Estimating Prevalence of COVID-19 Infection and SARS-CoV-2 Antibodies in MS Patients

Study Overview
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Brief Summary
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This non-interventional, biospecimen collection study is designed to help us better understand whether MS patients have impaired immune defenses to COVID-19 infection. The potential influence of immune modulating medications for MS will be considered through these exploratory studies. This study is also designed to provide context for interpretation of anti-SARS CoV2 serologies in MS patients during convalescence from COVID-19 infection.

Official Title
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Estimating Prevalence of COVID-19 Infection and SARS-CoV-2 Antibodies in MS Patients With and Without Ocrelizumab Treatment, and Comparing Immune Responses to COVID-19 in MS Patients on Ocrelizumab and Healthy Controls

Conditions
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Multiple Sclerosis, Covid19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Part A and B): ● Patient is outside of infectious period of COVID-19 defined as follows: Patient with mild to moderate illness who are not severely immunocompromised: At least 10 days have passed since symptoms first appeared and At least 24 hours have passed since last fever without the use of fever-reducing medications and Symptoms (e.g. cough, shortness of breath) have improved Patient with severe to critical illness or who are severely immunocompromised: At least 10 days and up to 20 days have passed since symptoms first appeared At least 24 hours have passed since last fever without the use of fever-reducing medications and Symptoms (e.g. cough, shortness of breath) have improved Clinician-diagnosed MS treated or untreated with an approved DMT, Ages 18 to 60, EDSS 0 - 7, Able to give informed consent, Able to complete, or have someone help complete the patient questionnaire, No high dose steroids, or IVIG, or PLEX use within 3 months of blood sample, No convalescent plasma and/or polyclonal antibody treatments for COVID-19 within 3 months of blood sample collection. Inclusion Criteria (Part B only) COVID-19 positive patients, who received OCR within 6 months of COVID 19 infection, EDSS 0 - 6. Inclusion Critera (Redraws Only) Completed standard of care COVID-19 vaccination series On Ocrevus, glatiramer, interferon b, or not on any treatment disease-modifying treatment at the time of vaccination. Exclusion Criteria (Part A and B): Concurrent immunosuppressive therapy, active systemic cancer, primary or acquired immunodeficiency (i.e., CVID, HIV infection), Active drug or alcohol abuse, Other anti-CD20 therapy apart from OCR, Uncontrolled diabetes mellitus, End-organ failure (cardiac, pulmonary, renal, hepatic), Systemic lupus erythematosus (SLE). Exclusion Criteria (Part B only): EDSS >6, Active infection (e.g., hepatitis). Exclusion Criteria (Healthy Controls Sample) Concurrent immunosuppressive therapy, active systemic cancer, primary or acquired immunodeficiency (e.g. CVID, HIV infection), Active ongoing drug or alcohol abuse, Age >60 or <18, Uncontrolled diabetes mellitus, End-organ failure (cardiac, pulmonary, renal, hepatic), SLE No high dose steroids, or intravenous immunoglobulin (IVIG) or plasma exchange (PLEX) use within 3 months of blood sample collection, No convalescent plasma and/or polyclonal antibody treatments for COVID-19 within 3 months of blood sample collection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seropositivie Rate Against SARS-CoV-2 | Seropositivity rate against SARS-CoV-2 (nucleocapsid and/or spike proteins, as available) as measured by the Roche DIA antibody assay in MS patients. | Baseline, Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T Cell Response | SARS-CoV-2 specific T cells will be measured using a well-validated assay such as ELISpot (enzyme-linked immune absorbent spot) to measure T cell responses to stimulation. | Baseline, Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disease-Modifying Therapy