RhinovirusIPCoRVNCT05348707
Impact of Covid-19 on Rhinovirus Epidemic
An observational study of Rhinovirus, run by Hospices Civils de Lyon.
Trial summary
Rhinovirus (RV) has long been known as the main etiological agent of "common colds" among children and adults. Indeed, RV is involved in more than 50% of upper respiratory tract infections (URTIs), mostly characterized by nasal congestion, rhinorrhea, sore throat and cough. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Rhinovirus
- What is being tested?
- epidemiology
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- May 2022to May 2023
- 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 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Child hospitalized at the " Hopital Femme Mere Enfant ", Lyon, France - Positive rhinovirus-PCR
Who may be able to join
- - Child hospitalized at the " Hopital Femme Mere Enfant ", Lyon, France
- Positive rhinovirus-PCR
Who cannot join
- - parent's refusal to participate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Covid-19 Pandemic on the Epidemiology of Rhinovirus
Rhinovirus (RV) has long been known as the main etiological agent of "common colds" among children and adults. Indeed, RV is involved in more than 50% of upper respiratory tract infections (URTIs), mostly characterized by nasal congestion, rhinorrhea, sore throat and cough. RV can also cause mild to severe lower respiratory tract infections (LRTIs) such as acute bronchiolitis, pneumonia and exacerbations of underlying chronic lung diseases. RV circulates worldwide, especially in temperate climate zones (i.e. many areas of the USA and Europe) and is responsible for annual outbreaks from early fall to the end of spring.
The covid-19 pandemic in 2020 seemed to interfere with the usual seasonal epidemics. For example, the winter Respiratory Syncytial Virus (RSV) epidemic in Lyon, France, was delayed for several months and reduced by half in terms of incidence of hospitalization cases. This can be explained by the widespread deployment of barrier gestures and social distancing measures, known as "non pharmacological interventions" (NPI).
However, the Covid-19 pandemic doesn't seem to have the same reducing impact on Rhinovirus epidemic. A better understanding of viral interactions and factors influencing RV epidemiology as well as the identification of populations at greater risk are required to improve preventive strategies and reduce the burden of Rhinovirus.
- Conditions
- Rhinovirus
- Being tested
- epidemiology
- Keywords
- Rhinovirus epidemic, SARS-CoV2/Rhinovirus interaction, Children, Non-pharmacological-interventions, Bronchiolitis, Asthma, Pneumonia, Fever, Meningitis, Rhinovirus infection in children less than 1 years of age
- Medical subject headings
- Bronchiolitis, Asthma, Pneumonia, Fever, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidemiologyOther
Also called Medical record analysis
To review 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 | Infants hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for Rhinovirus from 17th March 2019 to 16th March 2020. Receives: Other: epidemiology | |
| Per Covid 19 cohort year 1 | Infant hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for Rhinovirus from 17th March 2020 to 16th March 2021. The need to recruit patients for an additional per-covid year (from 17th March 2021 to 16th March 2022) will be evaluated after the data from the first 2 years of recruitment are available. Receives: Other: epidemiology | |
| Per Covid 19 cohort, year 2 | Infants hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for Rhinovirus from 17th March 2021 to 16th March 2022. The need to recruit patients for this additional cohort will be evaluated after the data from the first 2 years of recruitment are available and analyzed. Receives: Other: epidemiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the number of children hospitalized for a Rhinovirus-infection in the period of pre Covid-19 pandemic.
Description of number of clinical picture cases for pre-SARS-CoV-2 pandemic year.
Measured: From one year before the SARS-CoV-2 pandemic until the beginning of the SARS-CoV-2 pandemic
Evolution of the number of children hospitalized for a Rhinovirus-infection in the period of per-Covid-19 pandemic.
Description of number of clinical picture cases for per-SARS-CoV-2 pandemic year.
Measured: From the beginning of the SARS-CoV-2 pandemic until one year latter
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 startMay 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionMay 2023 (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
- 400 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
- NCT05348707
- Sponsor's protocol ID
- 502_2
- Acronym
- IPCoRV
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Covid-19 Pandemic on the Epidemiology of Rhinovirus
- ClinicalTrials.gov ID
- NCT05348707
- Acronym / sponsor ID
- IPCoRV / 502_2
- Conditions
- Rhinovirus
- Keywords
- Rhinovirus epidemic, SARS-CoV2/Rhinovirus interaction, Children, Non-pharmacological-interventions, Bronchiolitis, Asthma, Pneumonia, Fever
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- May 2023 (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.
