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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

Status Approved

  • First Submitted Date

    2020/11/20

  • Registered Date

    2020/11/27

  • Last Updated Date

    2022/06/23

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005641
    Unique Protocol ID EudraCT Number 2020-003369-20
    Public/Brief Title A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients with Mild to Moderate SARS-CoV-2 Infection
    Scientific Title 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
    Acronym
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    Registered at Other Registry Yes
    Name of Registry / Registration Number ClinicalTrials.gov-NCT04602000
    Healthcare Benefit Approval Status Submitted pending
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CNUH 2020-09-023-002
    Approval Date 2020-09-25
    Institutional Review Board Name CNUH IRB
    Institutional Review Board Address 282, Munhwa-ro, Jung-gu, Daejeon
    Institutional Review Board Telephone 042-280-6715
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name YeonSook Kim
    Title MD, PhD
    Telephone +82-42-280-8109
    Affiliation Chungnam National University Hospital
    Address 282 Munwha-ro, Jung-gu, DaeJeon, Republic of Korea
    Contact Person for Public Queries
    Name YeonSook Kim
    Title MD, PhD
    Telephone +82-42-280-8109
    Affiliation Chungnam National University Hospital
    Address 282 Munwha-ro, Jung-gu, DaeJeon, Republic of Korea
    Contact Person for Updating Information
    Name JooHee Lee
    Title Manager
    Telephone +82-32-850-5809
    Affiliation Celltrion
    Address 23, Academy-ro, Yeonsu-gu, Incheon, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 13 - Multi-national}
    Overall Recruitment Status Completed
    Date of First Enrollment 2020-10-07 Actual
    Target Number of Participant 1600
    Primary Completion Date 2021-05-21 , Actual
    Study Completion Date 2021-10-20 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Chungnam National University
    Recruitment Status Completed
    Date of First Enrollment 2020-10-07 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Gachon University, Donginchoen Gil Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-10-27 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Seoul Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2020-11-10 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Inha University Hospital
    Recruitment Status Withdrawn Withdrawn Reason : 첫 연구대상자 등록 전 전체 환자 모집 완료
    Date of First Enrollment
    Recruitment Status by Participating Study Site 5
    Name of Study Incheon Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2020-11-09 ,
    Recruitment Status by Participating Study Site 6
    Name of Study National Medical Center
    Recruitment Status Withdrawn Withdrawn Reason : 첫 연구대상자 등록 전 전체 환자 모집 완료
    Date of First Enrollment
    Recruitment Status by Participating Study Site 7
    Name of Study Kyungpook National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2021-04-07 ,
    Recruitment Status by Participating Study Site 8
    Name of Study Kyungpook National University Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2021-03-31 ,
    Recruitment Status by Participating Study Site 9
    Name of Study Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2020-11-24 ,
    Recruitment Status by Participating Study Site 10
    Name of Study Chonnam National University Hospital
    Recruitment Status Withdrawn Withdrawn Reason : 첫 연구대상자 등록 전 전체 환자 모집 완료
    Date of First Enrollment
    Recruitment Status by Participating Study Site 11
    Name of Study Ajou University Hospital
    Recruitment Status Withdrawn Withdrawn Reason : 첫 연구대상자 등록 전 전체 환자 모집 완료
    Date of First Enrollment
    Recruitment Status by Participating Study Site 12
    Name of Study Keimyung University Dongsan Hospital
    Recruitment Status Completed
    Date of First Enrollment 2021-04-21 ,
    Recruitment Status by Participating Study Site 13
    Name of Study Chonnam National University Bitgoeul Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-11-11 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Celltrion
    Organization Type Pharmaceutical Company
    Project ID
    2. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Government
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Celltrion
    Organization Type Pharmaceutical Company
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This was a Phase 2/3 study to assess the efficacy about therapeutic effect of CT-P59 to the mild to moderate severe acute respiratory syndrome coronavirus (SARS-CoV-2)  infected patients and the safety during the study.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase2/Phase3
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator, Caregiver, Outcome Accessor
    Allocation RCT
    Intervention Type /Biological/Vaccine, /Non-Stem Cell  
    Intervention Description
    Test Investigational Product:
    Part 1
    • CT-P59 80 mg/kg by single intravenous (IV) infusion over 90 minutes (±15 minutes) with Standard of Care (SoC)
    • CT-P59 40 mg/kg by single IV infusion over 90 minutes (±15 minutes) with SoC
    Part 2
    • CT-P59 40 mg/kg by single IV infusion over 60 minutes (±15 minutes) with SoC
    
    Reference Investigational Product:
    Part 1
    • Placebo matching in volume of CT-P59 80 mg/kg by single IV infusion over 90 minutes (±15 minutes) with SoC
    Part 2
    • Placebo matching in volume of CT-P59 40 mg/kg by single IV infusion over 60 minutes (±15 minutes) with SoC
    Number of Arms 5
    Arm 1

    Arm Label

    CT-P59 40 mg/kg (Part 1)

    Target Number of Participant

    100

    Arm Type

    Experimental

    Arm Description

    CT-P59 40 mg/kg is administered as an intravenous (IV) infusion over 90 minutes (± 15 minutes).
    In Part 1, subjects are randomly assigned into CT-P59 40 mg/kg, CT-P59 80 mg/kg or placebo groups as 1:1:1 ratio.
    Arm 2

    Arm Label

    CT-P59 80 mg/kg (Part 1)

    Target Number of Participant

    100

    Arm Type

    Experimental

    Arm Description

    CT-P59 80 mg/kg is administered as an IV infusion over 90 minutes (± 15 minutes).
    In Part 1, subjects are randomly assigned into CT-P59 40 mg/kg, CT-P59 80 mg/kg or placebo groups as 1:1:1 ratio.
    Arm 3

    Arm Label

    Placebo (Part 1)

    Target Number of Participant

    100

    Arm Type

    Placebo comparator

    Arm Description

    Placebo matching in volume of CT-P59 80 mg/kg is administered as an IV infusion over 90 minutes (± 15 minutes).
    In Part 1, subjects are randomly assigned into CT-P59 40 mg/kg, CT-P59 80 mg/kg or placebo groups as 1:1:1 ratio.
    Arm 4

    Arm Label

    CT-P59 40 mg/kg (Part 2)

    Target Number of Participant

    650

    Arm Type

    Experimental

    Arm Description

    CT-P59 40 mg/kg is administered as an IV infusion over 60 minutes (± 15 minutes).
    In Part 2, patients are randomly assigned into CT-P59 40 mg/kg or placebo groups as 1:1 ratio.
    Arm 5

    Arm Label

    Placebo (Part 2)

    Target Number of Participant

    650

    Arm Type

    Placebo comparator

    Arm Description

    Placebo matching in volume of CT-P59 40 mg/kg is administered as an IV infusion over 60 minutes (± 15 minutes).
    In Part 2, patients are randomly assigned into CT-P59 40 mg/kg or placebo groups as 1:1 ratio.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (U00-U99)Codes for special purposes 
       (U07.1)Coronavirus disease 2019, virus identified [COVID-19, virus identified] 

    Mild to moderate symptoms of SARS-CoV-2 infection
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    • Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR. 
    • Oxygen saturation >94% on room air, and not requiring supplemental oxygen.
    • Patient whose onset of symptom is no more than 7 days prior to the study drug administration.
    • Patient had 1 or more of the SARS-CoV-2 infection-associated symptoms within but no more than 7 days prior to the study drug administration.
    Exclusion Criteria
    • Patient had current severe condition meeting one of the following:
    a. Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions (severe disease as defined in the World Health Organization Guidance, 2020).
    b. Respiratory distress with respiratory rate ≥30 breaths/min.
    c. Required supplemental oxygen.
    d. Experienced shock.
    e. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator’s discretion.
    • Patient had received or had 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, dexamethasone (alternative corticosteroids to dexamethasone), interferon beta-1b, ribavirin, and other immunomodulatory agents and human immunodeficiency virus protease inhibitors (lopinavir-ritonavir, etc.) 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
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 Infection (Part 1)
    Timepoint
    Up to Day 28
    Primary Outcome(s) 2
    Outcome
    Proportion of patients with negative conversion in nasopharyngeal swab specimen based on RT-qPCR at each visit (Part 1)
    Timepoint
    Up to Day 14
    Primary Outcome(s) 3
    Outcome
    Time to negative conversion in nasopharyngeal swab specimen (Part 1)
    Timepoint
    Up to Day 14
    Primary Outcome(s) 4
    Outcome
    Time to clinical recovery (Part 1)
    Timepoint
    Up to Day 14
    Primary Outcome(s) 5
    Outcome
    Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 Infection in high-risk patients (Part 2)
    Timepoint
    Up to Day 28
    Secondary Outcome(s) 1
    Outcome
    Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 Infection in all randomized patients (Part 2)
    Timepoint
    Up to Day 28
    Secondary Outcome(s) 2
    Outcome
    Time to clinical recovery in high-risk patients (Part 2)
    Timepoint
    Up to Day 14
    Secondary Outcome(s) 3
    Outcome
    Time to clinical recovery in all randomized patients (Part 2)
    Timepoint
    Up to Day 14
    Secondary Outcome(s) 4
    Outcome
    Proportion of patients with hospital admission due to SARS-CoV-2 Infection (Part 1 and Part 2)
    Timepoint
    Up to Day 28
    Secondary Outcome(s) 5
    Outcome
    Proportion of patients requiring supplemental oxygen due to SARS-CoV-2 Infection (Part 1 and Part 2)
    Timepoint
    Up to Day 28
    Secondary Outcome(s) 6
    Outcome
    Proportion of Patients with Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2)
    Timepoint
    Up to Day 28
    Secondary Outcome(s) 7
    Outcome
    Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2)
    Timepoint
    Up to Day 28
    Secondary Outcome(s) 8
    Outcome
    Proportion of Patients with Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2)
    Timepoint
    Up to Day 28
    Secondary Outcome(s) 9
    Outcome
    Proportion of Patients with All-cause mortality Due to SARS-CoV-2 Infection (Part 1 and Part 2)
    Timepoint
    Up to Day 28
    Secondary Outcome(s) 10
    Outcome
    Adverse events (AEs; including serious adverse events [SAEs])
    Timepoint
    Throughout the study
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered Yes
    Published
    Results Upload
    Final Enrollment Number 1642
    Number of Publication 1
    Publications 1
    Streinu-Cercel A, Săndulescu O, Preotescu L, Kim J, Kim Y, Cheon S, et al.. Efficacy and Safety of Regdanvimab (CT-P59): A Phase 2/3 Randomized, Double-Blind, Placebo Controlled Trial in Outpatients With Mild-to-Moderate Coronavirus Disease 2019. Open Forum Infectious Diseases. SCI. 2022-02-02 ,
    														 VOL : 9 page : 1 ~ 10
    														https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofac053/6520290?login=true
    														
