Clinical trial NCT05560906: Study of Virus-specific Lymphocytic Cell Populations in Non-invasive Nasal Mucosa Samples of MIS-C Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MIS-C Associated With COVID-19
COVID-19
Keywords: leukocytes
immunophenotype
nasal mucosa
curettage
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Leiden University Medical Center
First posted: 2022-09-30
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in leukocyte subpopulations in nasal mucosa and peripherial blood during MIS-C and convalescence.
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Pediatric teaching clinical hospital, Warsaw Medical University
state: Masovian
Study officials:
affiliation: Medical University of Warsaw
name: Wojciech Feleszko, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.