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    Summary
    EudraCT Number:2020-001310-38
    Sponsor's Protocol Code Number:CAPSID2020-DRK-BSD
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-31
    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 number2020-001310-38
    A.3Full title of the trial
    A randomized, prospective, open label clinical trial on the use of convalescent plasma compared to best supportive care in patients with severe COVID-19
    Randomisierte, prospektive, offene klinische Studie von Rekonvaleszentenplasma verglichen mit bestmöglicher supportiver Behandlung bei Patienten mit schwerer COVID-19-Erkrankung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study to assess positive value of blood plasma from donors having built immunity against the new corona virus (SARS-CoV-2) transfused to patients suffering from SARS-CoV-2 infection
    Klinische Studie zur Überprüfung der positiven Wirkung der Übertragung von Blutplasma von Spendern mit nachgewiesener Immunität gegen das neuartige Coronavirus (SARS-CoV-2) auf Patienten mit Infektion durch SARS-CoV-2
    A.3.2Name or abbreviated title of the trial where available
    Convalescent Plasma against COVID-19
    Rekonvaleszentenplasma gegen COVID-19
    A.4.1Sponsor's protocol code numberCAPSID2020-DRK-BSD
    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 SponsorDRK-Bluspendedienst Baden-Württemberg - Hessen gGmbH
    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 supportMinistry of Health
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIKT Ulm
    B.5.2Functional name of contact pointSixten Körper
    B.5.3 Address:
    B.5.3.1Street AddressHelmholtzstr. 10
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89081
    B.5.3.4CountryGermany
    B.5.4Telephone number0049731150519
    B.5.5Fax number0049731150509
    B.5.6E-mails.koerper@blutspende.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 Yes
    D.2.1.1.1Trade name Fresh frozen plasma (FFP) with marketing authorisation in Germany issued by PEI
    D.2.1.1.2Name of the Marketing Authorisation holderGerman marketing authorization holders for FFPs participating in this study
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameFor example "Gefrorenes Frischplasma / Apherese DRK Blutspendedienst"
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 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
    Patients with SARS-CoV-2 infection and:
    1. age ≥ 18 years and ≤ 75 years
    2. SARS-CoV-2 infection confirmed by PCR (BAL, sputum, nasal and/or pharyngeal
    swap)
    3. severe disease defined by at least one of the following:
    a. respiratory rate ≥ 30 breaths / minute under ambient air
    b. requirement of any type of ventilation support
    c. needs ICU treatment
    Patienten mit SARS-CoV-2-Infektion und:
    1. Alter ≥ 18 und ≤ 75 Jahre
    2. SARS-CoV-2-Infektion bestätigt durch PCR (BAL, Sputum, Nasen-/Rachenabstrich)
    3. schwere Erkrankung definiert durch eines der folgenden Kriterien:
    a. Atemfrequenz ≥ 30/Minute unter Umgebungsluft
    b. Notwendigkeit jeglicher Beatmungsunterstützung
    c. Notwendigkeit intensivmedizinischer Betreuung
    E.1.1.1Medical condition in easily understood language
    COVID-19 can cause pneumonias, which in severe cases can require automated assisted ventilation. In this context potentially fatal multiorgan dysfunction and circulatory failure may occur as well.
    COVID-19 kann Lungenentzündungen auslösen. In schweren Fällen ist eine maschinelle Beatmung erforderlich. Es können auch potentiell tödliches Kreislaufversagen und Multiorganversagen auftreten.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10047475
    E.1.2Term Viral pneumonia, unspecified
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10070267
    E.1.2Term SARS virus test positive
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021433
    E.1.2Term Immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10054540
    E.1.2Term Passive immunization
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To improve survival

    AND

    remove criteria of severe COVID-19 (CoV-2 infection) within 21 days after randomization
    Verlängerung des Überlebens

