EUCTR2020-006075-15-NL进行中（未招募）1 期
Convalescent Antibody-Mediated Treatment of COVID-19 Infections in Patients with B-cell dysfunction, a Randomized Trial. - COVID-Compromise Study
Amsterdam UMC0 个研究点目标入组 86 人开始时间: 2021年3月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patient is = 18 years of age, diagnosed with COVID-19 based on a positive PCR or antigen test.
- •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 inclusion.
- •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.
- •Cellular therapy related ICP
- •Allogeneic hematopoietic stem cell transplant (HSCT) in 12 months prior to inclusion.
- •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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 43
排除标准
- •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 program).
- •Known hypersensitivity to treatment with immunoglobulins (WHO grade 3-4).
- •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
相似试验
暂停
2 期
Convalescent Antibody-Mediated Treatment of COVID-19 Infections in Patients with B-cell dysfunction, a Randomized Trial (COVID-Compromise Study).NL-OMON51203Academisch Medisch Centrum86
招募中
不适用
COVID-CompromiseNL-OMON25136AmsterdamUMC86
尚未招募
3 期
Effect of COVID-19 convalescent plasma produced by HEMOPE: A randomized study, with a comparative group in several centersHypertensionDiabetes MellitusRBR-7jqpnwniversidade de Pernambuco
暂停
2 期
Clinical trial with convalescent plasma for Covid-19 therapyCOVID-19U07.1RBR-5r8gv8pniversidade de Brasília
Unknown
不适用
Remdesivir and Convalescent Plasma Therapy for Treatment of COVID-19 Infection in Nepal : A Registry StudyCovid19NCT04669990Nepal Health Research Council2,000