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Trial - NCT04555148


Column Value
Trial registration number NCT04555148
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04555148

First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Kyoung Ran Peck, Dr.

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

krpeck@skku.edu

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-09-18

Recruitment status
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- 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.)

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Green Cross Corporation

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

19

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Korea;Republic of

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

63

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Ordinal scale outcome

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Low", "treatment_id": 338, "treatment_name": "Covid19 hyper-immunoglobulin", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Medium", "treatment_id": 338, "treatment_name": "Covid19 hyper-immunoglobulin", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "High", "treatment_id": 338, "treatment_name": "Covid19 hyper-immunoglobulin", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]