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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2020/10/19
    • Registered Date : 2020/12/02
    • Last Updated Date : 2020/10/19
Background Information
1.Background  
CRIS Registration Number KCT0005649 
Unique Protocol ID GC5131A-HIG_P0201 
Public/Brief Title A prospective, open-label, randomized, multi-center, phase 2a study to evaluate the dose response, efficacy and safety of Hyper-Ig (Hyper-immunoglobulin) GC5131 in Patients with COVID-19 
Scientific Title A prospective, open-label, randomized, multi-center, phase 2a study to evaluate the dose response, efficacy and safety of Hyper-Ig (Hyper-immunoglobulin) GC5131 in Patients with COVID-19  
Acronym COVIDIG 
MFDS Regulated Study Yes
IND/IDE Protocol Yes
Registered at Other Registry Yes
Name of Registry/
Registration Number
ClinicalTrials.gov-NCT04555148 
Healthcare Benefit
Approval Status
Submitted pending
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number SMC 2020-08-028 
Approval Date 2020-09-18 
Institutional Review Board  
- Name Samsung Medical center IRB  
- Address 81, Irwon-ro, Gangnam-gu, Seoul 
- Telephone 02-3410-2973 
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Kyong Ran Peck 
- Title Prof. 
- Telephone +82-2-3410-0322 
- Affiliation Samsung Medical Center 
- Address 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea 
Contact Person for Public Queries
- Name Kyong Ran Peck 
- Title Prof. 
- Telephone +82-2-3410-0322 
- Affiliation Samsung Medical Center 
- Address 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea 
Contact Person for Updating Information
- Name Sangmi Kang 
- Title Manager 
- Telephone +82-31-260-9571 
- Affiliation Green Cross 
- Address 107, Ihyeon-ro 30beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea 
Status
4. Status Status  
Study Site Multi-center (Number of center : 10)
Overall Recruitment Status Recruiting  
Date of First Enrollment 2020-09-18 , Actual
Target Number of Participant 60
Primary Completion Date 2020-12-31 , Anticipated
Study Completion Date 2021-02-28 , Anticipated
Recruitment Status by Participating Study Site 1 
- Name of Study Site Chung-Ang Univerisity Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-09-18 , Actual
Recruitment Status by Participating Study Site 2 
- Name of Study Site Korea University Ansan Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-12-21 , Anticipated
Recruitment Status by Participating Study Site 3 
- Name of Study Site Asan Medical Center 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-12-21 , Anticipated
Recruitment Status by Participating Study Site 4 
- Name of Study Site Chungnam National University Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-10-08 , Actual
Recruitment Status by Participating Study Site 5 
- Name of Study Site Yonsei University Health System, Severance Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2020-12-21 , Anticipated
Recruitment Status by Participating Study Site 6 
- Name of Study Site Kyungpook National University Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2020-12-21 , Anticipated
Recruitment Status by Participating Study Site 7 
- Name of Study Site Ajou University Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2020-12-21 , Anticipated
Recruitment Status by Participating Study Site 8 
- Name of Study Site The Catholic University of Korea, Seoul St. Mary's Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2020-12-22 , Anticipated
Recruitment Status by Participating Study Site 9 
- Name of Study Site Myongji Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2020-12-21 , Anticipated
Recruitment Status by Participating Study Site 10 
- Name of Study Site Samsung Medical Center 
- Recruitment Status Recruiting  
- Date of First Enrollment 2020-11-11 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Korea Drug Development Fund 
- Organization Type Others  
- Project ID  
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Green Cross 
- Organization Type Pharmaceutical Company  
Study Summary
7. Study Summary  
Lay Summary GC5131 can be expected to show effective treatment as passive immunization, which was purified from COVID-19 recovered patients. In this clinical trial, efficacy and safety would be confirmed when GC5131 is administered as a therapeutic agent in patients with COVID-19 infection.  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Phase2 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation RCT 
Intervention Type /Biological/Vaccine, /Non-Stem Cell  
Intervention Description Low dose of GC5131, intermediate dose of GC5131, high dose of GC5131 (each 2500mg, 5000mg, 10000mg), once, iv,
If a subject were assigned into an each intervention group, prepare the number of assigned intervention vials. If assigned into placebo group, prepare 50 mL saline.
Start infusion at 0.01 to 0.02 mL/kg/min (e.g., 0.6 to 1.2 mL / min with a body weight of 60 kg) for 30 minutes, gradually increasing to0.06 for remainder of infusion.  
Number of Arms
Arm 1 Arm Label low dose 
Target Number of Participant 15 
Arm Type Experimental 
Arm Description 2500mg of GC5131, once, iv. If a subject were assigned into an each intervention group, prepare the number of assigned intervention vials. If assigned into placebo group, prepare 50 mL saline. Start infusion at 0.01 to 0.02 mL/kg/min (e.g., 0.6 to 1.2 mL / min with a body weight of 60 kg) for 30 minutes, gradually increasing to0.06 for remainder of infusion. 
Arm 2 Arm Label intermediate dose 
Target Number of Participant 15 
Arm Type Experimental 
Arm Description 5000mg of GC5131, once, iv If a subject were assigned into an each intervention group, prepare the number of assigned intervention vials. If assigned into placebo group, prepare 50 mL saline. Start infusion at 0.01 to 0.02 mL/kg/min (e.g., 0.6 to 1.2 mL / min with a body weight of 60 kg) for 30 minutes, gradually increasing to0.06 for remainder of infusion. 
Arm 3 Arm Label high dose 
Target Number of Participant 15 
Arm Type Experimental 
Arm Description 10000mg of GC5131, once, iv If a subject were assigned into an each intervention group, prepare the number of assigned intervention vials. If assigned into placebo group, prepare 50 mL saline. Start infusion at 0.01 to 0.02 mL/kg/min (e.g., 0.6 to 1.2 mL / min with a body weight of 60 kg) for 30 minutes, gradually increasing to0.06 for remainder of infusion. 
Arm 4 Arm Label placebo 
Target Number of Participant 15 
Arm Type Placebo comparator 
Arm Description 50 mL saline, once, iv If a subject were assigned into an each intervention group, prepare the number of assigned intervention vials. If assigned into placebo group, prepare 50 mL saline. Start infusion at 0.01 to 0.02 mL/kg/min (e.g., 0.6 to 1.2 mL / min with a body weight of 60 kg) for 30 minutes, gradually increasing to0.06 for remainder of infusion. 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Certain infectious and parasitic diseases
CORONAVIRUS INFECTIONS  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ No Limit
Description 1) The COVID-19 patient who diagnosed by PCR within 3 days prior to randomized And who is hospitalized with COVID-19 related symptoms
2) The subject who has symptoms of COVID-19 within 7 days
3) 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)
4) Willing and able to provide written informed consent prior to performing study procedures  
Exclusion Criteria 1) asymptomatic patient
2) The subject who requiring mechanical ventilation or ECMO
3) The subject who are underlying oxygen therapy before affected by COVID-19
4) The subject who have received antiviral drugs for other disease within 4 weeks History of allergy to IVIG or plasma products
5) The subject who received IVIG or convalescent plasma from a person who recovered from COVID-19
6) IgA deficiency
7) Cretinine > 2 X ULN
8) The subject with a history of thrombosis or high risk of thromboembolism
9) 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.)  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
- Outcome Percentage of subjects whose scores decreased by 2 points or reach level 1 or 2 by 9-ordinal scale 
- Timepoint at 7, 14, 21, 28 days 
Secondary Outcome(s) 1 
- Outcome viral convergent, CT value, titer 
- Timepoint at 7, 14, 21, 28 days 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No