NCT05348707

Brief Summary

Rhinovirus (RV) has long been known as the main etiological agent of "common colds" among children and adults. Indeed, RV is involved in more than 50% of upper respiratory tract infections (URTIs), mostly characterized by nasal congestion, rhinorrhea, sore throat and cough. RV can also cause mild to severe lower respiratory tract infections (LRTIs) such as acute bronchiolitis, pneumonia and exacerbations of underlying chronic lung diseases. RV circulates worldwide, especially in temperate climate zones (i.e. many areas of the USA and Europe) and is responsible for annual outbreaks from early fall to the end of spring. The covid-19 pandemic in 2020 seemed to interfere with the usual seasonal epidemics. For example, the winter Respiratory Syncytial Virus (RSV) epidemic in Lyon, France, was delayed for several months and reduced by half in terms of incidence of hospitalization cases. This can be explained by the widespread deployment of barrier gestures and social distancing measures, known as "non pharmacological interventions" (NPI). However, the Covid-19 pandemic doesn't seem to have the same reducing impact on Rhinovirus epidemic. A better understanding of viral interactions and factors influencing RV epidemiology as well as the identification of populations at greater risk are required to improve preventive strategies and reduce the burden of Rhinovirus.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 27, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

February 17, 2022

Last Update Submit

April 26, 2022

Conditions

Keywords

Rhinovirus epidemicSARS-CoV2/Rhinovirus interactionChildrenNon-pharmacological-interventionsBronchiolitisAsthmaPneumoniaFeverMeningitisRhinovirus infection in children less than 1 years of age

Outcome Measures

Primary Outcomes (2)

  • Evolution of the number of children hospitalized for a Rhinovirus-infection in the period of pre Covid-19 pandemic.

    Description of number of clinical picture cases for pre-SARS-CoV-2 pandemic year.

    From one year before the SARS-CoV-2 pandemic until the beginning of the SARS-CoV-2 pandemic

  • Evolution of the number of children hospitalized for a Rhinovirus-infection in the period of per-Covid-19 pandemic.

    Description of number of clinical picture cases for per-SARS-CoV-2 pandemic year.

    From the beginning of the SARS-CoV-2 pandemic until one year latter

Study Arms (3)

Pre Covid 19 cohort

Infants hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for Rhinovirus from 17th March 2019 to 16th March 2020.

Other: epidemiology

Per Covid 19 cohort year 1

Infant hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for Rhinovirus from 17th March 2020 to 16th March 2021. The need to recruit patients for an additional per-covid year (from 17th March 2021 to 16th March 2022) will be evaluated after the data from the first 2 years of recruitment are available.

Other: epidemiology

Per Covid 19 cohort, year 2

Infants hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for Rhinovirus from 17th March 2021 to 16th March 2022. The need to recruit patients for this additional cohort will be evaluated after the data from the first 2 years of recruitment are available and analyzed.

Other: epidemiology

Interventions

To review medical records to describe diagnosis and severity of the disease.

Also known as: Medical record analysis
Per Covid 19 cohort year 1Per Covid 19 cohort, year 2Pre Covid 19 cohort

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Child hospitalized at the " Hopital Femme Mere Enfant ", Lyon, France \- Positive rhinovirus-PCR

You may qualify if:

  • \- Child hospitalized at the " Hopital Femme Mere Enfant ", Lyon, France
  • Positive rhinovirus-PCR

You may not qualify if:

  • \- parent's refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BronchiolitisAsthmaPneumoniaFeverMeningitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsNeuroinflammatory DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

April 27, 2022

Study Start

May 1, 2022

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

April 27, 2022

Record last verified: 2022-02