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    The EU Clinical Trials Register currently displays   43617   clinical trials with a EudraCT protocol, of which   7208   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:2022-000714-33
    Sponsor's Protocol Code Number:PT26/17/01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-20
    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 - BfArM
    A.2EudraCT number2022-000714-33
    A.3Full title of the trial
    Efficacy and safety of Tiprelestat for treatment of severe COVID-19
    (COMCOVID trial)
    Wirksamkeit und Sicherheit von Tiprelestat zur Behandlung von schwerem COVID-19
    (COMCOVID Studie)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of Tiprelestat for treatment of severe COVID-19
    (COMCOVID trial)
    Wirksamkeit und Sicherheit von Tiprelestat zur Behandlung von schwerem COVID-19
    (COMCOVID Studie)
    A.3.2Name or abbreviated title of the trial where available
    COMCOVID trial
    COMCOVID Studie
    A.4.1Sponsor's protocol code numberPT26/17/01
    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 Sponsortiakis Biotech AG (formerly Proteo Biotech AG)
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supporttiakis Biotech AG (formerly Proteo Biotech AG)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportFederal Minestry of Education and Research
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationtiakis Biotech AG (formerly Proteo Biotech AG)
    B.5.2Functional name of contact pointPreclinical a. Clinical Development
    B.5.3 Address:
    B.5.3.1Street AddressSophienblatt 40
    B.5.3.2Town/ cityKiel
    B.5.3.3Post code24103
    B.5.3.4CountryGermany
    B.5.4Telephone number004915784009570
    B.5.5Fax numberBitteeintragen
    B.5.6E-mailhvzepelin@tiakis.bio
    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 nameTiprelestat
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTiprelestat
    D.3.9.1CAS number 820211-82-3
    D.3.9.3Other descriptive nameElafin
    D.3.9.4EV Substance CodeSUB192674
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number10
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboInfusion (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult patients with COVID-19 fulfilling the following criteria:
    - First laboratory-confirmation of the current episode of SARS-CoV-2 infection (COVID-19) as determined by PCR or antigen test (no self-tests) in any defined specimen collected within 10 days prior to trial enrolment.
    - Hospitalization for COVID-19 treatment
    - Oxygen therapy by mask / nasal prong (score 5 according to WHO COVID-19 clinical progression scale)
    E.1.1.1Medical condition in easily understood language
    Adult patients with PCR or rapid test confirmed COVID-19 (within last 10 days) hospitalized for COVID-19 with oxygen by mask or nasal prong.
    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 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of a 7-days treatment with Tiprelestat in patients who have been hospitalized for the treatment of COVID-19
    E.2.2Secondary objectives of the trial
    To assess the safety of Tiprelestat compared to placebo applied in patients who have been hospitalized for the treatment of COVID-19
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent and data protection declaration prior to initiation of any trial procedures
    2. Patient ≥18 years of age at time of enrolment and capable of providing informed consent by him-/herself
    3. Patient with COVID-19 fulfilling the following criteria:
    a. First laboratory-confirmation of the current episode of SARS-CoV-2 infection (COVID-19) as determined by PCR or antigen test (no self-tests) in any defined specimen collected within 10 days prior to trial enrolment.
    b. Hospitalization for COVID-19 treatment
    c. Oxygen therapy by mask / nasal prong (score 5 according to WHO COVID-19 clinical progression scale)
    E.4Principal exclusion criteria
    1. Life time expectancy of 2 days or less as judged by the investigator
    2. Malignant disease requiring chemotherapy, radiation therapy and / or immune therapy at the time of enrolment
    3. Patient requiring dialysis
    4. Concomitant respiratory disease requiring supplemental oxygen therapy, apart from COVID-19
    5. Only for female patients of childbearing potential: Pregnancy, positive pregnancy test on Day 1, breast feeding or no effective contraception
    6. Current or previous participation within the past 30 days in another interventional clinical trial with an investigational product
    7. Known to be or suspected of being unable to comply with the clinical trial protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
    8. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial
    9. Patient in custody by juridical or official order evidence of an uncooperative attitude
    10. Patient, who is a member of the staff of the trial center, staff of the sponsor or contract research organization (CRO), the investigator him- / herself or close relatives of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Number of days with any oxygen support (i.e. WHO COVID-19 clinical progression scale ≥5)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 after randomization to Day 29 or Day 1 after randomization to Day of Discharge, if earlier
    E.5.2Secondary end point(s)
    - Proportion of patients [n/N] with progression to severe disease according to the WHO COVID-19 clinical progression scale (score ≥6) (time frame: Day 1 after randomization to Day 29 or Day 1 after randomization to Day of Discharge, if earlier)
    - Time to first occurrence of severe disease (score ≥6) according to the WHO COVID-19 clinical progression scale *
    - Number of days of severe disease (score ≥6) according to the WHO COVID-19 clinical progression scale *
    - Number of days in ICU *
    - Number of days with ‘dyspnea’ *
    - Number of days with ‘fatigue’ *
    - 28-day mortality [n/N]
    - 90-day mortality [n/N]
    * Time frame: Day 1 after randomization to Day 29 or Day 1 after randomization to Day of Discharge, if earlier
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 after randomization to Day 29 or Day 1 after randomization to Day of Discharge, if earlier
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Ib: Additional pharmacokinetic whether Tiprelestat accumulates in the first 33 patients
    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 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 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 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: 96
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state296
    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)
    Plans for treatment or care after the subject ends the participation correspond to the expected treatment of that condition.
    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 Decision2023-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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