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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2021-006621-22
    Sponsor's Protocol Code Number:COVIC-19-G
    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:2021-12-23
    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 number2021-006621-22
    A.3Full title of the trial
    A Randomised Open-Label Trial of Early, Very High-Titre Convalescent Plasma Therapy in Clinically Vulnerable Individuals with Mild COVID-19 as model of early treatment in a pandemia with a new pathogen – Trial in Germany
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the efficacy of recovalescent plasma in vulnerable individuals with early-stage covid-19
    A.3.2Name or abbreviated title of the trial where available
    COVIC-19 study
    A.4.1Sponsor's protocol code numberCOVIC-19-G
    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-Blutspendedienst 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 supportBundesministerium für Bildung und Forschung
    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 AddressHelmholtzstraße 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.3.4Pharmaceutical 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
    Clinically Vulnerable Individuals with Mild COVID-19
    E.1.1.1Medical condition in easily understood language
    Patients with early stage of COVID-19, who are at high risk of developing a severe course
    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 10084355
    E.1.2Term COVID-19 virus test positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of plasma from COVID-19 convalescent donors (COVID-19 convalescent plasma) and standard of care versus standard of care alone in preventing hospitalisation or death by day 28 after randomisation, in clinically vulnerable patients recently infected by SARS-CoV-2.
    Standard of care therapy may include anti-SARS-CoV-2 specific medication listed as authorized in a dedicated appendix.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of COVID-19 convalescent plasma on:
    1. Hospitalisation for severe COVID-19
    2. Hospitalisation for severe COVID-19 requiring O2 support
    3. All-cause mortality
    4. Requirement for supplemental oxygen
    5. Requirement for non-invasive ventilation
    6. Requirement for mechanical ventilation
    7. The change in WHO Clinical Progression Scale score
    8. The duration of hospital stay
    9. The need for admission to ITU
    10. The duration of ITU stay
    11. Cases of long COVID-19 symptoms and the time to recovery
    12. Health-related quality of life

    To analyse the safety of COVID-19 convalescent plasma with regard to:
    1. SAEs and unexpected AEs
    2. Arterial and venous thrombotic events

    For more information including the exploratory objectives, please refer to the current protocol version
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Two patient populations will be included in the study: (1) unvaccinated elderly and high COVID-age population and (2) high-risk immunocompromised population.

    (1) Unvaccinated elderly and high COVID-age population:
    1. SARS-CoV-2 RNA or SARS-CoV-2 antigen detected in a specimen, ≤ 7 days after onset of symptoms
    2. Symptoms of COVID-19 (so including but not limited to: fever; cough; breathlessness; chest pain; wheeze; sore throat; haemoptysis; runny nose; fatigue; muscle or joint pain; confusion; headache; seizures; nausea; vomiting; diarrhoea; abdominal pain; poor appetite; skin ulcers or rash; ear pain; conjunctivitis; anosmia; bleeding; lymphadenopathy.52 The attending clinician will determine if symptoms are consistent with COVID-19.
    3. Clinical status not requiring admission to hospital for COVID-19 disease and oxygen support
    4. Ability to transfuse (per randomisation) within 7 days after onset of symptoms
    5. Men or women, 70 years or older

    OR
    under 70 years with significant comorbidities (arterial hypertension, diabetes, obesity, asthma or other chronic pulmonary disease, cardiovascular disease, cerebrovascular disease, chronic kidney disease / dialysis, liver disease, chronic neurological disease, rheumatoid arthritis, lupus or psoriasis) resulting in a ‘COVID-age’ of 70 years or more according to the ALAMA risk calculator https://alama.org.uk/covid-19-medical-risk-assessment/
    6. Signed written informed consent


    (2) High-risk immunocompromised population
    1. SARS-CoV-2 RNA or SARS-CoV-2 antigen detected in a specimen, ≤ 7 days after onset of symptoms
    2. Symptoms of COVID-19 (so including but not limited to: fever; cough; breathlessness; chest pain; wheeze; sore throat; haemoptysis; runny nose; fatigue; muscle or joint pain; confusion; headache; seizures; nausea; vomiting; diarrhoea; abdominal pain; poor appetite; skin ulcers or rash; ear pain; conjunctivitis; anosmia; bleeding; lymphadenopathy.52 The attending clinician will determine if symptoms are consistent with COVID-19.
    3. Clinical status not requiring admission to hospital for COVID-19 disease and oxygen support
    4. Ability to transfuse (per randomisation) within 7 days after onset of symptoms
    5. Male or female Adult ≥18 years of age with extremely high risk including:
    a. Patients with at least one of the following acquired immune deficiencies:
    i. Lymphoid malignancies treated within the last 12 months
    ii. Lymphoid malignancies with persistent hypogammaglobulinaemia (IgG < 5 g/L)
    iii. Myeloid malignancies treated by chemotherapy within the last 12 months
    iv. Myeloid malignancies treated with anti-BCL-2 drugs within the last 12 months
    v. Myeloid malignancies associated with prolonged neutropenia (≥ 6 weeks)
    vi. Solid tumour undergoing treatment with chemotherapy (until 3 months after completion of the last chemotherapy cycle).
    vii. Allogenic hematopoietic stem cell transplantation within the last 12 months or anytime if on-going treatment for chronic GVHD
    viii. Organ transplantation
    ix. Anti - B (CD20/CD19) MoAb and/or mycophenolate mofetil treatment within the last 12 months
    x. Anti-CD19/CD20 CAR-T cell treatment
    xi. ATG or alemtuzumab treatment within the last 6 months
    xii. AIDS

