Background Information

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

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

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

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

Source of Monetary/Material Support1
- Organization Name	Celltrion
- Organization Type	Pharmaceutical Company
- Project ID

Sponsor Organization

Sponsor Organization 1
- Organization Name	Ministry of Health & Welfare
- Organization Type	Government

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

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		3
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

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

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

Result Registerd	No

Sharing of Study Data Information

Sharing Statement	No