Multiple Sclerosis Clinical Trial
Estimating Prevalence of COVID-19 Infection and SARS-CoV-2 Antibodies in MS Patients
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.
Eligibility Criteria
Inclusion Criteria (Part A and B):
â— 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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
New York New York, 10016, United States
How clear is this clinincal trial information?