COVID-19 disease due to an infection with SARS-CoV2-virus
Conditions
Interventions
Trade Name: Nanogam
Product Name: Nanogam
Pharmaceutical Form: Solution for infusion
Trade Name: Nanogam
Product Name: Nanogam
Pharmaceutical Form: Solution for infusion
Sponsors
Amsterdam UMC
Eligibility
Sex/Gender
All
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 =65 years) yes F.1.3.1 Number of subjects for this age range 43
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 |
|---|---|
| Secondary Objective: • 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. ;Primary end point(s): • 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. ;Main Objective: To generate proof that convalescent antibody-mediated treatment of ICPs, who suffer from COVID-19 disease can protect ICPs from a more severe course of disease.;Timepoint(s) of evaluation of this end point: Day 1, 2, 3, 7, 10, 21, 28 and month 3, 6, 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the impact of convalescent antibody-mediated treatment in the ICP population on: • Severity of COVID-19 disease in patients that have no anti SARS-CoV-2 antibodies upon inclusion (‘per protocol’ analysis). • Duration of hospitalization. • 28-day 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. ;Timepoint(s) of evaluation of this end point: Day 1, 2, 3, 7, 10, 21, 28 and month 3, 6, 12 | — |
Countries
Netherlands
Contacts
Public Contactdr. J. Heijmans
Amsterdam UMC
Outcome results
None listed