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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2020/11/20
    • Registered Date : 2020/11/27
    • Last Updated Date : 2020/11/20
Background Information
1.Background  
CRIS Registration Number KCT0005641 
Unique Protocol ID EudraCT Number 2020-003369-20 
Public/Brief Title A Phase 2/3, Randomized, Parallel-group, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety 
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  
Registered at Other Registry Yes
Name of Registry/
Registration Number
ClinicalTrials.gov-NCT04602000 
Healthcare Benefit
Approval Status
Submitted pending
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number CNUH 2020-09-023-002 
Approval Date 2020-09-25 
Institutional Review Board  
- Name CNUH IRB  
- Address 282, Munhwa-ro, Jung-gu, Daejeon 
- Telephone 042-280-8715 
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name YeonSook Kim 
- Title MD, PhD 
- Telephone  
- 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  
- 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 +82-32-850-5707 
- Affiliation Celltrion 
- Address 23, Academy-ro, Yeonsu-gu, Incheon, Korea 
Status
4. Status Status  
Study Site Multi-center (Number of center : 11) - Multi-national
Overall Recruitment Status Recruiting  
Date of First Enrollment 2020-10-05 , Actual
Target Number of Participant 300
Primary Completion Date 2021-03-31 , Anticipated
Study Completion Date 2021-03-31 , Anticipated
Recruitment Status by Participating Study Site 1 
- Name of Study Site Chungnam National University 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-10-05 , Actual
Recruitment Status by Participating Study Site 2 
- Name of Study Site Gachon University, Donginchoen Gil Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-10-27 , Actual
Recruitment Status by Participating Study Site 3 
- Name of Study Site Seoul Medical Center 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-11-10 , Actual
Recruitment Status by Participating Study Site 4 
- Name of Study Site Inha University Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-11-24 , Anticipated
Recruitment Status by Participating Study Site 5 
- Name of Study Site Incheon Medical Center 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-11-09 , Actual
Recruitment Status by Participating Study Site 6 
- Name of Study Site National Medical Center 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-11-24 , Anticipated
Recruitment Status by Participating Study Site 7 
- Name of Study Site Kyungpook National University Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-11-24 , Anticipated
Recruitment Status by Participating Study Site 8 
- Name of Study Site Kyungpook National University Medical Center 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-11-24 , Anticipated
Recruitment Status by Participating Study Site 9 
- Name of Study Site Seoul Metropolitan Government Seoul National University Boramae Medical Center 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-11-24 , Anticipated
Recruitment Status by Participating Study Site 10 
- Name of Study Site Chonnam National University Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-11-24 , Anticipated
Recruitment Status by Participating Study Site 11 
- Name of Study Site Ajou University Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-11-19 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Celltrion 
- Organization Type Pharmaceutical Company  
- Project ID  
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Ministry of Health & Welfare 
- Organization Type Government  
Study Summary
7. Study Summary  
Lay Summary A Phase 2/3, Randomized, Parallel-group, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Phase2/Phase3 
Intervention Model Parallel  
Blinding/Masking Double 
Blinded Subject Subject, Investigator 
Allocation RCT 
Intervention Type Drug  
Intervention Description TBD  
Number of Arms
Arm 1 Arm Label CT-P59 A Group 
Target Number of Participant 100 
Arm Type Experimental 
Arm Description CT-P59 will be administrated. Subjects are randomizaed into 3 groups as 1:1:1 ratio. 
Arm 2 Arm Label CT-P59 B Group 
Target Number of Participant 100 
Arm Type Experimental 
Arm Description CT-P59 will be administrated. Subjects are randomizaed into 3 groups as 1:1:1 ratio. 
Arm 3 Arm Label Placebo 
Target Number of Participant 100 
Arm Type Placebo comparator 
Arm Description Placebo will be administrated. Subjects are randomizaed into 3 groups as 1:1:1 ratio 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of th respiratory system
SARS-CoV-2 Infection  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 18 Year ~ 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 / Not requiring supplemental oxygen.
• Patient whose onset of symptom is no more than 7 days prior to the study drug administration  
Exclusion Criteria • 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).
• Respiratory distress with respiratory rate ≥30 breaths/min.
• Requires supplemental oxygen.
• Experience shock.
• Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator’s discretion.
• 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, 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
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
- Outcome Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture 
- Timepoint Up to 28 Days 
Primary Outcome(s) 2 
- Outcome Time to clinical recovery 
- Timepoint Up to 14 days 
Secondary Outcome(s) 1 
- Outcome To evaluate the additional efficacy of CT-P59, 
- Timepoint Up to 90 days 
Secondary Outcome(s) 2 
- Outcome To evaluate overall safety of CT-P59, including immunogenicity and potential effects on the incidence of antibody-dependent enhancement (ADE To evaluate overall safety of CT-P59, including immunogenicity and potential effects on the incidence of antibody-dependent enhancement (ADE To evaluate the additional efficacy of CT-P59 
- Timepoint Up to 90 days 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No