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    Summary
    EudraCT Number:2020-003401-60
    Sponsor's Protocol Code Number:CT-P59_3.1
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-30
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2020-003401-60
    A.3Full title of the trial
    A Phase 2/3, Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of CT-P59 in Combination with Standard of Care in Hospitalized Patients with SARS-CoV-2 Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to evaluate the Efficacy and Safety of CT-P59 in Combination with Standard of Care in Hospitalized Patients with SARS-CoV-2 Infection
    A.4.1Sponsor's protocol code numberCT-P59_3.1
    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 SponsorCELLTRION, Inc.
    B.1.3.4CountryKorea, Republic of
    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 supportCELLTRION, Inc.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCELLTRION, Inc.
    B.5.2Functional name of contact pointSung Hyun Kim
    B.5.3 Address:
    B.5.3.1Street Address23, Academy-ro, Yeonsu-gu
    B.5.3.2Town/ city Incheon
    B.5.3.3Post code22014
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+82 32850 5000
    B.5.5Fax number+82 32850 5050
    B.5.6E-mailSungHyun.Kim@celltrion.com
    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.3.2Product code CT-P59
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeCT-P59
    D.3.9.3Other descriptive nameCT-P59
    D.3.9.4EV Substance CodeSUB215555
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Novel severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) infection
    E.1.1.1Medical condition in easily understood language
    Covid 19 infection
    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 10084271
    E.1.2Term SARS-CoV-2 test positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1
    To assess that CT-P59 has the potential therapeutic efficacy relative to Placebo as determined by time to recovery, defined as the first day, during the 28 days after enrollment, on which a patient satisfied categories 1, 2, or 3 on the 8-point ordinal scale for 7 days.
    Part 2
    To demonstrate that CT-P59 has the clinical meaningful therapeutic efficacy relative to Placebo as determined by the time to recovery, defined as the first day, during the 28 days after enrollment, on which a patient satisfied categories 1, 2, or 3 on the 8-point ordinal scale for 7 days.
    E.2.2Secondary objectives of the trial
    Part 1
    To evaluate overall safety of CT P59
    Part 2
    To evaluate the additional efficacy of CT-P59
    To evaluate overall safety of CT P59, including immunogenicity and potential effects on the incidence of antibody-dependent enhancement (ADE)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patient is male or female aged 18 years or older.
    2.Patient has local laboratory confirmation of SARS-CoV-2 infection by RT-PCR from the upper or lower respiratory tract specimens no more than 4 days prior to the administration of the study drug.
    Note: If there is available test result confirmed as SARS-CoV-2 infection prior to obtaining written informed consent (but no more than 4 days prior to the administration of the study drug) and that result was from the RT-PCR by the upper or lower respiratory tract specimen, that test result can be allowed.
    Note: During the screening period, only one re-test for RT-PCR will be allowed if study drug can be administered no more than 10 days from onset of symptom based on re-test results.
    3.Onset of symptom no more than 10 days prior to the administration of the study drug.
    4.Patient with conditions meeting the following criteria, and currently hospitalized (or will be hospitalized prior to the administration of the study drug):
    a)Oxygen saturation ≤ 94% on room air and/or PaO2/FiO2 ratio ≤ 300 mgHg, AND
    b)Requiring supplemental oxygen.
    5.Patient with abnormal radiographic findings in lung suggestive of SARS-CoV-2 infection by investigator’s discretion.
    6.Patient's weight is of ≤ 99.9 kg.
    7.Patient and/or their legally authorized representative must be informed and given ample time and opportunity to read and/or understand the nature and purpose of this study including possible risks and side effects and must sign the informed consent form (ICF) before any study specific procedures.
    8.Patient and their partner of childbearing potential must agree to use a highly effective method of contraception throughout the study (up to 6 months after the study drug administration) as specified in Section 6.2.2.7.
    E.4Principal exclusion criteria
    1.Patient who is requiring extracorporeal membrane oxygenation (ECMO), or invasive mechanical ventilation.
    2.Patient had a history of and/or concurrent use of medications including any therapy of following(s):
    a)Drugs with possible anti-SARS-CoV-2 activity or immunomodulators including but not limited to remdesivir, chloroquine, hydroxychloroquine, dexamethasone (alternative corticosteroids to dexamethasone), tocilizumab, sarilumab, and other immunomodulatory agents and human immunodeficiency virus (HIV) protease inhibitors for therapeutic purpose of SARS-CoV-2 infection prior to the study drug administration.
