Estimating Prevalence of COVID-19 Infection and SARS-CoV-2 Antibodies in MS Patients (NCT04682548) | Clinical Trial Compass
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 range18 Years ā 60 Years
SexALL
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):
ā 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 treatmenā¦