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NCT04818892 · ClinicalTrials.gov registry record
Immunogenicity of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease
A clinical trial, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- 222
- Enrollment target
NCT04818892: Completed study, sponsored by University of Wisconsin, Madison.
NCT04818892 is a clinical trial that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 222 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04818892 has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- 222 participants
- Enrollment target
Study Summary
The overall objective of this proposal is to evaluate the safety and immunogenicity of a COVID-19 vaccine in patients with Inflammatory Bowel Disease (IBD). This will help determine if immunosuppressive regimens impact COVID-19 vaccine response. The investigators will determine if certain groups may need more doses of a vaccine, with future adjuvanted vaccines or require a booster to maintain immunity. 260 participants with IBD and scheduled to get a COVID-19 vaccine will be recruited and can expect to be on study for 18 months.
Primary Outcome
The primary endpoint will be evaluating the change in humoral immunity between the immunosuppressive and non-immunosuppressive IBD treatment regimens following the recommended doses mRNA COVID-19 vaccine series.
Interventions
- DIAGNOSTIC_TEST Serological Assay for SARS-CoV-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2021-03-26 |
| Est. Completion | 2022-11-11 |
What the finished NCT04818892 record still lists
NCT04818892 is an observational study that tracks outcomes without assigning an intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Serological Assay for SARS-CoV-2 is the first listed.
NCT04818892 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04818892 about?
NCT04818892 is a clinical study titled "Immunogenicity of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease". The overall objective of this proposal is to evaluate the safety and immunogenicity of a COVID-19 vaccine in patients with Inflammatory Bowel Disease (IBD). This will help determine if immunosuppressive regimens impact COVID-19 vaccine response. The investigators will determine if certain groups may...
What is the current status of trial NCT04818892?
This trial is currently completed. The enrollment target is 222 participants. The study started on 2021-03-26. Estimated completion is 2022-11-11.
What interventions are being tested in trial NCT04818892?
The interventions under investigation include: Serological Assay for SARS-CoV-2 (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04818892?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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