    Results Upload CT-P59 3_2 최종 결과_CRIS 제출용_Final.pdf
    Date of Posting Results 2022/06/22
    Protocol URL or File Upload CT-P59 3_2_protocol_Final.pdf
    Brief Summary
    Study CT-P59 3.2 results demonstrated that CT-P59 was efficacious in treatment mild to moderate SARS-CoV-2 infection, compared to the placebo. 
    
    In Part 1, CT-P59 significantly reduced the proportion of patients with clinical symptoms requiring hospitalization or oxygen therapy due to SARS-CoV-2 infection up to Day 28, compared to the Placebo group (CT-P59 group: 4.4% vs. Placebo group: 8.7%). This demonstrates that CT-P59 would effectively reduce the clinical symptoms of patients and burden of the healthcare system due to SARS-CoV-2 infection. Also, CT-P59 effectively reduced the time to negative conversion by RT-qPCR and time to clinical recovery up to Day 14, compared to the placebo. The median [95% CI] time to negative conversion by RT-qPCR up to Day 14 was 12.75 [9.00, 12.84), 11.89 [8.94, 12.91), 12.94 [12.75, 13.99), and the median [95% CI] time to clinical recovery up to Day 14 was 7.18 [5.50, 9.37), 7.30 [5.72, 9.33), 8.80 [6.88, 13.09) in CT-P59 40 mg/kg, CT-P59 80 mg/kg, and Placebo groups, respectively. The mean CT-P59 serum concentration throughout the study was higher in the CT-P59 80 mg/kg group compared to CT-P59 40 mg/kg group and showed dose proportionality at all time points. Based on the Part 1 results, CT-P59 40 mg/kg was selected as the appropriate dose for CT-P59 treatment. 
    
    In Part 2, results of CT-P59 were statistically significant by reducing the proportion of patients with clinical symptoms requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28, compared to the Placebo group in both high-risk and all randomized patients ([high-risk patients] CT-P59 40 mg/kg group 3.1% and Placebo group 11.1%, p<0.0001; [all randomized patients] 2.4% and 8.0%, p<0.0001, respectively). Also, the median time to clinical recovery [95% CI) up to Day 14 reduced in the CT-P59 40 mg/kg group of high-risk and all randomized patients, compared to the Placebo group ([high-risk patients] CT-P59 40 mg/kg group: 9.27 [8.27, 11.05) and Placebo group: not calculated [12.35, not calculated) days; [all randomized patients] 8.38 [7.91, 9.33) and 13.25 [11.94, not calculated) days, respectively), and the differences in time to clinical recovery between the groups were statistically significant (p<0.0001). Reduced proportion of patients with clinical symptoms and time to clinical recovery demonstrate that CT-P59 would effectively reduce burden of the healthcare system due to SARS-CoV-2 infection by preventing the progression of disease severity. Collectively, CT-P59 40 mg/kg met its primary and all key secondary endpoints, with other secondary endpoints trended in favor of CT-P59, providing a strong indication of efficacy.
    
    Overall, in Part 1 and Part 2, CT-P59 was well tolerated and safety profile following CT-P59 administration did not show any significant safety issues.
    Also, greater reductions from baseline viral load were shown in CT-P59 compared to placebo.
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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