The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.
Biological: GC5131
COVID19 Hyper-Immunoglobulin
Other: Placebo
Placebo
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.)
Samsung Medical Center
Seoul, Korea, Republic of