COVID-Compromise
- Conditions
- COVID-19
- Registration Number
- NL-OMON25136
- Lead Sponsor
- AmsterdamUMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 86
? 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).
? 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method more severe course of COVID-19
- Secondary Outcome Measures
Name Time Method - To evaluate the impact of convalescent antibody-mediated treatment on duration of<br>hospitalization in the ICP population.<br>- To evaluate the impact of convalescent antibody-mediated treatment on mortality in the ICP<br>population.<br>- To evaluate the impact of convalescent antibody-mediated treatment on ICU admission in the<br>ICP population.<br>- To evaluate the impact of convalescent antibody-mediated treatment on symptom duration in<br>the ICP population.<br>- To evaluate the impact of convalescent antibody-mediated treatment on viral clearance in the<br>ICP population.