    UND

    Wegfallen der Kriterien für eine schwere COVID-19-Erkrankung (CoV-2-Infektion) innerhalb von 21 Tagen nach Randomisierung
    E.2.2Secondary objectives of the trial
    - Time to clinical improvement on WHO R&D Blueprint seven-category ordinal scale by 2
    - Adverse events
    - Case fatality rate on days 21, 35 and 60
    - Length of hospital stay
    - Length of ICU stay
    - Duration of ventilation Support / ECMO
    - Time until negative SARS-CoV-2 PCR
    - Predictive value of comorbidities and inflammation markers
    - Feasibility of collection of plasma units
    - Kinetics of anti-SARS-CoV-2 antibodies in plasma of patients = plasma donors who recovered
    from a SARS-CoV-2 infection
    - Titer of anti-SARS-CoV-2 in transfused plasma units
    - Impact of donor characteristics on anti-SARS-CoV-2 humoral response
    - Course of anti-SARS-CoV-2 titer in patients
    - Effect of timing of plasma transfusions on outcome
    - Dauer bis zur klinischen Verbesserung auf siebenstufiger WHO R&D Blueprint-Skala um 2
    - Unerwünschte Wirkungen
    - Todesfallraten an den Tagen 21, 35 und 60
    - Dauer des Krankenhausaufenthaltes
    - Dauer des Aufenthaltes auf Intensivstation
    - Dauer der apparativen Beatmung / ECMO
    - Zeitdauer bis SARS-CoV-2-PCR negativ
    - Prädiktiver Wert von Begleiterkrankungen und Entzündungsparametern
    - Verfügbarkeit der notwendigen Plasmapräparate
    - Kinetik von Anti-SARS-CoV-Antikörpern im Plasma von Patienten = Plasmaspender, die von
    einer SARS-CoV-2-Infektion genesen sind
    - Anti-SARS-CoV-2-Antikörpertiter in transfundierten Plasmapräparaten
    - Einfluss von Spendercharakteristika auf die humorale Anti-SARS-CoV-2-Antwort
    - Verlauf der anti-SARS-CoV-2-Antikörpertiter in Patienten
    - Einfluss des Zeitpunkts der Plasmatransfusionen auf den Krankheitsverlauf
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with SARS-CoV-2 infection and:
    1. age ≥ 18 years and ≤ 75 years
    2. SARS-CoV-2 infection confirmed by PCR (BAL, sputum, nasal and/or pharyngeal
    swap)
    3. severe disease defined by at least one of the following:
    a. respiratory rate ≥ 30 breaths / minute under ambient air
    b. requirement of any type of ventilation support
    c. needs ICU Treatment
    4. Written informed consent by patient or legally authorized representative
    Patienten mit SARS-CoV-2-Infektion und:
    1. Alter ≥ 18 und ≤ 75 Jahre
    2. SARS-CoV-2-Infektion bestätigt durch PCR (BAL, Sputum, Nasen-/Rachenabstrich)
    3. schwere Erkrankung definiert durch eines der folgenden Kriterien:
    a. Atemfrequenz ≥ 30/Minute unter Umgebungsluft
    b. Notwendigkeit jeglicher Beatmungsunterstützung
    c. Notwendigkeit intensivmedizinischer Betreuung
    4. Aufklärung und vom Patienten oder einem gesetzlichen Vertreter unterschriebene
    Einverständniserklärung
    E.4Principal exclusion criteria
    1. Accompanying diseases other than COVID-19 with an expected survival time of
    less than 12 months
    2. In the opinion of the clinical team, progression to death is imminent and
    inevitable within the next 48 hours, irrespective of the provision of treatment
    3. Interval > 72 hours since start of ventilation support
    4. Not considered eligible for extracorporeal oxygenation support (even in case of
    severe ARDS according to Berlin classification with Horovitz-Index < 100 mg Hg)
    5. Chronic obstructive lung disease (COPD), stage 4
    6. Lung fibrosis with UIP pattern in CT and severe emphysema
    7. Chronic heart failure NYHA ≥ 3 and/or pre-existing reduction of left ventricular
    ejection fraction to ≤ 30%
    8. Cardiovascular failure requiring ≥ 0.5 µg/kg/min noradrenaline (or equivalent) or
    requiring more than two types of vasopressor medication
    9. Liver cirrhosis Child C
    10. Liver failure: Bilirubin > 5 x ULN and elevation of ALT or AST (> 10 x ULN)
    11. Any history of adverse reactions to plasma proteins
    12. Known deficiency of immunoglobulin A
    13. Pregnancy
    14. Breastfeeding women
    15. Volume overload until sufficiently treated
    16. Pulmonary edema
    17. Participation in another clinical trial for treatment of COVID-19
    1. Begleiterkrankungen neben COVID-19 mit einer Lebenserwartung < 12 Monaten
    2. Behandlungsunabhängige, infauste Prognose innerhalb der nächsten 48 Stunden
    3. Zeitintervall > 72 Stunden seit Beginn der maschinellen Beatmung
    4. Nicht geeignet für ECMO
    5. COPD Stadium 4
    6. Lungenfibrose und schweres Emphysem
    7. Chronische Herzinsuffizienz (NYHA ≥ 3) und/oder vorbestehende Reduktion der
    linksventrikulären Ejektionsfraktion ≤ 30%
    8. Herzkreislaufversagen mit Bedarf von ≥ 0.5 µg/kg/min Noradrenalin (oder
    Äquivalent) oder Bedarf von mehr als 2 vasopressorisch aktiven Substanzen
    9. Leberzirrhose Child C
    10. Leberversagen: Erhöhung des Bilirubins (> 5 x oberer Normwert) und Erhöhung
    der ALT oder der AST (> 10 x oberer Normwert)
    11. Anamnestisch unerwünschte Arzneimittelwirkungen gegenüber Plasmaproteinen
    12. Bekannte Immunoglobulin A-Defizienz
    13. Schwangerschaft
    14. Stillzeit
    15. Volumenüberladung
    16. Lungenödem
    17. Teilnahme an einer anderen Studie zur Behandlung von COVID-19
    E.5 End points
    E.5.1Primary end point(s)
    Composite endpoint of:

    - Survival

    AND

    - no longer fulfilling criteria of severe COVID-19 within 21 days after randomization

    All criteria must be met in order to fulfill the primary endpoint.
    Kombinierter Endpunkt bestehend aus:

    - Überleben

    UND

    - Wegfallen der Kriterien für eine schwere COVID-19-Erkrankung (CoV-2-Infektion) innerhalb von 21 Tagen nach Randomisierung

    Beide Kriterien müssen gegeben sein, um den kombinierten primären Endpunkt zu erfüllen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment group: Day 21

    Control group: Days 14 and 21
    Behandlungsgruppe: Tag 21

    Kontrollgruppe: Tage 14 und 21
    E.5.2Secondary end point(s)
    - Time to clinical improvement on WHO R&D Blueprint seven-category ordinal scale by 2
    - Adverse events
    - Case fatality rate on days 21, 35 and 60
    - Length of hospital stay
    - Length of ICU stay
    - Duration of ventilation Support / ECMO
    - Time until negative SARS-CoV-2 PCR
    - Predictive value of comorbidities and inflammation markers
    - Feasibility of collection of plasma units
    - Kinetics of anti-SARS-CoV-2 antibodies in plasma of patients = plasma donors who recovered
    from a SARS-CoV-2 infection
    - Titer of anti-SARS-CoV-2 in transfused plasma units
    - Impact of donor characteristics on anti-SARS-CoV-2 humoral response
    - Course of anti-SARS-CoV-2 titer in patients
    - Effect of timing of plasma transfusions on outcome
    - Dauer bis zur klinischen Verbesserung auf siebenstufiger WHO R&D Blueprint-Skala um 2
    - Unerwünschte Wirkungen
    - Todesfallraten an den Tagen 21, 35 und 60
    - Dauer des Krankenhausaufenthaltes
    - Dauer des Aufenthaltes auf Intensivstation
    - Dauer der apparativen Beatmung / ECMO
    - Zeitdauer bis SARS-CoV-2-PCR negativ
    - Prädiktiver Wert von Begleiterkrankungen und Entzündungsparametern
    - Verfügbarkeit der notwendigen Plasmapräparate
    - Kinetik von Anti-SARS-CoV-Antikörpern im Plasma von Patienten = Plasmaspender, die von
    einer SARS-CoV-2-Infektion genesen sind
    - Anti-SARS-CoV-2-Antikörpertiter in transfundierten Plasmapräparaten
    - Einfluss von Spendercharakteristika auf die humorale Anti-SARS-CoV-2-Antwort
    - Verlauf der anti-SARS-CoV-2-Antikörpertiter in Patienten
    - Einfluss des Zeitpunkts der Plasmatransfusionen auf den Krankheitsverlauf
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment group: Prior to transfusion of convalescent plasma on days 1, 3 and 5 and one day after infusion (days 2, 4 and 6) and every week thereafter up to day 21.

    Cross-over group: Prior to transfusion of convalescent plasma on days 15, 17 and 19 and one day after infusion (days 16, 18 and 20) and every week thereafter up to day 35.
    Behandlungsgruppe: Vor Transfusion des Konvaleszentenplasmas an den Tagen 1, 3 and 5 und einen Tag nach Infusion (Tage 2, 4 and 6) sowie danach einmal wöchentlich bis Tag 21

    Cross-over-Gruppe: Vor Transfusion des Konvaleszentenplasmas an den Tagen 15, 17 und 19 und einen Tag nach Infusion (Tage 16, 18 und 20) sowie danach einmal wöchentlich bis Tag 35
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Cross-over erlaubt bei Patienten mit fortschreitender COVID-19-Erkrankung
    Cross-over allowed for patients with progressive COVID-19
    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
    Beste supportive Therapie
    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 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
    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 months10
    E.8.9.1In the Member State concerned 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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 2020-03-31. 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
    Legal representative

    OR

    Combination of alleged patient will PLUS opinion of a physician independent of the clinical trial team
    Gesetzlicher Vertreter

    ODER

    Kombination aus mutmaßlichem Patientenwillen PLUS Meinung eines nicht an der Studie beteiligten Arztes
    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)
    None
    Keine
    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 Decision2020-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-06
    P. End of Trial
    P.End of Trial StatusOngoing
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