Status:
COMPLETED
Estimating Prevalence of COVID-19 Infection and SARS-CoV-2 Antibodies in MS Patients
Lead Sponsor:
NYU Langone Health
Conditions:
Multiple Sclerosis
Covid19
Eligibility:
All Genders
18-60 years
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 immun...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 15 2022
Estimated Enrollment :
920 Patients enrolled
Trial Details
Trial ID
NCT04682548
Start Date
January 5 2021
End Date
September 15 2022
Last Update
November 3 2022
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016