NL-OMON51203
Suspended
Phase 2
Convalescent Antibody-Mediated Treatment of COVID-19 Infections in Patients with B-cell dysfunction, a Randomized Trial (COVID-Compromise Study). - COVID-Compromise Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 86
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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
Exclusion Criteria
- •\- Patient or legal representative is unable to provide written informed consent
- •\- Life expectancy of \< 28 days in the opinion of the treating physician
- •\- 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
- •\- Known IgA deficiency (defined as absence of IgA and possibility of anti\-IgA
- •antibodies), patients with disease related reduced levels of IgA (e.g. in
- •myeloma or lymphoma) may be included in the study.
- •\- Known previous grade 3 or 4 hypersensitivity reactions to treatment with
- •immunoglobulins
Outcomes
Primary Outcomes
Not specified
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