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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:2020-002122-82
    Sponsor's Protocol Code Number:UKER-COV2-01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-07
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-002122-82
    A.3Full title of the trial
    Prospective open-label randomized controlled phase 2b clinical study in parallel groups for the assessment of efficacy and safety of immune therapy with COVID-19 convalescent plasma plus standard treatment vs. standard treatment alone of subjects with severe COVID-19
    Prospektive, randomisierte, kontrollierte, offene klinische Prüfung der Phase 2b in Parallelgruppen zur Bewertung der Wirksamkeit und Verträglichkeit einer Immuntherapie mit COVID-19 Rekonvaleszentenplasma plus Standardtherapie versus Standardtherapie allein zur Behandlung von Patienten mit schwerer COVID-19-Infektion
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study for the Evaluation of efficacy and safety of a Treatment with Plasma gained from patients who recovered from COVID-19 infection and given to patients who are currently suffering from a severe COVID-19 infection
    Klinische Studie zur Bestimmung von Wirksamkeit und Sicherheit einer Behandlung mit Plasma, das von genesenen Patienten gewonnen wird und an Patienten verabreicht, die aktuell an einer schweren COVID-19-Infektion leiden
    A.3.2Name or abbreviated title of the trial where available
    IPCO
    A.4.1Sponsor's protocol code numberUKER-COV2-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04712344
    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 SponsorUniversitätsklinikum Erlangen
    B.1.3.4CountryGermany
    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 supportUniversitätsklinikum Erlangen
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportFraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V.
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Erlangen
    B.5.2Functional name of contact pointTransfusionsmedizinische Abteilung
    B.5.3 Address:
    B.5.3.1Street AddressKrankenhausstr. 12
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number004991318536346
    B.5.5Fax number004991318536973
    B.5.6E-mailholger.hackstein@uk-erlangen.de
    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.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 nameCOVID-19 Immunplasma FAU
    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 INNCOVID-19 convalescent plasma
    D.3.9.3Other descriptive nameSARS-CoV-2 convalescent plasma
    D.3.9.4EV Substance CodeSUB213708
    D.3.10 Strength
    D.3.10.1Concentration unit µl/ml microlitre(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number870 to 910
    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) Yes
    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
    ARDS due to COVID-19 necessitating invasive mechanical ventilation
    Invasive mechanische Beatmung bei ARDS aufgrund von COVID-19
    E.1.1.1Medical condition in easily understood language
    acute lung failure and machine Ventilation due to COVID-19
    Akutes Lungenversagen und maschinelle Beatmung aufgrund einer schweren COVID-19-Infektion
    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 LLT
    E.1.2Classification code 10084270
    E.1.2Term SARS-CoV-2 acute respiratory disease
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003083
    E.1.2Term ARDS
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of impact of immune therapy with COVID-19 convalescent plasma on severity of COVID-19
    Ermittlung des Einflusses einer Immuntherapie mit COVID-19-Rekonvaleszentenplasma auf den Schweregrad von COVID-19
    E.2.2Secondary objectives of the trial
    Assessment of impact of immune therapy with COVID-19 convalescent plasma on
    • markers for ARDS due to severe COVID-19 infection.
    • short-term all-cause mortality.
    • time course of ARDS due to severe COVID-19.
    Assessment of safety and tolerability of immune therapy with COVID-19 convalescent plasma.
    Ermittlung des Einflusses einer Immuntherapie mit COVID-19-Rekonvaleszentenplasma auf
    - ARDS-Marker verursacht durch schwere COVID-19-Infektion
    - Kurzzeit-Sterblichkeit
    - Zeitlicher Verlauf eines COVID-19-verursachten ARDS
    Ermittlung von Sicherheit und Verträglichkeit einer Immuntherapie mit COVID-19-Rekonvaleszentenplasma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subject aged ≥18 years.
    2. Estimated BMI ≥19kg/m² to ≤40kg/m².
    3. Florid SARS-CoV-2 infection confirmed by RT-PCR in tracheo-bronchial secretion sample or pharyngeal swab sample.
    4. ARDS with Horovitz index <300mmHg.
    5. Necessity of invasive mechanical ventilation.
    6. Written informed consent obtained from the subject’s legal representative or under such arrangement as is legally acceptable in Germany (see Section 13.3).
    7. Subject’s assent if obtainable.
    1. Männliche oder weibliche Patienten ≥18 Jahre
    2. BMI zwischen 19 und 40kg/m²
    3. Floride SARS-CoV-2-Infektion, nachgewiesen durch RT-PCR aus Tracheobronchialsekret oder Rachenabstrich
    4. ARDS mit einem Horovitz-Index < 300mmHg
    5. Notwendigkeit einer invasiven mechanischen Beatmung
    6. Schriftliche Einwilligung durch den gesetzlichen Vertreter oder unter sonstigen gesetzlich vorgesehenen Bedingungen
    7. Assent des Patienten, sofern möglich
    E.4Principal exclusion criteria
    1. Adverse reaction to plasma proteins in medical history.
    2. Interval >72h since endotracheal intubation.
    3. Current or imminent necessity of ECMO treatment.
    4. Pre-existing COPD GOLD stage 4.
    5. Chronic congestive heart failure NYHA ≥3.
    6. Pre-existing left ventricular ejection fraction <30%.
    7. Liver cirrhosis Child-Pugh class C.
    8. Acute liver failure with bilirubin >5x ULN and either ALT or AST >10x ULN.
    9. Known congenital, selective severe deficiency of immunoglobulin A (IgA not detectable or close to detection Limit in contrast to other Ig).
    10. Cardiovascular resuscitation in the 14 days prior to Screening Visit [V1].
    11. Organ or bone marrow transplant in the three months prior to Screening Visit [V1].
    12. Pregnancy.
    13. Breastfeeding woman.
    14.  Previous exposure to COVID-19 convalescent plasma
    1. Unerwünschte Reaktion auf Plasmaproteine in der medizinischen Vorgeschichte
    2. >72 Stunden seit endotrachealer Intubation
    3. Laufende oder unmittelbar bevorstehende Notwendigkeit einer ECMO
    4. Vorbestehende COPD GOLD-Stadium 4
    5. Chronische Herzinsuffizient NYHA ≥3
    6. Eingeschränkte linksventrikuläre Ejektionsfraktion <30%
    7. Leberzirrhose Child-Pugh Klasse C
    8. Akutes Leberversagen mit Bilirubin >5x ULN and entweder ALT oder AST >10x ULN
    9. Bekannter angeborener, schwerer selektiver IgA-Mangel
    10. Kardiopulmonale Wiederbelebung in den 14 Tagen vor Screening
    11. Organ- oder Knochenmarkstransplantation in den drei Monaten von Screening
    12. Schwangerschaft
    13. Stillzeit
    14. Frühere Exposition gegenüber COVID-19 Rekonvaleszentenplasma
    E.5 End points
    E.5.1Primary end point(s)
    Change in SOFA score from Baseline Visit [Day 1, Visit 2] to Day 8 [Visit 9]
    Änderung des SOFA-Scores von Baseline (Visite 2) bis Tag 8 (Visite 9)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 8 (Visit 9)
    Tag 8 (Visite 9)
    E.5.2Secondary end point(s)
    - SOFA score: Mean change from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until extubation, whichever comes first
    - Rescue therapy: Number and proportion of subjects without rescue therapy until and including Day 8 [Visit 9]
    - ECMO: Mean number of days without ECMO during the period from Baseline Visit [Day 1, Visit 2] until and including Day 8 [Visit 9], Day 15 [Visit 13], and Day 29 [Visit 15], per treatment group and per subject
    - Invasive mechanical ventilation parameters and endotracheal Intubation: Mean number of days without invasive mechanical ventilation during the period from Baseline Visit [Day 1, Visit 2] until and including Day 8 [Visit 9], Day 15 [Visit 13], and Day 29 [Visit 15], per treatment group and per subject
    - Survival: Number and proportion of subjects having died until and including Day 29 [Visit 15] and End of Study Visit [Day 61±3 days, Visit 16]
    - Safety:  Cumulated number and proportion of subjects with AE, AR, SAE, SAR, and SUSAR from Baseline Visit [Day 1, Visit 2] until and including Day 11 [Visit 12]
    - SOFA-Score: Mittelwert der Änderung von Baseline im Vergleich zu allen darauffolgenden Visiten bis einschließlich Tag 29 (Visite 15) oder zum Zeitpunkt der Extubation
    - Rescue-Therapie: Anzahl und Anteil der Studienteilnehmer, die bis Ende Tag 8 (Visite 9) keine Rescue-Therapie benötigen
    - ECMO: Durchschnittliche Anzahl der Tage ohne ECMO im Zeitraum von Baseline bis einschließlich Ende Tag 8 (Visite 9), Tag 15 (Visite 13) und Tag 29 (Visite 15), getrennt nach Behandlungsarm und pro Studienteilnehmer
    - Invasive mechanische Beatmung: Durchschnittliche Anzahl von Tagen ohne invasive mechanische Beatmung im Zeitraum von Baseline bis einschließlich Ende Tag 8 (Visite 9), Tag 15 (Visite 13) und Tag 29 (Visite 15), getrennt nach Behandlungsarm und pro Studienteilnehmer
    - Überleben: Anzahl und Anteil an Studienteilnehmern, die bis einschließlich Tag 29 (Visite 15) und EOS (Tag 61±3 Tage, Visite 16) versterben
    - Safety: Kumulative Anzahl und Anteil an Studienteilnehmer mit AE, AR, SAE, SAR, und SUSAR von Baseline bis einschließlich Tag 11 (Visite 12)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline until EOS (day 61 -3/+21 days)
    Baseline bis End of study (Tag 61 -3/+21 Tage)
    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 No
    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
    Standardbehandlung
    standard 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 concerned4
    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 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
    date when the last subject has completed Visit 16 (day 61 +/- 3 days; EOS) or the date of the last visit of the last subject should that subject drop out earlier for other reasons, respectively
    Datum, zu dem der letzte Teilnehmer Visit 16 (Tag 61 +/- Tage; EOS) komplettiert hat bzw. Datum der letzten Visite des letzten Studienteilnehmers, sofern dieser vor Visite 16 ausgeschieden ist.
    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 months12
    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: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-05-07. Yes
    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
    Sedation to tolerate invasive mechanical Ventilation
    Sedierung aufgrund der invasiven mechanischen Ventilation
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state58
    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)
    expected Standard Treatment post ARSD and invasive mechanical ventilation
    übliche Standardtherapie nach ARDS und invasiver Beatmung
    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 Decision2020-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-18
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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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