COVID-19TofCoMSNCT05403463
The Effect of Covid-19 on the Disease Course of Multiple Sclerosis :Belgian Lessons Learned From Rocky I to Rocky IV
An observational study of COVID-19, run by Marie D'hooghe at 1 site in Belgium.
Trial summary
Retrospective observational cohort study. ToFCoMS: two years of follow-up of COVID-19 in MS. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- How many people
- 230 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2022to 1 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MS patients with Covid 19 infection
Who may be able to join
- diagnosis of Multiple Sclerosis Covid 19 infection with PCR test
Who cannot join
- other diagnosis than Multiple Sclerosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Covid-19 on the Disease Course of Multiple Sclerosis
Retrospective observational cohort study. ToFCoMS: two years of follow-up of COVID-19 in MS.
Read the detailed description
Methods The Nationaal Multiple Sclerose Centrum (NMSC) Melsbroek is a large highly-specialized center specifically focusing on neurological management, multidisciplinary care and rehabilitation in patients with MS. Since March 2020 (i.e., the onset of the pandemic in Belgium, and the first of five waves of spiking infection numbers thus far in our country), clinical data of patients followed at the center have been collected in a local database in case of COVID-19 diagnosis. The following items have been recorded: name, gender and date of COVID-19 diagnosis; age, Expanded Disability Status Scale score, MS duration, clinical subtype and DMT regimen at time of COVID-19 diagnosis; COVID-19 severity (method 1: categorized as ambulatory, hospitalized, death; method 2: categorized as asymptomatic, mild illness, moderate illness, severe illness, critical illness and death); vaccination status (categorized as non-vaccinated, fully vaccinated, fully vaccinated + booster) at time of COVID-19 diagnosis. On February 28, 2022, this database was locked and consisted of 234180 unique individual COVID-19 cases.
The NMSC Melsbroek features a second and more large database containing a broad variety of (para)clinical information gathered during routine follow-up, which includes regular testing of general disability with the EDSS, leg function/ambulation with the Timed 25-Foot Walk Test (T25FWT), hand function/dexterity using the 9-Hole Peg Test (9HPT) and cognition/information processing speed with the Symbol Digit Modalities Test (SDMT). For each of these parameters, the first two assessments before COVID-19 diagnosis (labelled T0 and T1, respectively; T1 is the closest to COVID-19 diagnosis), and the first thereafter (labelled T2), were retrieved for each COVID-19 subject. If clinical measurements were performed during an in-house stay for rehabilitation purposes, only those performed on admission were retained (thus not necessarily those the closest to the COVID-19 infection).
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
vaccination status and progression MS
As secondary outcomes, the investigators want to explore whether (a) there is a relationship between COVID-19 severity and the evolution of clinical disability (i.e., differences between T-1 and T1), (b) vaccination status affects COVID-19 severity (in the total cohort as well as stratified according to DMT) and evolution of clinical disability (i.e., differences between T-1 and T1) and (c) DMT influences COVID-19 severity and evolution of clinical disability (i.e., differences between T-1 and T1).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Mar 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marie D'hooghe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marie D'hooghe, National MS Center Melsbroek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403463
- Sponsor's protocol ID
- TofComs
- Acronym
- TofCoMS
- Status last verified
- Jun 2022
- First submitted
- 2 Jun 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD
Publications
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.
PubMed 36807080
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Covid-19 on the Disease Course of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05403463
- Acronym / sponsor ID
- TofCoMS / TofComs
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Marie D'hoogheUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 3 Jun 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.
Retrospective observational cohort study. ToFCoMS: two years of follow-up of COVID-19 in MS.
Detailed description
Methods The Nationaal Multiple Sclerose Centrum (NMSC) Melsbroek is a large highly-specialized center specifically focusing on neurological management, multidisciplinary care and rehabilitation in patients with MS. Since March 2020 (i.e., the onset of the pandemic in Belgium, and the first of five waves of spiking infection numbers thus far in our country), clinical data of patients followed at the center have been collected in a local database in case of COVID-19 diagnosis. The following items have been recorded: name, gender and date of COVID-19 diagnosis; age, Expanded Disability Status Scale score, MS duration, clinical subtype and DMT regimen at time of COVID-19 diagnosis; COVID-19 severity (method 1: categorized as ambulatory, hospitalized, death; method 2: categorized as asymptomatic, mild illness, moderate illness, severe illness, critical illness and death); vaccination status (categorized as non-vaccinated, fully vaccinated, fully vaccinated + booster) at time of COVID-19 diagnosis. On February 28, 2022, this database was locked and consisted of 234180 unique individual COVID-19 cases.
The NMSC Melsbroek features a second and more large database containing a broad variety of (para)clinical information gathered during routine follow-up, which includes regular testing of general disability with the EDSS, leg function/ambulation with the Timed 25-Foot Walk Test (T25FWT), hand function/dexterity using the 9-Hole Peg Test (9HPT) and cognition/information processing speed with the Symbol Digit Modalities Test (SDMT). For each of these parameters, the first two assessments before COVID-19 diagnosis (labelled T0 and T1, respectively; T1 is the closest to COVID-19 diagnosis), and the first thereafter (labelled T2), were retrieved for each COVID-19 subject. If clinical measurements were performed during an in-house stay for rehabilitation purposes, only those performed on admission were retained (thus not necessarily those the closest to the COVID-19 infection).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MS patients with Covid 19 infection
Key inclusion criteria (1 listed)
- diagnosis of Multiple Sclerosis Covid 19 infection with PCR test
Key exclusion criteria (1 listed)
- other diagnosis than Multiple Sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The investigators hereby aim to answer the question whether COVID-19 affects the progression of clinical disability in MS
Time frame: 2 years
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.
1 secondary outcome
vaccination status and progression MS
Time frame: 2 years
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 8 Jun 2022.
- Derived from this study: PubMed 36807080Peeters 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.
- Individual participant dataSharing planned: No. no IPD
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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 COVID-19, run by Marie D'hooghe at 1 site in Belgium.
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 1 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 8 Jun 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 Belgium. 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?
The investigators hereby aim to answer the question whether COVID-19 affects the progression of clinical disability in MS (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05403463, which also lists 1 linked publication.
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 8 Jun 2022.