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    Summary
    EudraCT Number:2020-003369-20
    Sponsor's Protocol Code Number:CT-P59_3.2
    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 number2020-003369-20
    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 Outpatients 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 CT-P59 in Combination with Standard of Care in Outpatients with SARS-CoV-2 Infection
    A.4.1Sponsor's protocol code numberCT-P59_3.2
    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/ cityIncheon
    B.5.3.3Post code22014
    B.5.3.4CountryIreland
    B.5.4Telephone number+8232850 5000
    B.5.5Fax number+8232850 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.3.9.3Other descriptive nameCT-P59
    D.3.9.4EV Substance CodeSUB215555
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    SARS CoV 2 infection in outpatients
    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
    P 1 To assess the potential therapeutic efficacy of CT-P59 as determined by proportion of patient with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit up to Day 14/ To assess the potential therapeutic efficacy of CT-P59 as determined by time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture up to Day 14/ To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14/ To assess the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28 P 2 To demonstrate the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28
    E.2.2Secondary objectives of the trial
    Part 1 and 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.Adult male or female patient, aged 18 to 75 years, both inclusive.
    2.Patient is diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test.
    3.Patient with conditions meeting all of the following criteria:
    a.Oxygen saturation > 94% on room air.
    b.Not requiring supplemental oxygen.
    4.Patient whose onset of symptom is no more than 7 days prior to the study drug administration. Onset time of symptom is defined as the time when the patient experienced the presence of at least one SARS-CoV-2 infection associated symptom.
    5.Patient has one or more of the following (but not limiting to) SARS-CoV-2 infection associated symptoms within 7 days prior to the study drug administration:
    Feeling feverish
    Cough
    Shortness of breath or difficulty breathing
    Sore throat
    Body pain or muscle pain
    Fatigue
    Headache
    Chills
    Nasal obstruction or congestion
    Loss of taste or smell
    Nausea or vomiting
    Diarrhea
    6.Patient has one or more of the following SARS-CoV-2 infection associated symptoms present within 48 hours prior to the study drug administration:
    Feeling feverish
    Cough
    Shortness of breath or difficulty breathing
    Sore throat
    Body pain or muscle pain
    Fatigue
    Headache
    7.Patient with a body weight of ≤99.9 kg
    8.Patient (or legal guardian, if applicable) who is 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 ICF prior to participation in the study.
    9.For both male and female patients, the patient and his or her partner of childbearing potential who agree to use a highly effective or medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug as specified below:
    Combined (estrogen and progestogen containing) or progestogen-only hormonal contraception associated with inhibition of ovulation
    Intrauterine devices
    True abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence of the duration of exposure to investigational drug, and withdrawal are not acceptable methods of contraception.
    Condom in addition to use spermicide, hormonal contraceptive or barrier method in female; for male patient with his female partner of childbearing potential only. Spermicide condom (condoms coated with spermicide) use alone is not allowed.
    Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use any highly effective or medically acceptable methods of contraception. Menopausal females must have experienced their last period more than 12 months prior to the date of informed consent to be classified as not of childbearing potential.
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria will be excluded from the study: 1.Patient with current serious condition meeting one of the following criteria: a.Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions.. b.Respiratory distress with respiratory rate ≥ 30 breaths/min. c.Requires supplemental oxygen. d.Experience shock. e.Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator’s discretion. 2.Patient who has received or has a plan to receive any of following prohibited medications or treatments: a.Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to remdesivir, chloroquine, hydroxychloroquine (unless used chronically for autoimmune diseases), dexamethasone, and other immunomodulatory agents and human immunodeficiency virus (HIV) protease inhibitors for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration. b.Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration. c.Any other investigational device or medical product including but not limited to any monoclonal antibody (tocilizumab, sarilumab, etc.), 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 who has a current or history of any of the following infections: a.Any active infection other than SARS-CoV-2 requiring systemic treatment. b.Documented current infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C. c.Severe infection, in the investigator’s opinion, within 30 days prior to the administration of study drug that required parenteral antibiotic use or hospitalization. 5.Patient who has a medical condition including one or more of the following at Screening: a.Any uncontrolled clinically significant respiratory disease in the investigator’s opinion (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis, asthma). b.Abnormal liver function values including but not limited to the aspartate transaminase, alanine transaminase or alkaline phosphatase ≥5 × upper limit normal c.Renal impairment (estimated glomerular filtration rate <30 mL/min/1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis. d.History or presence of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status within 6 months prior to the study drug administration. e.Presence of clinically significant abnormality on a 12-lead ECG at Screening that, at the investigator's clinical judgment, may compromise the safety of the patient or affect the outcome of the study. f. Uncontrolled diabetes mellitus or hypertension, at the discretion of investigator. g. Any active malignancy. h. Currently immunocompromised, whether due to underlying medical condition (e.g., malignancy, transplantation) or medical therapy (e.g., medications, chemotherapy, radiation). i. Any co-morbidity requiring surgery within <7 days prior to the study drug administration, or that is considered life threatening within 30 days prior to study drug administration. j. Any conditions significantly affecting the nervous system (i.e., neuropathic conditions or nervous system damage) k. Patient shows evidence of a condition (psychological, emotional problems, any disorders or resultant therapy) that is likely to invalidate health information, consent, or limit the ability of the patient to comply with the protocol requirements in the opinion of the investigator. l. 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 arms.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy for Part 1:
    •Proportion of patient with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit up to Day 14 OR
    •Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture up to Day 14 OR
    •Time to clinical recovery up to Day 14 OR
    •Proportion of patients with experiencing clinical symptom requiring additional prescription medication, hospitalization, or oxygen therapy up to Day 28
    Clinical recovery is defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist being recorded as ‘absent’ or ‘mild’ in intensity for at least 24 hours. To meet the clinical recovery, symptoms ‘moderate’ or ‘severe’ in intensity at baseline should be changed to ‘mild’ or ‘absent’, or symptoms ‘mild’ in intensity at baseline should be changed to ‘absent’, after the study drug administration. If a symptom ‘absent’ in intensity at baseline becomes ‘severe’, ‘moderate’, or ‘mild’ during the study, this should be changed back to ‘absent’ for at least 24 hours. Symptoms of SARS-CoV-2 Infection Symptom Checklist are defined as feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache
    Efficacy for Part 2: The primary efficacy endpoint of Part 2 is a proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    Day 28
    E.5.2Secondary end point(s)
    Secondary endpoints of Part 1 and Part 2 will be analyzed throughout the study.
    Efficacy
    The following secondary efficacy endpoints will be assessed up to Day 14 and up to Day 28.
    •Proportion of patients requiring supplemental oxygen due to SARS-CoV-2 infection
    •Proportion of patients with intensive care unit transfer due to SARS-CoV-2 infection
    •Proportion of patients with all-cause mortality •Time to clinical recovery
    •Duration of fever defined as the last day in the patient diary on which the temperature > 38℃ (100.4°F) is recorded, or a potentially antipyretic drug (acetaminophen or ibuprofen) is taken
    • Proportion of patients with hospital admission due to SARS-CoV-2 infection
    • Proportion of mechanical ventilation due to SARS-CoV-2 infection
    • Proportion of patients requiring additional prescription medication due to SARS-CoV-2 infection
    • Proportion of patients with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit
    • Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture
    Safety
    Safety assessments will occur throughout the study.
    The following safety parameters are determined as secondary safety endpoints:
    •Adverse events (including SAEs)
    •Adverse events of special interest (Infusion related reactions [hypersensitivity/ anaphylactic reactions])
    •Potential effects on the incidence of ADE
    •Immunogenicity
    •Vital sign measurements (blood pressure, heart rate, respiratory rate, SpO2 and body temperature), weight and BMI
    •Hypersensitivity monitoring
    •12-lead electrocardiogram
    •Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection related signs and symptoms
    •Radiography (chest x-ray or chest CT)
    •Physical examination findings
    •Clinical laboratory analyses (clinical chemistry, hematology and urinalysis)
    •Pregnancy testing (serum)
    •Prior and concomitant medications
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 14
    Day 28
    Throughout the study
    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 trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Czech Republic
    France
    Hungary
    India
    Ireland
    Italy
    Korea, Republic of
    Mexico
    Peru
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Sweden
    Ukraine
    United Kingdom
    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 years2
    E.8.9.2In all countries concerned by the trial months0
    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: 900
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 1020
    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
    P.Date of the global end of the trial2021-10-20
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