COVID-19 on Disease Activity in Radiologically Isolated Syndrome Cohort

Completed

• Conditions: Multiple Sclerosis; COVID-19
• Interventions: Other: NO intervention

• Registration Number: NCT05387395
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-24
• Study Start: 2022-05-31
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

• patients belong to the RISC cohort;
• totally vaccinated ou partially vaccinated patient
• vaccination status known

Exclusion Criteria

• presented a first clinical event before the COVID19 vaccination

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
complete vaccination	NO intervention	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	NO intervention	Other cases were defined as incomplete or absent vaccination.

Primary Outcome Measures

Name	Time	Method
COVID 19 vaccination and clinical conversion to multiple sclerosis risk	year 2	number of patients with a conversion to MS in each group

Secondary Outcome Measures

Name	Time	Method
COVID 19 vaccination and evidence disease activity risk	year 2	number of patients with an evidence disease activity in each group
multiple sclerosis evolution and history of COVID 19 infection	year 2	number of patients with a conversion to MS in each group

Trial Locations

Locations (1)

Nice University Hospital; 🇫🇷 Nice, France