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SARS-CoV-2VIRCHILLDNCT06224062

Virus and Bronchial Epithelium in Children and the Elderly

A study testing SARS-CoV-2, Adenovirus (AdV) and Rhinovirus in people with SARS-CoV-2, run by University Hospital, Bordeaux at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
SARS-CoV-2
What is being tested?
SARS-CoV-2, Adenovirus (AdV) and Rhinovirus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteFrance
Study dates
28 Oct 2022to 28 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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,
Show all 13Show fewer
  • 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
  • Requiring as part of the care, thoracic surgery such as lobectomy, pneumonectomy or lung transplantation in the Thoracic Surgery Department of Haut Lévêque du Chu Hospital in Bordeaux or inclusion in the TUBE study, described below.
  • having received an information note and not having objected to their participation in the research

Who cannot join

  • No affiliation or non-beneficiary of a social security system
  • During a period of relative exclusion compared to another protocol
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Bordeaux University Hospital

    Bordeaux, 33076

    Michael FAYON, MDPhD, michael.fayon@chu-bordeaux.fr

    Matthieu THUMEREL, MD

    Recruiting

Other trials in France

About this study

Official title: Comparison of SARS-CoV-2, AdenoVIRus and Rhinovirus Infection of the Respiratory Epithelium in CHILdren vs. the eLDerly

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.

Read the detailed description

The objective of the VIRCHILLD project is to identify age-related modifications of the bronchial epithelium physiology able to explain differences in the response to respiratory viruses. Several epidemiological and cell-based data have demonstrated that respiratory virus infections differentially affect children, adults or the elderly populations. Perhaps, this difference has been put most notably into the spotlight by the current worldwide pandemic of SARS-CoV-2 with a large part of the deaths occurring in the elderly population whereas very few deaths amongst children have been recorded. According to some studies, this could be linked to a decreased transmission and/or viral load with SARS-CoV-2 in children compared to adults and elderly. What is less in the public eye is the observation that other major respiratory virus targeting the bronchial epithelium such as rhinovirus and adenovirus 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 determines virus susceptibility and virus propagation. Such hypothesis is supported by the literature and our own strong preliminary data. A highly complementing consortium composed of experts in lung physiology, pulmonary transcriptomic, respiratory viruses and ultrastructure analysis will address the question. The investigators will use three major respiratory pathogens (AdV, RV and SARS-CoV-2) to infect reconstituted fully functional respiratory epithelium obtained from children, adults and elderly and study parameters of virus infection and epithelial response. This project should highlight specific therapeutic targets against respiratory viruses with a high prevalence in children such as rhinovirus and adenoviruses to increase the therapeutic arsenal of clinician against those infections.

Conditions
SARS-CoV-2
Being tested
SARS-CoV-2, Adenovirus (AdV), Rhinovirus, No Intervention
Keywords
Adenovirus, SARS-COV-2, Rhinovirus, Children, Elderly
Medical subject headings
Adenoviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2Biological

    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.

  • Adenovirus (AdV)Biological

    Infection with C-type viruses (e.g. HAd-C5) using bronchial epithelium from adult donors

  • RhinovirusBiological

    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

  • No InterventionBiological

    no infection

Study groups in NCT06224062
Study groupRoleWhat they receive
childrenExperimentalreconstituted fully functional respiratory epithelium obtained from children (0 -18 years old)
Receives: Biological: SARS-CoV-2; Biological: Adenovirus (AdV); Biological: Rhinovirus; Biological: No Intervention
adultsExperimentalreconstituted fully functional respiratory epithelium obtained from adults (18 to 60 years old)
Receives: Biological: SARS-CoV-2; Biological: Adenovirus (AdV); Biological: Rhinovirus; Biological: No Intervention
elderlyExperimentalreconstituted fully functional respiratory epithelium obtained from adults (over 60 years old)
Receives: Biological: SARS-CoV-2; Biological: Adenovirus (AdV); Biological: Rhinovirus; Biological: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: after 24 hours of infection

  2. 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

    Measured: after 24 hours of infection

  3. 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

    Measured: after 24 hours of infection

  4. 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

    Measured: after 24 hours of infection

  5. 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

    Measured: after 24 hours of infection

  6. 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

    Measured: after 24 hours of infection

  7. 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

    Measured: after 24 hours of infection

  8. 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.

    Measured: after 24 hours of infection

  9. 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.

    Measured: after 24 hours of infection

Secondary outcomes (36)
  1. number of viral particles - Rhinovirus - Children-48

    number of viral particles produced at the apical level after 48 hours of infection (Rhinovirus) by epithelia reconstituted in-vitro from samples from children

    Measured: after 48 hours of infection

  2. number of viral particles - Rhinovirus - Children-72

    number of viral particles produced at the apical level after 72 hours of infection (Rhinovirus) by epithelia reconstituted in-vitro from samples from children

    Measured: after 72 hours of infection

  3. number of viral particles - Rhinovirus - Children-96

    number of viral particles produced at the apical level after 96 hours of infection (Rhinovirus) by epithelia reconstituted in-vitro from samples from children

    Measured: after 96 hours of infection

  4. number of viral particles - Rhinovirus - Children-168

    number of viral particles produced at the apical level after 168 hours of infection (Rhinovirus) by epithelia reconstituted in-vitro from samples from children

    Measured: after 168 hours of infection

  5. number of viral particles - Adenovirus - Children -48

    number of viral particles produced at the apical level after 48 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from children

    Measured: after 48 hours of infection

  6. number of viral particles - Adenovirus - Children -72

    number of viral particles produced at the apical level after 72 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from children

    Measured: after 72 hours of infection

  7. number of viral particles - Adenovirus - Children -96

    number of viral particles produced at the apical level after 96 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from children

    Measured: after 96 hours of infection

  8. number of viral particles - Adenovirus - Children -168

    number of viral particles produced at the apical level after 168 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from children

    Measured: after 168 hours of infection

  9. number of viral particles - SARS-CoV-2 - Children-48

    number of viral particles produced at the apical level after 48 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from children

    Measured: after 48 hours of infection

  10. number of viral particles - SARS-CoV-2 - Children-72

    number of viral particles produced at the apical level after 72 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from children

    Measured: after 72 hours of infection

  11. number of viral particles - SARS-CoV-2 - Children-96

    number of viral particles produced at the apical level after 96 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from children

    Measured: after 96 hours of infection

  12. number of viral particles - SARS-CoV-2 - Children-168

    number of viral particles produced at the apical level after 168 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from children

    Measured: after 168 hours of infection

  13. number of viral particles - Adenovirus - Adults-48

    number of viral particles produced at the apical level after 48 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from adults

    Measured: after 48 hours of infection

  14. number of viral particles - Adenovirus - Adults-72

    number of viral particles produced at the apical level after 72 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from adults

    Measured: after 72 hours of infection

  15. number of viral particles - Adenovirus - Adults-96

    number of viral particles produced at the apical level after 96 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from adults

    Measured: after 96 hours of infection

  16. number of viral particles - Adenovirus - Adults-168

    number of viral particles produced at the apical level after 168 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from adults

    Measured: after 168 hours of infection

  17. number of viral particles - Rhinovirus - Adults-48

    number of viral particles produced at the apical level after 48 hours of infection (Rhinovirus) by epithelia reconstituted in-vitro from samples from adults

    Measured: after 48 hours of infection

  18. number of viral particles - Rhinovirus - Adults-72

    number of viral particles produced at the apical level after 72 hours of infection (Rhinovirus) by epithelia reconstituted in-vitro from samples from adults

    Measured: after 72 hours of infection

  19. number of viral particles - Rhinovirus - Adults-96

    number of viral particles produced at the apical level after 96 hours of infection (Rhinovirus) by epithelia reconstituted in-vitro from samples from adults

