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    The EU Clinical Trials Register currently displays   40657   clinical trials with a EudraCT protocol, of which   6636   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001408-41
    Sponsor's Protocol Code Number:UKF-MIT-2020-01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-07
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-001408-41
    A.3Full title of the trial
    A prospective, randomized, double blinded placebo-controlled trial to evaluate the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of efficacy and safety of an tocilizumab treatment in patients with severe COVID-19 pneumonia
    A.3.2Name or abbreviated title of the trial where available
    TOC-COVID
    A.4.1Sponsor's protocol code numberUKF-MIT-2020-01
    A.5.4Other Identifiers
    Name:DRKS Number:DRKS00021238
    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 SponsorUniversitätsklinikum Freiburg
    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 supportUniversitätsklinikum Freiburg
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Freiburg
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressBreisacher Straße 153
    B.5.3.2Town/ cityFreiburg i. Br
    B.5.3.3Post code79110
    B.5.3.4CountryGermany
    B.5.4Telephone number+4976127034010
    B.5.5Fax number+497612709633322
    B.5.6E-mailtobias.wengenmayer@uniklinik-freiburg.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 RoActemra®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRoactemra®
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracavernous use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRoactemra®
    D.3.9.1CAS number 375823-41-9
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe COVID-19 pneumonia
    E.1.1.1Medical condition in easily understood language
    In many patients SARS-CoV2 causes a disease named COVID-19. In this trial patients with a pneumonia and severe respiratory insufficiency will be analyzed.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061229
    E.1.2Term Lung 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
    Evaluation of the efficacy and safety of a treatment with Tocilizumab in patients with severe COVID-19 pneumonia
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Proof of SARS-CoV2
    2. Severe respiratory failure:
    a. ambient air SpO2 ≤ 92% or
    b. Need of ≥ 6l O2/min or
    c. NIV (non-invasive ventilation) or
    d. IMV (invasive mechanical ventilation)
    3. ≥ 18 years
    4. Written informed consent obtained from the patient or legal authorized representative or investigator consilium (“Gießener Modell”) according to international guidelines and local laws;
    E.4Principal exclusion criteria
    1. Non-invasive or invasive mechanical ventilation ≥ 48 hours
    2. Pregnancy or breast feeding
    3. Liver injury or failure (AST/ALT ≥ 5x ULN)
    4. Leukocytes < 2 × 103/µl
    5. Thrombocytes < 50 × 103/μl
    6. Severe bacterial infection (PCT > 3ng/ml)
    7. Acute or chronic diverticulitis
    8. Immunosuppressive therapy (e.g. mycophenolate, azathioprine, methotrexate, biologicals, prednisolone >10mg/d; exceptions are: prednisolone ≤ 10mg/d, sulfasalazine or hydroxychloroquine)
    9. Known active or chronic tuberculosis
    10. Known active or chronic viral hepatitis
    11. Known allergic reactions to tocilizumab or its ingredients
    12. Life expectation of less than 1 year (independent of COVID-19)
    13. Participation in any other interventional clinical trial within the last 30 days before the start of this trial
    14. Simultaneous participation in other interventional trials (except for participation in COVID 19 trials) which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
    15. Failure to use one of the following safe methods of contraception: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception;
    Women can only take part in this study if the risk of becoming pregnant is absolutely minimized. Save contraceptive methods comprise: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception and have to be used while participating in the study
    E.5 End points
    E.5.1Primary end point(s)
    • Ventilator free days (d) (VFD) in the first 28 days after randomisation
    o NIV, IMV and ECMO are defined as ventilator days
    o VFD=0, if the patient dies in the first 28 days after randomisation
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after randomisation
    E.5.2Secondary end point(s)
    • Mortality
    o 28-day mortality (%)
    o Hospital mortality in the first 28 days (%)
    • Admission to intensive care unit (ICU) (%)
    • Days on ICU in the first 28 days (d)
    • IMV free days (d) in the first 28 days after randomisation
    o IMV and ECMO are defined as ventilator days
    o IMV free days =0, if the patient dies in the first 28 days
    • Time to successful extubation within 28 days after randomisation (d)
    • Renal failure (%) and renal replacement therapy (%)
    • Change of ventilation mode and invasiveness:
    o Horowitz Index (paO2/fiO2)
    o fiO2 on NIV/IMV
    o O2-level on O2 nasal cannula, O2 mask and High-flow nasal cannula
    o PEEP und compliance on NIV/IMV
    o Extracorporeal membrane oxygenation (ECMO) support
    • SOFA-Score
    • APACHE-II Score
    • Seven-category scale
    • Richmond Agitation Sedation Scale (RASS)
    • Glasgow Coma Scale
    • Laboratory (PCT, IL-6, Ferritin, D-Dimers)

    Until end of the study (extended follow up)
    • Overall survival after 12 months
    • QOL after 6 and 12 months

    • Secondary infections/ complications
    o Bacterial infection
    o Septic shock
    o Hepatitis / acute liver injury
    o Acute liver failure
    o Myocarditis and concomitant cardiogenic shock
    o Renal failure
    • (Serious) adverse events
    • Laboratory parameters
    Until end of the study (extended follow up):
    • SAEs related to IMP as per investigator’s judgment

    E.5.2.1Timepoint(s) of evaluation of this end point
    In the first 28 days after randomisation
    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 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 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
    LPLV
    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
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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
    Most subjects will be able to give informed consent. In subjects that are not able to do so - because of sedation in case of mechanical ventilation) - the conservator in law will give the informed consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    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 Decision2020-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-08-31
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