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Epidemiological Characteristics of COVID-19 in Patients With MS or NMO (COVISEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355611
Recruitment Status : Unknown
Verified April 2020 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : April 21, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment
Multiple Sclerosis NMO Spectrum Disorder COVID-19 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 Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cohort Study Evaluating the Epidemiological Characteristics of Coronavirus Infection (SARS-CoV-2) in Patients With MS or NMO
Estimated Study Start Date : April 20, 2020
Estimated Primary Completion Date : April 20, 2022
Estimated Study Completion Date : April 20, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355611


Contacts
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Contact: Céline LOUAPRE, MD,PhD 1 42 16 57 66 ext +33 celine.louapre@aphp.fr

Locations
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France
Hôpital Pitié Salpétrière Recruiting
Paris, France, 75013
Contact: CELINE LOUAPRE, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04355611    
Other Study ID Numbers: APHP200482
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Factors
Additional relevant MeSH terms:
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COVID-19
Multiple Sclerosis
Neuromyelitis Optica
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Myelitis, Transverse
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases