Estimating Prevalence of COVID-19 Infection and SARS-CoV-2 Antibodies in MS Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Seropositivie Rate Against SARS-CoV-2 [Baseline, Day 0]
Seropositivity rate against SARS-CoV-2 (nucleocapsid and/or spike proteins, as available) as measured by the Roche DIA antibody assay in MS patients.
Secondary Outcome Measures
- T Cell Response [Baseline, Day 0]
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.
Other Outcome Measures
- T Cell response [Baseline, Day 0]
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.
- T Cell response [up to week 48 Post-Vaccination]
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.
- SARS-CoV-2 Antibodies Level [Baseline, Day 0]
SARS-CoV-2 antibodies will be measured and assessed with Roche DIA Assay
- SARS-CoV-2 Antibodies Level [up to week 48 Post-Vaccination]
SARS-CoV-2 antibodies will be measured and assessed with Roche DIA Assay
Eligibility Criteria
Criteria
Inclusion Criteria (Part A and B):
● Patient is outside of infectious period of COVID-19 defined as follows:
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Patient with mild to moderate illness who are not severely immunocompromised:
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At least 10 days have passed since symptoms first appeared and
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At least 24 hours have passed since last fever without the use of fever-reducing medications and
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Symptoms (e.g. cough, shortness of breath) have improved
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Patient with severe to critical illness or who are severely immunocompromised:
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At least 10 days and up to 20 days have passed since symptoms first appeared
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At least 24 hours have passed since last fever without the use of fever-reducing medications and
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Symptoms (e.g. cough, shortness of breath) have improved
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Clinician-diagnosed MS treated or untreated with an approved DMT,
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Ages 18 to 60,
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EDSS 0 - 7,
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Able to give informed consent,
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Able to complete, or have someone help complete the patient questionnaire,
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No high dose steroids, or IVIG, or PLEX use within 3 months of blood sample,
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No convalescent plasma and/or polyclonal antibody treatments for COVID-19 within 3 months of blood sample collection.
Inclusion Criteria (Part B only)
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COVID-19 positive patients, who received OCR within 6 months of COVID 19 infection,
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EDSS 0 - 6.
Inclusion Critera (Redraws Only)
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Completed standard of care COVID-19 vaccination series
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On Ocrevus, glatiramer, interferon b, or not on any treatment disease-modifying treatment at the time of vaccination.
Exclusion Criteria (Part A and B):
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Concurrent immunosuppressive therapy, active systemic cancer, primary or acquired immunodeficiency (i.e., CVID, HIV infection),
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Active drug or alcohol abuse,
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Other anti-CD20 therapy apart from OCR,
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Uncontrolled diabetes mellitus,
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End-organ failure (cardiac, pulmonary, renal, hepatic),
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Systemic lupus erythematosus (SLE).
Exclusion Criteria (Part B only):
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EDSS >6,
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Active infection (e.g., hepatitis).
Exclusion Criteria (Healthy Controls Sample)
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Concurrent immunosuppressive therapy, active systemic cancer, primary or acquired immunodeficiency (e.g. CVID, HIV infection),
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Active ongoing drug or alcohol abuse,
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Age >60 or <18,
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Uncontrolled diabetes mellitus,
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End-organ failure (cardiac, pulmonary, renal, hepatic),
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SLE
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No high dose steroids, or intravenous immunoglobulin (IVIG) or plasma exchange (PLEX) use within 3 months of blood sample collection,
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No convalescent plasma and/or polyclonal antibody treatments for COVID-19 within 3 months of blood sample collection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone Health | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Ilya Kister, MD, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-01799