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Randomized Open Label Trial Evaluating Efficacy and Safety of Intravenous Immunoglobulin (IVIg, Privigen) as Add-on to SoC Versus SoC Alone for Coronavirus Disease 2019 (COVID-19) in Patients with Severely Impaired B-cell Function
EU CTIS ID: 2025-522756-97-00
What this study is testing
To evaluate the efficacy of intravenous immunoglobulin as an add-on to SoC versus SoC alone in vaccine nonresponding severely immunocompromised patients with COVID-19 on clinical recovery and clearance of RNAemia by Day 28 after randomization
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years
- Signed informed consent to participate in the trial and being available for follow-up for the duration of the trial
- Symptomatic COVID-19 of any severity with a duration of ≥7 days
- Presence of SARS-CoV-2 RNA in blood plasma as detected by RT-PCR within 96 hours from randomization.
- Having received full initial COVID-19 vaccination (at least two doses) with any COVID-19 vaccine at least four weeks prior
- Severely impaired B-cell function due to either disease or treatment according to the Investigator, including hematological malignancy, rejection therapy following solid organ transplantation, and current or previous anti-CD20 monoclonal antibody treatment.
You likely can't join if
- Previous treatment with IVIg, plasma or monoclonal anti-SARS-CoV-2 IgG during the last three months
- Ongoing treatment with direct acting anti-SARS-CoV-2 antivirals
- Any severe events related to previous treatment with IVIg or any blood product
- Participants who cannot receive any available SoC antiviral treatment according to the Investigator
- Pregnancy or intent to become pregnant within the study period (6 months) or ongoing breastfeeding
- Severe underlying condition with an expected survival less than six months
See the full eligibility criteria
- Age ≥18 years
- Signed informed consent to participate in the trial and being available for follow-up for the duration of the trial
- Symptomatic COVID-19 of any severity with a duration of ≥7 days
- Presence of SARS-CoV-2 RNA in blood plasma as detected by RT-PCR within 96 hours from randomization.
- Having received full initial COVID-19 vaccination (at least two doses) with any COVID-19 vaccine at least four weeks prior
- Severely impaired B-cell function due to either disease or treatment according to the Investigator, including hematological malignancy, rejection therapy following solid organ transplantation, and current or previous anti-CD20 monoclonal antibody treatment.
- Anti-SARS-CoV-2 Spike IgG level below the detection limit for seropositivity for the available serological instrument within one week from randomization
- Signed informed consent to participate in the trial and being available for follow-up for the duration of the trial
- Negative pregnancy test for persons of childbearing potential (POCP)
- Highly effective and/or adequate anticonceptual methods (combined or progesterone-only hormonal contraception, intrauterine device, sexual abstinence, condom or cap/diaphragm/sponge with spermicide) for POCP for the duration of treatment with anti-SARS-CoV-2 antivirals. Participants who receive Nirmaltrelvir/Ritonavir and are using combined hormonal contraceptives will be advised to use an effective alternative contraceptive method or an additional barrier method of contraception during treatment with this medicinal product, and until one menstrual cycle after stopping the treatment.
- Previous treatment with IVIg, plasma or monoclonal anti-SARS-CoV-2 IgG during the last three months
- Ongoing treatment with direct acting anti-SARS-CoV-2 antivirals
- Any severe events related to previous treatment with IVIg or any blood product
- Participants who cannot receive any available SoC antiviral treatment according to the Investigator
- Pregnancy or intent to become pregnant within the study period (6 months) or ongoing breastfeeding
- Severe underlying condition with an expected survival less than six months
- Unable to provide signed informed consent
- Participation or recent participation (within 30 days) in a clinical trial with an investigational medicinal product
- Previous participation in this trial
- Otherwise not suitable for participation in the study according to the view of the Investigator
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.