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

Sponsor
Medical University of Warsaw (Other)
Overall Status
Recruiting
CT.gov ID
NCT05560906
Collaborator
Erasmus Medical Center (Other), Leiden University Medical Center (Other)
20
Enrollment
1
Location
11.8
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    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
    Actual Study Start Date :
    Dec 6, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Control group

    Healthy patients under 18 years of age.
    MIS-C group

    Patients with MIS-C diagnosed, based on WHO diagnostic criteria.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pediatric teaching clinical hospital, Warsaw Medical University Warsaw Masovian Poland 02-091

    Sponsors and Collaborators

    • Medical University of Warsaw
    • Erasmus Medical Center
    • Leiden University Medical Center

    Investigators

    • Principal Investigator: Wojciech Feleszko, MD., PhD, Medical University of Warsaw

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Wojciech Feleszko, Associate Professor, MD., PhD, Medical University of Warsaw
    ClinicalTrials.gov Identifier:
    NCT05560906
    Other Study ID Numbers:
    • NAWA015
    First Posted:
    Sep 30, 2022
    Last Update Posted:
    Sep 30, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wojciech Feleszko, Associate Professor, MD., PhD, Medical University of Warsaw
    leukocytes
    immunophenotype
    nasal mucosa
    curettage
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Sep 30, 2022