COVID-19
Conditions
Interventions
treatment with Nanogam (purified immunoglobulin concentrate) with or without high dose neutralizing anti COVID-19 antibodies
Sponsors
AmsterdamUMC
Eligibility
Inclusion criteria
Inclusion criteria: ? 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).
Exclusion criteria
Exclusion criteria: ? 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| more severe course of COVID-19 | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate the impact of convalescent antibody-mediated treatment on duration of hospitalization in the ICP population. - To evaluate the impact of convalescent antibody-mediated treatment on mortality in the ICP population. - To evaluate the impact of convalescent antibody-mediated treatment on ICU admission in the ICP population. - To evaluate the impact of convalescent antibody-mediated treatment on symptom duration in the ICP population. - To evaluate the impact of convalescent antibody-mediated treatment on viral clearance in the ICP population. | — |
Contacts
Public ContactJarom Heijmans
AmsterdamUMC
Outcome results
None listed