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

COVID-19 Clinical Trial

— COVISEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355611
• Other study ID #: APHP200482
• Status: Completed
• Start date: April 17, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2465
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Multiple Sclerosis
• Neuromyelitis Optica
• NMO Spectrum Disorder

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Pitié Salpétrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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