b-cell dysfunction
Conditions
Interventions
After randomization, one group (43 patients) receives treatment with Nanogam
containing high titre neutralizing anti-SARS-CoV-2 antibodies (further referred
to as Nanogam plus). The other group (43
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patient is >= 18 years of age, diagnosed with COVID-19 based on a positive PCR or antigen test in combination with COVID-19 related symptoms (e.g. Fever, hypoxia, gastrointestinal symptoms). - 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. Or from at least two classes in combination with negative anti-SARS-CoV-2 antibodies
Exclusion criteria
Exclusion criteria: - Patient or legal representative is unable to provide written informed consent - Life expectancy of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The endpoint of this study is a severe course of disease, which is defined until day 28 after randomization: * 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Severity of COVID-19 disease in patients that have no anti SARS-CoV-2 antibodies upon inclusion (*per protocol* analysis). * Duration of hospitalization. * 28 days overall mortality. * The four individual endpoints that compose the primary endpoint. * Time to complete recovery from COVID-19 related symptoms. * Rate of viral decay * Development of long-term persistent neutralizing antibodies against SARS-COV-2 * T-cell immunity as measured by in vitro specific T cell response to COVID-19 tetrameric antigens. | — |
Countries
Netherlands
Outcome results
None listed