RSV InfectionIPCoVRSNCT04944160
Impact of the Covid-19 on Respiratory Syncytial Virus (RSV) Epidemic
An observational study of RSV Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- RSV Infection
- What is being tested?
- Medical records analysis and Comparison of cohorts
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2021to 28 Jun 2021
- 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: Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France with viral respiratory infection.
Who may be able to join
- • Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France
- Polymerase Chain Reaction (PCR) positive at Respiratory Syncytial Virus (RSV)
Who cannot join
- • Parent's refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- RSV Infection
- Being tested
- Medical records analysis, Comparison of cohorts
- Keywords
- bronchiolitis, Asthma, Pneumonia
- Medical subject headings
- Respiratory Syncytial Virus Infections, Bronchiolitis, Asthma, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical records analysisOther
To review of medical records to describe diagnosis and severity of the disease.
Comparison of cohortsOther
Also called Epidemiology
To compare pre and post 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 reverse transcriptase - polymerase chain reaction (RT-PCR) positive for Respiratory Syncytial Virus (RSV) during the 2019-2020 winter epidemic Receives: Other: Medical records analysis; Other: Comparison of cohorts | |
| 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 Receives: Other: Medical records analysis; Other: Comparison of cohorts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the number of children hospitalized for a RSV-infection during pre and post-Covid-19 pandemic RSV-winter-epidemic.
Measured: 2019-2020-winter-epidemic and 2020-2021-winter-epidemic are assessed during June and July, 2021.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start15 Mar 2021
- Primary completion15 May 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RSV InfectionStudies 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 (actual)
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
- NCT04944160
- Sponsor's protocol ID
- 502
- Acronym
- IPCoVRS
- Status last verified
- Jun 2021
- First submitted
- 28 Jun 2021
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Casalegno JS, Ploin D, Cantais A, Masson E, Bard E, Valette M, Fanget R, Targe SC, Myar-Dury AF, Doret-Dion M, Massoud M, Queromes G, Vanhems P, Claris O, Butin M, Pillet S, Ader F, Bin S, Gaymard A, Lina B, Morfin F; VRS study group in Lyon; Javouhey E, Gillet Y. Characteristics of the delayed respiratory syncytial virus epidemic, 2020/2021, Rhone Loire, France. Euro Surveill. 2021 Jul;26(29):2100630. doi: 10.2807/1560-7917.ES.2021.26.29.2100630.
PubMed 34296674
Study at a glance
From the registry record, last updated by the sponsor on 2 May 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
- ClinicalTrials.gov ID
- NCT04944160
- Acronym / sponsor ID
- IPCoVRS / 502
- Conditions
- RSV Infection
- Keywords
- bronchiolitis, Asthma, Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 29 Jun 2021 (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 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre Covid-19 cohort | – | Other: Medical records analysis, Other: Comparison of cohortsChildren 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 |
| Post Covid-19 cohort | – | Other: Medical records analysis, Other: Comparison of cohortsChildren 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 |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France with viral respiratory infection.
Key inclusion criteria (2 listed)
- • Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France
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 |
|---|---|---|
| Medical records analysisTo review of medical records to describe diagnosis and severity of the disease. | Other | Post Covid-19 cohort, Pre Covid-19 cohort |
| Comparison of cohortsAlso: EpidemiologyTo compare pre and post Covid-19 epidemics in terms of numbers of admissions, and proportion of severe disease. | Other | Post Covid-19 cohort, Pre Covid-19 cohort |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 34296674Casalegno JS, Ploin D, Cantais A, Masson E, Bard E, Valette M, Fanget R, Targe SC, Myar-Dury AF, Doret-Dion M, Massoud M, Queromes G, Vanhems P, Claris O, Butin M, Pillet S, Ader F, Bin S, Gaymard A, Lina B, Morfin F; VRS study group in Lyon; Javouhey E, Gillet Y. Characteristics of the delayed respiratory syncytial virus epidemic, 2020/2021, Rhone Loire, France. Euro Surveill. 2021 Jul;26(29):2100630. doi: 10.2807/1560-7917.ES.2021.26.29.2100630.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSV Infection, run by Hospices Civils de Lyon at 1 site 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: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04944160, which also lists 1 linked publication.
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 2 May 2022.