NL-OMON25136
Recruiting
Not Applicable
Convalescent Antibody-Mediated Treatment of COVID-19 Infections in Patients with B-cell dysfunction, a Randomized Trial COVID-Compromise Study
AmsterdamUMC0 sites86 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AmsterdamUMC
- Enrollment
- 86
- Status
- Recruiting
- 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
- •? 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.
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
Outcomes
Primary Outcomes
Not specified
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