Study of Virus-specific Lymphocytic Cell Populations in Non-invasive Nasal Mucosa Samples of MIS-C Patients
- Conditions
- MIS-C Associated With COVID-19COVID-19
- Registration Number
- NCT05560906
- Lead Sponsor
- Medical University of Warsaw
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- MIS-C diagnosis based of WHO diagnostic criteria.
- immunosuppressive treatment received up to 3 months before
- intranasal drugs received up to 7 days before
- COVID-19 vaccination
- no consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in leukocyte subpopulations in nasal mucosa and peripherial blood during MIS-C and convalescence. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pediatric teaching clinical hospital, Warsaw Medical University
🇵🇱Warsaw, Masovian, Poland