- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04944160
Impact of the Covid-19 on Respiratory Syncytial Virus (RSV) Epidemic (IPCoVRS)
April 26, 2022 updated by: Hospices Civils de Lyon
Impact of the Covid-19 Pandemic on the Epidemiology of Respiratory Syncytial Virus
The magnitude of seasonal Respiratory Syncytial Virus (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" (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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
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 Locations
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Bron, France, 69500
- Groupement Hospitalier Est - Hospices Civils de Lyon
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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 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France with viral respiratory infection.
Description
Inclusion Criteria:
• Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France
- Polymerase Chain Reaction (PCR) positive at Respiratory Syncytial Virus (RSV)
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 |
|---|---|
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Pre Covid-19 cohort
Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a reverse transcriptase - polymerase chain reaction (RT-PCR) positive for Respiratory Syncytial Virus (RSV) during the 2019-2020 winter epidemic
|
To review of medical records to describe diagnosis and severity of the disease.
To compare pre and post Covid-19 epidemics in terms of numbers of admissions, and proportion of severe disease.
Other Names:
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|
Post Covid-19 cohort
Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a reverse transcriptase - polymerase chain reaction (RT-PCR) positive for Respiratory Syncytial Virus (RSV) during the 2020-2021 winter epidemic
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To review of medical records to describe diagnosis and severity of the disease.
To compare pre and post Covid-19 epidemics in terms of numbers of admissions, and proportion of severe disease.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Reduction of the number of children hospitalized for a RSV-infection during pre and post-Covid-19 pandemic RSV-winter-epidemic.
Time Frame: 2019-2020-winter-epidemic and 2020-2021-winter-epidemic are assessed during June and July, 2021.
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2019-2020-winter-epidemic and 2020-2021-winter-epidemic are assessed during June and July, 2021.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
March 15, 2021
Primary Completion (Actual)
May 15, 2021
Study Completion (Actual)
June 28, 2021
Study Registration Dates
First Submitted
June 28, 2021
First Submitted That Met QC Criteria
June 28, 2021
First Posted (Actual)
June 29, 2021
Study Record Updates
Last Update Posted (Actual)
May 2, 2022
Last Update Submitted That Met QC Criteria
April 26, 2022
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 502
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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