Epidemiological Characteristics of COVID-19 in Patients With MS or NMO (COVISEP)
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|ClinicalTrials.gov Identifier: NCT04355611|
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : April 29, 2020
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis NMO Spectrum Disorder COVID-19||Other: Evaluation of the epidemiological characteristics of coronavirus infection (SARS-CoV-2)|
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|
|Estimated Enrollment :||2000 participants|
|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|
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
- 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
- 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
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
|Contact: Céline LOUAPRE, MD,PhD||1 42 16 57 66 ext +firstname.lastname@example.org|
|Hôpital Pitié Salpétrière||Recruiting|
|Paris, France, 75013|
|Contact: CELINE LOUAPRE, MD|