COVID-19 on Disease Activity in Radiologically Isolated Syndrome Cohort

COVID-19 Clinical Trial

— VaxiRIS  

Official title:

Impact of COVID 19 Vaccination or Infection on Disease Activity in Radiologically Isolated Syndrome Cohort: the VaxiRIS Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05387395
• Other study ID #: 22Neuro02
• Status: Completed
• Start date: May 31, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Multiple Sclerosis

Intervention

Other:
• NO intervention
no intervention

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID 19 vaccination and clinical conversion to multiple sclerosis risk	number of patients with a conversion to MS in each group	year 2
Secondary	COVID 19 vaccination and evidence disease activity risk	number of patients with an evidence disease activity in each group	year 2
Secondary	multiple sclerosis evolution and history of COVID 19 infection	number of patients with a conversion to MS in each group	year 2