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

NCT05560906 | Unknown

• 1 other identifier: NAWA015
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

MIS-C Associated With COVID-19; COVID-19

Keywords

leukocytes; immunophenotype; nasal mucosa; curettage

Outcome Measures

Primary Outcomes (1)

• Change in leukocyte subpopulations in nasal mucosa and peripherial blood during MIS-C and convalescence.

  The cellular subpopulations will be characterized and clustered using prepared immunomarker array.

  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)

Study Arms (2)

Control group

Healthy patients under 18 years of age.

MIS-C group

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Acute MIS-C patients who have not received any treatment that could have altered nasal mucosa leukocyte composition. Samples will be collected from them at three time points.

You may qualify if:

• MIS-C diagnosis based of WHO diagnostic criteria.

You may not qualify if:

• immunosuppressive treatment received up to 3 months before
• intranasal drugs received up to 7 days before
• COVID-19 vaccination
• no consent

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Erasmus Medical Center: collaborator
• Leiden University Medical Center: collaborator

Study Sites (1)

Pediatric teaching clinical hospital, Warsaw Medical University

Warsaw, Masovian Voivodeship, 02-091, Poland

RECRUITING

Related Publications (9)

• Radia T, Williams N, Agrawal P, Harman K, Weale J, Cook J, Gupta A. Multi-system inflammatory syndrome in children & adolescents (MIS-C): A systematic review of clinical features and presentation. Paediatr Respir Rev. 2021 Jun;38:51-57. doi: 10.1016/j.prrv.2020.08.001. Epub 2020 Aug 11.

  PMID: 32891582 BACKGROUND

• Pawar R, Gavade V, Patil N, Mali V, Girwalkar A, Tarkasband V, Loya S, Chavan A, Nanivadekar N, Shinde R, Patil U, Lakshminrusimha S. Neonatal Multisystem Inflammatory Syndrome (MIS-N) Associated with Prenatal Maternal SARS-CoV-2: A Case Series. Children (Basel). 2021 Jul 2;8(7):572. doi: 10.3390/children8070572.

  PMID: 34356552 BACKGROUND

• Whittaker E, Bamford A, Kenny J, Kaforou M, Jones CE, Shah P, Ramnarayan P, Fraisse A, Miller O, Davies P, Kucera F, Brierley J, McDougall M, Carter M, Tremoulet A, Shimizu C, Herberg J, Burns JC, Lyall H, Levin M; PIMS-TS Study Group and EUCLIDS and PERFORM Consortia. Clinical Characteristics of 58 Children With a Pediatric Inflammatory Multisystem Syndrome Temporally Associated With SARS-CoV-2. JAMA. 2020 Jul 21;324(3):259-269. doi: 10.1001/jama.2020.10369.

  PMID: 32511692 BACKGROUND

• Verdoni L, Mazza A, Gervasoni A, Martelli L, Ruggeri M, Ciuffreda M, Bonanomi E, D'Antiga L. An outbreak of severe Kawasaki-like disease at the Italian epicentre of the SARS-CoV-2 epidemic: an observational cohort study. Lancet. 2020 Jun 6;395(10239):1771-1778. doi: 10.1016/S0140-6736(20)31103-X. Epub 2020 May 13.

  PMID: 32410760 BACKGROUND

• Godfred-Cato S, Bryant B, Leung J, Oster ME, Conklin L, Abrams J, Roguski K, Wallace B, Prezzato E, Koumans EH, Lee EH, Geevarughese A, Lash MK, Reilly KH, Pulver WP, Thomas D, Feder KA, Hsu KK, Plipat N, Richardson G, Reid H, Lim S, Schmitz A, Pierce T, Hrapcak S, Datta D, Morris SB, Clarke K, Belay E; California MIS-C Response Team. COVID-19-Associated Multisystem Inflammatory Syndrome in Children - United States, March-July 2020. MMWR Morb Mortal Wkly Rep. 2020 Aug 14;69(32):1074-1080. doi: 10.15585/mmwr.mm6932e2.

  PMID: 32790663 BACKGROUND

• Harwood R, Allin B, Jones CE, Whittaker E, Ramnarayan P, Ramanan AV, Kaleem M, Tulloh R, Peters MJ, Almond S, Davis PJ, Levin M, Tometzki A, Faust SN, Knight M, Kenny S; PIMS-TS National Consensus Management Study Group. A national consensus management pathway for paediatric inflammatory multisystem syndrome temporally associated with COVID-19 (PIMS-TS): results of a national Delphi process. Lancet Child Adolesc Health. 2021 Feb;5(2):133-141. doi: 10.1016/S2352-4642(20)30304-7. Epub 2020 Sep 18.

  PMID: 32956615 BACKGROUND

• Gruber CN, Patel RS, Trachtman R, Lepow L, Amanat F, Krammer F, Wilson KM, Onel K, Geanon D, Tuballes K, Patel M, Mouskas K, O'Donnell T, Merritt E, Simons NW, Barcessat V, Del Valle DM, Udondem S, Kang G, Gangadharan S, Ofori-Amanfo G, Laserson U, Rahman A, Kim-Schulze S, Charney AW, Gnjatic S, Gelb BD, Merad M, Bogunovic D. Mapping Systemic Inflammation and Antibody Responses in Multisystem Inflammatory Syndrome in Children (MIS-C). Cell. 2020 Nov 12;183(4):982-995.e14. doi: 10.1016/j.cell.2020.09.034. Epub 2020 Sep 14.

  PMID: 32991843 BACKGROUND

• Okarska-Napierala M, Mandziuk J, Feleszko W, Stelmaszczyk-Emmel A, Panczyk M, Demkow U, Kuchar E. Recurrent assessment of lymphocyte subsets in 32 patients with multisystem inflammatory syndrome in children (MIS-C). Pediatr Allergy Immunol. 2021 Nov;32(8):1857-1865. doi: 10.1111/pai.13611. Epub 2021 Aug 11.

  PMID: 34331778 BACKGROUND

• Roukens AHE, Pothast CR, Konig M, Huisman W, Dalebout T, Tak T, Azimi S, Kruize Y, Hagedoorn RS, Zlei M, Staal FJT, de Bie FJ, van Dongen JJM, Arbous SM, Zhang JLH, Verheij M, Prins C, van der Does AM, Hiemstra PS, de Vries JJC, Janse JJ, Roestenberg M, Myeni SK, Kikkert M, Yazdanbakhsh M, Heemskerk MHM, Smits HH, Jochems SP; in collaboration with BEAT-COVID group; in collaboration with COVID-19 LUMC group. Prolonged activation of nasal immune cell populations and development of tissue-resident SARS-CoV-2-specific CD8+ T cell responses following COVID-19. Nat Immunol. 2022 Jan;23(1):23-32. doi: 10.1038/s41590-021-01095-w. Epub 2021 Dec 22.

  PMID: 34937933 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripherial blood mononuclear cell samples Whole blood samples Leukocytes obtained during nasal mucosa curettage

MeSH Terms

Conditions

pediatric multisystem inflammatory disease, COVID-19 related; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wojciech Feleszko, MD., PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wojciech Feleszko, MD., PhD

CONTACT

693468074; wojciech.feleszko@wum.edu.pl

Ziemowit Strzelczyk

CONTACT

505545747; ziemekstrzelczyk@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD., PhD

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 30, 2022
• Study Start: December 6, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After study patient data is processed.
• Access Criteria: Upon researcher's personal request.

Locations

PL (1)