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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682548
• Other study ID #: 20-01799
• Status: Completed
• Start date: January 5, 2021
• Est. completion date: September 15, 2022

Study information

• Verified date: November 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 920
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Multiple Sclerosis

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	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
Other	SARS-CoV-2 Antibodies Level	SARS-CoV-2 antibodies will be measured and assessed with Roche DIA Assay	Baseline, Day 0
Other	SARS-CoV-2 Antibodies Level	SARS-CoV-2 antibodies will be measured and assessed with Roche DIA Assay	up to week 48 Post-Vaccination
Primary	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	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