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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:2020-001497-30
    Sponsor's Protocol Code Number:ALXN1210-COV-305
    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:2020-05-14
    Trial results View 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 number2020-001497-30
    A.3Full title of the trial
    A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome
    Estudio de fase III, abierto, aleatorizado y controlado para evaluar la eficacia y la seguridad de ravulizumab administrado por vía intravenosa comparado con el mejor tratamiento sintomático en pacientes con neumonía grave, lesión pulmonar aguda o síndrome de dificultad respiratoria aguda por COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ravulizumab for the treatment of patients with Coronavirus Disease 2019
    A.4.1Sponsor's protocol code numberALXN1210-COV-305
    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 SponsorAlexion Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlexion Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlexion Europe SAS
    B.5.2Functional name of contact pointEuropean Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address103–105 rue Anatole France
    B.5.3.2Town/ cityLevallois-Perret
    B.5.3.3Post code92300
    B.5.3.4CountryFrance
    B.5.4Telephone number+331 47 10 06 15
    B.5.5Fax number+331 47 10 06 11
    B.5.6E-mailclinicaltrials.eu@alexion.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 Ultomiris
    D.2.1.1.2Name of the Marketing Authorisation holderAlexion Europe SAS
    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.3.1Product nameravulizumab
    D.3.2Product code ALXN1210
    D.3.4Pharmaceutical form Concentrate for 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 INNravulizumab
    D.3.9.2Current sponsor codeALXN1210
    D.3.9.3Other descriptive nameFc- and CDR-modified humanised monoclonal antibody against C5
    D.3.9.4EV Substance CodeSUB172162
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    COVID-19 severe pneumonia, acute lung injury, or acute respiratory distress syndrome
    COVID-19 neumonía grave, lesión pulmonar aguda o síndrome de dificultad respiratoria aguda
    E.1.1.1Medical condition in easily understood language
    COVID-19 pneumonia
    Neumonía COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061229
    E.1.2Term Lung 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 effect of ravulizumab + Best Supportive Care (BSC) compared with BSC alone on the survival of patients with COVID-19
    Evaluar el efecto de ravulizumab + Mejor Tratamiento de Supervivencia (MTS )comparado con solo MTS sobre la supervivencia de los pacientes con COVID-19
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of ravulizumab + BSC compared with BSC alone on outcomes in patients with COVID-19
    To characterize the overall safety of ravulizumab + BSC compared with BSC alone in patients with COVID-19
    To characterize the PK/PD and immunogenicity of ravulizumab in patients with COVID-19
    To assess the effect of C5 inhibition on systemic activation of complement and inflammation in patients with COVID-19
    Evaluar el efecto de ravulizumab + MTS comparado con solo MTS sobre la supervivencia de los pacientes con COVID-19
    Caracterizar la seguridad general de ravulizumab + MTS comparado con solo MTS en pacientes con COVID-19
    Caracterizar la FC, FD e inmunogenicidad de ravulizumab en pacientes adultos con COVID-19
    Evaluar el efecto de la inhibición del C5 en la activación sistémica del complemento y la inflamación en los pacientes con COVID-19
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent.
    2. Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization.
    3. Severe pneumonia, acute lung injury, or ARDS confirmed by computed tomography (CT) or X-ray at Screening or within the 3 days prior to Screening, as part of the patient's routine clinical care.
    4. Severe pneumonia, acute lung injury, or ARDS requiring oxygen supplementation with invasive or noninvasive mechanical ventilation.
    5. Female patients of childbearing potential and male patients with female partners of childbearing potential must follow protocol-specified contraception guidance for avoiding pregnancy for 8 months after treatment with the study drug.
