Covid19
Conditions
Brief summary
The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.
Interventions
BIOLOGICALGC5131
COVID19 Hyper-Immunoglobulin
OTHERPlacebo
Placebo
Sponsors
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ordinal scale outcome | 7, 14, 21, 28 days | The percent of participants changed by 2 points or more |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral negative | 1, 3, 5, 7, 10 days | The percents of negative patients for COVID-19 virus |
| Change in NEWS2 (National Early Warning Score 2) | 7, 14, 21, 28 days | The change of National Early Warning Score 2 (NEWS) from baseline |
| mortality | 28 days | The percent of participants |
Countries
South Korea
Outcome results
None listed