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COVIDIG (COVID-19 Hyper-ImmunoGlobulin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04555148
Recruitment Status : Completed
First Posted : September 18, 2020
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: GC5131 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : September 19, 2020
Actual Primary Completion Date : January 22, 2021
Actual Study Completion Date : April 23, 2021

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




Primary Outcome Measures :
  1. Ordinal scale outcome [ Time Frame: 7, 14, 21, 28 days ]
    The percent of participants changed by 2 points or more


Secondary Outcome Measures :
  1. Viral negative [ Time Frame: 1, 3, 5, 7, 10 days ]
    The percents of negative patients for COVID-19 virus

  2. Change in NEWS2 (National Early Warning Score 2) [ Time Frame: 7, 14, 21, 28 days ]
    The change of National Early Warning Score 2 (NEWS) from baseline

  3. mortality [ Time Frame: 28 days ]
    The percent of participants



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04555148


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Green Cross Corporation
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Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT04555148    
Other Study ID Numbers: GC5131A-HIG_P0201
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases