Multiple SclerosisVaxiRISNCT05387395
COVID-19 on Disease Activity in Radiologically Isolated Syndrome Cohort
An observational study of Multiple Sclerosis and COVID-19, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, COVID-19
- Type of treatment
- Vaccines
- How many people
- 217 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2022to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients fulfilling the Radiologic Isolated Syndrome criteria
Who may be able to join
- patients belong to the RISC cohort;
- totally vaccinated ou partially vaccinated patient
- vaccination status known
Who cannot join
- presented a first clinical event before the COVID19 vaccination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of COVID 19 Vaccination or Infection on Disease Activity in Radiologically Isolated Syndrome Cohort: the VaxiRIS Study
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.
- Conditions
- Multiple Sclerosis, COVID-19
- Being tested
- NO intervention
- Medical subject headings
- Multiple Sclerosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NO intervention | |
| incomplete vaccination | Other cases were defined as incomplete or absent vaccination. Receives: Other: NO intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID 19 vaccination and clinical conversion to multiple sclerosis risk
number of patients with a conversion to MS in each group
Measured: year 2
Secondary outcomes (2)
COVID 19 vaccination and evidence disease activity risk
number of patients with an evidence disease activity in each group
Measured: year 2
multiple sclerosis evolution and history of COVID 19 infection
number of patients with a conversion to MS in each group
Measured: year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start31 May 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387395
- Sponsor's protocol ID
- 22Neuro02
- Acronym
- VaxiRIS
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID 19 Vaccination or Infection on Disease Activity in Radiologically Isolated Syndrome Cohort: the VaxiRIS Study
- ClinicalTrials.gov ID
- NCT05387395
- Acronym / sponsor ID
- VaxiRIS / 22Neuro02
- Conditions
- Multiple Sclerosis, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete vaccination | – | Other: NO interventionComplete 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 | – | Other: NO interventionOther cases were defined as incomplete or absent vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients fulfilling the Radiologic Isolated Syndrome criteria
Key inclusion criteria (3 listed)
- patients belong to the RISC cohort;
- totally vaccinated ou partially vaccinated patient
- vaccination status known
Key exclusion criteria (1 listed)
- presented a first clinical event before the COVID19 vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO interventionno intervention | Other | complete vaccination, incomplete vaccination |
Primary outcome
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
2 secondary outcomes
COVID 19 vaccination and evidence disease activity risk
Time frame: year 2
multiple sclerosis evolution and history of COVID 19 infection
Time frame: year 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and COVID-19, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID 19 vaccination and clinical conversion to multiple sclerosis risk (time frame: year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.