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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Vaesterbotten, Umea University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02], Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2026-02-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Region Vasterbotten

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

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

Secondary objectives 5

1. To evaluate the efficacy of IVIg as an add-on to SoC versus SoC alone on clinical improvement and clearance of RNAemia at Day 10 after randomization
2. To evaluate the efficacy of IVIg as an add-on to SoC versus SoC alone on sustained recovery and clearing of the viral infection
3. To evaluate the efficacy of IVIg as an add-on to SoC versus SoC alone on improved clinical status at days 10 and 28
4. To evaluate the efficacy of IVIg as an add-on to SoC versus SoC alone in preventing progression to severe COVID-19 up to and by Day 28 after randomization.
5. To assess the safety of IVIg as add-on to SoC versus SoC alone

Conditions and MedDRA coding

COVID-19 and Severely Impaired B-cell Function

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Age ≥18 years
2. Symptomatic COVID-19 of any severity with a duration of ≥7 days
3. Presence of SARS-CoV-2 RNA in blood plasma as detected by RT-PCR within 96 hours from randomization.
4. Having received full initial COVID-19 vaccination (at least two doses) with any COVID-19 vaccine at least four weeks prior
5. 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.
6. Anti-SARS-CoV-2 Spike IgG level below the detection limit for seropositivity for the available serological instrument within one week from randomization
7. Signed informed consent to participate in the trial and being available for follow-up for the duration of the trial
8. Negative pregnancy test for persons of childbearing potential (POCP)
9. 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.
10. Signed informed consent to participate in the trial and being available for follow-up for the duration of the trial

Exclusion criteria 10

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 5

1. 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
2. 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.
3. Ranked-based comparison of 10-category ordinal WHO Clinical Progression Scale score as assessed by the Investigator at days 10 and 28 AR
4. 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.
5. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Vaesterbotten

Sponsor organisation

Region Vaesterbotten

Address

Koksvagen 11, Alidhem Alidhem

City

Umea

Postcode

907 37

Country

Sweden

Scientific contact point

Organisation

Region Vaesterbotten

Contact name

Johan Normark

Public contact point

Organisation

Region Vaesterbotten

Contact name

Johan Normark

Umea University

Sponsor organisation

Umea University

Address

Universitetstorget 4, Alidhem Alidhem

City

Umea

Postcode

907 36

Country

Sweden

Scientific contact point

Organisation

Region Vaesterbotten

Contact name

Johan Normark

Public contact point

Organisation

Region Vaesterbotten

Contact name

Johan Normark

Sponsor responsibilities

Article 77 compliance

Region Vaesterbotten

Contact point sponsor

Region Vaesterbotten

Article 77 implementation

Region Vaesterbotten

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications