Virus and Bronchial Epithelium in Children and the Elderly
VIRCHILLD
Comparison of SARS-CoV-2, AdenoVIRus and Rhinovirus Infection of the Respiratory Epithelium in CHILdren vs. the eLDerly
1 other identifier
interventional
200
1 country
1
Brief Summary
The objective of the VIRCHILLD project is to identify age-related modifications of the bronchial epithelium physiology that account for differences in the response and susceptibility to respiratory viruses. Epidemiology and cell-based data show that respiratory virus infections differentially affect children, adults or the elderly populations. The current worldwide pandemic of SARS-CoV-2 clearly highlighted this notion with a large part of the deaths occurring in the elderly population and very few deaths amongst children. This may be linked to a decreased transmission and/or viral load with SARS-CoV-2 in children compared to adults and elderly. Less in the public eye is the observation that other major respiratory virus targeting the bronchial epithelium (BE) such as rhinovirus (RV) and adenovirus (AdV) cause important clinical feature in children and have a much lower incidence in adults and the elderly populations, which is the opposite to the situation with SARS-CoV-2. Based on this remarkable discrepancy between respiratory viruses the investigators hypothesize that intrinsic age-controlled properties of the respiratory epithelium under resting physiological conditions determine virus susceptibility and virus propagation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 28, 2022
CompletedFirst Submitted
Initial submission to the registry
December 22, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2025
CompletedJanuary 25, 2024
December 1, 2023
2.5 years
December 22, 2023
January 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
number of viral particles - Rhinovirus - Children -24
number of viral particles produced at the apical level after 24 hours of infection (Rhinovirus) by epithelia reconstituted in-vitro from samples from children
after 24 hours of infection
number of viral particles - Adenovirus - Children -24
number of viral particles produced at the apical level after 24 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from children
after 24 hours of infection
number of viral particles - SARS-CoV-2 - Children-24
number of viral particles produced at the apical level after 24 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from children
after 24 hours of infection
number of viral particles - Rhinovirus - Adults-24
number of viral particles produced at the apical level after 24 hours of infection (Rhinovirus) by epithelia reconstituted in-vitro from samples from adults
after 24 hours of infection
number of viral particles - Adenovirus - Adults-24
number of viral particles produced at the apical level after 24 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from adults
after 24 hours of infection
number of viral particles - SARS-CoV-2 - Adults-24
number of viral particles produced at the apical level after 24 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from adults
after 24 hours of infection
number of viral particles - Rhinovirus - elderly-24
number of viral particles produced at the apical level after 24 hours of infection ( Rhinovirus) by epithelia reconstituted in-vitro from samples from elderly people
after 24 hours of infection
number of viral particles - Adenovirus - Elderly-24
number of viral particles produced at the apical level after 24 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from elderly people.
after 24 hours of infection
number of viral particles - SARS-CoV-2 - Elderly-24
number of viral particles produced at the apical level after 24 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from elderly people.
after 24 hours of infection
Secondary Outcomes (36)
number of viral particles - Rhinovirus - Children-48
after 48 hours of infection
number of viral particles - Rhinovirus - Children-72
after 72 hours of infection
number of viral particles - Rhinovirus - Children-96
after 96 hours of infection
number of viral particles - Rhinovirus - Children-168
after 168 hours of infection
number of viral particles - Adenovirus - Children -48
after 48 hours of infection
- +31 more secondary outcomes
Study Arms (3)
children
EXPERIMENTALreconstituted fully functional respiratory epithelium obtained from children (0 -18 years old)
adults
EXPERIMENTALreconstituted fully functional respiratory epithelium obtained from adults (18 to 60 years old)
elderly
EXPERIMENTALreconstituted fully functional respiratory epithelium obtained from adults (over 60 years old)
Interventions
Circulating strains of SARS-CoV-2 (including variants of concern) were already collected, cultured and purified. The Wuhan reference strain will be used in the VIRCHILLD study to infect cells.
Infection with C-type viruses (e.g. HAd-C5) using bronchial epithelium from adult donors
RV is a member of the picornaviridae family; small non-enveloped viruses with a single strand positive RNA genome protected by an icosahedral capsid. They are divided in more than 160 serotypes classed in subtype A, B and C. RV-A and RV-C infections will be used in the VIRCHILLD study
Eligibility Criteria
You may qualify if:
- For pediatric patients requiring research-specific bronchial brushing:
- Child under 18 years old,
- Requiring bronchoscopy as part of routine care
- Having informed and signed consent from the holders of parental authority
- For pediatric patients whose bronchial brushing will be carried out as part of their care and for those whose surgical waste will be collected for research:
- Child under 18 years old,
- Requiring as part of routine care bronchoscopy and brushing or bronchial fibroscopy under general anesthesia or surgical resection/lobectomy
- Having expressed their non-opposition to their child's participation in research
- For adult patients:
- Man or woman
- Aged 18 or over
- having received an information note and not having objected to their participation in the research
You may not qualify if:
- No affiliation or non-beneficiary of a social security system
- Patient born before 36 weeks of amenorrhea
- Patient with a documented history of pulmonary fibrosis, primary pulmonary hypertension, cystic fibrosis, pulmonary malformation or chronic viral infections (hepatitis, HIV).
- Patient with any dental, nasopharyngeal or bronchial infection with fever (\> 38°C) requiring systemic antibiotics in the previous 4 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bordeaux University Hospital
Bordeaux, 33076, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael FAYON, MDPhD
University Hospital, Bordeaux
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2023
First Posted
January 25, 2024
Study Start
October 28, 2022
Primary Completion
April 28, 2025
Study Completion
April 28, 2025
Last Updated
January 25, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share