IPCoVRS-2: Impact of the Covid-19 on RSV

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05348616

Collaborator

(none)

600

Enrollment

Locations

Anticipated Duration (Months)

300

Patients Per Site

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinovirus RSV Infection	Other: epidemiology Other: epidemiology

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Annual evolution of the number and severity of RSV-infection in hospitalized children during per-Covid-19 epidemic compared to pre-Covid-19 pandemic [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.