COVIDIG (COVID-19 Hyper-ImmunoGlobulin)
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
1 other identifier
interventional
63
1 country
1
Brief Summary
The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2020
CompletedFirst Posted
Study publicly available on registry
September 18, 2020
CompletedStudy Start
First participant enrolled
September 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2021
CompletedAugust 24, 2021
August 1, 2021
4 months
September 16, 2020
August 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Ordinal scale outcome
The percent of participants changed by 2 points or more
7, 14, 21, 28 days
Secondary Outcomes (3)
Viral negative
1, 3, 5, 7, 10 days
Change in NEWS2 (National Early Warning Score 2)
7, 14, 21, 28 days
mortality
28 days
Study Arms (4)
Placebo
PLACEBO COMPARATORSaline
Low dose Treatment
EXPERIMENTALLow dose treatment
Medium dose Treatment
EXPERIMENTALMedium dose Treatment
High dose Treatment
EXPERIMENTALHigh dose Treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2020
First Posted
September 18, 2020
Study Start
September 19, 2020
Primary Completion
January 22, 2021
Study Completion
April 23, 2021
Last Updated
August 24, 2021
Record last verified: 2021-08