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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04877496
Other study ID # 4749
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 26, 2021
Est. completion date October 31, 2021

Study information

Verified date May 2021
Source University Hospital Inselspital, Berne
Contact Daniel Sidler, MD PhD
Phone 0041316323144
Email daniel.sidler@insel.ch
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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 vaccination. Immune responses of antibodies and SARS-CoV2-specific T-cells to the vaccination will be quantified and the rituximab effect on COVID19 vaccine-induced immune responses is analyzed.


Recruitment information / eligibility

Status Recruiting
Enrollment 425
Est. completion date October 31, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients who were treated with anti-CD20 treatment since 01.01.2010 2. 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) 3. Volunteers without a history of anti-CD20 treatment exposure 4. All: written informed consent. Exclusion Criteria: Exclusion criteria for patients (any of the following) 1. Patients aged 18 years and younger at time of study enrollment and/or 2. Pregnant or lactating women at time of study enrollment and/or 3. Patients who do not provide written informed consent and/or 4. Patients who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology) 5. Patients who are in a dependency relationship with the study personnel (hierarchical, social) Exclusion criteria for volunteers (any of the following) 1. Volunteers aged 18 years and younger at time of study enrollment and/or 2. Pregnant or lactating women at time of study enrollment and/or 3. Volunteers who do not provide informed consent and/or 4. Volunteers who suffer from an active autoimmune disease, active cancer, immunosuppressive therapy, history of anti-CD20 treatment and/or 5. Volunteers who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology) 6. Volunteers who did not complete their COVID19 vaccination 7. Volunteers who are in a dependency relationship with the study personnel (hierarchical, social)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
History of exposure to anti-CD20 treatment since 01/01/2010
Intravenous treatment history of anti-CD20 treatment since 01/01/2010
Biological:
Completion of COVID19 vaccine at least 4 weeks ago
Completion of COVID19 vaccination course at least 4 weeks ago.

Locations

Country Name City State
Switzerland University Hospital Bern Inselspital Bern BE

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Humoral immune response to SARS-CoV2 spike protein Percentage of all patients developing IgG antibodies against SARS-CoV2 spike protein that is comparable to the immunological response in immunocompetent controls (-2 standard deviations of mean) At least 4 weeks after completion of COVID19 vaccination
Secondary Correlation of IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence Multivariable regression models for IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence as confounding variables. At least 4 weeks after completion of COVID19 vaccination
Secondary Correlation of IgG antibodies against SARS-CoV2 with time interval since last dose of rituximab At least 4 weeks after completion of COVID19 vaccination
Secondary Correlation of IgG antibodies against SARS-CoV2 with cumulative dose of rituximab received. At least 4 weeks after completion of COVID19 vaccination
Secondary T cell anti-SARS-CoV2 response after COVID19 vaccination At least 4 weeks after completion of COVID19 vaccination
Secondary Correlation between IgG antibodies against SARS-CoV2 and B-cell counts, T-cell counts and total immunoglobulin levels Multivariable regression models for IgG antibodies against SARS-CoV2 with B-cell counts, T-cell counts and total immunoglobulin levels as confounders. At least 4 weeks after completion of COVID19 vaccination
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