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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-005280-31
    Sponsor's Protocol Code Number:INHALAVID
    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:2021-02-01
    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 number2020-005280-31
    A.3Full title of the trial
    Phase IV, single-center, randomized and open-label study to evaluate the impact of early treatment with a combination of an inhaled corticosteroid and a long-acting β2 adrenergic agonist (budesonide / formoterol) versus standard of care on the evolution of the disease in vulnerable patients with COVID-19: INHALAVID Trial
    Estudio de fase IV, unicéntrico, aleatorizado y abierto para evaluar el impacto del tratamiento precoz con una combinación de un corticoide inhalado y un agonista adrenérgico β2 de acción prolongada (budesonida/formoterol) versus tratamiento habitual sobre la evolución de la enfermedad en pacientes vulnerables con COVID-19: Ensayo INHALAVID
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the impact of early treatment with a budesonide / formoterol versus standard of care on the evolution of the disease in vulnerable patients with COVID-19: INHALAVID Trial
    Estudio dpara evaluar el impacto del tratamiento precoz con budesonida/formoterol versus tratamiento habitual sobre la evolución de la enfermedad en pacientes vulnerables con COVID-19: Ensayo INHALAVID
    A.4.1Sponsor's protocol code numberINHALAVID
    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 Eurecat
    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 supportLaboratorios Bial S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic Science S.L.
    B.5.2Functional name of contact pointClinical Trials Department
    B.5.3 Address:
    B.5.3.1Street AddressCalle Azcona, 31
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28028
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914561105
    B.5.5Fax number0034914561126
    B.5.6E-mailensayosclinicos@dynasolutions.com
    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 Biresp Spiromax
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 number320
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFORMOTEROL
    D.3.9.1CAS number 73573-87-2
    D.3.9.4EV Substance CodeSUB07788MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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
    Enfermedad en pacientes vulnerables con COVID-19
    Disease in vulnerable patients with COVID-19
    E.1.1.1Medical condition in easily understood language
    Disease cause by COVID-19
    Enfermedad por 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 10051905
    E.1.2Term Coronavirus infection
    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 main objective of the study is to evaluate the effect of the inhaled budesonide / formoterol combination (BiResp Spiromax®) on the evolution of patients at risk with COVID-19 compared to standard of care.
    El objetivo principal del estudio es evaluar el efecto de la combinación budesonida/formoterol inhalado (BiResp Spiromax®) sobre la evolución de los enfermos de riesgo con COVID-19 en comparación con el estándar de cuidados.
    E.2.2Secondary objectives of the trial
    1. Evaluate and compare the impact on the rate of hospital admissions
    2. Evaluate and compare the mortality for the patients assigned to the two treatment groups.
    3. Evaluate and compare the rate of admission to the ICU for the patients assigned to the two treatment groups.
    4. Evaluate and compare the length of hospital stay for the patients assigned to the two treatment groups.
    5. Evaluate and compare the safety profile for the patients assigned to the two treatment groups.
    1. Evaluar y comparar el impacto sobre la tasa de ingresos hospitalarios
    2. Evaluar y comparar la mortalidad de los pacientes asignados a los dos grupos de tratamiento.
    3. Evaluar y comparar la tasa de ingresos en la UCI de los pacientes asignados a los dos grupos de tratamiento.
    4. Evaluar y comparar la duración de la estancia hospitalaria de los pacientes asignados a los dos grupos de tratamiento.
    5. Evaluar y comparar el perfil de seguridad de los pacientes asignados a los dos grupos de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients capable of understanding the terms of the trial and agreeing to participate on it.
    2. Patients who sign the informed consent or oral consent with subsequent written confirmation.
    3. Patients ≥ 65 years of age or ≥ 50 years with a documented diagnosis in the medical history of at least one of the following comorbidities: arterial hypertension (diagnosed in the medical history and under treatment with antihypertensive drugs, cardiovascular disease, obesity (BMI > 30), diabetes, COPD, or active cancer.
    4. Positive antigen test for SARS-CoV-2.
    5. Less than 10 days from the appearance of the first symptoms at the time of randomization
    1. Pacientes capaces de entender los términos del ensayo y que acepten participar en el mismo.
    2. Pacientes que firmen el consentimiento informado o consentimiento oral con confirmación posterior por escrito.
    3. Pacientes ≥ 65 años de edad o ≥ de 50 años con un diagnóstico documentado en el historial médico de al menos una de las siguientes comorbilidades: hipertensión arterial (diagnosticada en la historia clínica y en tratamiento con antihipertensivos, enfermedad cardiovascular, obesidad (IMC >30), diabetes, EPOC o cáncer activo.
    4. Prueba de antígeno positiva para SARS-CoV-2.
    5. Menos de 10 días desde la aparición de los primeros síntomas en el momento de la aleatorización
    E.4Principal exclusion criteria
    1. Current treatment with inhaled beta-adrenergic blockers (including eye drops), corticosteroids, or beta 2 -agonists for any indication.
    2. Patients with contraindications for the use of budesonide / formoterol: hypersensitivity to the active substances or to the excipient included, lactose monohydrate, or in case of active pulmonary tuberculosis.
    3. Patients with a previous history of cardiac arrhythmias (eg, atrial fibrillation, supraventricular tachycardia, and extrasystoles).
    4. Patients who are participating in another clinical trial.
    5. Pregnant or lactating women.
    6. Women and men of childbearing potential who are unwilling to use an effective contraceptive method (such as oral contraceptives, intrauterine device, or barrier method of contraception along with spermicide or surgical sterilization), during the study.
    1. Tratamiento actual con bloqueantes adrenérgicos β (incluidos los colirios), corticosteroides o agonistas β 2 inhalados por cualquier indicación.
    2. Pacientes con contraindicaciones para el empleo de budesonida/formoterol: hipersensibilidad a los principios activos o al excipiente incluido, lactosa monohidrato, o en caso de tuberculosis pulmonar activa.
    3. Pacientes con historia previa de arritmias cardíacas (p. ej., fibrilación auricular, taquicardia supraventricular y extrasístoles).
    4. Pacientes que estén participando en otro ensayo clínico.
    5. Mujeres embarazadas o en periodo de lactancia.
    6. Mujeres y hombres en edad fértil que no estén dispuestos a utilizar un método anticonceptivo eficaz (como anticonceptivos orales, dispositivo intrauterino o método de barrera anticonceptivo junto con espermicida o esterilización quirúrgica), durante el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Change in the Dublin-Boston score [1] in the 2 treatment groups from the start of treatment (D0) to day 4 (D + 4). A significant clinical response in terms of the Dublin-Boston score will be considered a decline on the scale of at least one category. The percentage of patients included in categories -1 and -2 to D + 4 will be compared
    Cambio en la puntuación Dublín-Boston [1] en los 2 grupos de tratamiento desde el inicio del tratamiento (D0) al día 4 (D+4). Se considerará una respuesta clínica significativa en términos de la puntuación Dublín-Boston un descenso en la escala de al menos una categoría. Se comparará el porcentaje de pacientes incluido en las categorías -1 y -2 al D+4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the start of treatment (D0) to day 4 (D+4)
    Desde el inicio del tratamiento (D0) al día 4 (D+4)
    E.5.2Secondary end point(s)
    • Percentage of patients requiring admission to the hospital ward for COVID-19 after 30 days from the start of treatment.
    • Mortality from COVID-19 at +30 days. Death or death from COVID is defined when it is caused by respiratory failure, acute respiratory distress syndrome, multiorgan failure or any other serious complication, during the course of the evolution of an acute infection by SARS-CoV-2.
    • Frequency of comorbidities.
    • Percentage of patients requiring admission to the ICU.
    • Days of length of hospital stay
    • The variables to be measured will be the frequency of adverse events, the frequency of serious adverse effects, the frequency of adverse effects that lead to the interruption of treatment, the number of deaths and the frequency of laboratory changes not directly related to COVID disease. -19.
    • Porcentaje de pacientes que requieren ingreso en la planta de hospitalización por COVID-19 durante 30 días desde el inicio de tratamiento.
    • Mortalidad por COVID-19 a los +30 días. Se define fallecimiento o muerte por COVID cuando este se produce por insuficiencia respiratoria, síndrome de distrés respiratorio agudo, fallo multiorgánico o cualquier otra complicación grave, en el transcurso de la evolución de una infección aguda por SARS-CoV-2.
    • Frecuencia de comorbilidades.
    • Porcentaje de pacientes que requieren ingreso en UCI.
    • Días de duración de la estancia hospitalaria
    • Las variables a medir serán la frecuencia de eventos adversos, la frecuencia de efectos adversos graves, la frecuencia de efectos adversos que conlleven la interrupción del tratamiento, el número de muertes y la frecuencia de alteraciones de laboratorio no directamente relacionados con la enfermedad por COVID-19.
    E.5.2.1Timepoint(s) of evaluation of this end point
    D0, D+4, D+7, D+14, D+30 (End of Treatment Visit/ Early withdrawal)
    D0, D+4, D+7, D+14, D+30 (Visita final/ retirada prematura)
    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 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 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 Yes
    E.8.2.3.1Comparator description
    Tratamiento habitual/estándar de cuidados
    Routine/standard treatment
    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
    UVUP
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 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)
    Expected normal treatment
    Tratamiento clínico habitual o estándar
    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 Decision2021-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-18
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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