Clinical trial NCT04355611: Epidemiological Characteristics of COVID-19 in Patients With MS or NMO
Official title: Cohort Study Evaluating the Epidemiological Characteristics of Coronavirus Infection (SARS-CoV-2) in Patients With MS or NMO
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
NMO Spectrum Disorder
COVID-19
Keywords: Factors
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 2465
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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).

Eligibility 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

Primary outcomes:
measure: Clinical severity
timeFrame: 6 months
Secondary outcomes:
measure: EDSS (Expanded Disability Status Scale)
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpétrière
Study officials:
References: