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OpenTrials
Completed

NCT Number: NCT05387395

COVID-19 on Disease Activity in Radiologically Isolated Syndrome Cohort

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System COVID-19 Coronaviridae Infections Coronavirus Infections Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Infections Lung Diseases Nervous System Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nice University Hospital

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. COVID 19 vaccination and clinical conversion to multiple sclerosis risk

    Time frame: year 2

    number of patients with a conversion to MS in each group

Secondary outcomes

  1. COVID 19 vaccination and evidence disease activity risk

    Time frame: year 2

    number of patients with an evidence disease activity in each group

  2. multiple sclerosis evolution and history of COVID 19 infection

    Time frame: year 2

    number of patients with a conversion to MS in each group

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: VaxiRIS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 24, 2022
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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