CompletedNot Applicable

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

United States920 participantsStarted 2021-01-05

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 treatmen…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Seropositivie Rate Against SARS-CoV-2

Timeframe: Baseline, Day 0

Trial details

NCT IDNCT04682548

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-09-15

View on ClinicalTrials.gov More Multiple Sclerosis trials