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    Summary
    EudraCT Number:2020-001541-39
    Sponsor's Protocol Code Number:BEVACOR
    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:2020-04-27
    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 number2020-001541-39
    A.3Full title of the trial
    Pilot study of single-dose bevacizumab as a treatment for acute respiratory distress syndrome in patients with COVID-19
    Estudio piloto de bevacizumab dosis única como tratamiento 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
    Pilot study of bevacizumab as a treatment for respiratory distress in patients with COVID-19
    Estudio de bevacizumab como tratamiento del distres respiratorio en pacientes con COVID-19
    A.4.1Sponsor's protocol code numberBEVACOR
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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.3.4Pharmaceutical form Solution for infusion
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Acute respiratory distress syndrome in patients with COVID-19
    Síndrome de distres respiratorio agudo en pacientes con COVID-19
    E.1.1.1Medical condition in easily understood language
    Acute respiratory diseasee in patients with COVID-19
    Problemas respiratorios agudos en pacientes con 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10001052
    E.1.2Term Acute respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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
    - To evaluate the crude mortality rate at 28 days.
    - Evaluar la tasa de mortalidad bruta a los 28 días.
    E.2.2Secondary objectives of the trial
    - To evaluate the improvement in the PaO2 / FiO2 ratio at 24 hours, at 72 hours, at 7 days, 14 days and 28 days.
    - To evaluate the improvement in the degree of dyspnea at 72 hours and at 7 days according to the Likert scale (-3 to +3).
    - To evaluate the improvement of the radiological findings by (simple radiology) at 72 hours and at 7 days.
    - To evaluate the improvement in transcutaneous O2 saturation at 24 hours, at 72 hours and at 7 days.
    - To evaluate the improvement in PaO2.
    - To measure the decrease in mortality (crude rate per month).
    - To evaluate the toxicity of the established strategy.
    - Evaluar la mejoría en el ratio PaO2/FiO2 a las 24 horas, a las 72 horas, a los 7 días, 14 días y 28 días.
    - Evaluar la mejoría en el grado de disnea a las 72 horas y a los 7 días según la escala Likert (-3 a +3).
    - Evaluar la mejoría de los hallazgos radiológicos por (radiología simple) a las 72 horas y a los 7 días.
    - Evaluar la mejoría saturación de O2 transcutánea a las 24 horas, a las 72 horas y a los 7 días.
    - Evaluar la mejoría en la PaO2.
    - Medir la disminución de la mortalidad (tasa cruda al mes).
    - Evaluar la toxicidad de la estrategia establecida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 and <90 years
    2. Diagnosis confirmed by COVID-19 PCR
    3. Radiological image compatible with bilateral non-cardiogenic pleuropulmonary exudate
    4. Having received antiviral and anti-inflammatory therapy according to the protocol of the Reina Sofía University Hospital in Córdoba
    5. Present any of the following clinical-functional criteria:
    5.a. Respiratory distress: Tachypnea> 30 breaths / minute
    5.b. Partial arterial oxygen pressure (PaO2) / Inspiration fraction (FiO2) ≤ 300 mmHg
    6. Signature of direct or delegated informed consent
    1. Edad ≥ 18 y < 90 años
    2. Diagnostico confirmado mediante PCR de COVID-19
    3. Imagen radiológica compatible con exudado pleuropulmonar bilateral no cardiogénico
    4. Haber recibido terapia antiviral y antiinflamatoria según protocolo de hospital Universitario Reina Sofía de Córdoba
    5. Presentar alguno de los siguientes criterios clínico-funcionales:
    5.a. Distres respiratorio: Taquipnea > 30 respiraciones/minuto
    5.b. Presión Parcial arterial de oxigeno (PaO2)/Fracción de inspiración (FiO2) ≤ 300 mmHg
    6. Firma de consentimiento informado directo o delegado
    E.4Principal exclusion criteria
    1. Severe liver dysfunction (Child Pugh ≥ 3 or AST> 5 times normal)
    2. Severe renal dysfunction with glomerular filtration <30 mL / minute or in treatment with hemodialysis or peritoneal dialysis)
    3. Poorly controlled arterial hypertension (TAs> 160 mmHg or TAd <100 mmHg) or having a previous history of hypertensive crisis or hypertensive encephalopathy
    4. History of poorly controlled heart disease with a NYHA> 2
    5. History of thrombosis the previous 6 months
    6. Signs of active bleeding
    7. Open wounds, gastrointestinal perforation fractures
    8. Diagnosis of thrombophilic diseases or bleeding diathesis
    9. Active viral hepatitis or HIV not adequately treated
    10. Intolerance or allergy to bevacizumab or its components
    11. Pregnancy
    1. Disfunción hepática grave (Child Pugh ≥ 3 o AST > 5 veces lo normal)
    2. Disfunción renal severa con filtrado glomerular < 30 mL/minuto o en tratamiento con hemodiálisis o diálisis peritoneal)
    3. Hipertensión arterial mal controlada (TAs > 160 mmHg o TAd <100 mmHg) o tener historia previa de crisis hipertensiva o encefalopatía hipertensiva
    4. Historia de cardiopatía mal controlada con un NYHA > 2
    5. Historia de trombosis los 6 meses previos
    6. Signos de sangrado activo
    7. Heridas abiertas, fracturas perforación gastrointestinal
    8. Diagnóstico de enfermedades trombofílicas o de diátesis hemorrágica
    9. Hepatitis vírica activa o VIH no tratados adecuadamente
    10. Intolerancia o alergia a bevacizumab o sus compontes
    11. Embarazo
    E.5 End points
    E.5.1Primary end point(s)
    1. Crude mortality at 28 days.
    1. Mortalidad cruda a los 28 días.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after the inclusion of the patient.
    A los 28 días tras la inclusión del paciente.
    E.5.2Secondary end point(s)
    1. PaO2 / FiO2 ratio: it will be measured the average of three evaluations of this ratio with a time interval of at least 6 hours, before and after administration of bevacizumab at 24 hours, at 72 hours, at 7 days, 14 days and 28 days.

