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

NCT ID: NCT04682548

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 920 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-05
• Study Completion Date: 2022-09-15

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.

Conditions

Multiple Sclerosis; Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

● 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.

• 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

• 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).

• EDSS >6,
• Active infection (e.g., hepatitis).

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilya Kister, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

20-01799

Identifier Type: -

Identifier Source: org_study_id