Clinical trial NCT04682548: Estimating Prevalence of COVID-19 Infection and SARS-CoV-2 Antibodies in MS Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Covid19
Keywords: Disease-Modifying Therapy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 920
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Seropositivie Rate Against SARS-CoV-2
timeFrame: Baseline, Day 0
Secondary outcomes:
measure: T Cell Response
timeFrame: Baseline, Day 0
Other outcomes:
measure: T Cell response
timeFrame: Baseline, Day 0
measure: T Cell response
timeFrame: up to week 48 Post-Vaccination
measure: SARS-CoV-2 Antibodies Level
timeFrame: Baseline, Day 0
measure: SARS-CoV-2 Antibodies Level
timeFrame: up to week 48 Post-Vaccination
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ilya Kister, MD
role: PRINCIPAL_INVESTIGATOR
References: