COVIDIG (COVID-19 Hyper-ImmunoGlobulin)

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Biological: GC5131
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline | Other: Placebo<br>* Placebo<br>|
| Experimental: Low dose Treatment<br>Low dose treatment | Biological: GC5131<br>* COVID19 Hyper-Immunoglobulin<br>|
| Experimental: Medium dose Treatment<br>Medium dose Treatment | Biological: GC5131<br>* COVID19 Hyper-Immunoglobulin<br>|
| Experimental: High dose Treatment<br>High dose Treatment | Biological: GC5131<br>* COVID19 Hyper-Immunoglobulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ordinal scale outcome | The percent of participants changed by 2 points or more | 7, 14, 21, 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral negative | The percents of negative patients for COVID-19 virus | 1, 3, 5, 7, 10 days | 
| Change in NEWS2 (National Early Warning Score 2) | The change of National Early Warning Score 2 (NEWS) from baseline | 7, 14, 21, 28 days | 
| mortality | The percent of participants | 28 days |