Official Title
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
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.

Completed
Multiple Sclerosis
COVID19
Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 60 Years
Countries
United States
Locations

NYU Langone Health
New York, New York, United States

Ilya Kister, MD, Principal Investigator
NYU Langone Health

NYU Langone Health
NCT Number
Keywords
Disease-Modifying Therapy
MeSH Terms
COVID-19
Multiple Sclerosis