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Study of Virus-specific Lymphocytic Cell Populations in Non-invasive Nasal Mucosa Samples of MIS-C Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05560906
Enrollment
20
Registered
2022-09-30
Start date
2021-12-06
Completion date
2022-12-31
Last updated
2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, MIS-C Associated With COVID-19

Keywords

leukocytes, immunophenotype, nasal mucosa, curettage

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.

Interventions

None listed

Sponsors

Erasmus Medical Center
CollaboratorOTHER
Leiden University Medical Center
CollaboratorOTHER
Medical University of Warsaw
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

Poland

Contacts

Primary ContactWojciech Feleszko, MD., PhD
wojciech.feleszko@wum.edu.pl693468074
Backup ContactZiemowit Strzelczyk
ziemekstrzelczyk@gmail.com505545747

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026