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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   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:2020-001659-42
    Sponsor's Protocol Code Number:ANTITROMBINA
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    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 number2020-001659-42
    A.3Full title of the trial
    Pilot study of antithrombin as prophylaxis of acute respiratory distress syndrome in patients with COVID-19
    Estudio piloto de antitrombina como profilaxis del síndrome de distres respiratorio agudo en pacientes con COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of antithrombin as prophylaxis of acute respiratory disease in patients with COVID-19
    Estudio de antitrombina como profilaxis de problemas respiratorios agudos en pacientes con COVID-19
    A.4.1Sponsor's protocol code numberANTITROMBINA
    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 Biomédica de Córdoba
    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 supportFIBICO
    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 Biomédica de Córdoba
    B.5.2Functional name of contact pointAntonio Luque
    B.5.3 Address:
    B.5.3.1Street AddressEdificio IMIBIC. Avenida Menéndez Pidal s/n
    B.5.3.2Town/ cityCórdoba
    B.5.3.3Post code14004
    B.5.3.4CountrySpain
    B.5.4Telephone number0034671596070
    B.5.5Fax number0034957736571
    B.5.6E-mailuicec@imibic.org
    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 Anbinex
    D.2.1.1.2Name of the Marketing Authorisation holderInstituto Grifols, 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 nameHUMAN ANTITHROMBIN
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAntithrombin III
    D.3.9.3Other descriptive nameHUMAN ANTITHROMBIN
    D.3.9.4EV Substance CodeSUB61092
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Confirmed SARS-CoV-2 respiratory infection with poor prognostic factors
    Cuadro infeccioso respiratorio confirmado por SARS-CoV-2 con factores de mal pronóstico
    E.1.1.1Medical condition in easily understood language
    Confirmed COVID-19 disease
    Enfermedad confirmada de 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10061982
    E.1.2Term Severe acute respiratory syndrome
    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
    Decrease the risk of developing ARDS and death in high-risk COVID-19 patients
    Disminuir el riesgo de desarrollar SDRA y de muerte en los pacientes con COVID-19 de alto riesgo
    E.2.2Secondary objectives of the trial
    - To evaluate the improvement in oxygenation at 12, 24, 48, 72 and 96 hours.
    - To evaluate the improvement in analytical risk parameters for ARDS at 24, 48 and 72 hours.
    - To evaluate the radiological improvement.
    - To evaluate the rate of need for non-invasive and invasive mechanical ventilation.
    - To evaluate the time of use of mechanical ventilation.
    - To evaluate the mortality rate in hospital and one month after the pharmacological intervention.
    - To reviews the safety profile of the established treatment.
    - To Deepen in the anti-inflammatory mechanisms of AT.
    - Evaluar la mejoría en la oxigenación a las 12, 24, 48, 72 y 96 horas.
    - Evaluar la mejoría en los parámetros analíticos de riesgo para SDRA a las 24, 48 y 72 horas.
    - Evaluar la mejoría radiológica.
    - Evaluar la tasa de necesidad de ventilación mecánica no invasiva e invasiva.
    - Evaluar el tiempo de utilización de ventilación mecánica.
    - Evaluar la tasa de mortalidad hospitalaria y al mes de la intervención farmacológica.
    - Perfil de seguridad de la pauta establecida.
    - Profundización en los mecanismos antiinflamatorios de la AT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 and <85 years
    2. Diagnosis confirmed by COVID-19 PCR
    3. Radiological image compatible with COVID-19
    4. Present any of the following clinical-functional criteria considered RISK:
    4.a. Respiratory distress: Tachypnea> 26 breaths / minute
    4. b. PaO2 / FiO2 oxygenation index ≤ 300
    4.c. Alteration of one or more of the following parameters:
    4.c.i. DD> 1,000 µg / L
    4.c.ii. Ferritin> 800 ng / mL
    4.c.iii. Lymphocytes <800 cells / µL
    4.c.iv. PCR> 100 mg / L
    4.c.v. LDH> 500 U / L
    4.c.vi. IL-6> 15 pg / mL
    5. Direct or delegated verbal informed consent
    1. Edad ≥ 18 y < 85 años
    2. Diagnostico confirmado mediante PCR de COVID-19
    3. Imagen radiológica compatible con COVID-19
    4. Presentar alguno de los siguientes criterios clínico-funcionales considerados de RIESGO:
    4.a. Distrés respiratorio: Taquipnea > 26 respiraciones/minuto
    4. b. Índice de oxigenación PaO2/FiO2 ≤ 300
    4.c. Alteración de uno o más de los siguientes parámetros:
    4.c.i. DD > 1.000 µg/L
    4.c.ii. Ferritina > 800 ng/mL
    4.c.iii. Linfocitos < 800 cél/µL
    4.c.iv. PCR > 100 mg/L
    4.c.v. LDH > 500 U/L
    4.c.vi. IL-6 > 15 pg/mL
    5. Consentimiento informado verbal directo o delegado
    E.4Principal exclusion criteria
    1. Signs of active bleeding
    2. Immunosuppression by cancer or transplant
    3. Intolerance or allergy to AT or its components
    4. Pregnancy
    1. Signos de sangrado activo
    2. Inmunosupresión por cáncer o trasplante
    3. Intolerancia o alergia a AT o sus compontes
    4. Embarazo
    E.5 End points
    E.5.1Primary end point(s)
    Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation.
