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NCT04682548 | COMPLETED | Multiple Sclerosis

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

NYU Langone Health

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.

Condition or disease

Multiple Sclerosis

Covid19

Study Type : OBSERVATIONAL
Estimated Enrollment : 920 participants
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
Actual Study Start Date : 2021-01-05
Estimated Primary Completion Date : 2022-09-15
Estimated Study Completion Date : 2022-09-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Estimating Prevalence of COVID-19 Infection and SARS-CoV-2 Antibodies in MS Patients

Location Details

NCT04682548

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, New York

NYU Langone Health

New York, New York, United States, 10016