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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04555148
Recruitment Status : Recruiting
First Posted : September 18, 2020
Last Update Posted : September 18, 2020
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)
Estimated Enrollment : 60 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
Estimated Study Start Date : September 20, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : August 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 reduced 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 NEWS [ Time Frame: 7, 14, 21, 28 days ]
    The change of NEWS from baseline

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 Recruiting
Seoul, Korea, Republic of
Contact: Kyoung Ran Peck, Dr.    82-2-3410-3631    krpeck@skku.edu   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kyoung Ran Peck, Dr.    82-02-3410-3631    krpeck@skku.edu   
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: September 18, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No