Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2020-09-19
2021-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Placebo
Saline
Placebo
Placebo
Low dose Treatment
Low dose treatment
GC5131
COVID19 Hyper-Immunoglobulin
Medium dose Treatment
Medium dose Treatment
GC5131
COVID19 Hyper-Immunoglobulin
High dose Treatment
High dose Treatment
GC5131
COVID19 Hyper-Immunoglobulin
Interventions
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GC5131
COVID19 Hyper-Immunoglobulin
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
19 Years
ALL
No
Sponsors
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Green Cross Corporation
INDUSTRY
Responsible Party
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Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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GC5131A-HIG_P0201
Identifier Type: -
Identifier Source: org_study_id
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