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    The EU Clinical Trials Register currently displays   39795   clinical trials with a EudraCT protocol, of which   6532   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).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2020-001497-30
    Sponsor's Protocol Code Number:ALXN1210-COV-305
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-12
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    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
    Studio di Fase 3, in aperto, randomizzato, controllato, per valutare l’efficacia e la sicurezza di ravulizumab somministrato per via endovenosa rispetto alla migliore terapia di supporto in pazienti con polmonite grave, lesione polmonare acuta o sindrome da distress respiratorio acuto da 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
    ravulizumab per il trattamento dei pazienti con malattia da Coronavirus 2019
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberALXN1210-COV-305
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04369469
    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.1.3.4CountryUnited 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.5.4Telephone number0033147100615
    B.5.5Fax number0033147100611
    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 No
    D. name Ultomiris
    D. of the Marketing Authorisation holderAlexion Europe SAS - EU/1/19/1371/001
    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.3.9.4EV 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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Polmonite grave, lesione polmonare acuta o sindrome da distress respiratorio acuto da COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 pneumonia
    Polmonite da 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 22.1
    E.1.2Level LLT
    E.1.2Classification code 10061229
    E.1.2Term Lung infection
    E.1.2System Organ Class 100000004862
    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
    Valutare l’effetto di ravulizumab + migliore terapia di supporto (best supportive care, BSC) rispetto alla BSC da sola sulla sopravvivenza dei pazienti 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
    Valutare l’efficacia di ravulizumab + BSC rispetto alla BSC da sola sugli esiti nei pazienti con COVID-19
    Caratterizzare la sicurezza complessiva di ravulizumab + BSC rispetto alla BSC da sola nei pazienti con COVID-19
    Caratterizzare PK/PD e immunogenicità di ravulizumab nei pazienti con COVID-19
    Valutare l’effetto dell’inibizione di C5 sull’attivazione sistemica del complemento e sull’infiammazione nei pazienti 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. Respiratory Distress requiring mechanical ventilation, which can be either invasive (requiring endotracheal intubation) or noninvasive (with continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP]).
    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. Soggetti di sesso maschile o femminile di età =18 anni e con peso =40 kg al momento della firma del consenso informato.
    2. Diagnosi confermata di infezione da SARS-CoV-2 che si presenta come COVID-19 grave che richiede il ricovero in ospedale.
    3. Polmonite grave, lesione polmonare acuta o sindrome da distress respiratorio acuto (ARDS) confermate da tomografia computerizzata (TAC) o radiografia allo screening o entro i 3 giorni precedenti lo screening, come parte delle cure cliniche di routine del paziente.
    4. Distress respiratorio che richiede ventilazione meccanica, che può essere invasiva (che richiede intubazione endotracheale) o non invasiva (con pressione positiva continua delle vie aeree [CPAP] o pressione positiva bilivello delle vie aeree [BiPAP]).
    5. Le pazienti in età fertile e i pazienti di sesso maschile con compagne di sesso femminile in età fertile devono seguire le linee guida di contraccezione previste dal protocollo per evitare una gravidanza negli 8 mesi successivi al trattamento con il farmaco dello studio.
    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. Intravenous immunoglobulin (IVIg) within 4 weeks prior to randomization on Day 1.
    6.Treatment with investigational therapy in a clinical study within 30 days before randomization, or within 5 half -lives of that investigational therapy, whichever is greater
    a.Investigational therapies will be allowed if received as part of best supportive care through an expanded access protocol or emergency approval for the treatment of COVID 19.
    b.Investigational antiviral therapies (such as remdesivir) will be allowed even if received as part of a clinical study.
    7. Female patients who are breastfeeding or who have a positive pregnancy test result at Screening.
    8. History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins.
    9.Patient who is not currently vaccinated against N. meningitidis, unless the patient agrees to receive prophylactic treatment with appropriate antibiotics for at least 8 months after the last infusion of study drug or until at least 2 weeks after the patient receives vaccination against N. meningitidis.
    1. Non si prevede che il paziente sopravviva per più di 24 ore.
    2. Il paziente è in ventilazione meccanica invasiva con intubazione per più di 48 ore prima dello screening.
    3. Grave malattia cardiaca preesistente (vale a dire, classe 3 o 4 della New York Heart Association o sindrome coronarica acuta o tachicardie ventricolari persistenti).
    4. Il paziente ha un’infezione da Neisseria meningitidis non risolta.
    5. Uso dei seguenti farmaci e terapie:
    a. Attuale trattamento con un inibitore del complemento,
    b. Immunoglobulina endovenosa (IVIg) nelle 4 settimane precedentila randomizzazione al giorno 1.
    6.Trattamento con terapia sperimentale in uno studio clinico entro 30 giorni prima della randomizzazione, o entro 5 emivite di quella terapia sperimentale, a seconda di quale sia maggiore
    a. Le terapie investigative saranno consentite se ricevute come parte delle migliori cure di supporto attraverso un protocollo di accesso esteso o l'approvazione di emergenza per il trattamento di COVID 19.
    b. Le terapie antivirali sperimentali (come il remdesivir) saranno consentite anche se ricevute come parte di uno studio clinico.
    7. Pazienti di sesso femminile che allattano o che hanno un risultato positivo al test di gravidanza allo Screening.
    8. Storia di ipersensibilità a qualsiasi ingrediente contenuto nel farmaco in studio, inclusa l'ipersensibilità alle proteine ¿¿murine.
    9.Paziente che non è attualmente vaccinato contro N. meningitidis, a meno che il paziente non accetti di ricevere un trattamento profilattico con antibiotici appropriati per almeno 8 mesi dopo l'ultima infusione del farmaco in studio o fino ad almeno 2 settimane dopo che il paziente riceve la vaccinazione contro N. meningitidis.
    E.5 End points
    E.5.1Primary end point(s)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 29
    Al giorno 29
    E.5.2Secondary end point(s)
    - Number of days free of mechanical ventilation at day 29
    - Duration of intensive care unit stay at day 29
    - Change from baseline in SOFA score at day 29
    - Change from baseline in SpO2/FiO2 at Day 29
    - Duration of hospitalization at day 29
    - Survival (based on all-cause mortality) at Day 60 and Day 90
    - Numero di giorni senza ventilazione meccanica al giorno 29
    - Durata della degenza in terapia intensiva al giorno 29
    - Variazione rispetto al basale nel punteggio SOFA al giorno 29
    - Variazione rispetto al basale di SpO2 / FiO2 al giorno 29
    - Durata del ricovero al giorno 29
    - Sopravvivenza (basata sulla mortalità per tutte le cause) al giorno 60 e al giorno 90
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 29
    Day 60 and Day 90 (survival only)
    Giorno 29
    Giorno 60 e Giorno 90 (solo sopravvivenza)
    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
    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. 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. description
    Migliore terapia di supporto
    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 concerned6
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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. of subjects incapable of giving consent
    Unconscious patients
    Pazienti incoscienti
    F.3.3.7Others Yes
    F. of other specific vulnerable populations
    geriatric patients
    Pazienti geriatrici
    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
    I pazienti torneranno in cura dal proprio medico
    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 Decision2020-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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