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.
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.
Locations (1)
NYU Langone Health
New York, New York, United States
Outcomes
Primary Outcomes
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.
Time frame: Baseline, Day 0
Secondary Outcomes
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.