    or
    b. Patients with primary lymphoid immune deficiencies:
    i. B cell deficiencies (such as Bruton agammaglobulinemia)
    ii. T cell deficiencies (such as Wiskott Aldrich disease)
    iii. Combined deficiencies (such as Common variable immunodeficiency )

    or
    c. Patients without detectable seroconversion ≥ 3 weeks after complete vaccination schedule with an approved vaccine.
    6. Signed written informed consent
    E.4Principal exclusion criteria
    (1) Unvaccinated elderly and high COVID-age population:
    1. Age < 18 years
    2. Prior or concurrent treatment for COVID-19 (unless listed as authorized specific treatment in the Appendix)
    3. History of documented SARS-CoV-2 infection in the last 90 days prior to enrolment
    4. Prior anti-SARS-CoV-2 immunization
    5. Contraindication to receiving CCP including previous history of transfusion-related acute lung injury (TRALI) or moderate or severe allergic reaction to blood components
    6. Known participant objection to receiving plasma products
    7. Primary or acquired immune deficiency listed below (see cohort 2)
    8. Refusal to participate expressed by patient or legally authorised representative
    9. Pregnancy

    (2) High-risk immunocompromised population
    1. Age < 18 years
    2. Prior or concurrent treatment for COVID-19 (dexamethasone, anti-IL-6/IL6R, remdesivir) except for prophylactic administration of anti-SARS-Cov2 monoclonal antibodies (pre or post exposure) in cohort 2 and authorized specific treatment in the Appendix)
    3. History of documented SARS-CoV-2 infection in the last 90 days prior to enrollment
    4. Contraindication to receiving CCP including previous history of transfusion-related acute lung injury (TRALI) or moderate or severe allergic reaction to blood components
    5. Known participant objection to receiving plasma products
    6. Refusal to participate expressed by patient or legally authorised representative
    7. Pregnancy

    Any patient eligible for both cohorts will be included in cohort 2.
    Enrolment in other trials after reaching the primary end-point is authorised.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint definition: the proportion of patients hospitalised or death by day 28.
    The primary outcome will be analysed using logistic regression adjusted for randomisation stratification variables (results will be expressed as odds ratios with 95% confidence intervals). Adjustment for major prognostic factors will be considered depending on the evolution of medical knowledge on the prognosis of patients infected by SARS-Cov-2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28 after randomisation
    E.5.2Secondary end point(s)
    Secondary endpoints include the following:
    • Proportion of hospitalisation for progressive COVID-19 symptoms, or death (stages 4 to 9 of the WHO scale)
    • Proportion of hospitalisation for progressive COVID-19 symptoms requiring O2 support, or death (stages 5 to 9 of the WHO scale)
    • All-cause mortality
    • Proportion of patients with supplemental oxygen
    • Proportion of patients with non-invasive ventilation
    • Proportion of patients with mechanical ventilation
    • Change in 10-point WHO Clinical Progression Scale score
    • Duration of hospital admission
    • Proportion of patients with ITU admission
    • Duration of ITU admission
    • Proportion of patients with long COVID-19 symptoms and time to recovery assessed by questionnaire
    • Participant experience assessed through validated quality of life questionnaires, including EQ-5D, and assessment of long COVID-19 symptoms

    Safety analysis of intervention
    Safety endpoints include the following:
    • Number of serious Adverse Events
    • Number of Grade 3 and 4 adverse events
    • Arterial and venous thromboembolic events

    Exploratory endpoints
    • Change in SARS-CoV-2 RNA level (Polymerase chain reactione, Cycle Threshold value) in oral or nose/throat swab samples
    • Change in anti-SARS-CoV-2 spike antibody levels in blood
    • SARS-CoV-2 whole-genome sequence analysis in oral or nose/throat swab samples
    • Proportion and clinical characteristics of patients with cultivable virus
    • Virus sequence variation and cultivability over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints:
    • Hospitalisation 14 and 28 days after randomisation
    • Mortality: day 28, 90, 180 after randomisation
    • Supplemental oxygen: day 14, 28 after randomisation
    • Ventilation: day 14, 28 after randomisation
    • ITU: 28 days after randomisation
    • Long COVID-19 symptoms and Quality of Life: day 28, 180 post randomisation

    Safety analysis:
    • SAEs and AE (Grade 3, 4): 72 h after randomisation
    • Arterial and venous thromboembolic events: 28, 90, 180 days after randomization

    Exploratory outcomes:
    • RNA level: day 3, 14, 28, hospitalization, 180 (cohort 2)
    • Anti-SARS-CoV-2 spike antibody levels: days 3, 14, 28, hospitalization
    • SARS-CoV-2 whole-genome sequence analysis: day 1, 28, hospitalization, 180
    • clinical characteristics: day 28, hospitalisation, 180
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    France
    Germany
    Netherlands
    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 years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 340
    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 2021-12-23. 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 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 state226
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 454
    F.4.2.2In the whole clinical trial 680
    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 the end of the trial, patients will be treated according to clinical routine
    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 Decision2022-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-14
    P. End of Trial
    P.End of Trial StatusOngoing
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