Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159283
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-12-04
Brief Title:
Intravenous Immunoglobulin Replacement Therapy for Persistent COVID-19 in Patients With B-cell Impairment
Sponsor:
Jaehoon Ko
Organization:
Samsung Medical Center
Study Overview
Official Title:
Intravenous Immunoglobulin Replacement Therapy for Persistent COVID-19 in Patients With B-cell Impairment a Multicenter Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
This project aims to provide passive immunization to patients with persistent COVID-19 who experience inflammation owing to continuous replication of SARS-CoV-2 as a consequence of B-cell impairment that hinders normal antibody formation As opposed to relying on the non-specific immune mechanism of IVIG in other studies this trial focuses on the antiviral effect and antibody-dependent cytotoxicity induced by SARS-CoV-2-specific antibodies from plasma donors who have formed high antibody titers through vaccination and breakthrough infections Thus in contrast to previous studies the therapy may demonstrate clinical efficacy In this work we aim to elucidate the role of IVIG in treating persistent COVID-19 in patients with B-cell depletion who cannot produce antibodies and to establish grounds for clinical application of the therapy
Once the participants voluntarily provide written consent to participate in the trial they will undergo screening tests and eligible participants will be randomly assigned to the treatment or control standard of care group in a 11 ratio
Once the participants voluntarily provide written consent to participate in the trial they will undergo screening tests and eligible participants will be randomly assigned to the treatment or control standard of care group in a 11 ratio
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None