NCT05403463

Brief Summary

Retrospective observational cohort study. ToFCoMS: two years of follow-up of COVID-19 in MS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 2, 2022

Last Update Submit

June 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The investigators hereby aim to answer the question whether COVID-19 affects the progression of clinical disability in MS

    The difference between the values measured at T-2 and T-1 (i.e., before COVID-19) will be compared, after adjustment for the time interval, with the difference between the respective values measured at T-1 and T1 (i.e., after COVID-19) for T25WT, 9HPT and SDMT. The investigators hereby aim to answer the question whether COVID-19 affects the progression of clinical disability in MS. Its effect on SDMT evolution has been defined as the primary endpoint of our study.

    2 years

Secondary Outcomes (1)

  • vaccination status and progression MS

    2 years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MS patients with Covid 19 infection

You may qualify if:

  • diagnosis of Multiple Sclerosis Covid 19 infection with PCR test

You may not qualify if:

  • other diagnosis than Multiple Sclerosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationaal MS center

Melsbroek, Vlaams Brabant, 1820, Belgium

Location

Related Publications (1)

  • Peeters G, Van Remoortel A, Nagels G, Van Schependom J, D'haeseleer M. Occurrence and Severity of Coronavirus Disease 2019 Are Associated With Clinical Disability Worsening in Patients With Multiple Sclerosis. Neurol Neuroimmunol Neuroinflamm. 2023 Feb 17;10(3):e200089. doi: 10.1212/NXI.0000000000200089. Print 2023 May.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
neuroloog

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 3, 2022

Study Start

March 1, 2022

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

no IPD

Locations