    Note: During the study, authorized drugs (or drugs approved for emergency use) against SARS-CoV-2 infection such as remdesivir or dexamethasone (alternative corticosteroids to dexamethasone), could be used by investigator’s discretion considering the local practice where there is available supply
    b)Any SARS-CoV-2 human intravenous immunoglobulin (hIVIG), convalescent plasma from a person who recovered from SARS-CoV-2 infection or SARS-CoV-2 nMAb for the treatment of SARS-CoV-2 infection prior to the study drug administration.
    c)Any other investigational device or medical product including but not limited to any monoclonal antibody, fusion proteins or biologics for the treatment of SARS-CoV-2 infection prior to the study drug administration.
    d)Use of medications that are contraindicated with SoC.
    e)SARS-CoV-2 vaccine prior to the study drug administration.
    3.Patient has known allergy or hypersensitivity reaction to any monoclonal antibody or to any components of study drug.
    4.Patient has a history of and/or current disease or medical condition including any of following(s):
    a)Any active malignancy.
    b)Known severe liver disease (e.g., cirrhosis, or an Alanine Aminotransferase [ALT] level >5 × upper limit of normal [ULN], or an Aspartate Aminotransferase [AST] level >5 × the ULN).
    c)Renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.
    d)Any medical condition that, in the opinion of the site investigator, would place the patient at an unreasonably increased risk through participation in this study, including any past or concurrent conditions that would preclude randomization to one or more of the assigned treatment groups.
    e)Stroke or myocardial infarction, which is suspected to be related to SARS-CoV-2 infection after the onset of symptom.
    f)Documented current infection with HIV, hepatitis B or hepatitis C.
    5.Patient who has received any other investigational device or medical product within 4 weeks prior to the study drug administration or 5 half-lives, whichever is longer.
    6.Patient currently abuses alcohol or drugs.
    7.Patient is not eligible for the study participation for whatever reason (including clinical laboratory results) in the opinion of the investigator, or shows evidence of a condition (psychological, emotional problems, any disorders or resultant therapy) that is likely to invalidate informed consent, or limited the ability of the patient to comply with the protocol requirements in the opinion of the investigator, or unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study, or is unable to give written informed consent or to comply fully with the protocol.
    8.Anticipated transfer to another hospital which is not a study site.
    9.Female patient who is currently pregnant or breastfeeding or planning to be pregnant or to breastfeed, or male patient is planning to father a child or donate sperms throughout the study (up to 6 months after the study drug administration).
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints
    The 8-point ordinal scale will be evaluated as primary endpoint (Section 6.1.1);
    - Time to recovery, defined as the first day, during the 28 days after enrollment, on which a patient satisfied categories 1, 2 or 3 on the 8-point ordinal scale for 7 days.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    Day 28
    E.5.2Secondary end point(s)
    Secondary efficacy and safety endpoints will be analyzed throughout the study.
    The following parameters for the study drug will be determined as secondary endpoints:
    •Proportion of recovered patients on Day 7, 14 and 28
    •Proportion of intensive care unit transfer on Day 14 and 28
    •Mortality rate on Day 14, 28 and 90
    •Clinical status by the 8-point ordinal scale on Day 7, 14 and 28
    •Time to improvement of at least 1 point from the status at baseline by 8-point ordinal scale up to Day 28
    •Change from baseline of the 8-point ordinal scale on Day 7, 14 and 28
    •Duration of hospitalization in survivors up to Day 28
    •Number of free days of supplemental oxygen up to Day 28
    •Proportion of new mechanical ventilation use on Day 14 and 28
    •Change from baseline of National Early Warning Score (NEWS) on Day 7, 14 and 28

    Safety endpoints:
    The safety endpoints will be assessed using the followings: AEs (including SAEs and AESI), potential effects on the incidence of ADE, immunogenicity, vital signs, hypersensitivity monitoring, ECG findings, SARS-CoV-2 infection related signs and symptoms, radiography (chest x-ray or chest CT), physical examination findings, clinical laboratory tests, pregnancy tests, and prior and concomitant medications.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7
    Day 14
    Day 28
    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 No
    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) Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Bulgaria
    Germany
    India
    Korea, Republic of
    Mexico
    Peru
    Poland
    Romania
    Russian Federation
    South Africa
    Sweden
    Ukraine
    United States
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 700
    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)
    Standard care
    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 Decision2020-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
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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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