Epidemiological Characteristics of COVID-19 in Patients With MS or NMO
COVISEP
Cohort Study Evaluating the Epidemiological Characteristics of Coronavirus Infection (SARS-CoV-2) in Patients With MS or NMO
1 other identifier
observational
2,465
1 country
1
Brief Summary
The purpose of this study is to collect French medical data for patients with Multiple Sclerosis (MS) or NeuroMyelitis Optica (NMO) spectrum disorder who are diagnosed or strongly suspected of being infected with Covid19. The objective of this study is to provide scientific information regarding the possible risk factors in these patients, as a large part of them receive immunomodulatory or immunosuppressive treatments. The main objective of this study is thus to determine the epidemiological (eg, age, form of disease, disability) and pharmacological (related to immunomodulatory or immunosuppressive treatments) factors favoring the occurrence of a severe form of Covid-19 in MS and NMO patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2020
CompletedStudy Start
First participant enrolled
April 17, 2020
CompletedFirst Posted
Study publicly available on registry
April 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedFebruary 5, 2024
February 1, 2024
2.2 years
April 17, 2020
February 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical severity
The main outcome measure is a clinical severity score on a 7-point severity scale at Nadir (in medicine, the most severe point in the progression of symptoms of a pathology). Nadir scale from 1 : Not hospitalized, no limitation of activities to 7 :Death
6 months
Secondary Outcomes (1)
EDSS (Expanded Disability Status Scale)
6 months
Study Arms (1)
Patients with MS or NMO
Cohort study evaluating the epidemiological characteristics of coronavirus infection (SARS-CoV-2) in patients with MS or NMO
Interventions
Epidemiological characteristics of coronavirus infection (SARS-CoV-2) in patients with MS or NMO
Eligibility Criteria
Patients with Multiple Sclerosis (MS) or NeuroMyelitis Optica (NMO) spectrum disorder who are diagnosed or strongly suspected of being infected with Covid19.
You may qualify if:
- Patient with MS or NMO
- at least one of the following four criteria:
- COVID + biologically confirmed
- Typical ground glass opacity on thoracic CT-scan in epidemic areas
- Anosmia or ageusia of sudden onset in the absence of rhinitis or nasal obstruction
- Typical symptoms (triad associating cough, fever, asthenia) in epidemic zone
- Non opposition of the patient to the use of these data or non opposition of the confidential counselor / parent / relative (if the patient is unable to give his non-opposition, with collection as soon as possible of the non opposition of the patient) or non opposition of the 2 holders of parental authority (for minor patients)
- \- Patient under guardianship or safety measure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Pitié Salpétrière
Paris, 75013, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2020
First Posted
April 21, 2020
Study Start
April 17, 2020
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
February 5, 2024
Record last verified: 2024-02