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    The EU Clinical Trials Register currently displays   39185   clinical trials with a EudraCT protocol, of which   6421   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-004695-18
    Sponsor's Protocol Code Number:RES-Q-HR
    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:2020-10-15
    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 number2020-004695-18
    A.3Full title of the trial
    Reconvalescent plasma/Camostat mesylate early in Sars-CoV-2 Q-PCR positive high risk individuals
    Rekonvaleszenten Plasma / Camostat mesylat bei Sars-CoV-2 Q-PCR-positiven Personen mit hohem Risiko im Frühstadium
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Plasma from Covid 19 recovered patients or camostat as a therapy for early SARS-CoV-2 infection in high risk individuals
    Plasma von Covid 19-genesenen Patienten oder Camostat als Therapie für frühe SARS-CoV-2-Infektionen bei Personen mit hohem Risiko für einen schweren Verlauf
    A.3.2Name or abbreviated title of the trial where available
    RES-Q HR
    A.4.1Sponsor's protocol code numberRES-Q-HR
    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 SponsorHeinrich-Heine-University Düsseldorf
    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 supportBundesministerium für Gesundheit
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Center Düsseldorf
    B.5.2Functional name of contact pointClinic for Gastroenterology, Hepato
    B.5.3 Address:
    B.5.3.1Street AddressMoorenstr. 5
    B.5.3.2Town/ cityDüsseldorf
    B.5.3.3Post code40225
    B.5.3.4CountryGermany
    B.5.4Telephone number00492118116330
    B.5.5Fax number00492118118752
    B.5.6E-mailverena.keitel@med.uni-duesseldorf.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 Foipan
    D.2.1.1.2Name of the Marketing Authorisation holderOno Pharmaceutical Co., Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameFoipan
    D.3.2Product code ONO 305
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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.IMP: 2
    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 nameconvalescent plasma
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The novel coronavirus designated SARS CoV-2, and the disease caused by this virus designated COVID-19. No treatment is available for early disease stages and non-hospitalized patients to date. This trial focusses on SARS-CoV-2 positive patients with pre-existing risk factors for a moderate or severe COVID-19 disease course.
    E.1.1.1Medical condition in easily understood language
    SARS-CoV-2 infected patients to be treated at an early stage after positive testing and of high risk to develop moderate to severe and potentially life-threatening pneumonia.
    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 10053983
    E.1.2Term Corona virus infection
    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 10084272
    E.1.2Term SARS-CoV-2 infection
    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 10084442
    E.1.2Term SARS-CoV-2 PCR test positive
    E.1.2System Organ Class 100000004848
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The working hypothesis to be tested in the RES-Q HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO COVID-19 ordinal scale within 28 days after randomization.
    E.2.2Secondary objectives of the trial
    Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 4b-8 by day 8, day 14, day 56 and day 90;
    Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 3-4a by day 8, day 14, day 28, day 56 and day 90;
    "Event-free” survival at day 90 and evaluation of all-cause mortality at day 90 using Kaplan-Meier;
    The proportion of patients with remdesivir therapy and WHO status at initiation of remdesivir;
    The proportion of patients on dexamethasone therapy and WHO status at baseline dexamethasone;
    Time to resolution of COVID-19 related symptoms (e.g. fever);
    Time to first negative SARS-CoV-2-PCR ;
    Duration of oxygen therapy (in days);
    Frequency of occurrence of COVID-19 pneumonia;
    Percentage of participants in each group with need for mechanical ventilation (and ventilation days);
    Duration of hospital stay (in days), duration in intensive care/IMC (in days);
    All-cause mortality at day 28
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Individuals ≥ 18 years with SARS-CoV-2 infection, confirmed by PCR before study enrollment
    2. SARS-CoV-2 positive PCR ≤ 3 days old (date of NP swab)
    3. Presence of ≥ 1 SARS-CoV-2 typical symptom (fever, cough, shortness of breath, sore throat, headache, fatigue, smell/and or taste disorder, diarrhea, abdominal symptoms, exanthema) and symptom duration ≤ 3 days.
    4. Ability to provide written informed consent, or presence of appointed legal guardian or authorized representative who can be informed in the patient's interest and can provided informed consent
    5. Presence of at least one of the following criteria:
    - Patients > 75 years
    - Patients > 65 years with at least one other risk factor (BMI >35 kg/m2, coronary artery disease, CKD with GFR <60 ml/min, diabetes mellitus, active tumor disease)
    - Patients with a BMI >35 kg/m2 with at least one other risk factor (CAD, CKD with GFR <60 ml/min, diabetes mellitus, active tumor disease)
    - Patients with a BMI >40 kg/m2
    - Patients with chronic obstructive pulmonary disease (COPD) and/or pulmonary fibrosis
    - Patients with CKD and a GFR <30 ml/min
    - Patients with chronic liver disease defined as liver cirrhosis child B or C
    E.4Principal exclusion criteria
    1. Age <18 years
    2. Pregnant women or breast-feeding mothers
    3. Previous transfusion reaction or other contraindication to a plasma transfusion
    4. Known hypersensitivity to camostat mesylate and/or severe pancreatitis
    5. Volume stress due to CP administration would be intolerable
    6. Known IgA deficiency
    7. Life expectancy < 6 months
    8. Duration SARS-CoV-2 typical symptoms > 3 days
    9. SARS-CoV-2 PCR detection older than 3 days
    10. SARS-CoV-2 associated clinical condition ≥ WHO stage 3 (patients hospitalized for other reasons than COVID-19 may be included if they fulfill all inclusion and none of the exclusion criteria)
    11. Previously or currently hospitalized due to SARS-CoV-2
    12. Previous antiviral therapy for SARS-CoV-2
    13. ALT or AST > 5 x ULN at screening
    14. Accommodation in an institution due to legal orders (§40(4) AMG).
    15. Any psycho-social condition hampering compliance with the study protocol.
    16. Evidence of current drug or alcohol abuse.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the number of individuals whose clinical status is on the COVID-19 modified WHO ordinal scale ≥ 4b up to and including day 28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 3-4a by day 28
    E.5.2Secondary end point(s)
    • Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 4b-8 by day 8, day 14, day 56 and day 90
    • Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 3-4a by day 8, day 14, day 28, day 56 and day 90
    • "Event-free” (not hospitalized, no COVID-19 associated long-term effects such secondary sclerosing cholangitis, pulmonary disease, no reinfection) survival at day 90 and evaluation of all-cause mortality at day 90 using Kaplan-Meier
    E.5.2.1Timepoint(s) of evaluation of this end point
    Results of study visits day 8, day 14, day 28, day 56 and day 90 after inclusion into the study.
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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
    4-arm, multicenter, randomized, partly double-blind, controlled trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned15
    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 months6
    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: 199
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 795
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Approximately 80% of subjects are expected to be 65 years and older. Some of these patients might be incapable of giving consent personally. From subjects, which cannot give consent personally, a legal guardian must give consent for the subject.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state994
    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
    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 Decision2020-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-12
    P. End of Trial
    P.End of Trial StatusOngoing
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