COVIDIG (COVID-19 Hyper-ImmunoGlobulin)

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555148
• Other study ID #: GC5131A-HIG_P0201
• Status: Completed
• Phase: Phase 2
• Start date: September 19, 2020
• Est. completion date: April 23, 2021

Study information

• Verified date: August 2021
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 23, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Covid19

Intervention

Biological:
• GC5131
COVID19 Hyper-Immunoglobulin

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ordinal scale outcome	The percent of participants changed by 2 points or more	7, 14, 21, 28 days
Secondary	Viral negative	The percents of negative patients for COVID-19 virus	1, 3, 5, 7, 10 days
Secondary	Change in NEWS2 (National Early Warning Score 2)	The change of National Early Warning Score 2 (NEWS) from baseline	7, 14, 21, 28 days
Secondary	mortality	The percent of participants	28 days