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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 0 |
| T Cell response |
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:
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
Inclusion Criteria (Part B only)
Inclusion Critera (Redraws Only)
Exclusion Criteria (Part A and B):
Exclusion Criteria (Part B only):
Exclusion Criteria (Healthy Controls Sample)
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Projected study size is 1000 MS patients for primary objective and additional 40 non-autoimmune COVID-19 convalescent control and 20 COVID-19 negative healthy controls.
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| Name | Affiliation | Role |
|---|---|---|
| Ilya Kister, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41279857 | Derived | Curtin R, Velmurugu Y, Dibba F, Hao Y, Sreenivasaiah C, Khodadadi-Jamayran A, Nyovanie S, Kim A, Samanovic ML, Mulligan M, Priest J, Cabatingan M, Winger RC, Patskovsky Y, Kister I, Silverman GJ, Krogsgaard M. Persistent Classical and Atypical Memory B Cells Underlie Heterogeneous Vaccine Responses in Ocrelizumab-Treated Multiple Sclerosis. bioRxiv [Preprint]. 2025 Nov 4:2025.11.03.686372. doi: 10.1101/2025.11.03.686372. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Blood samples will be obtained from participants.
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.
| up to week 48 Post-Vaccination |
| SARS-CoV-2 Antibodies Level | SARS-CoV-2 antibodies will be measured and assessed with Roche DIA Assay | Baseline, Day 0 |
| SARS-CoV-2 Antibodies Level | SARS-CoV-2 antibodies will be measured and assessed with Roche DIA Assay | up to week 48 Post-Vaccination |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |