2025-522756-97-00招募中2 期
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
Region Vaesterbotten, Umea University8 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2026年2月6日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 8
- 主要终点
- 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.
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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.
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.
次要结局
- 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
- 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.
- Ranked-based comparison of 10-category ordinal WHO Clinical Progression Scale score as assessed by the Investigator at days 10 and 28 AR
- 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.
- 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
研究者
Johan Normark
Scientific
Region Vaesterbotten
研究点 (8)
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