    2. Time to clinical improvement: time (in days) to improvement in the National Early Warning Score 2 (NEWS). It is defined as time in days from randomization to any of the following criteria: (i) improvement of two points on the 7-category scale or, (ii) discharge from the hospital. The criteria reached before are used.

    3. Time (in days) until improvement in oxygenation for at least 48 hours:
    - Time to verify an increase in the SpO2 / FiO2 ratio with respect to the worst SpO2 / FiO2 prior to treatment with bevacizumab.
    - Time until the need for oxygen to maintain saturation in ambient air ≥ 93%.
    - Favorable radiological evolution established by three radiologists.
    - Number of days in need of supplemental oxygen.
    - Average time in the duration of:
    - High flow nasal oxygen.
    - Noninvasive mechanical ventilation.
    - Invasive mechanical ventilation.
    4. Proportion of patients requiring invasive mechanical ventilation.

    Security Variables
    1. Incidence of adverse events related to medication and its administration.
    2. Incidence in the appearance of serious bacterial, fungal or opportunistic infections.
    3. Incidence of perforation of the gastrointestinal tract.
    4. Mean white blood cell and neutrophil count.
    5. Average hemoglobin levels.
    6. Average platelet count.
    7. Average levels of creatinemia.
    8. Average bilirubin levels.
    9. Average ALT and AST levels.
    10. Development of HTA.
    11. Hemorrhages.
    12. Thromboembolic events.
    1. Relación PaO2/FiO2: se tendrá en cuenta el promedio de tres evaluaciones de dicho ratio con intervalo temporal de al menos 6 horas, previo y tras la administración de bevacizumab a las 24 horas, a las 72 horas, a los 7 días, 14 días y 28 días.

    2. Tiempo hasta la mejoría clínica: tiempo (en días) hasta la mejoría en el National Early Warning Score 2 (NEWS). Se define como tiempo en días desde la aleatorización a cualquiera de los siguientes criterios: (i) mejoría de dos puntos en la escala de 7 categorías o, (ii) alta del hospital. Se utiliza el criterio que se alcance antes.

    3. Tiempo (en días) hasta la mejoría en oxigenación durante al menos 48 horas:
    - Tiempo hasta constatar un incremento en la relación SpO2/FiO2 con respecto a la peor SpO2 / FiO2 previo al tratamiento con bevacizumab.
    - Tiempo hasta la ausencia de necesidad de oxígeno para mantener una saturación a aire ambiente ≥ 93%.
    - Evolución radiológica favorable establecida por tres radiólogos.
    - Número de días con necesidad de oxigeno suplementario.
    - Tiempo medio en la duración de:
    - Oxígeno nasal de alto flujo.
    - Ventilación mecánica no invasiva.
    - Ventilación mecánica invasiva.
    4. Proporción de pacientes que precisan ventilación mecánica invasiva.

    Variables de Seguridad
    1. Incidencia de eventos adversos relacionados con la medicación y su administración.
    2. Incidencia en la aparición de infecciones graves bacterianas, fúngicas u oportunistas.
    3. Incidencia de perforación del tracto gastrointestinal.
    4. Media de recuento de leucocitos y neutrófilos.
    5. Media de niveles de hemoglobina.
    6. Media de recuento de plaquetas.
    7. Niveles medios de creatinemia.
    8. Niveles medios de bilirrubina.
    9. Niveles medios de ALT y AST.
    10. Desarrollo de HTA.
    11. Hemorragias.
    12. Eventos tromboembólicos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 24 hours, at 72 hours, at 7 days, 14 days and 28 days after the inclusion of the patient.
    A las 24 horas, a las 72 horas, a los 7 días, 14 días y 28 días tras la inclusión del paciente.
    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 No
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    Estudio piloto
    Pilot study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    The last visit of the last subject undergoing the trial
    Última visita del último paciente del 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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state22
    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)
    The subject will receive the best available treatment.
    El paciente recibirá el 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 Decision2020-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-23
    P. End of Trial
    P.End of Trial StatusOngoing
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