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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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Locations


Not yet recruiting

United States, New York

NYU Langone Health

New York, New York, United States, 10016

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