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COVID-19 on Disease Activity in Radiologically Isolated Syndrome Cohort

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05387395
Acronym
VaxiRIS
Enrollment
217
Registered
2022-05-24
Start date
2022-05-31
Completion date
2022-07-01
Last updated
2022-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Multiple Sclerosis

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.

Interventions

OTHERNO intervention

no intervention

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
COVID 19 vaccination and clinical conversion to multiple sclerosis riskyear 2number of patients with a conversion to MS in each group

Secondary

MeasureTime frameDescription
COVID 19 vaccination and evidence disease activity riskyear 2number of patients with an evidence disease activity in each group
multiple sclerosis evolution and history of COVID 19 infectionyear 2number of patients with a conversion to MS in each group

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026