Back to resultsCOVIDIG (COVID-19 Hyper-ImmunoGlobulin)
Primary Purpose
Covid19
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GC5131
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- The COVID-19 patient who diagnosed by PCR within 3 days prior to randomized And who is hospitalized with COVID-19 related symptoms
- The subject who has symptoms of COVID-19 within 7 days
- The subject with pneumonia confirmed by imaging diagnosis related to COVID-19 OR a 70-year-old or older OR 60-year-old or older with underlying disease (diabetes or hypertension or obesity or smoker)
- Willing and able to provide written informed consent prior to performing study procedures
Exclusion Criteria:
- asymptomatic patient
- The subject who requiring mechanical ventilation or ECMO
- The subject who are underlying oxygen therapy before affected by COVID-19
- The subject who have received antiviral drugs for other disease within 4 weeks
- History of allergy to IVIG or plasma products
- The subject who received IVIG or convalescent plasma from a person who recovered from COVID-19
- IgA deficiency
- Cretinine > 2 X ULN
- The subject with a history of thrombosis or high risk of thromboembolism
- The subject with reduced heart function [NYHA (New York Heart Association) Functional Class III or IV]; or cerebral cardiovascular disorder or a patient with the medical history (ischemic disease, cardiovascular disease, cerebrovascular disorder, blood vessel disorder, etc.)
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Low dose Treatment
Medium dose Treatment
High dose Treatment
Arm Description
Saline
Low dose treatment
Medium dose Treatment
High dose Treatment
Outcomes
Primary Outcome Measures
Ordinal scale outcome
The percent of participants changed by 2 points or more
Secondary Outcome Measures
Viral negative
The percents of negative patients for COVID-19 virus
Change in NEWS2 (National Early Warning Score 2)
The change of National Early Warning Score 2 (NEWS) from baseline
mortality
The percent of participants
Full Information
NCT ID
NCT04555148
First Posted
September 16, 2020
Last Updated
August 17, 2021
Sponsor
Green Cross Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04555148
Brief Title
COVIDIG (COVID-19 Hyper-ImmunoGlobulin)
Official Title
A Prospective, Open-label, Randomized, Multi-center, Phase 2a Study to Evaluation the Dose Response, Efficacy and Safety of Hyper-Ig (Hyper-immunoglobulin) GC5131 in Patients With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 19, 2020 (Actual)
Primary Completion Date
January 22, 2021 (Actual)
Study Completion Date
April 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Arm Title
Low dose Treatment
Arm Type
Experimental
Arm Description
Low dose treatment
Arm Title
Medium dose Treatment
Arm Type
Experimental
Arm Description
Medium dose Treatment
Arm Title
High dose Treatment
Arm Type
Experimental
Arm Description
High dose Treatment
Intervention Type
Biological
Intervention Name(s)
GC5131
Intervention Description
COVID19 Hyper-Immunoglobulin
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Ordinal scale outcome
Description
The percent of participants changed by 2 points or more
Time Frame
7, 14, 21, 28 days
Secondary Outcome Measure Information:
Title
Viral negative
Description
The percents of negative patients for COVID-19 virus
Time Frame
1, 3, 5, 7, 10 days
Title
Change in NEWS2 (National Early Warning Score 2)
Description
The change of National Early Warning Score 2 (NEWS) from baseline
Time Frame
7, 14, 21, 28 days
Title
mortality
Description
The percent of participants
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The COVID-19 patient who diagnosed by PCR within 3 days prior to randomized And who is hospitalized with COVID-19 related symptoms
The subject who has symptoms of COVID-19 within 7 days
The subject with pneumonia confirmed by imaging diagnosis related to COVID-19 OR a 70-year-old or older OR 60-year-old or older with underlying disease (diabetes or hypertension or obesity or smoker)
Willing and able to provide written informed consent prior to performing study procedures
Exclusion Criteria:
asymptomatic patient
The subject who requiring mechanical ventilation or ECMO
The subject who are underlying oxygen therapy before affected by COVID-19
The subject who have received antiviral drugs for other disease within 4 weeks
History of allergy to IVIG or plasma products
The subject who received IVIG or convalescent plasma from a person who recovered from COVID-19
IgA deficiency
Cretinine > 2 X ULN
The subject with a history of thrombosis or high risk of thromboembolism
The subject with reduced heart function [NYHA (New York Heart Association) Functional Class III or IV]; or cerebral cardiovascular disorder or a patient with the medical history (ischemic disease, cardiovascular disease, cerebrovascular disorder, blood vessel disorder, etc.)
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
COVIDIG (COVID-19 Hyper-ImmunoGlobulin)
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