Actively Recruiting
Intravenous Immunoglobulin Replacement Therapy for Persistent COVID-19 in Patients With B-cell Impairment
Led by Jaehoon Ko · Updated on 2024-05-16
58
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized controlled trial aiming to investigate the efficacy of intravenous immunoglobulin (IVIG) replacement therapy under the hypothesis that immunoglobulin replacement would have therapeutic effects on persistent COVID-19 in patients with B-cell impairment.
CONDITIONS
Official Title
Intravenous Immunoglobulin Replacement Therapy for Persistent COVID-19 in Patients With B-cell Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written consent to participate in the trial
- Age 19 years or older
- Confirmed diagnosis of COVID-19 by approved tests such as RT-PCR, Xpert, film array, or rapid antigen test
- Persistent COVID-19 defined by no improvement or worsening of symptoms/signs of active inflammation (fever, pneumonia, dyspnea requiring oxygen) after at least 2 weeks from symptom onset or diagnosis
- Presence of symptoms including fever of 37.8 0C or higher lasting more than 48 hours, persistent cough despite treatment, or dyspnea on flat surface walking
- Signs of active inflammation including pulmonary infiltration on chest imaging or decreased oxygen saturation
- Patients with B-cell impairment due to hematologic malignancies, B-cell targeting chemotherapy within past 3 months, diseases causing B-cell depletion, or congenital primary immunodeficiency with reduced antibody formation
- Confirmation of peripheral B-cell reduction to less than 1% by flow cytometry for some participants
You will not qualify if you...
- Difficulty controlling underlying disease or life expectancy less than 3 months even after COVID-19 treatment
- T-cell impairment due to unsuspendable T-cell suppressive drugs or HIV infection with CD4 count below 500 cells/bcL or persistent HIV viral RNA
- IVIG or COVID-19 convalescent plasma therapy within 3 months prior to screening
- History of serious reactions or hypersensitivity to blood products, IVIG, or IgG
- Immunoglobulin A (IgA) deficiency or presence of IgA antibodies
- Uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Hemolytic or hemorrhagic anemia
- Impaired cardiac function classified as New York Heart Association Functional Class III or IV
- High clinical risk for thrombosis or embolism due to medical history
- Pregnancy or breastfeeding
- Current participation in another COVID-19 drug clinical trial
- Investigator’s discretion for other reasons deemed inappropriate for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jaehoon Ko
Seoul, South Korea
Actively Recruiting
Research Team
J
Jaehoon Ko, Ph,MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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