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

NCT04682548 | Completed

• 1 other identifier: 20-01799
• Study Type: observational
• Target: 920
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Covid19

Keywords

Disease-Modifying Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• T Cell Response

  Baseline, Day 0

Other Outcomes (4)

• T Cell response

  Baseline, Day 0

• T Cell response

  up to week 48 Post-Vaccination

• SARS-CoV-2 Antibodies Level

  Baseline, Day 0

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• ● 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,

You may not qualify if:

• 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).
• EDSS \>6,
• Active infection (e.g., hepatitis).
• 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,

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 41279857 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be obtained from participants.

MeSH Terms

Conditions

Multiple Sclerosis; COVID-19

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ilya Kister, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 23, 2020
• Study Start: January 5, 2021
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)