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    Summary
    EudraCT Number:2020-002166-13
    Sponsor's Protocol Code Number:HUB-MdI-ICAT-COVID-201
    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:2020-07-22
    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 number2020-002166-13
    A.3Full title of the trial
    Randomized, open, multicenter phase II clinical trial, proof of concept, to evaluate efficacy and safety of Icatibant in hospitalized patients with SARS-COV-2 (COVID-19) without assisted ventilation compared with standard care
    ENSAYO CLÍNICO DE FASE II, PRUEBA DE CONCEPTO, CON ASIGNACIÓN ALEATORIA, ABIERTO Y MULTICÉNTRICO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE ICATIBANT EN PACIENTES INFECTADOS POR SARS-CoV-2 (COVID-19) E INGRESADOS EN UNIDADES DE HOSPITALIZACIÓN, SIN VENTILACIÓN MECÁNICA, COMPARADO CON EL ESTANDAR DE CUIDADO (ICAT·COVID)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigating the Efficacy and Safety ICATIBANT For The Treatment of Patients with SARS-CoV-2 (COVID-19) Infection
    Eficacia y seguridad de Icatibant en el tratamiento de pacientes con infección por SARS-CoV-2 (COVID-19)
    A.3.2Name or abbreviated title of the trial where available
    HUB-MdI-ICAT-COVID-201
    HUB-MdI-ICAT-COVID-201
    A.4.1Sponsor's protocol code numberHUB-MdI-ICAT-COVID-201
    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 SponsorDr. Ramón Lleonart Bellfill / Dr. Xavier Corbella Virós
    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 supportpending23
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Ramón Lleonart Bellfill / Dr. Xavier Corbella Virós
    B.5.2Functional name of contact pointDr. Ramón Lleonart Bellfill
    B.5.3 Address:
    B.5.3.1Street AddressCalle Feixa Llarga, s/n
    B.5.3.2Town/ cityL'Hospitalet de Llobregat (Barcelona)
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number00349326076002344
    B.5.5Fax number0034932607672
    B.5.6E-mailrlleonart@bellvitgehospital.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 Firazyr®
    D.2.1.1.2Name of the Marketing Authorisation holderShire Pharmaceuticals Ireland Limited
    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 nameIcatibant (Firazyr®)
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNICATIBANT
    D.3.9.1CAS number 130308-48-4
    D.3.9.4EV Substance CodeSUB08104MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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
    Pneumonia caused by COVID-19
    Neumonía causada por COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10070255
    E.1.2Term Coronavirus test positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084381
    E.1.2Term Coronavirus pneumonia
    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 study the efficacy and safety of icatibant in adult patients admitted to hospitalization units for pneumonia caused by COVID-19, without mechanical ventilation, 10±1 days after starting treatment or discharge from hospital if this occurs before 10 days.
    Estudiar la eficacia y seguridad del icatibant en pacientes adultos, ingresados en unidades de hospitalización por neumonía causada por COVID-19, sin ventilación mecánica, a los 10±1 días de haber iniciado el tratamiento o alta hospitalaria si ésta sucede antes de los 10 días.
    E.2.2Secondary objectives of the trial
    Clinical:
    - time to reach a 48-hour clinical response.
    -time to reach an afebrile state of 48 hours
    - long term efficacy
    - role of drug treatments used in the standard of care (SoC) on efficacy and safety.
    - duration (days) of the hospital stay.
    - influence of time (days with illness) on the response to treatment.
    -incidence of complications related to COVID-19
    - incidence of relapse of SARS-CoV-2 pneumonia
    - incidence of re-entry for any reason
    - incidence of new consultations to the emergency department for any cause
    - incidence of mortality from Covid-19
    - incidence of all-cause mortality
    Safety:
    icatibant: SAEs incidence according to severity up to 28±3 from hospital discharge.
    Clínicos:
    - tiempo hasta alcanzar una respuesta clínica de 48 horas.
    -tiempo hasta alcanzar un estado afebril de 48 horas.
    - eficacia a largo plazo
    - papel de los tratamientos farmacológicos utilizados en el estándar de cuidado
    (SoC) en la eficacia y seguridad.
    - duración (días) de la estancia hospitalaria.
    - influencia del tiempo transcurrido desde el inicio de los síntomas (días con enfermedad) en la respuesta al tratamiento.
