No registrations found.
ID
Source
Health condition
COVID-19
Sponsors and support
Intervention
Outcome measures
Primary outcome
more severe course of COVID-19
Secondary outcome
- 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.
Background summary
A more severe course of COVID-19 infections has been reported in immunocompromised patients (ICPs), such as those suffering from innate immune disorders, (haematological) malignancies, or patients who are treated with immunosuppressive medication. The common denominator among
these patients is an impaired B-cell or T-cell function, or depletion, and these patients are unable to generate sufficient neutralizing antiviral antibody titres or their production is delayed. To date, no specific therapeutic strategies have convincingly been shown effective in this patient population. Treatment with neutralizing antiviral antibodies from convalescent patients has been tested in the general population. In this population, one study has shown promising results when it is administered in the very first stages of disease, but not in hospitalized patients. This discrepancy is thought to result from the redundant effect of exogenous antibodies in these patients, in whom high titres of neutralizing antibodies are typically present at hospital admission. In those who are still antibody negative at admission, all but few start producing antibodies within days after admission as well. Since immunocompromised patients may not develop neutralizing antibodies, exogenously provided antibodies could be a functional adjuvant therapy of COVID-19, also in later stages of disease (e.g. upon hospitalization), but no trials to data have addressed this question.
Study 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.
Study design
clinical until 28 days.
Intervention
treatment with Nanogam (purified immunoglobulin concentrate) with or without high dose neutralizing anti COVID-19 antibodies
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9436 |
| Other | METC AMC : METC 2021_032 |