HUMAN NORMAL IMMUNOGLOBULIN for COVID-19|Severely impaired B-cell function

Inclusion criteria

• {"criterion_text":"- Age ≥18 years"}
• {"criterion_text":"- Signed informed consent to participate in the trial and being available for follow-up for the duration of the trial"}
• {"criterion_text":"- Symptomatic COVID-19 of any severity with a duration of ≥7 days"}
• {"criterion_text":"- Presence of SARS-CoV-2 RNA in blood plasma as detected by RT-PCR within 96 hours from randomization."}
• {"criterion_text":"- Having received full initial COVID-19 vaccination (at least two doses) with any COVID-19 vaccine at least four weeks prior"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Anti-SARS-CoV-2 Spike IgG level below the detection limit for seropositivity for the available serological instrument within one week from randomization"}
• {"criterion_text":"- Signed informed consent to participate in the trial and being available for follow-up for the duration of the trial"}
• {"criterion_text":"- Negative pregnancy test for persons of childbearing potential (POCP)"}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- Previous treatment with IVIg, plasma or monoclonal anti-SARS-CoV-2 IgG during the last three months"}
• {"criterion_text":"- Ongoing treatment with direct acting anti-SARS-CoV-2 antivirals"}
• {"criterion_text":"- Any severe events related to previous treatment with IVIg or any blood product"}
• {"criterion_text":"- Participants who cannot receive any available SoC antiviral treatment according to the Investigator"}
• {"criterion_text":"- Pregnancy or intent to become pregnant within the study period (6 months) or ongoing breastfeeding"}
• {"criterion_text":"- Severe underlying condition with an expected survival less than six months"}
• {"criterion_text":"- Unable to provide signed informed consent"}
• {"criterion_text":"- Participation or recent participation (within 30 days) in a clinical trial with an investigational medicinal product"}
• {"criterion_text":"- Previous participation in this trial"}
• {"criterion_text":"- Otherwise not suitable for participation in the study according to the view of the Investigator"}

Primary endpoints

• {"endpoint_text":"- Proportion of participants with clinical recovery (defined as a score of 0 or 1 according to the WHO Clinical Progression Scale) and no detectable SARS-CoV-2 RNA in blood plasma at Day 28, without receiving additional SARS-CoV-2 directed treatment (direct acting antivirals and/or IVIg) beyond SoC after randomization.","definition_or_measurement_approach":"Clinical recovery defined as WHO Clinical Progression Scale score of 0 or 1; and no detectable SARS-CoV-2 RNA in blood plasma at Day 28. Assessment excludes participants who received additional SARS-CoV-2 directed treatment beyond SoC after randomization."}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants with clinical improvement (defined as a reduced score of ≥1 according to the WHO clinical progression scale) and no detectable SARS-CoV-2 RNA in blood plasma at Day 10 after randomization","definition_or_measurement_approach":"Clinical improvement defined as reduction of ≥1 point on WHO Clinical Progression Scale; and no detectable SARS-CoV-2 RNA in blood plasma at Day 10."}
• {"endpoint_text":"- Proportion of participants with sustained clinical recovery (defined as a score of 0 or 1 according to the WHO Clinical Progression Scale) and no baseline SARS-CoV-2 straina RNA in blood plasma and nasopharyngeal sample at days 90 and 180, without additional SARS-CoV-2 directed treatment (direct acting antivirals and/or IVIg) beyond SoC after randomization.","definition_or_measurement_approach":"Sustained clinical recovery defined as WHO score 0 or 1 at days 90 and 180 and absence of baseline SARS-CoV-2 RNA in blood plasma and nasopharyngeal samples; excludes those receiving additional directed treatment beyond SoC."}
• {"endpoint_text":"- Ranked-based comparison of 10-category ordinal WHO Clinical Progression Scale score as assessed by the Investigator at days 10 and 28 AR","definition_or_measurement_approach":"Rank-based comparison of the 10-category WHO Clinical Progression Scale assessed at days 10 and 28 by Investigator."}
• {"endpoint_text":"- Proportion of participants with severe COVID-19 (defined as a score of ≥6 according to the WHO clinical progression scale) up to and by Day 28 after randomization.","definition_or_measurement_approach":"Severe COVID-19 defined as WHO Clinical Progression Scale score ≥6 assessed up to Day 28."}
• {"endpoint_text":"- AEs/SAEs. Assessments related to AEs include: Occurrence/frequency, Relationship to the Investigational Medicinal Product (IMP) as assessed by the investigator, Intensity, Seriousness, Death, AEs leading to withdrawal from the study, Other significant AEs","definition_or_measurement_approach":"Safety assessments include occurrence/frequency, investigator-assessed relationship to IMP, intensity, seriousness, death, AEs leading to withdrawal, and other significant AEs."}

Sweden

Earliest CTIS Part Ii Submission Date

16-01-2026

Latest Decision Or Authorization Date

06-02-2026

Processing Time Days

21

Number Of Sites

9

Number Of Participants

92

Primary sponsor

Full Name

Region Vaesterbotten

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Co-sponsors

• Umea University