Status:
UNKNOWN
Responses to COVID19 Vaccination in Patients With a Treatment History of Rituximab.
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
COVID19 Vaccination
Rituximab
Eligibility:
All Genders
18+ years
Brief Summary
Patients with treatment history of rituximab since 01.01.2019 and immunocompetent volunteers will be contacted to give a blood sample after their COVID19 vaccination, and in a subset also before vacci...
Eligibility Criteria
Inclusion
- Patients who were treated with anti-CD20 treatment since 01.01.2010
- Patients who received a COVID19 vaccination (completion of all required doses) until target date (initial target: 30.05.21, but can be delayed to 30.06.21, 30.07.21 or 30.08.21 in case of insufficient enrollment)
- Volunteers without a history of anti-CD20 treatment exposure
- All: written informed consent.
Exclusion
- Exclusion criteria for patients (any of the following)
- Patients aged 18 years and younger at time of study enrollment and/or
- Pregnant or lactating women at time of study enrollment and/or
- Patients who do not provide written informed consent and/or
- Patients who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
- Patients who are in a dependency relationship with the study personnel (hierarchical, social)
- Exclusion criteria for volunteers (any of the following)
- Volunteers aged 18 years and younger at time of study enrollment and/or
- Pregnant or lactating women at time of study enrollment and/or
- Volunteers who do not provide informed consent and/or
- Volunteers who suffer from an active autoimmune disease, active cancer, immunosuppressive therapy, history of anti-CD20 treatment and/or
- Volunteers who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
- Volunteers who did not complete their COVID19 vaccination
- Volunteers who are in a dependency relationship with the study personnel (hierarchical, social)
Key Trial Info
Start Date :
April 26 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2021
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT04877496
Start Date
April 26 2021
End Date
October 31 2021
Last Update
June 2 2021
Active Locations (1)
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1
University Hospital Bern Inselspital
Bern, Canton of Bern, Switzerland, 3010