COVIDIG (COVID-19 Hyper-ImmunoGlobulin)

Phase 2

Completed

• Conditions: Covid19
• Interventions: Biological: GC5131; Other: Placebo

• Registration Number: NCT04555148
• Lead Sponsor: Green Cross Corporation

Brief Summary

The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-18
• Study Start: 2020-09-19
• Primary Completion: 2021-01-22
• Study Completion: 2021-04-23
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

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

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose Treatment	GC5131	Low dose treatment
High dose Treatment	GC5131	High dose Treatment
Placebo	Placebo	Saline
Medium dose Treatment	GC5131	Medium dose Treatment

Primary Outcome Measures

Name	Time	Method
Ordinal scale outcome	7, 14, 21, 28 days	The percent of participants changed by 2 points or more

Secondary Outcome Measures

Name	Time	Method
Change in NEWS2 (National Early Warning Score 2)	7, 14, 21, 28 days	The change of National Early Warning Score 2 (NEWS) from baseline
Viral negative	1, 3, 5, 7, 10 days	The percents of negative patients for COVID-19 virus
mortality	28 days	The percent of participants

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of