Multiple SclerosisNCT04682548
Estimating Prevalence of COVID-19 Infection and SARS-CoV-2 Antibodies in MS Patients
An observational study of Multiple Sclerosis and Covid19, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Covid19
- How many people
- 920 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 15 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- ● 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:
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- 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.
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Keywords
- Disease-Modifying Therapy
- Medical subject headings
- Multiple Sclerosis, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 0
Secondary outcomes (1)
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.
Measured: Baseline, Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start5 Jan 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 920 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilya Kister, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682548
- Sponsor's protocol ID
- 20-01799
- Status last verified
- Nov 2022
- First submitted
- 22 Dec 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Curtin R, Velmurugu Y, Dibba F, Hao Y, Sreenivasaiah C, Khodadadi-Jamayran A, Nyovanie S, Kim A, Samanovic ML, Mulligan M, Priest J, Cabatingan M, Winger RC, Patskovsky Y, Kister I, Silverman GJ, Krogsgaard M. Persistent Classical and Atypical Memory B Cells Underlie Heterogeneous Vaccine Responses in Ocrelizumab-Treated Multiple Sclerosis. bioRxiv [Preprint]. 2025 Nov 4:2025.11.03.686372. doi: 10.1101/2025.11.03.686372.
PubMed 41279857
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04682548
- Acronym / sponsor ID
- 20-01799
- Conditions
- Multiple Sclerosis, Covid19
- Keywords
- Disease-Modifying Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 920 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (20 listed)
- Patient with mild to moderate illness who are not severely immunocompromised:
- Patient with severe to critical illness or who are severely immunocompromised:
- COVID-19 positive patients, who received OCR within 6 months of COVID 19 infection,
- EDSS 0 - 6.
- Completed standard of care COVID-19 vaccination series
Key exclusion criteria (16 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Seropositivie Rate Against SARS-CoV-2
Time frame: Baseline, Day 0
Seropositivity rate against SARS-CoV-2 (nucleocapsid and/or spike proteins, as available) as measured by the Roche DIA antibody assay in MS patients.
1 secondary outcome
T Cell Response
Time frame: Baseline, Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 41279857Curtin R, Velmurugu Y, Dibba F, Hao Y, Sreenivasaiah C, Khodadadi-Jamayran A, Nyovanie S, Kim A, Samanovic ML, Mulligan M, Priest J, Cabatingan M, Winger RC, Patskovsky Y, Kister I, Silverman GJ, Krogsgaard M. Persistent Classical and Atypical Memory B Cells Underlie Heterogeneous Vaccine Responses in Ocrelizumab-Treated Multiple Sclerosis. bioRxiv [Preprint]. 2025 Nov 4:2025.11.03.686372. doi: 10.1101/2025.11.03.686372.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilya Kister, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Covid19, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seropositivie Rate Against SARS-CoV-2 (time frame: Baseline, Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04682548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.