COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-006075-15/NL

Amsterdam UMC - dr. J. Heijmans

j.heijmans@amsterdamumc.nl

2021-03-19

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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).

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).

2

Amsterdam UMC

18

100

Netherlands

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

86

• Start of adjunctive ventilator support (HFNO, mechanical ventilation) or an indication to do so but due to due to previously agreed treatment restrictions HFNO or mechanical ventilation is not initiated. • Admission to an intensive care unit for progression of respiratory insufficiency. • No clinical improvement on day 7 after randomization or any day thereafter after first day of treatment (based on oxygen use in patients that require oxygen and based on clinical disease burden (including fever) in patients that require no oxygen). • Readmission for COVID-19.

Dose 2

Phase 3

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}]