID19) confirmados mediante test antigénico o PCR Edad ≥ 18 años
    presenta una pcr ≥ 66 mg/L y ≤150 mg/L en el momento de la inclusión o Pandemic score [13] al ingreso > 200 con pcr 9.7-149 mg/L en el momento de la inclusión
    Nivel 4 de la escala de la OMS [14], con necesidad de oxigenoterapia en GN ≥ 1 lpm para mantener saturación ≥ 94%.
    Inicio de los síntomas ≤ 10 días antes de la fecha de la inclusión.
    E.4Principal exclusion criteria
    Patients with criteria of respiratory distress at the time of randomisation, understood as need for OCNAF/NIMV/MIV (levels 5 and 6 of the WHO scale) or O2 saturation ≤ 92% and/or RF ≥ 30 despite oxygen in NG at 4 litres.

    Patients with allergy or contraindication to the use of systemic corticosteroids.

    Patients with severe asthma or chronic lung disease with home oxygen requirements and active corticosteroid therapy.

    Patients on chronic corticosteroid therapy

    Use of corticosteroids daily in the 15 days prior to hospital admission.

    Indication for steroid use due to other clinical conditions of the patient (e.g. septic shock)

    Pregnant or actively breastfeeding women

    Patients with suspected or confirmed bacterial, fungal, or viral infection other than SARS-CoV-2 itself at time of randomisation

    Patients with confirmed past or latent tuberculosis infection prior to inclusion.

    Patients with known HIV infection with CD4 below 500 cells/mm3 or on active treatment with protease inhibitors or boosters such as cobicistat or ritonavir.

    Patients with active oncological processes in the last year or on active treatment with chemotherapy.

    Patients with life expectancy < 3 months at inclusion due to clinical conditions other than SARS-CoV-2 pneumonia.

    Patients expected to die within 48-72 hours.

    Patients included in another clinical trial.
    Pacientes con criterio de distrés respiratorio en el momento de la randomización, entendido como necesidad de OCNAF/VMNI/VMI (niveles 5 y 6 de la escala de la OMS) o saturación de O2 ≤ 92% y/o FR ≥ 30 pese a oxígeno en GN a 4 litros.

    Pacientes con alergia o contraindicación para el uso de corticoides sistémicos

    Pacientes con asma grave o patología pulmonar crónica con requerimientos de oxigeno domiciliario y tratamiento activo con corticoides

    Pacientes en tratamiento con corticoides de manera crónica

    Uso de corticoides diariamente en los 15 días previos al ingreso hospitalario

    Indicación de uso de corticoides por otras condiciones clínicas del paciente (por ejemplo, shock séptico)

    Mujeres embarazadas o con lactancia activa

    Pacientes con sospecha o confirmación de infección bacteriana, fúngica, o viriasis diferente del propio SARS-CoV-2 en el momento de la randomización

    Pacientes con infección tuberculosa pasada o latente confirmada previo al momento de la inclusión.

    Pacientes con infección por HIV conocida con CD4 por debajo de 500 cel/mm3 o en tratamiento activo con inhibidores de la proteasa o potenciadores como el cobicistat o ritonavir.

    Pacientes con procesos oncológicos activos en el último año o en tratamiento activo con quimioterapia.

    Pacientes con esperanza de vida < 3 meses en el momento de la inclusión por condiciones clínicas diferentes de la neumonía por SARS-CoV-2.

    Pacientes con fallecimiento esperable en las siguientes 48-72 horas

    Pacientes incluidos en otro ensayo clínico.
    E.5 End points
    E.5.1Primary end point(s)
    Requirement of respiratory therapy with NIV/MIV/OCNAF
    Need for respiratory support with NIMV/MIV/OCNAF
    Days of hospitalization counted from signature of informed consent to time of discharge from hospital
    Requerimiento de terapia respiratoria con VMNI/VMI/OCNAF
    Necesidad de soporte respiratorio con VMNI/VMI/OCNAF
    Días de hospitalización contados desde la firma del consentimiento informado hasta el momento de abandono del hospital
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 days
    10 días
    E.5.2Secondary end point(s)
    Days of respiratory therapy with NIV/MIV/OCNAF (counted individually and grouped in case they were sequential and consecutive).
    Mortality during admission and at 30, 60 and 90 days, from all causes.
    Días de terapia respiratoria con VMNI/VMI/OCNAF (contados de forma individual y agrupados en caso de que fueran secuenciales y consecutivas)
    Mortalidad durante el ingreso y a 30, 60 y 90 días, por todas las causas
    E.5.2.1Timepoint(s) of evaluation of this end point
    100 days
    100 días
    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 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) 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    diferentes dosis del mismo producto
    different dosage of the same product
    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
    LVLS
    Última visita del último 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 months9
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state200
    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)
    Patients will be followed up 30, 60 and 90 days after the end of treatment.
    Se realizará un seguimiento de los pacientes a los 30, 60 y 90 días después de finalizar el tratamiento
    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 Decision2021-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-23
    P. End of Trial
    P.End of Trial StatusOngoing
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