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NCT05060354 · ClinicalTrials.gov registry record
COVID-19 Vaccine Response in Treated MS Patients
A clinical trial, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- 159
- Enrollment target
NCT05060354: Completed study, sponsored by Brigham and Women's Hospital.
NCT05060354 is a clinical trial that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 159 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05060354 has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- 159 participants
- Enrollment target
Study Summary
The primary goal of this study is to assess the impact of the two major disease modifying therapy (DMT) classes (B cell therapies and S1P modulators) on humoral and cell-mediated immunity to SARS- CoV-2 vaccination compared to non-MS controls. We have chosen to compare DMT-treated MS patients to non-MS controls because the pivotal vaccine studies were conducted in non-MS healthy control groups in which there is significant clinical data and validated assays for antibody responses.
Primary Outcome
Compare the percentage of MS patients on immunotherapy with a positive SARS-CoV-2 Spike antibody response, using the Roche Elecsys® Anti-SARS-CoV-2 S immunoassay for the quantitative, in vitro determination of antibodies to SARS-CoV- 2 in human serum and plasma. It is an Electro-chemiluminescence immunoassay (ECLIA) test using a double-antigen sandwich assay. A positive seroconversion defined as level\>0.4U/ml.
Interventions
- OTHER Blood draw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2023-09-28 |
What the finished NCT05060354 record still lists
NCT05060354 is an observational study that tracks outcomes without assigning an intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Blood draw is the first listed.
NCT05060354 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05060354 about?
NCT05060354 is a clinical study titled "COVID-19 Vaccine Response in Treated MS Patients". The primary goal of this study is to assess the impact of the two major disease modifying therapy (DMT) classes (B cell therapies and S1P modulators) on humoral and cell-mediated immunity to SARS- CoV-2 vaccination compared to non-MS controls. We have chosen to compare DMT-treated MS patients to non...
What is the current status of trial NCT05060354?
This trial is currently completed. The enrollment target is 159 participants. The study started on 2021-06-01. Estimated completion is 2023-09-28.
What interventions are being tested in trial NCT05060354?
The interventions under investigation include: Blood draw (OTHER).
Who is sponsoring clinical trial NCT05060354?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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