NCT06159283

Intravenous Immunoglobulin Replacement Therapy for Persistent COVID-19 in Patients With B-cell Impairment

Intravenous Immunoglobulin Replacement Therapy for Persistent COVID-19 in Patients With B-cell Impairment: a Multicenter Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Jaehoon Ko · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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 1:1 ratio.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Immunoglobulins	Dosage is Immunoglobulin 1,000mg/kg IV. It administer over 2\~3 days.

Timeline

• Start date: 2024-03-18
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2023-12-06
• Last updated: 2024-05-16

Locations

1 site across 1 country: South Korea