    1. Hombres o mujeres ≥ 18 años de edad y ≥ 40 kg al momento de dar su consentimiento informado.
    2. Diagnóstico confirmado de infección por SARS-CoV-2 que se presenta como COVID-19 grave que requiere hospitalización.
    3. Neumonía severa, lesión pulmonar aguda o SDRA confirmada por tomografía computarizada (TC) o rayos X en la evaluación o dentro de los 3 días previos a la evaluación, como parte de la atención clínica de rutina del paciente.
    4. Neumonía severa, lesión pulmonar aguda o SDRA que requiere suplementación de oxígeno con ventilación mecánica invasiva o no invasiva.
    5. Las pacientes en edad fértil y las pacientes masculinas con parejas en edad fértil deben seguir las pautas anticonceptivas especificadas en el protocolo para evitar el embarazo durante 8 meses después del tratamiento con el fármaco del estudio
    E.4Principal exclusion criteria
    1. Patient is not expected to survive for more than 24 hours.
    2. Patient is on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening.
    3. Severe pre-existing cardiac disease (ie, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias).
    4. Patient has an unresolved Neisseria meningitidis infection.
    5. Use of the following medications and therapies:
    a. Current treatment with a complement inhibitor,
    b. Rituximab within 3 months of Screening,
    c. Mitoxantrone within 3 months of Screening, and
    d. Intravenous immunoglobulin (IVIg) within 3 weeks prior to Screening.
    6. Participation in another interventional treatment study within 30 days before initiation of ravulizumab on Day 1 in this study or within 5 half lives of that investigational product, whichever is greater.
    7. Female patients who are breastfeeding or who have a positive pregnancy test result at Screening or on Day 1.
    8. History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins.
    1. Pacientes que no se espera que sobrevivan más de 24 horas.
    2. El paciente recibe ventilación mecánica invasiva con intubación durante más de 48 horas antes de la detección.
    3. Enfermedad cardíaca preexistente severa (es decir, New York Heart Association Clase 3 o Clase 4, síndrome coronario agudo o taquiarritmias ventriculares persistentes).
    4. El paciente tiene una infección de Neisseria meningitidis no resuelta.
    5. Uso de los siguientes medicamentos y terapias:
    a. Tratamiento actual con un inhibidor del complemento,
    b. Rituximab dentro de los 3 meses de la detección,
    C. Mitoxantrona dentro de los 3 meses de la detección, y
    d. Inmunoglobulina intravenosa (IgIV) dentro de las 3 semanas previas a la detección.
    6. Participación en otro estudio de tratamiento intervencionista dentro de los 30 días antes del inicio de ravulizumab en el día 1 de este estudio o dentro de las 5 medias vidas de ese producto en investigación, lo que sea mayor.
    7. Pacientes de sexo femenino que están amamantando o que tienen un resultado positivo en la prueba de embarazo en la detección o en el día 1.
    8. Historial de hipersensibilidad a cualquier ingrediente contenido en el fármaco del estudio, incluida la hipersensibilidad a las proteínas murinas.
    E.5 End points
    E.5.1Primary end point(s)
    Survival
    Supervivencia
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 29
    Día 29
    E.5.2Secondary end point(s)
    - Number of days free of mechanical ventilation
    - Change from baseline in SpO2/FiO2
    - Duration of intensive care unit stay
    - Change from baseline in SOFA score
    - Duration of hospitalization
    - Survival
    - Número de días sin ventilación mecánica.
    - Cambio desde la línea de base en SpO2 / FiO2
    - Duración de la estancia en la unidad de cuidados intensivos.
    - Cambio desde la línea de base en la puntuación SOFA
    - Duración de la hospitalización.
    - supervivencia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 29
    Day 60 and Day 90 (survival only)
    Día 29
    Día 60 y Día 90 (solo supervivencia)
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenicidad
    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 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 Tratamiento de Supervivencia
    Best Supportive Care
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Unconscious patients
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    geriatric patients
    F.4 Planned number of subjects to be included
    F.4.1In the member state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 270
    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)
    Patients will return to the care of his/her physician
    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 Decision2020-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-09-01
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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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