VaxiRIS: COVID-19 on Disease Activity in Radiologically Isolated Syndrome Cohort

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Completed
• CT.gov ID: NCT05387395
• Collaborator: (none)
• Enrollment: 217
• Location: 1
• Actual Duration (Months): 1
• Patients Per Site Per Month: 213.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis; COVID-19	Other: NO intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 217 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of COVID 19 Vaccination or Infection on Disease Activity in Radiologically Isolated Syndrome Cohort: the VaxiRIS Study
• Actual Study Start Date: May 31, 2022
• Actual Primary Completion Date: Jul 1, 2022
• Actual Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: NO intervention; no intervention
incomplete vaccination Other cases were defined as incomplete or absent vaccination.	Other: NO intervention; no intervention

Outcome Measures

Primary Outcome Measures

1. 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

1. COVID 19 vaccination and evidence disease activity risk [year 2]

   number of patients with an evidence disease activity in each group

2. multiple sclerosis evolution and history of COVID 19 infection [year 2]

   number of patients with a conversion to MS in each group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nice University Hospital	Nice		France	06000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT05387395
• Other Study ID Numbers: 22Neuro02
• First Posted: May 24, 2022
• Last Update Posted: Aug 1, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Additional relevant MeSH terms: COVID-19; Multiple Sclerosis

Study Results

No Results Posted as of Aug 1, 2022