GC5131 can be expected to show effective treatment as passive immunization, which was purified from COVID-19 recovered patients.  In this clinical trial, efficacy and safety would be confirmed when GC5131 is administered as a therapeutic agent in patients with COVID-19 infection.

Treatment

Low dose of GC5131, intermediate dose of GC5131, high dose of GC5131 (each  2500mg, 5000mg, 10000mg), once, iv,
If a subject were assigned into an each intervention group, prepare the number of assigned intervention vials. If assigned into placebo group, prepare 50 mL saline.
Start infusion at 0.01 to 0.02 mL/kg/min (e.g., 0.6 to 1.2 mL / min with a body weight of 60 kg) for 30 minutes, gradually increasing to0.06 for remainder of infusion.

Arm Label

Target Number of Participant

Arm Type

Arm Description

2500mg of GC5131, once, iv.
If a subject were assigned into an each intervention group, prepare the number of assigned intervention vials. If assigned into placebo group, prepare 50 mL saline.
Start infusion at 0.01 to 0.02 mL/kg/min (e.g., 0.6 to 1.2 mL / min with a body weight of 60 kg) for 30 minutes, gradually increasing to0.06 for remainder of infusion.

Arm Label

Target Number of Participant

Arm Type

Arm Description

5000mg of GC5131, once, iv
If a subject were assigned into an each intervention group, prepare the number of assigned intervention vials. If assigned into placebo group, prepare 50 mL saline.
Start infusion at 0.01 to 0.02 mL/kg/min (e.g., 0.6 to 1.2 mL / min with a body weight of 60 kg) for 30 minutes, gradually increasing to0.06 for remainder of infusion.

Arm Label

Target Number of Participant

Arm Type

Arm Description

10000mg of GC5131, once, iv
If a subject were assigned into an each intervention group, prepare the number of assigned intervention vials. If assigned into placebo group, prepare 50 mL saline.
Start infusion at 0.01 to 0.02 mL/kg/min (e.g., 0.6 to 1.2 mL / min with a body weight of 60 kg) for 30 minutes, gradually increasing to0.06 for remainder of infusion.

Arm Label

Target Number of Participant

Arm Type

Arm Description

50 mL saline, once, iv
If a subject were assigned into an each intervention group, prepare the number of assigned intervention vials. If assigned into placebo group, prepare 50 mL saline.
Start infusion at 0.01 to 0.02 mL/kg/min (e.g., 0.6 to 1.2 mL / min with a body weight of 60 kg) for 30 minutes, gradually increasing to0.06 for remainder of infusion.

Gender

Age

Description

1) The COVID-19 patient who diagnosed by PCR within 3 days prior to randomized And who is hospitalized with COVID-19 related symptoms
2) The subject who has symptoms of COVID-19 within 7 days
3) 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)
4) Willing and able to provide written informed consent prior to performing study procedures

1) asymptomatic patient
2) The subject who requiring mechanical ventilation or ECMO
3) The subject who are underlying oxygen therapy before affected by COVID-19
4) The subject who have received antiviral drugs for other disease within 4 weeks History of allergy to IVIG or plasma products
5) The subject who received IVIG or convalescent plasma from a person who recovered from COVID-19
6) IgA deficiency
7) Cretinine > 2 X ULN
8) The subject with a history of thrombosis or high risk of thromboembolism
9) 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.)

Percentage of subjects whose scores decreased by 2 points or reach level 1 or 2 by 9-ordinal scale

at 7, 14, 21, 28 days

viral convergent, CT value, titer

at 7, 14, 21, 28 days

In terms of both safety and efficacy, the appropriate minimum dose is 10,000 mg of GC5131.
In addition, considering the variables that may affect the interpretation of the efficacy results, it is expected that the effect of GC5131 will be confirmed in the elderly who need passive immunity or COVID-19 patients with underlying diseases through the next additional study.