Impact of the Covid-19 on RSV (IPCoVRS-2)

April 27, 2022 updated by: Hospices Civils de Lyon

Impact of the Covid-19 Pandemic on the Epidemiology of Respiratory Syncytial Virus

The magnitude of seasonal RSV epidemics brings each year new logistical challenges for the hospitalization of young infants with bronchiolitis that overwhelm hospital capacities and lead to specific winter plans with deprogramming and mobilization of human and logistical resources. The Covid-19 pandemic has changed the way winter epidemics are presented. For example, the seasonal RSV epidemic was shifted by several months in Lyon, with an impression of a lower incidence of hospitalized cases, with a population of older children and with fewer signs of clinical severity. This is largely attributable to the widespread use of barrier gestures and social distancing measures, known as "non-pharmacological interventions" or NPI. Given the magnitude of the reduction of the RSV epidemic, it is legitimate to analyze the benefits of NPIs to draw lessons for maintaining preventive measures around RSV-vulnerable populations; moreover, new preventive pharmacological interventions are soon to be marketed, whether they are particularly refined and long half-life anti-RSV monoclonal antibodies, RSV vaccines for mothers or for newborns and infants. In this perspective, it is crucial to properly define the populations at risk of severe disease to establish a legitimate hierarchy in the implementation of different preventive strategies. The study of the RSV epidemic is a high potential model because of the convergence of epidemiological, virological, and pharmacological knowledge. However, the study of the impact of the pandemic on the epidemiology of rhinovirus also seems promising because, for reasons unknown to date, it seems that the pandemic did not have the same reducing impact on the rhinovirus epidemic; in the latter case, the interest is to confirm the resistance of this virus and to look for more fundamental explanations, for example, on viral interactions.

On a previous study (see NTC 04944160), 519 infants and children were recruited in the Pre-Covid-19 season population, and 277 infants and children were recruited in the first Per-Covid-19 season population.

In the present study, the objective is to assess the epidemiology of RVS in infants from the birth cohorts of the tertiary teaching hospitals of Lyon, France, during the Pre-Covid-19 (2013-2020) and the Per-Covid-19 (2020-2025) years.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69004
        • Virology Lab
      • Lyon, France, 69500
        • Pediatric Departement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

: Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for RSV

Description

Inclusion Criteria:

  • Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France
  • Positive RSV-PCR

Exclusion Criteria:

  • • Parent's refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pre Covid-19 cohort
Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for RSV during the 2013-2020 winter epidemic
Other: epidemiology
To review of medical records to describe diagnosis and severity of the disease.
Other Names:
  • Medical records analysis
Other: epidemiology
To compare pre- and per-Covid-19 epidemics in terms of numbers of admissions, and proportion of severe disease.
Other Names:
  • comparison of cohorts
Per-Covid-19 cohort
Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for RSV during the 2020-2021, 2021-2022, 2022-2023, 2023-2024 and 2024-2025 epidemics. The need for continuation of the study will be reassessed after each season.
Other: epidemiology
To review of medical records to describe diagnosis and severity of the disease.
Other Names:
  • Medical records analysis
Other: epidemiology
To compare pre- and per-Covid-19 epidemics in terms of numbers of admissions, and proportion of severe disease.
Other Names:
  • comparison of cohorts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual evolution of the number and severity of RSV-infection in hospitalized children during per-Covid-19 epidemic compared to pre-Covid-19 pandemic
Time Frame: Day 0
Description of number of cases for each clinical picture according to pre-SARS-CoV-2 pandemic and per-SARS-CoV-2 pandemic year.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2022

Primary Completion (ANTICIPATED)

July 1, 2025

Study Completion (ANTICIPATED)

July 1, 2025

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (ACTUAL)

April 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502_4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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