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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Multiple Sclerosis; NMO Spectrum Disorder
• Intervention / Treatment: Other: Evaluation of the epidemiological characteristics of coronavirus infection (SARS-CoV-2)

Detailed Description

There are currently no data on the consequences of coronavirus infection in patients with Multiple Sclerosis (MS) or NeuroMyelitis Optica (NMO) spectrum disorder. Numerous questions have emerged regarding the management of immunoactive therapy in the case of infection or suspected infection related to the SARS-CoV-2 virus. Currently, the recommendations issued by the French MS Society are to maintain the disease modifying therapies (DMT) for MS and NMO, but a case-by-case discussion with the expert neurologist for suspected or confirmed COVID+ patients remain highly recommended. Besides DMT, neurological disability could also be a risk factor for severe infection, regardless of the age of the patient.

It is therefore essential to have epidemiological data to describe the characteristics of the clinical expression of coronavirus infection (Covid-19) and factors enhancing the occurrence of severe forms in patients with MS or NMO during of the 2020 pandemic.

This study involves all hospital and neurologists ensuring the follow-up of patients with MS and NMO via the 23 CRC-SEP and associated hospital centers. This multicenter study is based on an already functional network organization, grouping together around forty hospital centers, participating either in the French MS registry (OFSEP), or in the French MS Society (SFSEP). It also benefits from the support of the French clinical research network (FCRIN) through the thematic clinical research network on MS and related diseases (FCRIN4MS). Each day, participating centers will enter data from MS or NMO patients newly tested positive for SARS-CoV-2 or strongly suspected to be diagnosed with COVID-19 using a specific computerized record (CRF Redcap).

• Study Type: Observational
• Enrollment (Actual): 2465

Contacts and Locations

• Study Contact: Name: Céline LOUAPRE, MD,PhD; Phone Number: +33 1 42 16 57 66; Email: celine.louapre@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Hopital Pitie Salpetriere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Multiple Sclerosis (MS) or NeuroMyelitis Optica (NMO) spectrum disorder who are diagnosed or strongly suspected of being infected with Covid19.

Description

Inclusion criteria

• 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)

Non-inclusion criteria

- Patient under guardianship or safety measure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with MS or NMO; Cohort study evaluating the epidemiological characteristics of coronavirus infection (SARS-CoV-2) in patients with MS or NMO	Other: Evaluation of the epidemiological characteristics of coronavirus infection (SARS-CoV-2); Epidemiological characteristics of coronavirus infection (SARS-CoV-2) in patients with MS or NMO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EDSS (Expanded Disability Status Scale)	EDSS is the Expanded Disability Severity Scale, a measure of neurological disability in patients with MS or NMO. EDSS Scale from 0: normal neurological examination to 10: MS-related Death	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Factors
• Additional Relevant MeSH Terms: Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Myelitis, Transverse; Optic Neuritis; Multiple Sclerosis; COVID-19; Neuromyelitis Optica
• Other Study ID Numbers: APHP200482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No