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    Summary
    EudraCT Number:2020-004682-39
    Sponsor's Protocol Code Number:KFJ-2020-02_NORMOSANG
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-13
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2020-004682-39
    A.3Full title of the trial
    Pilot, open-label, monocentric study evaluating safety and clinical effect of application of NORMOSANG® in patients with COVID-19 disease
    Pilotní, otevřená, monocentrická studie hodnotící bezpečnost a klinický efekt podání přípravku NORMOSANG® u pacientů s onemocněním COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot, open-label, monocentric study evaluating safety and clinical effect of application of NORMOSANG® in patients with COVID-19 disease
    Pilotní, otevřená, monocentrická studie hodnotící bezpečnost a klinický efekt podání přípravku NORMOSANG® u pacientů s onemocněním COVID-19
    A.4.1Sponsor's protocol code numberKFJ-2020-02_NORMOSANG
    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 SponsorThomayerova nemocnice
    B.1.3.4CountryCzechia
    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 supportThomayerova nemocnice
    B.4.2CountryCzechia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThomayerova nemocnice
    B.5.2Functional name of contact pointSkopek -trial coordinator
    B.5.3 Address:
    B.5.3.1Street AddressVidenska 800
    B.5.3.2Town/ cityPraha
    B.5.3.3Post code14059
    B.5.3.4CountryCzechia
    B.5.4Telephone number420261082567
    B.5.6E-mailjiri.skopek1@ftn.cz
    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 NORMOSANG
    D.2.1.1.2Name of the Marketing Authorisation holderRecordati Rare Diseases
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameNormosang
    D.3.4Pharmaceutical form Concentrate for concentrate for 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 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
    Patients with COVID -19 disease
    Pacienti trpící infekcí COVID-19
    E.1.1.1Medical condition in easily understood language
    Patients with COVID -19 disease
    Pacienti trpící infekcí 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 verify safety and the potential of a registered drug in the fight against a highly contagious pandemic disease
    ověřit bezpečnost a potenciál registrovaného léčiva v boji proti vysoce nakažlivému pandemicky se šířícímu onemocnění
    E.2.2Secondary objectives of the trial
    - monitoring the frequency of worsening of patients into severe disease with the need for supportive lung ventilation;
    -monitoring of time to normalization of immunological parameters;
    -monitoring of time to normalization of body temperature, CRP, leukocyte count;
    -monitoring of the hospital lenght;
    - monitoring the rate of virus elimination from HCD secretions;
    -monitoring of the occurrence of adverse events
    -sledování četnosti zhoršení pacientů do těžké formy onemocnění s potřebou podpůrné plicní ventilace;
    -sledování doby do normalizace imunologických parametrů
    -sledování doby do normalizace tělesné teploty, CRP, počtu leukocytů,
    -sledování doby hospitalizace;
    -sledování rychlosti eliminace viru ze sekretů HCD;
    -sledování výskytu nežádoucích příhod
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Women or men aged 18 to 65 years;
    • Laboratory-proven COVID-19 disease (SARS-CoV-2 proven PCR) from upper airway swabs
    • Diseases with moderate clinical manifestations requiring hospitalization (eg fever, SpO2 ≥ 93% presence of respiratory symptoms - eg cough, dyspnea and / or X-ray infiltrate findings), as assessed by the treating physician;
    • Women of childbearing potential who may become pregnant must have a negative urine or blood pregnancy test at the initial visit and use an acceptable method of contraception for the duration of the study;
    (Acceptable methods of contraception include: barrier spermicide, oral, transdermal, injectable or implantable contraception, intrauterine device, abstinence, and surgical sterilization of the partner)
    Women who cannot become pregnant: after hysterectomy, bilateral oophorectomy, bilateral tubal ligation, are after menopause for at least 12 months or with proven infertility for any reason;
    • The patient's ability to cooperate and sign the informed consent form
    •Ženy nebo muži ve věku 18 až 65 let;
    •Laboratorně prokázané onemocnění COVID-19 (SARS-CoV-2 prokázaný PCR) ze stěru horních cest dýchacích
    •Onemocnění s klinickými projevy středního stupně vyžadující hospitalizaci (například zvýšená teplota, SpO2 ≥ 93% přítomnost respiračních symptomů – např. kašel, dyspnea a/nebo přítomnost RTG nálezu infiltrátu), dle hodnocení ošetřujícího lékaře;
    •Ženy ve fertilním věku, které mohou otěhotnět musí mít negativní těhotenský test v moči nebo krvi při vstupní návštěvě a používají přijatelnou metodu antikoncepce po dobu trvání studie;
    (Přijatelné metody antikoncepce zahrnují: spermicid s bariérou, orální, transdermální, injekční nebo implantovatelnou antikoncepci, nitroděložní zařízení, abstinenci a chirurgickou sterilizaci partnera)
    Ženy které nemohou otěhotnět: po hysterektomii, bilaterální ooforektomii, bilaterální tubální ligaci, jsou po menopauze alespoň 12 měsíců nebo s prokázanou neplodností z jakéhokoli důvodu;
    •Schopnost pacienta spolupracovat a podepsat formulář informovaného souhlasu
    E.4Principal exclusion criteria
    • Need for pulmonary ventilation at study entry;
    • Known hypersensitivity to the active substance;
    • Pregnancy and breast-feeding;
    • Value of Fe2 +, ferritin, Hb, HCT (all above ULN);
    • Patients with ongoing uncontrolled cardiac, metabolic, endocrinological, hepatic, renal, neurological or psychiatric illnesses in whom participation in a clinical trial could pose an additional risk at the discretion of the study physician
    •Potřeba plicní ventilace v čase vstupu do studie;
    •Známá hypersenzitivita na léčivou látku;
    •Těhotenství a kojení.
    •Hodnota Fe2+, ferritin, Hb, HCT (vše nad ULN)
    •Pacienti s probíhajícím nekontrolovaným kardiálním, metabolickým, endokrinologickým, hepatálním, renálním, neurologickým či psychiatrickým onemocněním, u kterých by účast v klinickém hodnocení mohla podle uvážení studijního lékaře představovat dodatečné riziko;
    E.5 End points
    E.5.1Primary end point(s)
    confirmation of safety of the drug
    Průkaz bezpečnosti podání přípravku
    E.5.1.1Timepoint(s) of evaluation of this end point
    within 28 days after drug administration
    během 28 dnů od podání léčiva
    E.5.2Secondary end point(s)
    - evaluation of the change in symptom score
    -- influence on selected laboratory parameters during the development of COVID-19 disease
    - monitoring the frequency of deterioration of patients into severe disease with the need for supportive lung ventilation;
    - monitoring the time to normalization of immunological parameters
    - monitoring of time to normalization of body temperature, CRP, leukocyte count,
    - monitoring of hospitalization time;
    - monitoring the rate of virus elimination from HCD secretions;
    - monitoring for adverse events.
    -vyhodnocení změny symptomového skóre
    -ovlivnění vybraných laboratorních parametrů v průběhu rozvoje onemocnění COVID-19
    -sledování četnosti zhoršení pacientů do těžké formy onemocnění s potřebou podpůrné plicní ventilace;
    -sledování doby do normalizace imunologických parametrů
    -sledování doby do normalizace tělesné teploty, CRP, počtu leukocytů,
    -sledování doby hospitalizace;
    -sledování rychlosti eliminace viru ze sekretů HCD;
    -sledování výskytu nežádoucích příhod.
    E.5.2.1Timepoint(s) of evaluation of this end point
    weekly, till Day 28
    týdně, do dne 28
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) 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 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.8.2.4Number of treatment arms in the trial1
    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
    1) last visit of the last subject undergoing the trial
    2) premature end of trial due to lack of patients or safety concerns
    1) poslední návštěva posledního subjektu účastnícího se studie
    2) předčasné ukončení studie z důvodu nedostatku pacientů nebo pro obavy o bezpečnost pacientů
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state8
    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)
    no special study treatment is planned
    žádná další léčba po skončení studie není plánována
    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 Decision2020-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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