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Phase Ⅱ Study to Evaluate the Efficacy and Safety of Regdanvimab for Patients with Mild to Moderate Symptoms of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

Status Approved

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	KCT0006254
Unique Protocol ID	115288-202012-HR-051-01
Public/Brief Title	Phase Ⅱ Study to Evaluate the Efficacy and Safety of Regdanvimab for Patients with Mild to Moderate Symptoms of Severe Acute Respiratory Syndrome Coronavirus 2 Infection
Scientific Title	Phase Ⅱ Study to Evaluate the Efficacy and Safety of Regdanvimab for Patients with Mild to Moderate Symptoms of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
Acronym
MFDS Regulated Study	Yes
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Submitted pending

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	115288-202012-HR-051-01
Approval Date	2021-01-12
Institutional Review Board Name	Committee on Ethics in Clinical Research
Institutional Review Board Address	Incheon Medical Center 217 Bangchungno, Dong-gu, Incheon
Institutional Review Board Telephone	032-580-6565
Data Monitoring Committee	Yes Incheon Medical Center IRB

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	Jin Yong Kim
Title	MD, MPH
Telephone	+82-32-580-6496
Affiliation	Incheon Medical Center
Address	217 Banchuk-ro, Dong-gu, Incheon
Contact Person for Public Queries
Name	Jin Yong Kim
Title	MD, MPH
Telephone	+82-32-580-6496
Affiliation	Incheon Medical Center
Address	217 Banchuk-ro, Dong-gu, Incheon
Contact Person for Updating Information
Name	Jin Yong Kim
Title	MD, MPH
Telephone	+82-32-580-6496
Affiliation	Incheon Medical Center
Address	217 Banchuk-ro, Dong-gu, Incheon

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
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2021-02-03 Actual
Target Number of Participant	20
Primary Completion Date	2021-09-09 , Anticipated
Study Completion Date	2021-09-09 , Anticipated
Name of Study	Incheon Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2021-02-03 ,

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

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Incheon Medical Center
Organization Type	Others

7. Study Summary

Study Summary Information
Lay Summary	Phase Ⅱ Study to Evaluate the Efficacy and Safety of Regdanvimab for Patients with Mild to Moderate Symptoms of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

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
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	Drug
Intervention Description	40 mg/kg of Regdanvimab (960 mg/16 mL) administered by intravenous (IV) for 90 minutes (with a margin of error of ±15 minutes).
Number of Arms	1
Arm 1	Arm Label Regdanvimab Group
	Target Number of Participant 20
	Arm Type Others
	Arm Description 40 mg/kg of Regdanvimab (960 mg/16 mL) administered by intravenous (IV) for 90 minutes (with a margin of error of ±15 minutes).

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] Study to Evaluate the Efficacy and Safety of Regdanvimab for Patients with Mild to Moderate Symptoms of Severe Acute Respiratory Syndrome Coronavirus 2 Infection
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~No Limit
	Description • mild COVID-19 infection diagnosed by RT-PCR. • no more than 7 days prior to the study drug administration from the onset of symptoms
Exclusion Criteria	•Someone who needs supplemental oxygen therapy for SARS-CoV-2 infection. •According to World Health Organization guidelines, 2020 Any conditions suspected of being severe symptoms of SARS-CoV-2 infection.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Safety
Outcome	Treatment-emergent adverse events
Timepoint	Up to Day 100
Secondary Outcome(s) 1
Outcome	Potential effects on the incidence of antibody-dependent enhancement
Timepoint	Up to Day 100
Secondary Outcome(s) 2
Outcome	Clinical laboratory test(clinical chemistry, hematology, and urinalysis)
Timepoint	Up to Day 28

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	No

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