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    The EU Clinical Trials Register currently displays   38157   clinical trials with a EudraCT protocol, of which   6266   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001616-18
    Sponsor's Protocol Code Number:TACTIC-COVID
    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:2020-04-20
    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 number2020-001616-18
    A.3Full title of the trial
    Treatment with inhaled corticoids in patients with COVID-19 admitted to hospital with pneumonia
    Tratamiento con corticoides inhalados en enfermos COVID-19 ingresados por neumonía
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    treatment with inhaled corticoids in patients with covid-19 and pneumonia
    Tratamiento con corticoides inhalados en enfermos COVID-19 con neumonía
    A.4.1Sponsor's protocol code numberTACTIC-COVID
    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 SponsorFundació Clinic per a la Recerca Biomèdica
    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 supportAstrazeneca
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trials Unit -FCRB
    B.5.2Functional name of contact pointCTU CLINIC
    B.5.3 Address:
    B.5.3.1Street AddressCasanova 150
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number00349322754003343
    B.5.5Fax number0034932279877
    B.5.6E-mailsvarea@clinic.cat
    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 Pulmicort Turbuhaler 400 microgramos/inhalacion polvo para inhalacion
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca Farmacéutica Spain, 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.3.1Product namebudesonide
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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
    COVID19
    COVID19
    E.1.1.1Medical condition in easily understood language
    COVID19
    COVID19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Check whether adding Inhaled corticoids (budesonide) reduces or not the risk of ARDS and improves prognosis in COVID19 patients admitted with pneumonia
    Comprobar si el añadir tratamiento con corticoides inhalados (budesonida) en pacientes COVID19 ingresados por neumonía reduce el riesgo de distrés respiratorio agudo y mejora su pronóstico.
    E.2.2Secondary objectives of the trial
    • Assess the effect of IC in the duration of hospital stay
    • Complications during admittance
    • Circulating levels of systemic inflammation markers
    • Mortality at 30 and 90 days after hospital discharge
    -evaluar el efecto de este tratamiento en la duración de la estancia hospitalaria,
    -las complicaciones durante el ingreso,
    -los niveles circulantes de marcadores de infamación sistémica
    -la mortalidad a los 30 y 90 días del alta hospitalaria
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. COVID19
    2. Age >18 and <80
    3. Admitted for pneumonia (status #3 and #4 OMS scale)
    4. Informed consent
    1. Pacientes con COVID19
    2. Pacientes >18 y <80 años de edad
    3. Pacientes ingresados por neumonía (estatus #3 and #4 de la escala de la OMS)
    4. Aceptación y firma de consentimiento informado
    E.4Principal exclusion criteria
    1. Pregnancy
    2. Contraindications for inhaled corticoids therapy
    3. Participating in another intervention trial on COVID19
    4. Current treatment with inhaled or systemic corticosteroids
    1. Embarazo
    2. Pacientes en los que el tratamiento en investigación esté contraindicado.
    3. Participación en otro estudio de intervención con COVID19
    4. En tratamiento actual con corticoides sistémicos y o inhalados
    E.5 End points
    E.5.1Primary end point(s)
    proportion of subjects with therapeutic failure.
    Is a composite outcome: patients requiring mechanical ventilation, high flow oxygenotherapy, receiving systemic corticoids and/or anti IL1 , anti IL-6 and/or dying for any cause
    proporción de pacientes presentan fracaso terapéutico. Se trata de una variable compuesta: incluye ventilación mecánica (invasiva o no invasiva), oxigenoterapia de alto flujo, tratamiento con corticoides sistémicos y/o tratamiento con anti-IL-1, anti IL-6 o que fallecen por cualquier causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 15 after initiating treatment
    Día +15 desde inicio de tratamiento
    E.5.2Secondary end point(s)
    1- Clinical evolution (discharge, ARDS, death, ICU refusal)
    2- Temperature heart rate, blood pressure, PaO2/FiO2
    3-Systemic biomarkers
    4- Duration of hospital stay
    5- Complications during admittance (infectious, CV, metabolic, others)
    6- Mortality for any cause
    7- vital status
    8- changes in clinical status (OMS 7 point scale)
    1-Evolución clínica (alta, ARDS, exitus, denegación UCI por otros motivos)
    2-Temperatura, frecuencia cardíaca, tensión arterial y PaO2/FiO2
    3- Biomarcadores sistémicos
    4- Duración del ingreso (días)
    5- Complicaciones durante el ingreso (infecciosas, cardiovasculares, metabólicas, otras)
    6- mortalidad por cualquier causa
    7- estado vital
    8- Variación en el estatus clínico utilizando la escala ordinal de 7 puntos de la OMS
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- admission, day 3, day 7 and discharge
    2- admission, day 3, day 7 and discharge
    3-admission, day 3, day 7 and discharge
    4- at discharge
    5- at discharge
    6- at exitus
    7- at exitus, day +30 and day +90 (if applicable)
    8- day 3, day 7, day 15 and discharge
    1 a la inclusión, día 3, día 7 y alta hospitalaria
    2- a la inclusión, día 3, día 7 y alta hospitalaria
    3-a la inclusión, día 3, día 7 y alta hospitalaria
    4- al alta
    5- al alta
    6- exitus
    7- exitus, día +30 y día +90 (si procede)
    8- al día 3, día 7, día 15 y alta hospitalaria
    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 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 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
    tratamiento estandar
    standar of care
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    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 Yes
    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
    Ultima visita de último sujeto
    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 months6
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    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 Decision2020-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
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