COVID-19 Clinical Trial
— COVISEPOfficial title:
Cohort Study Evaluating the Epidemiological Characteristics of Coronavirus Infection (SARS-CoV-2) in Patients With MS or NMO
NCT number | NCT04355611 |
Other study ID # | APHP200482 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 17, 2020 |
Est. completion date | June 30, 2022 |
Verified date | February 2024 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Pitié Salpétrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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 |
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