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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   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:2020-001632-10
    Sponsor's Protocol Code Number:SARS-CoV-2CP-HD-001
    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:2020-04-20
    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 number2020-001632-10
    A.3Full title of the trial
    A Randomized Open label Phase-II Clinical Trial with or without Infusion of Plasma from Subjects after Convalescence of SARS-CoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease
    Eine randomisierte offene klinische Phase-II-Studie mit oder ohne Infusion von Plasma von Patienten nach überstandener SARS-CoV-2 Infektion bei Hochrisikopatienten mit bestätigter schwerer SARS-CoV-2 Erkrankung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized Open label Phase-II Clinical Trial with or without Infusion of Plasma from Subjects after Convalescence of SARS-CoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease
    Eine randomisierte offene klinische Phase-II-Studie mit oder ohne Infusion von Plasma von Patienten nach überstandener SARS-CoV-2 Infektion bei Hochrisikopatienten mit bestätigter schwerer SARS-CoV-2 Erkrankung
    A.3.2Name or abbreviated title of the trial where available
    RECOVER
    A.4.1Sponsor's protocol code numberSARS-CoV-2CP-HD-001
    A.5.4Other Identifiers
    Name:EudraCT-N°Number:2020-001632-10
    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 SponsorRuprecht-Karls-Universität Heidelberg, Medical Faculty, University Hospital Heidelberg - Represented by its
    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 supportBMBF (application submitted)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Heidelberg; Dpt. of Internal Medicine V Hematology, Oncology and Rheumatology
    B.5.2Functional name of contact pointProf. Dr. Carsten Müller-Tidow
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 410
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.4Telephone number+49622156 8001
    B.5.5Fax number+49622156 33639
    B.5.6E-mailCarsten.Mueller-Tidow@med.uni-heidelberg.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 nameRekonvaleszentenplasma COVID-19 Apherese (HD)
    D.3.2Product code CP COVID19
    D.3.4Pharmaceutical form 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
    Coronavirus disease 2019 (COVID-19) / SARS-CoV-2 Disease
    E.1.1.1Medical condition in easily understood language
    Coronavirus Disease 2019 (COVID-19)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the time from randomization until an improvement defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of SARS-CoV-2 infection or standard of care.
    E.2.2Secondary objectives of the trial
    1. To assess overall survival, and the overall survival rate at 28, 56 and 84 days.
    2. To assess SARS-CoV-2 viral clearance and load, cytokine changes over time as well as antiviral antibody titers.
    3. To assess percentage of patients that required mechanical ventilation.
    4. To assess time from randomization until discharge.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. PCR confirmed SARS-CoV-2 infection in a respiratory tract sample.

    2. Oxygen saturation (SaO2) of 93% or less while breathing ambient air or a ratio of the
    partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of less than 300 mm Hg.

    3. High risk due to either pre-existing or concurrent hematological malignancy and/or ongoing chemotherapy for
    cancer (group 1)

    and/or
    chronic immunosuppression not meeting the criteria of group 1 (group 2)

    and/or
    Age ≥ 50 - 75 years meeting neither the criteria of group 1 nor group 2 (group 3)
    and at least one of these criteria: Lymphopenia < 0.8 x G/l
    and/or
    D-dimer > 1μg/mL

    and/or
    Age ≥ 75 years meeting neither the criteria of group 1 nor group 2 (group 4).

    4. Provision of written informed consent.

    5. Patient is able to understand and comply with the protocol for the duration of the study, including treatment and scheduled visits and examinations.

    6. Male or female patient aged ≥ 18 years.

    7. Postmenopausal or evidence of non-childbearing status. For women of childbearing potential: negative urine or serum pregnancy test within 14 days prior to study treatment.
    E.4Principal exclusion criteria
    1. Dementia, psychiatric or cognitive illness or recreational drug/alcohol use that in the
    opinion of the principle investigator, would affect subject safety and/or compliance.

    2. Contraindication to transfusion or history of prior reactions to transfusion blood
    products.

    3. Patients with known selective IgA deficiency.

    4. Patients with mechanical ventilation and/or extracoporal membrane oxygenation
    (ECMO) at time of initial inclusion into the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Time to clinical improvement by two points on
    a seven point ordinal scale or live discharge from the hospital.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment response is assessed continuously until day 28, thereafter weekly until day 56,
    70 and finally at day 84.
    E.5.2Secondary end point(s)
    - Overall survival, defined as the time from randomization until death from any cause.

    - 28-day, 56-day and 84-day overall survival rates.

    - SARS-CoV-2 viral clearance and load as well as antibody titers.

    - Requirement mechanical ventilation (yes/no).

    - Time until discharge from randomization, taking death as competing risk into account.

    - Viral load, changes in antibody titers and cytokine profiles are analyzed in an exploratory manner using paired non-parametric tests (before – after treatment).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuously.
    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 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 No
    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 Yes
    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.8.2.4Number of treatment arms in the trial2
    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 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
    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 months
    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: 87
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 87
    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 No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state174
    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)
    After finishing all study-relevant procedures, therapy and follow-up period, all study patients will be followed in terms of routine care and treated if necessary.
    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 Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-19
    P. End of Trial
    P.End of Trial StatusOngoing
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