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