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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Covid19

• Study Type: Observational
• Enrollment (Actual): 920

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Projected study size is 1000 MS patients for primary objective and additional 40 non-autoimmune COVID-19 convalescent control and 20 COVID-19 negative healthy controls.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seropositivie Rate Against SARS-CoV-2	Seropositivity rate against SARS-CoV-2 (nucleocapsid and/or spike proteins, as available) as measured by the Roche DIA antibody assay in MS patients.	Baseline, Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T Cell Response	SARS-CoV-2 specific T cells will be measured using a well-validated assay such as ELISpot (enzyme-linked immune absorbent spot) to measure T cell responses to stimulation.	Baseline, Day 0

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
T Cell response	SARS-CoV-2 specific T cells will be measured using a well-validated assay such as ELISpot (enzyme-linked immune absorbent spot) to measure T cell responses to stimulation.	Baseline, Day 0
T Cell response	SARS-CoV-2 specific T cells will be measured using a well-validated assay such as ELISpot (enzyme-linked immune absorbent spot) to measure T cell responses to stimulation.	up to week 48 Post-Vaccination
SARS-CoV-2 Antibodies Level	SARS-CoV-2 antibodies will be measured and assessed with Roche DIA Assay	Baseline, Day 0
SARS-CoV-2 Antibodies Level	SARS-CoV-2 antibodies will be measured and assessed with Roche DIA Assay	up to week 48 Post-Vaccination

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Ilya Kister, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Disease-Modifying Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Multiple Sclerosis; COVID-19
• Other Study ID Numbers: 20-01799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No