Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

More Details

NCT ID
NCT04682548
Status
Completed
Sponsor
NYU Langone Health

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.