    Variable combinada: tasa de mortalidad o de empeoramiento con necesidad de ventilación mecánica no invasiva o con necesidad de ventilación mecánica invasiva.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily.
    Diariamente.
    E.5.2Secondary end point(s)
    EFFICACY VARIABLES
    1. Time to clinical improvement (decreased risk of developing ARDS or death): time (in days) to improvement in the National Early Warning (NEWS) Score 2. Defined as the time, in days, from the start of treatment a two-point improvement on this scale.
    2. Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.
    3. Improvement of the analytical parameters: time (in days) until the tendency to normalization (decrease ≥ 20%) of DD, ferritin, LDH, PCR and IL-6; the criteria reached before will be used.
    4. Time (in days) until improvement in oxygenation:
    - Time until the SpO2 / FiO2 ratio exceeds the worst SpO2 / FiO2 prior to AT treatment.
    - Time until the absence of oxygen need to maintain a basal saturation ≥ 92%.
    5. Time to radiological improvement in radiological report.
    6. Time (in days) of non-invasive mechanical ventilation.
    7. Time (in days) of invasive mechanical ventilation.
    8. Mortality rate in hospital and one month after pharmacological intervention.
    9. Percentage of patients who suffer any adverse effect related to pharmacological intervention.

    SAFETY VARIABLES
    1. Incidence of adverse events related to medication and its administration.
    2. Incidence in the appearance of allergic type hypersensitivity:
    2.1. Acne
    2.2. Generalized urticaria
    2.3. Chest tightness
    2.4. Dyspnoea
    2.5. Hypotension
    2.6. Anaphylaxis
    3. Incidence of parvovirus B19 infection.
    4. Bleeding.
    VARIABLES DE EFICACIA
    1. Tiempo hasta la mejoría clínica (disminución del riesgo de desarrollar SDRA o muerte): tiempo (en días) hasta la mejoría en el National Early Warning (NEWS) Score 2. Definido como el tiempo, en días, desde el inicio del tratamiento a la mejoría de dos puntos en esta escala.
    2. Evaluar la mejoría del índice de oxigenación - PaO2/FiO2- a las 24 y 48 horas.
    3. Mejoría de los parámetros analíticos: tiempo (en días) hasta la tendencia a la normalización (disminución ≥ 20%) del DD, la ferritina, la LDH, la PCR y la IL-6; se utilizará el criterio que se alcance antes.
    4. Tiempo (en días) hasta la mejoría en oxigenación:
    - Tiempo hasta que la relación SpO2/FiO2 supere a la peor SpO2/FiO2 previa al tratamiento con AT.
    - Tiempo hasta la ausencia de necesidad de oxígeno para mantener una saturación basal ≥ 92%.
    5. Tiempo hasta la mejoría radiológica en informe radiológico.
    6. Tiempo (en días) de ventilación mecánica no invasiva.
    7. Tiempo (en días) de ventilación mecánica invasiva.
    8. Tasa de mortalidad hospitalaria y al mes de la intervención farmacológica.
    9. Porcentaje de pacientes que sufren cualquier efecto adverso relacionado con la intervención farmacológica.

    VARIABLES DE SEGURIDAD
    1. Incidencia de eventos adversos relacionados con la medicación y su administración.
    2. Incidencia en la aparición de hipersensibilidad de tipo alérgico:
    2.1. Erupción cutánea
    2.2. Urticaria generalizada
    2.3. Opresión torácica
    2.4. Disnea
    2.5. Hipotensión
    2.6. Anafilaxia
    3. Incidencia de infección por parvovirus B19.
    4. Hemorragias.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily.
    Diariamente.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Mejor terapia disponible en el centro
    Best available treatment at site
    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 visit of the last subject undergoing the trial
    Última visita del último paciente en el estudio
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state46
    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)
    Best available treatment.
    Mejor tratamiento disponible.
    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 StatusCompleted
    P.Date of the global end of the trial2021-01-15
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