COVID-19 on Disease Activity in Radiologically Isolated Syndrome Cohort
VaxiRIS
Impact of COVID 19 Vaccination or Infection on Disease Activity in Radiologically Isolated Syndrome Cohort: the VaxiRIS Study
1 other identifier
observational
217
1 country
1
Brief Summary
The Radiologically Isolated Syndrome (RIS) is defined as incidental Magnetic Resonance Imaging (MRI) abnormalities fulfil the criteria for dissemination in space, suggestive of multiple sclerosis. Nowadays, mandatory vaccination in patients with multiple sclerosis (MS) is widely recommended. Regarding COVID19, the absence of specific warnings led to the proposal of vaccination in patients with inflammatory diseases of the central nervous system. We aimed to evaluate if COVID19 vaccination or infection increased the risk of clinical conversion to multiple sclerosis or evidence of disease activity (EDA) in a cohort of RIS subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2022
CompletedFirst Posted
Study publicly available on registry
May 24, 2022
CompletedStudy Start
First participant enrolled
May 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedAugust 1, 2022
May 1, 2022
1 month
May 23, 2022
July 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
COVID 19 vaccination and clinical conversion to multiple sclerosis risk
number of patients with a conversion to MS in each group
year 2
Secondary Outcomes (2)
COVID 19 vaccination and evidence disease activity risk
year 2
multiple sclerosis evolution and history of COVID 19 infection
year 2
Study Arms (2)
complete vaccination
Complete vaccination was defined as administering two doses of mRNA or AstraZeneca vaccine, administration of one dose of Jansen vaccine, or administration of one dose of any vaccine in patients with a history of COVID19 infection.
incomplete vaccination
Other cases were defined as incomplete or absent vaccination.
Interventions
Eligibility Criteria
Patients fulfilling the Radiologic Isolated Syndrome criteria
You may qualify if:
- patients belong to the RISC cohort;
- totally vaccinated ou partially vaccinated patient
- vaccination status known
You may not qualify if:
- presented a first clinical event before the COVID19 vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nice University Hospital
Nice, 06000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2022
First Posted
May 24, 2022
Study Start
May 31, 2022
Primary Completion
July 1, 2022
Study Completion
July 1, 2022
Last Updated
August 1, 2022
Record last verified: 2022-05