NL-OMON51203暂停2 期
Convalescent Antibody-Mediated Treatment of COVID-19 Infections in Patients with B-cell dysfunction, a Randomized Trial (COVID-Compromise Study). - COVID-Compromise Study
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patient is >= 18 years of age, diagnosed with COVID-19 based on a positive PCR
- •or antigen test in combination with COVID-19 related symptoms (e.g. Fever,
- •hypoxia, gastrointestinal symptoms).
- •- Hospitalized.
- •AND one of immunocompromised conditions/treatments below
- •B-cell inhibition related ICP
- •- Use of anti-CD19 or -CD20 directed antibody therapy in 6 months prior to
- •- Previous or current treatment with drugs that significantly impair B cell
- •function (e.g. ibrutinib, venetoclax, acalabrutinib, idelalisib etc) within 6
- •months prior to inclusion
- •Other immunosuppression/treatment related ICP
- •- Patients treated with bendamustine, purine analogues or anti-thymocyte
- •globulin within 6 months prior to inclusion.
- •- Solid organ transplant patients that are taking systemic immunosuppressive
- •drugs from at least three pharmacological classes. Or from at least two classes
- •in combination with negative anti-SARS-CoV-2 antibodies <= 96 hours prior to
- •Cellular therapy related ICP
- •- Allogeneic hematopoietic stem cell transplant (HSCT) in 12 months prior to
- •- HSCT for which systemic therapy against graft-versus-host-disease is used.
- •- Recipient of CAR-T cells < 2 years prior to inclusion.
- •Disease related ICP
- •- Chronic B-cell leukemia*s: CLL, HCL, PLL, multiple myeloma, Waldenströms
- •macroglobulinemia
- •Congenital ICP
- •- Congenital disorder resulting in severe B-cell dysfunction or depletion
- •requiring immunoglobulin suppletion (e.g. agammaglobulinemia).
排除标准
- •- Patient or legal representative is unable to provide written informed consent
- •- Life expectancy of < 28 days in the opinion of the treating physician
- •- Has previously participated in this study.
- •- Has previously received convalescent plasma with high level neutralizing
- •anti-SARS-CoV-2 antibodies (either in other study or in compassionate use
- •- Known IgA deficiency (defined as absence of IgA and possibility of anti-IgA
- •antibodies), patients with disease related reduced levels of IgA (e.g. in
- •myeloma or lymphoma) may be included in the study.
- •- Known previous grade 3 or 4 hypersensitivity reactions to treatment with
- •immunoglobulins
- •- Patient who has reached endpoint already at admission (direct adjunctive
- •oxygen therapy in the form of high-flow nasal oxygen (HFNO), mechanical
- •ventilation or ICU admission for other reason).
研究者
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