Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39587   clinical trials with a EudraCT protocol, of which   6490   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-002009-25
    Sponsor's Protocol Code Number:SARSCov2EFTI1.0
    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:2020-06-04
    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 number2020-002009-25
    A.3Full title of the trial
    The efficacy and safety of Eftilagimod Alpha Treatment by immune modulation in COVID-19 disease (EAT COVID trial)
    Účinnost a bezpečnost léčby Eftilagimodem alfa imunitní modulací u onemocnění COVID-19 (studie EAT COVID)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The efficacy and safety of Eftilagimod Alpha Treatment in COVID-19 disease (EAT COVID trial)
    Účinnost a bezpečnost léčby Eftilagimodem alfa u onemocnění COVID-19 (studie EAT COVID)
    A.3.2Name or abbreviated title of the trial where available
    EAT COVID trial
    studie EAT COVID
    A.4.1Sponsor's protocol code numberSARSCov2EFTI1.0
    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 SponsorFakultni nemocnice Plzen
    B.1.3.4CountryCzech Republic
    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 supportLekarska fakulta UK Plzen
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFakultni nemocnice
    B.5.2Functional name of contact pointProf Martin Matejovic
    B.5.3 Address:
    B.5.3.1Street AddressAlej Svobody 80
    B.5.3.2Town/ cityPlzen
    B.5.3.3Post code30460
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420377103111
    B.5.5Fax number+420377103959
    B.5.6E-mailmatejovic@fnplzen.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 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 nameEftilagimod Alpha
    D.3.2Product code IMP321
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 disease
    nemoc COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 disease
    nemoc COVID-19
    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 PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We aim to assess the effects of Eftilagimod alpha (Efti) on the number of days alive without life-support in adult patients hospitalised with COVID-19. Eftilagimod Alpha leads to enhanced presentation of viral antigens to T-cells resulting in an effective, sustained antiviral response and viral clearance.
    Snažíme se posoudit účinky Eftilagimod alpha (Efti) na počet dnů života bez podpory orgánů u dospělých pacientů hospitalizovaných s COVID-19. Eftilagimod Alpha vede k lepší prezentaci virových antigenů T-buňkám, což vede k účinné a trvalé antivirové odpovědi a ke clearance viru.
    E.2.2Secondary objectives of the trial
    To evaluate the effects of Efti on indicators of inflammation, need for oxygen therapy, mechanical ventilation, length of hospitalisation and mortality.
    Vyhodnocení účinků Efti na ukazatele zánětu, potřeby kyslíkové terapie, mechanické ventilace, délky hospitalizace a úmrtnosti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults (>18yrs of age) with confirmed COVID-19 disease who require hospital admission
    2. Need for less than 8L/min of O2 via supplemental device to maintain SpO2 > 92%
    3. Signed informed consent by patient
    1. Dospělí (18 let a více) s potvrzenou nemocí COVID-19, kteří vyžadují hospitalizaci
    2. Potřebují méně než 8L/min O2 prostřednictvím jakéhokoliv zařízení k udržení FiO2 > 92%
    3. Podepsaný informovaný souhlas pacienta
    E.4Principal exclusion criteria
    1. Patients who require > 8L O2/min via a supplemental device to maintain SpO2>92%
    2. Patients who are in shock as defined by vasopressor requirements
    3. Patients with clear limitations of treatment (not for intubation)
    4. Moribund patients
    5. Pregnant patients
    6. Known allergy to Eftilagimod Alpha, or L-Arginine
    1. Pacienti, kteří potřebují > 8L O2/min prostřednictvím doplňkového zařízení k udržení SpO2>92%
    2. Pacienti, kteří jsou v šoku - definováno požadavky na vasopresor
    3. Pacienti s jasnými omezeními léčby (ne pro intubaci)
    4. Umírající pacienti
    5. Těhotné pacientky
    6. Známá alergie na Eftilagimod Alpha, nebo L-arginin
    E.5 End points
    E.5.1Primary end point(s)
    patient’s clinical status (on a 7-point ordinal scale) at day 15 as per an adapted WHO recommended study protocol.

    1. Not hospitalized,
    2. Hospitalized, not requiring supplemental oxygen
    3. Hospitalized, requiring supplemental oxygen
    4. Hospitalized, on high flow oxygen device
    5. Hospitalized in ICU, on non-invasive ventilation
    6. Hospitalized in ICU, on invasive mechanical ventilation or ECMO
    7. Death
    klinický stav pacienta (v 7-bodové řadové stupnici) v den 15 podle upraveného protokolu doporučeného WHO.

    1. Nehospitalizován
    2. Hospitalizován, nevyžaduje doplňkový kyslík
    3. Hospitalizován, vyžadující doplňkový kyslík
    4. Hospitalizován, na vysokoprůtokovém kyslíkovém zařízení
    5. Hospitalizován na JIP, na neinvazivní ventilaci
    6. Hospitalizován na JIP, na invazivní mechanické ventilaci nebo ECMO
    7. Smrt
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 15 post study entry
    Den 15 od zařazení do studie
    E.5.2Secondary end point(s)
    1. Supplemental oxygen free days in the first 28 days (up to day 29)
    2. Ventilator free days in the first 28 days (up to day 29)
    3. Subject clinical status (on a 7-point ordinal scale as above) at day 7 and day 21, respectively
    4. ICU LOS
    5. Hospital LOS
    6. Mortality at 28 and 90 days
    1. Dny bez přídatného kyslíku v prvních 28 dnech (až do dne 29)
    2. Dny bez ventilátoru v prvních 28 dnech (do dne 29)
    3. Klinický stav subjektu (na stupnici 7 bodů, jak je uvedeno výše) v den 7 a v den 21
    4. Délka hospitalizace na JIP
    5. Délka hospitalizace v nemocnici
    6. Smrtnost ve dnech 28 a 90 dnů
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7, 21, 28, and 90 post study entry
    7, 21, 28 a 90 dnů po vstupu do studie
    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 Yes
    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 Yes
    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 years2
    E.8.9.1In the Member State concerned months
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    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 2020-06-04. 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 state104
    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
    Žádný
    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 Decision2020-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-01
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA