Covid19, Multiple Sclerosis
Conditions
Keywords
Disease-Modifying Therapy
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.
Interventions
None listed
Sponsors
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| SARS-CoV-2 Antibodies Level | Baseline, Day 0 | SARS-CoV-2 antibodies will be measured and assessed with Roche DIA Assay |
Countries
United States
Outcome results
None listed