A prospective, open-label, randomized, multi-center, phase 2a study to evaluate the dose response, efficacy and safety of Hyper-Ig (Hyper-immunoglobulin) GC5131 in Patients with COVID-19

Not Applicable

Completed

• Conditions: Codes for special purposes

• Registration Number: KCT0005649
• Lead Sponsor: Green Cross

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-02-28
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

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

Exclusion Criteria

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.)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
viral convergent, CT value, titer