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    Summary
    EudraCT Number:2020-005486-14
    Sponsor's Protocol Code Number:EPIC-19
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-12-04
    Trial results View 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-005486-14
    A.3Full title of the trial
    Using of convalescent plasma in the treatment of COVID-19 patients with metabolomic and laboratory evaluation of the progress of plasma therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Using of convalescent plasma in the treatment of COVID-19 patients
    A.3.2Name or abbreviated title of the trial where available
    EPIC-19 (Efficacy of convalescent Plasma In Covid-19)
    A.4.1Sponsor's protocol code numberEPIC-19
    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 SponsorWroclaw Medical University
    B.1.3.4CountryPoland
    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 supportWroclaw Medical University
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment and Clinic of Internal and Occupational Diseases, Hypertension and Clinical Oncology Medical University
    B.5.2Functional name of contact pointClinical Trial Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressBorowska 213
    B.5.3.2Town/ cityWroclaw
    B.5.3.3Post code50-556
    B.5.3.4CountryPoland
    B.5.4Telephone number4871736 40 00
    B.5.6E-mailgrzegorz.mazur@umed.wroc.pl
    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 OSOCZE OZDROWIEŃCÓW COVID-19
    D.2.1.1.2Name of the Marketing Authorisation holderRegional Center for Blood donation and Haemotherapy name of prof dr hab. Tadeusz Dorobisz
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 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 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 Yes
    D.3.11.13.1Other medicinal product typeBlood component - plasma freshly frozen after inactivation from Covid-19 convalescents in full composition unprocessed industrially
    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 (Coronavirus Disease 2019) – acute infectious disease of the respiratory system caused by SARS-CoV-2 infection
    E.1.1.1Medical condition in easily understood language
    Covid-19 (Coronavirus Disease 2019) – acute infectious disease of the respiratory system caused by SARS-CoV-2 infection
    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
    Evaluation of the efficacy of convalescent plasma (CP) in COVID-19 therapy in the Polish population.
    Assessment of the difference in serological response in convalescents who have been infected with SARS-CoV-2 asymptomatically and convalescents with clinical symptoms of COVID-19.
    E.2.2Secondary objectives of the trial
    • Assessment of the impact of anti-SARS-CoV-2 antibodies (IgM, IgG, IgA) in convalescents on the effectiveness of CP therapy in COVID-19.
    • Assessment of CP safety in COVID-19 therapy in the Polish population;
    Exploratory objective: To determine new metabolomic markers in the blood of clinical trial participants - donors and recipients influencing and / or determining the clinical response to CP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    FOR CLINICAL TRIAL PARTICIPANTS – THE DONORS:
    Plasma donors will be recruited from two populations of COVID-19 recoveries: hospitalized and quarantined:
    1. Age: from 18 to 65 (inclusive)
    2. Body weight ≥ 50 kg
    3. Body temperature: Normal body temperature
    4. Heart rate: 50 to 100 beats per minute
    5. Arterial pressure: blood pressure values ≤180 mmHg for systolic pressure; ≤100 mmHg for diastolic pressure
    6. Positive assessment of health condition based on a medical examination
    7. Laboratory tests (obligatory for blood donors, before the procedure of collecting blood or its components): hemoglobin concentration or morphology, including the number of platelets, the number of white blood cells should remain within the laboratory norms according to the RCKiK SOP procedures
    8. Plasma donors will be recruited after meeting the mandatory criteria - according to the RCKiK procedure described in Appendix no. 13 to the protocol

    FOR CLINICAL TRIAL PARTICIPANTS – THE RECIPIENTS:

    Patients hospitalized with a diagnosis of severe COVID-19 who meet the following criteria will be eligible for plasma transfusion:
    1. Patients ≥18 years of age,
    2. Patients hospitalized with a diagnosis of severe COVID-19,
    3. Patients with SARS-CoV-2 infection confirmed by RT-PCR,
    4. Patients who meet at least one of the criteria:
    a. symptoms of respiratory failure with tachypnoea > 30 breaths / minute,
    b. blood O2 saturation <94%,
    c. O2 partial pressure (PaO2) ≤ 80 mmHg,
    d. MEWS severity score ≥ 3 points.
    E.4Principal exclusion criteria
    FOR CLINICAL TRIAL PARTICIPANTS – THE DONORS:
    Volunteers with absolute contraindications or with temporary inability to donate blood will not be included in the clinical trial.

    FOR CLINICAL TRIAL PARTICIPANTS – THE RECIPIENTS
    1. Patients with a history of hypersensitivity to plasma, including anaphylactic shock in previous transfusions, allergic reactions to citrate, primary IgA deficiency,
    2. Patients with symptoms of severe multi-organ failure,
    3. Patients with known allergic reactions to chemical compounds used or generated in the procedure of pathogens inactivation,
    4. Patients with active thrombosis.
    E.5 End points
    E.5.1Primary end point(s)
    1. Death, for any reason (within 28 days).
    2. The need for further hospitalization of the patient, assessed 28 days after administration of the investigational product - plasma.
    3. For subjects with respiratory assistance:
    a. time to take one's own breath (extubation), measured over a period of 28 days
    b. time of stay in the intensive care unit (ICU), measured over a period of 28 days
    c. time of disconnection from CPAP / High Flow ventilation, measured over a period of 28 days
    d. time to elimination of SARS-CoV-2 (RT-PCR), measured over a period of 28 days
    e. time to serological response (SARS-CoV-2 antibodies) measured in 1, 3, 7 and 28 days.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, Day 3, Day 7 and Day 28
    E.5.2Secondary end point(s)
    Major secondary endpoints:
    1. number of patients with hypersensitivity reactions after CP therapy
    2. number of patients with renal failure requiring renal replacement therapy
    3. number of patients with heart failure.
    Other secondary and exploratory endpoints:
    1. Changes in evaluation criteria in the following scales:
    a. SIRS,
    b. ECOG,
    c. MEWS
    d. Apache II
    assessed on the day of transfusion (day 0) and then on days 1, 3, 7 and 28 after plasma transfusion.
    2. Changes in laboratory parameters made during the qualification visit and on days 1, 3, 7 and 28 after plasma transfusion:
    a. Blood count with smear
    b. Inflammation parameters: CRP, procalcitonin, ferritin, D-Dimer, LDH
    c. Capillary gasometry
    3. Changes in the level of SARS-CoV-2 antibodies (IgM, IgG, IgA) determined during the qualification visit and after 3, 7 and 28 days after plasma transfusion.
    4. The number of new metabolomic markers in the blood of clinical trial participants - donors and recipients during the qualifying visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, Day 3, Day 7 and Day 28
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    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 months3
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 2020-12-04. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    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
    Covid-19 convalescents after infection with SARS-CoV-2/COVID-19
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    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 Decision2020-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-01-04
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