COVID-19 trials registries data warehouse

https://trialregister.nl/trial/9436

Jarom Heijmans

j.heijmans@amsterdamumc.nl

2021-04-22

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 antigentest.? Hospitalized.AND one of immunocompromised conditions/treatments belowB-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 inclusionOther immunosuppression/treatment related ICP? Patients treated with bendamustine, purine analogues or anti-thymocyte globulin within 6months prior to inclusion.? Solid organ transplant patients that are taking systemic immunosuppressive drugs from atleast 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, WaldenströmsmacroglobulinemiaCongenital ICP? Congenital disorder resulting in severe B-cell dysfunction or depletion requiringimmunoglobulin suppletion (e.g. agammaglobulinemia).

? Has previously participated in this study.? Has previously received convalescent plasma with high level neutralizing anti-SARS-CoV-2antibodies (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 inthe form of high-flow nasal oxygen (HFNO), mechanical ventilation or ICU admission for otherreason).

2

AmsterdamUMC

18

100

Netherlands

Moderate disease at enrollment

3: Moderate disease at enrollment

86

more severe course of COVID-19

Not reported

[{"arm_notes": "", "treatment_id": 859, "treatment_name": "Nanogam (purified immunoglobulin concentrate)", "treatment_type": "Immunoglobulins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1641, "treatment_name": "High dose neutralizing anti covid-19 antibodies+nanogam (purified immunoglobulin concentrate)", "treatment_type": "Immunoglobulins sars-cov-2 specific+immunoglobulins", "pharmacological_treatment": "Pharmacological treatment"}]