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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   42732   clinical trials with a EudraCT protocol, of which   7035   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
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    Summary
    EudraCT Number:2021-000864-32
    Sponsor's Protocol Code Number:NL76798.078.21
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-03-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-000864-32
    A.3Full title of the trial
    A Phase I-II study of virus neutralizing antibodies against SARS-CoV-2. A focus on convalescent plasma and hyperimmune anti-SARS-CoV2 immunoglobulines
    Een fase I-II studie over virus neutraliserende antilichamen tegen SARS-CoV-2. Focus op convalescent plasma en hyperimmune anti-SARS-CoV-2 antilichamen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The ConvP COVig PKPD study: an investigation for the use of plasma or antibodies against the novel coronavirus (SARS-CoV-2)
    De ConvP COVig PKPD studie: een onderzoek naar nuttig gebruik van plasma of antilichamen voor behandeling van het nieuwe coronavirus (SARS-CoV-2)
    A.3.2Name or abbreviated title of the trial where available
    ConvP COVig PKPD study
    ConvP COVig PKPD studie
    A.4.1Sponsor's protocol code numberNL76798.078.21
    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 SponsorErasmus MC
    B.1.3.4CountryNetherlands
    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 supportZONMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointBart Rijnders
    B.5.3 Address:
    B.5.3.1Street Address's-Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015CE
    B.5.3.4CountryNetherlands
    B.5.6E-mailb.rijnders@erasmusmc.nl
    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 Nanogam 100 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderSanquin Plasma Products B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical 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) No
    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
    COVID-19 or protective effect against in B-cell depleted patients
    COVID-19 of bescherming tegen deze infectie bij B-cel gedepleteerde patiënten
    E.1.1.1Medical condition in easily understood language
    Patient with a weakened immune system
    Patiënten met een verminderd immuunsysteem
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084464
    E.1.2Term COVID-19 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 create a population pharmacokinetic model of SARS-COV-2 neutralizing antibodies as present in ConvP and Nanogam plus.
    Het ontwikkelen van een farmacokinetisch model van SARS-CoV2- neutraliserende antilichamen, aanwezig in ConvP en Nanogam plus.
    E.2.2Secondary objectives of the trial
    We will test this on patients with B-cell depletion and/or dysfunction. Because they are unable or hardly able to make neutralizing antibodies themselves, this could give them a protective effect against COVID19.

    Safety of convalescent plasma or nanogam will be evaluated
    Dit zal getest worden op patiënten met B-cel depletie of dysfunctie. Deze groep heeft echter weinig tot geen kans tot aanmaken van eigen neutraliserende antistoffen. Dit zou hen een protectief effect kunnen geven tegen een COVID-19 infectie.

    Veiligheid van convalescent plasma of nanogam zullen geëvalueerd worden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    18 years or older
    Written informed consent
    B-cell depeleted status because of: prior B-cell depletion therapy (latest administration <6 monthts) or common variable immune deficiency requiring IVIG substitution
    18 jaar of ouder,
    Geïnformeerde toestemming gegeven
    B-cel gedepleteerde status na één van volgende:
    o B-cel depleterende therapie
    o CVID (common variable immuundeficiëntie waarvoor IVIG substitutie noodzakelijk)
    E.4Principal exclusion criteria
    Symptoms of respiratory infection at time of inclusion
    Anti-SARS-CoV2 antibodies prior to administration of study product
    Positive SARS-CoV-2 PCR
    Known previous history of transfusion-related acute lung injury
    Known IgA deficiency
    Known hypersensitivity to human immunoglobulins
    Liver cirrhosis
    Received anti-SARS-CoV-2 vaccination in the 4 weeks preceding screening or between screening and baseline
    Symptomen van een bovenste luchtweginfectie
    Aanwezigheid van anti-SARS-CoV2 antilichamen voor toediening van het studieproduct
    Positieve SARS-CoV-2 PCR
    Voorgeschiedenis van transfusie-gerelateerde acute longschade
    Gekende IgA deficiëntie
    Gekende overgevoeligheid aan humane immunoglobulines
    Levercirrose
    Anti-SARS-CoV-2 vaccinatie 4 weken of minder voor screening of tussen screening en inclusie
    E.5 End points
    E.5.1Primary end point(s)
    Main study parameter/endpoint
    • Pharmacokinetics of virus neutralizing antibodies of convalescent plasma

    • Pharmacokinetics of virus neutralizing antibodies of Nanogam plus
    Primair eindpunt:
    - Farmacokinetisch model van virus neutraliserende antilichamen na toediening van convalescent plasma

    - Farmacokinetisch model van virus neutraliserende antilichamen na toediening van Nanogam plus
    E.5.1.1Timepoint(s) of evaluation of this end point
    Control of titer before administration of study product. One and 24 hours post-administration.
    After 3 and 7 days
    After 2, 4, 6, 8, 12, 18 and 24 weeks
    Controle van antistoftiter:
    Voor toediening van studieproduct
    Na 1 en 24 uur
    Na 3 en 7 dagen
    Na 2, 4, 6, 8, 12, 18 en 24 weken
    E.5.2Secondary end point(s)
    • The incidence of COVID-19 during follow-up until antibody levels have become undetectable
    • Percentage of patients with adverse events after administration of convalescent plasma
    • Percentage of patients with adverse events after administration of Nanogamplus
    Other study parameters (if applicable)
    • Whenever a breakthrough infection is diagnosed, we will do everything possible to collect the SARS-CoV-2 strain for sequencing in order to identify new or emerging variants of concern (e.g. strain 501.V2 or P.1 also known as the South-African or Brazilian variant) to evaluate the virus neutralizing capacity of the ConvP or Nanogamplus that the patient received.
    - Incidentie van COVID-19 tijdens follow-up van antilichaam titers tot ze niet meer detecteerbaar zijn.

    - Percentage van patiënten met ernstige bijwerkingen na toediening van convalescent plasma
    - Percentage van patiënten met ernstige bijwerkingen na toediening van Nanogam plus

    Indien er een doorbraakinfectie gediagnosticeerd is, zal er geprobeerd worden het virus-strain te isoleren en sequencen ter opsporing van mutanten (zoals de Zuid-Afrikaanse of Britse variant) om zo de virus neutraliserende capaciteit van het toegediende middel te evalueren.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Same timepoints of main end point
    Zelfde tijdstippen als primair eindpunt
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Determining the perfect dose of convalescent plasma or Nanogam.
    Determinering van de perfecte dosis convalescent plasma of Nanogam
    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 No
    E.8.1.1Randomised No
    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 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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Last visit last subject
    Laatste bezoek van laatste patiënt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    B-cell depleted patients
    B-cell gedepleteerde patiënten
    F.4 Planned number of subjects to be included
    F.4.1In the member state104
    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
    Geen
    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 Decision2021-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-04-04
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