Epidemiological Characteristics of COVID-19 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System COVID-19 Coronaviridae Infections Coronavirus Infections Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Infections Lung Diseases Myelitis, Transverse NMO Spectrum Disorder Nervous System Diseases Neuromyelitis Optica Nidovirales Infections Optic Nerve Diseases Optic Neuritis Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pitié Salpétrière

Paris, 75013, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of the epidemiological characteristics of coronavirus infection (SARS-CoV-2)

Other

Epidemiological characteristics of coronavirus infection (SARS-CoV-2) in patients with MS or NMO

Primary outcomes

Clinical severity

Time frame: 6 months

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

Secondary outcomes

EDSS (Expanded Disability Status Scale)

Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Cohort Study Evaluating the Epidemiological Characteristics of Coronavirus Infection (SARS-CoV-2) in Patients With MS or NMO

Acronym: COVISEP

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Apr 21, 2020
Registry last updated: Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed