Convalescent Antibody-Mediated Treatment of COVID-19 Infections in Patients with B-cell dysfunction, a Randomized Trial COVID-Compromise Study

AmsterdamUMC0 个研究点目标入组 86 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•? Patient is = 18 years of age, diagnosed with COVID-19 based on a positive PCR or antigen
•? 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).

•? 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

发起方

AmsterdamUMC