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    The EU Clinical Trials Register currently displays   43926   clinical trials with a EudraCT protocol, of which   7306   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:2020-003503-34
    Sponsor's Protocol Code Number:Uni-Koeln-4288
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-10
    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 number2020-003503-34
    A.3Full title of the trial
    A Phase 1/2a Trial of the Intravenous Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals
    Eine Phase-1/2a-Studie der intravenösen Verabreichung des SARS-CoV-2-neutralisierenden monoklonalen Antikörpers DZIF-10c an SARS-CoV-2-infizierte und -uninfizierte Personen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to test the safety, half-life, and antiviral efficacy of a new drug (human antibody) called DZIF-10c (administered intravenously) in healthy volunteers and SARS-CoV-2-infected participants
    Studie zur Bewertung der Sicherheit, Halbwertszeit und antiviralen Wirksamkeit eines neuen Medikamentes (humaner Antikörper) namens DZIF-10c (intravenös verabreicht) mit gesunden Personen und mit SARS-CoV2 infizierten Personen
    A.3.2Name or abbreviated title of the trial where available
    DZIF-10c_Infusion
    DZIF-10c_Infusion
    A.4.1Sponsor's protocol code numberUni-Koeln-4288
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04631666
    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 SponsorUniversity of Cologne
    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 supportGerman Center for Infection Research (DZIF)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBoehringer Ingelheim
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTC Cologne
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressGleueler Str. 269
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50935
    B.5.3.4CountryGermany
    B.5.4Telephone number0049221478 88790
    B.5.5Fax number0049221478 88209
    B.5.6E-mailsebastian.meller@uk-koeln.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 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 nameDZIF-10c
    D.3.2Product code EX 14870
    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 INNEX 14870
    D.3.9.2Current sponsor codeEX 14870
    D.3.9.3Other descriptive nameDZIF-10c
    D.3.9.4EV Substance CodeSUB218333
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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
    SARS-CoV-2 infection (only mild to moderate disease)
    SARS-CoV-2 Infektion mit leichten oder mildem Krankheitsbild
    E.1.1.1Medical condition in easily understood language
    COVID-19 (only mild to moderate disease)
    COVID-19 mit leichten oder mildem Krankheitsbild
    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 LLT
    E.1.2Classification code 10084272
    E.1.2Term SARS-CoV-2 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 evaluate the safety and tolerability of a single intravenous infusion of DZIF-10c in SARS-CoV-2-uninfected and SARS-CoV-2-infected individuals.
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    - To determine the pharmacokinetics of DZIF-10c after a single intravenous infusion.
    - To determine the development of antibodies targeting DZIF-10c (anti-drug antibodies, ADA) following a single DZIF-10c infusion.
    - To evaluate the effect of a single DZIF-10c infusion on viral shedding in nasopharyngeal swabs by qRT-PCR in SARS-CoV-2-infected individuals.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Groups 1A-1D
    - Age 18 to 65.
    - SARS-CoV-2-RNA negative naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).
    - Non-reactivity of serum antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.

    Groups 2C-2D
    - Age 18 to 70.
    - SARS-CoV-2-RNA positive naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).
    - Onset of COVID-19 symptoms (e.g., sore throat, cough, fever, chills, fatigue, dys- or anosmia, dys- or angeusia, headache, muscle pain, gastrointestinal symptoms) within 7 days prior to study drug administration
    OR
    Non-reactivity of serum or plasma antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.
    - Disease severity score 1-4 as defined by the WHO Clinical Progression Scale (WHO, Lancet Inf Dis 2020)
    E.4Principal exclusion criteria
    - Known hypersensitivity to any constituent of the investigational medicinal product.
    - Hepatitis B infection indicated by detectable HBsAg (Hepatitis B surface antigen) in blood.
    - Detectable antibodies against hepatitis C virus in blood unless active hepatitis C is ruled out by negative HCV-RNA.
    - HIV infection indicated by detectable HIV antigen and/or HIV antibodies in blood.
    - Blood laboratory parameter abnormalities as listed below
    - Neutrophil count ≤1,000 cells/µl
    - Hemoglobin ≤10 g/dl
    - Platelet count ≤100,000 cells/µl
    - ALT ≥2.0 x ULN
    - AST ≥2.0 x ULN
    - Total bilirubin ≥1.5 ULN
    - eGFR <60 ml/min/1.73m2
    - Pregnancy or lactation.
    - Any vaccination within 14 days prior to DZIF-10c administration.
    - Receipt of any SARS-CoV-2 vaccine or SARS-CoV-2 monoclonal antibody in the past.
    - Diagnosis of bronchial asthma or history of bronchial hyperresponsiveness, COPD, pulmonary fibrosis, or other chronic lung diseases.
    - Any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer.
    - History of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months (a single administration of systemic corticosteroids within ≤6 months and ≥4 weeks of enrollment is acceptable).
    - Participation in another clinical trial of an investigational medicinal product within the past 12 weeks or expected participation during this study.
    - Dependency on the principal investigator or study staff; or site personnel directly affiliated with this trial.
    - Legally incapacitated individuals
    - Individuals held in an institution by legal or official order
    - If engaging in sexual activity that could result in pregnancy, inability or unwilligness to comply with the requirements for highly effective contraception.
    E.5 End points
    E.5.1Primary end point(s)
    The rate of adverse events that occur during study
    E.5.1.1Timepoint(s) of evaluation of this end point
    - The dose limiting toxicity (DLT) period comprises the first 7 days after treatment with DZIF-10c, adverse evnets until End of follow up period (90 day after treatment with DZIF-10c)
    E.5.2Secondary end point(s)
    - The pharmacokinetic profile of DZIF-10c, including elimination half-life, peak serum concentration, area under the curve, clearance, and volume of distribution.
    - The frequency and magnitude of anti-drug antibodies targeting DZIF-10c following DZIF-10c infusion.
    - SARS-CoV-2 RNA shedding in nasopharyngeal swabs determined by qRT-PCR in SARS-CoV-2-infected individuals.
    E.5.2.1Timepoint(s) of evaluation of this end point
    please see protocol
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    1) open-label dose-escalation phase, 2 ) Randomized double-blind placebo-controlled phase
    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 concerned6
    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 years
    E.8.9.1In the Member State concerned months10
    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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state69
    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 Decision2020-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-11
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