    Measured: after 96 hours of infection

  20. number of viral particles - Rhinovirus - Adults-168

    number of viral particles produced at the apical level after 168 hours of infection (Rhinovirus) by epithelia reconstituted in-vitro from samples from adults

    Measured: after 168 hours of infection

  21. number of viral particles - SARS-CoV-2 - Adults-48

    number of viral particles produced at the apical level after 48 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from adults

    Measured: after 48 hours of infection

  22. number of viral particles - SARS-CoV-2 - Adults-72

    number of viral particles produced at the apical level after 72 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from adults

    Measured: after 72 hours of infection

  23. number of viral particles - SARS-CoV-2 - Adults-96

    number of viral particles produced at the apical level after 96 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from adults

    Measured: after 96 hours of infection

  24. number of viral particles - SARS-CoV-2 - Adults-168

    number of viral particles produced at the apical level after 168 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from adults

    Measured: after 168 hours of infection

  25. number of viral particles - Rhinovirus - elderly-48

    number of viral particles produced at the apical level after 48 hours of infection ( Rhinovirus) by epithelia reconstituted in-vitro from samples from elderly people

    Measured: after 48 hours of infection

  26. number of viral particles - Rhinovirus - elderly-72

    number of viral particles produced at the apical level after 72 hours of infection ( Rhinovirus) by epithelia reconstituted in-vitro from samples from elderly people

    Measured: after 72 hours of infection

  27. number of viral particles - Rhinovirus - elderly-96

    number of viral particles produced at the apical level after 96 hours of infection ( Rhinovirus) by epithelia reconstituted in-vitro from samples from elderly people

    Measured: after 96 hours of infection

  28. number of viral particles - Rhinovirus - elderly-168

    number of viral particles produced at the apical level after 168 hours of infection ( Rhinovirus) by epithelia reconstituted in-vitro from samples from elderly people

    Measured: after 168 hours of infection

  29. number of viral particles - Adenovirus - Elderly-48

    number of viral particles produced at the apical level after 48 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from elderly people.

    Measured: after 48 hours of infection

  30. number of viral particles - Adenovirus - Elderly-72

    number of viral particles produced at the apical level after 72 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from elderly people.

    Measured: after 72 hours of infection

  31. number of viral particles - Adenovirus - Elderly-96

    number of viral particles produced at the apical level after 96 hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from elderly people.

    Measured: after 96 hours of infection

  32. number of viral particles - Adenovirus - Elderly-168

    number of viral particles produced at the apical level after 168hours of infection (Adenovirus) by epithelia reconstituted in-vitro from samples from elderly people.

    Measured: after 168 hours of infection

  33. number of viral particles - SARS-CoV-2 - Elderly-48

    number of viral particles produced at the apical level after 48 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from elderly people.

    Measured: after 48 hours of infection

  34. number of viral particles - SARS-CoV-2 - Elderly-72

    number of viral particles produced at the apical level after 72 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from elderly people.

    Measured: after 72 hours of infection

  35. number of viral particles - SARS-CoV-2 - Elderly-96

    number of viral particles produced at the apical level after 96 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from elderly people.

    Measured: after 96 hours of infection

  36. number of viral particles - SARS-CoV-2 - Elderly-168

    number of viral particles produced at the apical level after 168 hours of infection (SARS-CoV-2 ) by epithelia reconstituted in-vitro from samples from elderly people.

    Measured: after 168 hours of infection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2024
  2. Study start28 Oct 2022
  3. Primary completion28 Apr 2025 (estimated)
  4. Study completion28 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06224062
Sponsor's protocol ID
CHUBX 2021/43
Acronym
VIRCHILLD
Status last verified
Dec 2023
First submitted
22 Dec 2023
Last updated
25 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SARS-CoV-2, Adenovirus (AdV) and Rhinovirus in people with SARS-CoV-2, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Thomas TRIAN, PhD (05 55 47 30 27 50, thomas.trian@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of viral particles - Rhinovirus - Children -24 (time frame: after 24 hours of infection). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.

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