RhinovirusIPCoVRS-2NCT05348655
Impact of the Covid-19 on RSV Epidemic in the Metropolis of Lyon
An observational study of Rhinovirus and RSV Infection in Children Less Than 5 Years of Age, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Rhinovirus, RSV Infection in Children Less Than 5 Years of Age
- What is being tested?
- epidemiology
- How many people
- 600 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2022to Jul 2025
- Phase
- Observational
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for RSV
Who may be able to join
- Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France
- Positive RSV-PCR
Who cannot join
- Parent's refusal to participate
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Impact of the Covid-19 Pandemic on the Epidemiology of Respiratory Syncytial Virus in the Metropolis of Lyon
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 were recruited in the Pre-Covid-19 season population, and 277 infants were recruited in the first Per-Covid-19 season population.
- Being tested
- epidemiology
- Keywords
- RSV epidemic, Covid-19-RSV interaction, Non-pharmacological-interventions, Bronchiolitis, Asthma, Pneumonia
- Medical subject headings
- Bronchiolitis, Asthma, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidemiologyOther
Also called Medical records analysis
To review of medical records to describe diagnosis and severity of the disease
epidemiologyOther
Also called Comparison of cohorts
To compare pre- and per-Covid-19 epidemics in terms of numbers of admissions, and proportion of severe disease.
| Study group | Role | What they receive |
|---|---|---|
| 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 2019-2020 winter epidemic Receives: Other: epidemiology | |
| 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, and 2023-2024 epidemic. The need for continuation of the study will be reassessed after each season Receives: Other: epidemiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual evolution of the number and severity of RSV-infection in hospitalized children during per-Covid-19 epidemic compared to pre-Covid-19 pandemic.
Description of number of cases for each clinical picture according to pre-SARS-CoV-2 pandemic and per-SARS-CoV-2 pandemic year.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study startJun 2022 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinovirusStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348655
- Sponsor's protocol ID
- 502_3
- Acronym
- IPCoVRS-2
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Covid-19 Pandemic on the Epidemiology of Respiratory Syncytial Virus in the Metropolis of Lyon
- ClinicalTrials.gov ID
- NCT05348655
- Acronym / sponsor ID
- IPCoVRS-2 / 502_3
- Keywords
- RSV epidemic, Covid-19-RSV interaction, Non-pharmacological-interventions, Bronchiolitis, Asthma, Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 were recruited in the Pre-Covid-19 season population, and 277 infants were recruited in the first Per-Covid-19 season population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre Covid-19 cohort | – | Other: epidemiologyChildren hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for RSV during the 2019-2020 winter epidemic |
| Per Covid-19 cohort | – | Other: epidemiologyChildren 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, and 2023-2024 epidemic. The need for continuation of the study will be reassessed after each season |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for RSV
Key inclusion criteria (2 listed)
- Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France
- Positive RSV-PCR
Key exclusion criteria (1 listed)
- Parent's refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidemiologyAlso: Medical records analysisTo review of medical records to describe diagnosis and severity of the disease | Other | Per Covid-19 cohort, Pre Covid-19 cohort |
| epidemiologyAlso: Comparison of cohortsTo compare pre- and per-Covid-19 epidemics in terms of numbers of admissions, and proportion of severe disease. | Other | Per Covid-19 cohort, Pre Covid-19 cohort |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinovirus and RSV Infection in Children Less Than 5 Years of Age, run by Hospices Civils de Lyon at 2 sites 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 2 inclusion and 1 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Dominique PLOIN, PhD (04 27 85 56 42, dominique.ploin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 27 Apr 2022.