Study of Virus-specific Lymphocytic Cell Populations in Non-invasive Nasal Mucosa Samples of MIS-C Patients, and Intra-population Shifts in Inflammatory Tissues in the Acute Phase of MIS-C and in Health
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- MIS-C Associated With COVID-19
- Sponsor
- Medical University of Warsaw
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in leukocyte subpopulations in nasal mucosa and peripherial blood during MIS-C and convalescence.
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The aim of the study is to make an accurate assessment of immune cells obtained from nasal mucosa and peripherial blood of MIS-C patients during the disease and the period of health.
Detailed Description
The study will consist of two parts. Initially, it will be of a cross-cutting comparative nature, when a group of healthy patients (control group) and a group of patients diagnosed with MIS-C/PIMS syndrome are compared with each other, based on nasal curettage swabs and peripheral blood, before the inclusion of systemic anti-inflammatory treatment (study group). In addition, an observation of the research group will be carried out, during which swabs and peripheral blood will be taken at two more control points.
Investigators
Wojciech Feleszko
Associate Professor, MD., PhD
Medical University of Warsaw
Eligibility Criteria
Inclusion Criteria
- •MIS-C diagnosis based of WHO diagnostic criteria.
Exclusion Criteria
- •immunosuppressive treatment received up to 3 months before
- •intranasal drugs received up to 7 days before
- •COVID-19 vaccination
- •no consent
Outcomes
Primary Outcomes
Change in leukocyte subpopulations in nasal mucosa and peripherial blood during MIS-C and convalescence.
Time Frame: Three clinical timepoints: (i) baseline (preferably before immunomodulatory treatment), (ii) convalescence, after major symptoms resolution (1 week +/-2 days after treatment introduction), (iii) outpatient control visit (6 weeks after hospital discharge)
The cellular subpopulations will be characterized and clustered using prepared immunomarker array.