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The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Saline |
|
| Low dose Treatment | Experimental | Low dose treatment |
|
| Medium dose Treatment | Experimental | Medium dose Treatment |
|
| High dose Treatment | Experimental | High dose Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC5131 | Biological | COVID19 Hyper-Immunoglobulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal scale outcome | The percent of participants changed by 2 points or more | 7, 14, 21, 28 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo | Other | Placebo |
|
| 7, 14, 21, 28 days |
| mortality | The percent of participants | 28 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |