COVIDIG (COVID-19 Hyper-ImmunoGlobulin)

Sponsor

Green Cross Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT04555148

Collaborator

(none)

Enrollment

Location

Arms

7.1

Actual Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19	Biological: GC5131 Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Open-label, Randomized, Multi-center, Phase 2a Study to Evaluation the Dose Response, Efficacy and Safety of Hyper-Ig (Hyper-immunoglobulin) GC5131 in Patients With COVID-19

Actual Study Start Date :

Sep 19, 2020

Actual Primary Completion Date :

Jan 22, 2021

Actual Study Completion Date :

Apr 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Saline	Other: Placebo Placebo
Experimental: Low dose Treatment Low dose treatment	Biological: GC5131 COVID19 Hyper-Immunoglobulin
Experimental: Medium dose Treatment Medium dose Treatment	Biological: GC5131 COVID19 Hyper-Immunoglobulin
Experimental: High dose Treatment High dose Treatment	Biological: GC5131 COVID19 Hyper-Immunoglobulin

Outcome Measures

Primary Outcome Measures

Ordinal scale outcome [7, 14, 21, 28 days]
The percent of participants changed by 2 points or more

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Green Cross Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Green Cross Corporation

ClinicalTrials.gov Identifier:

NCT04555148

Other Study ID Numbers:

GC5131A-HIG_P0201

First Posted:

Sep 18, 2020

Last Update Posted:

Aug 24, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Aug 24, 2021