Rhinovirus (RV) has long been known as the main etiological agent of "common colds" among children and adults. Indeed, RV is involved in more than 50% of upper respiratory tract infections (URTIs), mostly characterized by nasal congestion, rhinorrhea, sore throat and cough. RV can also cause mild to severe lower respiratory tract infections (LRTIs) such as acute bronchiolitis, pneumonia and exacerbations of underlying chronic lung diseases. RV circulates worldwide, especially in temperate climate zones (i.e. many areas of the USA and Europe) and is responsible for annual outbreaks from early fall to the end of spring.
The covid-19 pandemic in 2020 seemed to interfere with the usual seasonal epidemics. For example, the winter Respiratory Syncytial Virus (RSV) epidemic in Lyon, France, was delayed for several months and reduced by half in terms of incidence of hospitalization cases. This can be explained by the widespread deployment of barrier gestures and social distancing measures, known as "non pharmacological interventions" (NPI).
However, the Covid-19 pandemic doesn't seem to have the same reducing impact on Rhinovirus epidemic. A better understanding of viral interactions and factors influencing RV epidemiology as well as the identification of populations at greater risk are required to improve preventive strategies and reduce the burden of Rhinovirus.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre Covid 19 cohort | – | Other: epidemiologyInfants hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for Rhinovirus from 17th March 2019 to 16th March 2020. |
| Per Covid 19 cohort year 1 | – | Other: epidemiologyInfant hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for Rhinovirus from 17th March 2020 to 16th March 2021. The need to recruit patients for an additional per-covid year (from 17th March 2021 to 16th March 2022) will be evaluated after the data from the first 2 years of recruitment are available. |
| Per Covid 19 cohort, year 2 | – | Other: epidemiologyInfants hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for Rhinovirus from 17th March 2021 to 16th March 2022. The need to recruit patients for this additional cohort will be evaluated after the data from the first 2 years of recruitment are available and analyzed. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Child hospitalized at the " Hopital Femme Mere Enfant ", Lyon, France - Positive rhinovirus-PCR
Key inclusion criteria (2 listed)
- - Child hospitalized at the " Hopital Femme Mere Enfant ", Lyon, France
- Positive rhinovirus-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 record analysisTo review medical records to describe diagnosis and severity of the disease. | Other | Per Covid 19 cohort year 1, Per Covid 19 cohort, year 2, 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 year 1, Per Covid 19 cohort, year 2, Pre Covid 19 cohort |
Primary outcome
Evolution of the number of children hospitalized for a Rhinovirus-infection in the period of pre Covid-19 pandemic.
Time frame: From one year before the SARS-CoV-2 pandemic until the beginning of the SARS-CoV-2 pandemic
Description of number of clinical picture cases for pre-SARS-CoV-2 pandemic year.
Evolution of the number of children hospitalized for a Rhinovirus-infection in the period of per-Covid-19 pandemic.
Time frame: From the beginning of the SARS-CoV-2 pandemic until one year latter
Description of number of clinical picture cases for 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.
- Individual participant dataSharing planned: Undecided
Related trials for Rhinovirus
RecruitingPhase 2
Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD
Rhinovirus Infection
Not yet recruitingObservational study
ELderly REspiratory VIral Cohort
Influenza Viruses, Respiratory Syncytial Virus (RSV)
RecruitingPhase 1/2
RIG 101 Trial in Healthy Adults and Adults With Asthma
Healthy Adult Participants, Asthma Exacerbation
RecruitingObservational study
The Rhinovirus Hospitalization and Investigation of Nasal-airway Omics (RHINO) Study
Rhinovirus
RecruitingObservational study
Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France
Respiratory Tract Infections (RTI), Influenza -Like Illness
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinovirus, run by Hospices Civils de Lyon.
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.
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, MD (: 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?
Evolution of the number of children hospitalized for a Rhinovirus-infection in the period of pre Covid-19 pandemic. (time frame: From one year before the SARS-CoV-2 pandemic until the beginning of the SARS-CoV-2 pandemic). The study lists 2 primary outcomes in all. 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.