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

NYU Langone Health

Status: Completed

Conditions: Multiple Sclerosis; Covid19

Study type: Observational

Funder types: Other

Identifiers

NCT04682548

20-01799

Details and patient eligibility

About

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.

Enrollment: 920 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.