| Trial registration number
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KCT0005649 |
Full text link
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://cris.nih.go.kr/cris/search/detailSearchEn.do?seq=21172
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First author
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Kyong Ran Peck
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Contact
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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krpeck@skku.edu
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Registration date
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-12-02
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Recruitment status
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Completed
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Study design
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1) The COVID-19 patient who diagnosed by PCR within 3 days prior to randomized And who is hospitalized with COVID-19 related symptoms2) The subject who has symptoms of COVID-19 within 7 days3) 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
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Exclusion criteria
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
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.)
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Number of arms
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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4
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Funding
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Green Cross
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Inclusion age min
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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19
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Inclusion age max
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Democratic People's Republic of Korea
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Type of patients
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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60
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primary outcome
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Percentage of subjects whose scores decreased by 2 points or reach level 1 or 2 by 9-ordinal scale
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Notes
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 2
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Arms
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "2500mg", "treatment_id": 540, "treatment_name": "Gc5131", "treatment_type": "Immunoglobulins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "5000mg", "treatment_id": 540, "treatment_name": "Gc5131", "treatment_type": "Immunoglobulins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "10000mg", "treatment_id": 540, "treatment_name": "Gc5131", "treatment_type": "Immunoglobulins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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