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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2020-002434-33
    Sponsor's Protocol Code Number:Aprotinin1.0.
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-02-24
    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 number2020-002434-33
    A.3Full title of the trial
    Phase 3 randomized study to evaluate the safety and efficacy of aprotinin (Trasylol®) administered by inhalation nebulization in patients diagnosed with SARS-CoV-2 (COVID-19) with moderate severity compared to standard therapy.
    Estudio aleatorizado de fase 3 para evaluar la seguridad y la eficacia de la aprotinina (Trasylol®) administrada en nebulización por vía inhalatoria en pacientes con diagnóstico SARS-CoV-2 (COVID-19) con un estado de gravedad moderado en comparación con el tratamiento estándar.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    USE OF INHALATORY APROTININE AS AN ANTIVIRAL FOR TREATMENT OF SARS-CoV-2 (COVID-19) IN HOSPITALIZED PATIENTS.
    USO DE APROTININA POR VÍA INHALATORIA COMO ANTIVIRAL PARA EL TRATAMIENTO DEL SARS-CoV-2 (COVID-19) EN PACIENTES
    HOSPITALIZADOS.
    A.3.2Name or abbreviated title of the trial where available
    EFFICACY OF APROTININE IN COVID-19.
    EFICACIA DE LA APROTININA EN EL COVID-19.
    A.4.1Sponsor's protocol code numberAprotinin1.0.
    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 SponsorHospital General Universitario Ciudad Real
    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 supportHospital General Universitario Ciudad Real
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital General Universitario Ciudad Real
    B.5.2Functional name of contact pointCoordinador IDFCyB
    B.5.3 Address:
    B.5.3.1Street AddressCalle Obispo Rafael Torija S.N.
    B.5.3.2Town/ cityCiudad Real
    B.5.3.3Post code13005
    B.5.3.4CountrySpain
    B.5.6E-mailfjredondo@sescam.jccm.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 Aprotinine
    D.2.1.1.2Name of the Marketing Authorisation holderTrasylol
    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 nameTrasylol
    D.3.2Product code B02AB01
    D.3.4Pharmaceutical form Inhalation vapour
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with moderate SARS-CoV-2 pneumonia confirmed with a
    diagnosis of polymerase chain reaction (PCR) before randomization. The
    patient should be hospitalized and require ongoing medical care for
    SARS-CoV-2. With peripheral capillary O2 saturation levels (SpO2 ) >
    90% breathing ambient air. With radiographic evidence of pulmonary
    infiltrates.
    Pacientes con neumonía moderada por infección por SARS-CoV-2
    confirmada con diagnóstico de reacción en cadena de la polimerasa
    (PCR) antes de la aleatorización. El paciente debe estar hospitalizado y
    que requiera atención médica continua por SARS-CoV-2. Con niveles de
    saturación de O2 capilar periférico (SpO2 ) > 90 % respirando aire
    ambiente. Con evidencia radiográfica de infiltrados pulmonares.
    E.1.1.1Medical condition in easily understood language
    Insuficiencia respiratoria moderada por COVID-19
    Moderate respiratory failure due to COVID-19
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    Reduce the number of admissions to the Intensive Care Unit taking into
    account the ATS/IDSA criteria in the intervention group with respect to
    the control group.
    Disminuir el número de ingresos en la Unidad de Cuidados Intensivos
    teniendo en cuenta los criterios ATS/IDSA en el grupo de intervención
    respecto al grupo control.
    E.2.2Secondary objectives of the trial
    os:
    English - To improve clinical parameters in the successive days of follow-up in
    the intervention group.
    - To improve analytical parameters (hemogram, coagulation, and
    biochemical) in the successive days of follow-up in the intervention
    group.
    - To compare the SOFA Scale (respiratory complications, coagulation,
    liver, central nervous system alterations) in both groups on admission to
    the Intensive Care Unit.
    - Compare hospital stay, ICU stay and mortality in both groups.
    - Compare FEV 1 of patients in both groups after discharge from hospital.
    - Determine the possible adverse reactions of aprotinin administered by inhalation.
    - Mejorar parámetros clínicos en los sucesivos días de seguimiento en el
    grupo de intervención.
    - Mejorar parámetros analíticos (hemograma, coagulación, y
    bioquímicos) en los sucesivos días de seguimiento en el grupo de
    intervención.
    - Comparar la Escala SOFA (complicaciones respiratorias, coagulación,
    hepática, alteraciones sistema nervioso central) en ambos grupos al
    ingreso en la Unidad de Cuidados Intensivos.
    - Comparar estancia hospitalaria, estancia en UCI y mortalidad en ambos
    grupos.
    - Comparar la FEV 1 de los pacientes en ambos grupos tras el alta
    hospitalaria.
    - Determinar las posibles reacciones adversas de la aprotinina
    administrada por la vía inhalatoria
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients 18 years and older, either sex. Healthy volunteers are not
    allowed.
    Patients with moderate SARS-CoV-2 pneumonia confirmed with a
    diagnosis of polymerase chain reaction (PCR) before randomization. The
    patient should be hospitalized and require ongoing medical care for
    SARS-CoV-2. With peripheral capillary O2 saturation levels (SpO2 ) >
    90% breathing ambient air. With radiographic evidence of pulmonary
    infiltrates
    - Pacientes de 18 años y mayores, de cualquier sexo. No se admiten
    voluntarios sanos.
    - Pacientes con neumonía moderada por infección por SARS-CoV-2
    confirmada con diagnóstico de reacción en cadena de la polimerasa
    (PCR) antes de la
    aleatorización. El paciente debe estar hospitalizado y que requiera
    atención médica continua por SARS-CoV-2. Con niveles de saturación de
    O 2 capilar periférico (SpO 2 ) > 90 % respirando aire ambiente. Con
    evidencia radiográfica de infiltrados pulmonares
    E.4Principal exclusion criteria
    Those patients who do not present the signed documents, or whose
    informed consent is not obtained at a date prior to the completion of the
    study or any specific intervention in it.
    Patients who have had a previous exposure to aprotinin in the last 6
    months or with a known suspected allergy to aprotinin or high levels of
    antiprotinin IgG.
    Patients with a history of bleeding diathesis, deep vein thrombosis or
    pulmonary embolism or known clotting factor deficiency Based on the
    researcher's opinion on any medically significant active disease the
    patient may have.
    Patients who refuse to receive allogeneic blood products
    Patients with low red blood cell volume with blood transfusion needs
    (preoperative hematocrit of < 24% or hemoglobin of < 8 g / dl).
    Patients with a history of allergic asthma or lung atopy reactions or COPD.
    Patients with sepsis.
    Participation in any other clinical trial of an experimental treatment for
    SARS-CoV-2 or any other clinical trial in the last 30 days.
    Concurrent treatment with other agents with antiviral action actual or
    potential direct SARS-CoV-2 exposure < 24 hours prior to dosing of the
    study drug.
    Require mechanical ventilation at screening.
    Subjects with poor renal function (serum creatinine <2.5 mg/dL or 221
    µM).
    Pregnant or breastfeeding women or women of childbearing age in
    whom
    The possibility of pregnancy cannot be excluded by a pregnancy test
    negative and that they are not using a reliable method of contraception.
    Administration of other antifibrinolytic drugs (e.g., acid aminocaproic or
    tranexamic acid), or those patients undergoing chronic anticoagulant
    with acenocoumarol or warfarin that cannot be stopped temporarily the
    treatment.
    Aquellos pacientes que no presenten los documentos firmados, o que
    cuyo consentimiento informado no sea obtenido en una fecha anterior a
    la realización del estudio o cualquier intervención específica de él.
    Pacientes que hayan tenido una exposición previa a aprotinina en los
    últimos 6 meses o con una sospecha conocida de alergia a aprotinina o
    niveles de IgG antiaprotinina altos.
    Pacientes con antecedentes de diátesis hemorrágica, trombosis venosa
    profunda o embolia pulmonar o deficiencia conocida del factor de
    coagulación. Basado en la opinión del investigador sobre cualquier
    enfermedad médica significativa activa que el paciente pueda tener.
    Pacientes que se niegan a recibir productos sanguíneos alogénicos.
    Pacientes con volumen de glóbulos rojos bajos con necesidades de
    transfusión de sangre (hematocrito preoperatorio de < 24% o
    hemoglobina de < 8 g / dl).
    Pacientes con historia clínica de asma alérgica o reacciones de atopía
    pulmonar o EPOC.
    Pacientes con sepsis.
    Participación en cualquier otro ensayo clínico de un tratamiento
    experimental para SARS-CoV-2 o en cualquier otro ensayo clínico en los
    últimos 30 días.
    Tratamiento concurrente con otros agentes con actividad antiviral de
    acción directa real o posible contra el SARS-CoV-2 < 24 horas antes de la
    dosificación del fármaco del estudio.
    Requerir ventilación mecánica en el cribado.
    Sujetos con mala función renal (creatinina sérica <2,5 mg/dL ó 221 µM).
    Mujeres embarazadas o en periodo de lactancia o en edad fértil en
    quienes la posibilidad de embarazo no puede ser excluida por una
    prueba de embarazo negativa y que no están utilizando un método
    anticonceptivo fiable.
    Administración de otros medicamentos antifibrinolíticos (por ejemplo,
    ácido aminocaproico o ácido tranexámico), o aquellos pacientes en
    tratamiento anticoagulante crónico con acenocumarol o warfarina que
    no pueda suspenderse temporalmente el tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    Ingreso en UCI
    ICU Admission
    E.5.1.1Timepoint(s) of evaluation of this end point
    Mortalidad
    Mortality
    E.5.2Secondary end point(s)
    Admission
    Ingreso Hospitalario
    E.5.2.1Timepoint(s) of evaluation of this end point
    Mortalidad
    Mortality
    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 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) 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 No
    E.8.1.3Single blind Yes
    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
    práctica clínica habitual
    usual clinical practice
    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
    LAST DOSES
    ULTIMA DOSIS
    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 months4
    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 state105
    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)
    No
    No
    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 Decision2020-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-10-18
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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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