    -incidencia de complicaciones relacionadas con COVID-19
    - incidencia de recaída de neumonía por SARS-CoV-2
    - incidencia de reingresos por cualquier causa
    - incidencia de nuevas consultas a urgencias por cualquier causa
    - incidencia de mortalidad por COVID-19
    - incidencia de mortalidad por cualquier causa
    Seguridad:
    icatibant:incidencia AAGs según gravedad hasta 28±3 d./alta hospital.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1-adult patients (18 years or older), both sexes
    2-Sars-CoV-2 infection confirmed by PCR less than 4 days before randomization
    3-hospitalized with a diagnosis of SARS-CoV-2 pneumonia
    4-radiographic evidence of pulmonary infiltrates
    5-grade 4 or 5 on the ordinal scale for the evaluation of the patient's clinical condition
    6-pO2/FiO2 <380
    7-men and women of childbearing age who have heterosexual relations must be
    agreement to use the safe method(s) of contraception
    8-obtaining the informed consent of the patient or the legal representative.
    1-pacientes adultos (18 años o más), de ambos sexos
    2-infección por SARS-CoV-2 confirmada por PCR menos de 4 días antes de la aleatorización
    3-hospitalizados con diagnóstico de neumonía por SARS-CoV-2
    4-evidencia radiográfica de infiltrados pulmonares
    5-grado 4 ó 5 en la escala ordinal para la evaluación del estado clínico del paciente
    6-pO2/FiO2 <380
    7-los hombres y mujeres en edad fértil que tienen relaciones heterosexuales deben estar de acuerdo en usar el método o métodos de anticoncepción seguros
    8-obtención del consentimiento del paciente o representante legal.
    E.4Principal exclusion criteria
    1-imminent death (life expectancy less than 72h)
    2-known hypersensitivity or known adverse reactions to the study drug, or its
    metabolites or excipients of the formulation
    3-invasive mechanical ventilation
    4-participation in any other clinical trial
    5- ALT or AST > 5 x ULN
    6-creatinine clearance <50 mL/min using the Cockcroft-Gault formula for
    participants '18 years old [Cockcroft 1976]
    7-patients with recent acute coronary syndrome (<1 month)
    8-patients with a history of stroke
    9-positive pregnancy test
    10-pregnant or lactating woman
    1-muerte inminente (expectativa de vida menos de 72h)
    2-hipersensibilidad conocida o reacciones adversas conocidas al fármaco del estudio, o a sus metabolitos o a excipientes de la formulación
    3-ventilación mecánica invasiva
    4-participación en cualquier otro ensayo clínico
    5- ALT o AST > 5 x ULN
    6-eliminación de creatinina <50 mL/min utilizando la fórmula Cockcroft-Gault para participantes `18 años de edad [Cockcroft 1976]
    7-pacientes con síndrome coronario agudo reciente (< 1 mes)
    8-pacientes con antecedentes de accidente cerebrovascular
    9-prueba de embarazo positiva
    10-mujer embarazada o lactante
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy and safety will be evaluated 10 (±1) days after the start of treatment or at hospital discharge if before day 10: number of patients reaching grade 2
    (inpatient, no longer requiring supplemental oxygen and no longer requiring care
    or
    grade 1 (hospital discharge) of the ordinal scale of the clinical state of the
    patient for 48 hours straight* and who has not had an adverse reaction of
    3 or 4 or 5 according to the Criteria of Adverse Event Terminology (CTC-AE of the term in Common Terminology Criteria for Adverse Events).
    La eficacia y seguridad se evaluará a los 10 (±1) días de haber iniciado el tratamiento o al alta
    hospitalaria si ésta ocurre antes del día 10: número de pacientes que alcanzan el grado 2
    (paciente hospitalizado, que ya no requiere oxígeno suplementario y ya no requiere atención
    médica continua) o grado 1 (alta hospitalaria) de la escala ordinal del estado clínico del
    paciente durante 48 horas seguidas* y que no haya presentado una reacción adversa de grado
    3 ó 4 ó 5 según los Criterios de Terminología de Eventos Adversos (CTC-AE del término en
    inglés Common Terminology Criteria for Adverse Events).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 10±1
    Día 10±1
    E.5.2Secondary end point(s)
    Clinical:
    -Number (percentage) of patients who reach grade 2 or grade 1 during the 10 days of
    to have initiated treatment.
    - Number (percentage) of patients discharged from hospital who, since discharge
    The patient must be discharged from the hospital by the 28th day without a relapse or comorbidity related to COVID-19
    -Time ('days') until reaching an afebrile state: body temperature less or same as37.5ºC for 48
    hours without antipyretic medication
    -Long-term effectiveness (up to 28 days from discharge, visit 4): "number of patients" who
    on day 28th of discharge from the hospital continue at grade 2 or grade 1 on the state ordinal scale from the patient's hospital discharge.
    -Number of days of hospital stay (from the day of initiation of antiviral treatment to discharge from hospital)
    -complications related to COVID-19 up to 28 days of discharge from hospital (visit 4)
    -Number (percentage) of patients who need to be admitted to the ICU
    - Number (percentage) of patients needing supplemental oxygen since discharge
    hospitalization until the day of discharge
    - Number (percentage) of patients needing ICU admission and mechanical ventilation
    -Number (percentage) of patients diagnosed with other nosocomial infection
    -Number (percentage) of patients requiring hospital readmission within 28 days (visit 4) of discharge

    Mortality:
    - Number (percentage) of COVID-19-related deaths up to 28 days from hospital discharge (visit 4)
    -Number (percentage) of patients who died from any cause up to 28 days after discharge from hospital (visit 4)
    -Number of days until death
    safety:
    -Incidence of adverse events according to their severity and relationship to treatment
    -Number of patients with a grade 3 or 4 or 5 adverse reaction according to the CTC-EA
    Clínicos:
    •Número (porcentaje) de pacientes que alcanzan un grado 2 o grado 1 durante los 10 días de
    haber iniciado el tratamiento.
    • Número (porcentaje) de pacientes que se le haya dado el alta hospitalaria y que desde el alta
    hospitalaria hasta el día 28 del alta hospitalaria no presente una recaída o comorbilidad
    relacionada con COVID-19
    •Tiempo (‘días’) hasta alcanzar un estado afebril: temperatura corpórea menor o igual de37,5ºC durante 48 horas seguidas sin medicación antipirética
    •Eficacia a largo plazo (hasta 28 días del alta hospitalaria, visita 4): “número de pacientes” que
    en el día 28 del alta hospitalaria continúan en grado 2 o grado 1 de la escala ordinal del estado
    clínico del paciente desde el alta hospitalaria.
    •Número de días de estancia hospitalaria (desde el día del inicio del tratamiento antiviral hasta elalta hospitalaria)complicaciones relacionadas con COVID-19 hasta los 28 días del alta hospitalaria (visita 4):
    •Número (porcentaje) de pacientes que necesitan ingresar en la UCI
    • Número (porcentaje) de pacientes que necesitan oxígeno suplementario desde el alta
    hospitalaria hasta el día del alta
    • Número (porcentaje) de pacientes que necesitan ingresar en la UCI y ventilación mecánica
    •Número (porcentaje) de pacientes a los que se diagnostica otra infección nosocomial
    •Número (porcentaje) de pacientes que necesitan un reingreso hospitalario antes de los 28 días(visita 4) desde el alta hospitalaria

    Mortalidad:
    • Número (porcentaje) de pacientes fallecidos relacionadas con COVID-19 hasta los 28 días del
    alta hospitalaria (visita 4)
    •Número (porcentaje) de pacientes fallecidos por cualquier causa hasta los 28 días desde el alta hospitalaria (visita 4)
    •Número de días hasta deceso
    SEGURIDAD:
    •Incidencia de acontecimientos adversos según su gravedad y relación con el tratamiento
    •Número de pacientes con una reacción adversa de grado 3 ó 4 ó 5 según los CTC-AE.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study.
    Durante todo el estudio.
    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
    Tratamiento estándar de cuidado
    Standard of care treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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
    LVLP (last visit last patient)
    Última visita del último paciente.
    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 months18
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state120
    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 patients who finish their participation in this study, according to the evolution of their SARS-CoV-2 pneumonia at the last study visit (visit 4), if they need to continue in treatment at your doctor's discretion, then, they will continue with the medical tests and
    treatments prescribed by the doctor in accordance with his or her usual clinical practice.
    Los pacientes que finalicen su participación en este estudio, de acuerdo con la evolución de su neumonía por SARS-CoV-2 en la última visita del estudio (visita 4), si necesitan continuar en tratamiento a criterio del médico, entonces, continuarán con las pruebas médicas y tratamientos que les prescriba su médico de acuerdo con su práctica clínica habitual.
    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 Decision2020-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-17
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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