Covid19COVILLENCT04318431
Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children
A study testing Data collection and rhinopharyngeal swab in people with Covid19, run by Centre Hospitalier Intercommunal Creteil at 22 sites in France.
Trial summary
This study is expected to provide, for the first time, data on Cov2-SARS circulation in asymptomatic children and children with moderate respiratory symptoms in order to construct the severity pyramid of this novel pathogen. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Covid19
- What is being tested?
- Data collection and rhinopharyngeal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 22 sitesFrance
- Study dates
- 14 Apr 2020to 1 Jun 2020
- Phase
- Interventional
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Asymptomatic children:
- Age between birth and 15 years
- Carrying out a visit within the framework defined by the learned societies and professional organisations representative of paediatrics in France, i.e. :
- The consultation of the first month and all consultations involving compulsory vaccinations (2, 4, 5, 11, 12, 16 months).
- Consultations for acute pathologies, infectious or not.
- Monitoring of chronic diseases that warrant clinical examination (the majority of which can be carried out by telemedicine) or in the case of acute exacerbation.
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- In one of the participating outpatient centres
- During the study period
- With a clinical examination that does not reveal any progressive infectious pathology
- AND Pauci-symptomatic children
- Age between birth and 15 years,
- Consultant at one of the participating outpatient centres
- During the study period
- And presenting with a mild respiratory infection:
- Rhinopharyngitis, Acute otitis media, Angina, Bronchitis, etc.
- Acceptance to participate in the protocol by one of the holders of parental authority
- Affiliated to a social security
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
Cabinet du Dr Belaroussi
Boulogne, 92100
Cabinet du Dr Derkx
Champigny-sur-Marne, 94500
Cabinet du Dr Coicadan
Chennevières-sur-Marne, 94430
14 Av rené Samuel
Clamart, 92140
Cabinet du Dr Corrard
Combs-la-Ville, 77380
10 rue Delambre
Lagny-sur-Marne, 77400
157 Avenue du Général Leclerc
Maisons-Alfort, 94700
21 Grande Rue Charles de Gaulle
Nogent-sur-Marne, 94130
Cabinet du Dr Deberdt
Nogent-sur-Marne, 94130
Cabinet du Dr Wollner
Nogent-sur-Marne, 94130
4 allée des Norottes
Noisy-le-Grand, 93160
Cabinet du Dr D'acremont
Paris, 75009
146 Avenue Ledru Rollin
Paris, 75011
132 Boulevard du Montparnasse
Paris, 75014
Cabinet du Dr Romain
Paris, 75015
Cabinet du Dr Turberg-Romain
Paris, 75015
15 Quai Louis Blériot
Paris, 75016
Cabinet du Dr Michot
Paris, 75016
24 rue Volta
Puteaux, 92800
Cabinet du Dr Cohen
Saint-Maur-des-Fossés, 94100
Cabinet de Pédiatrie des Docteurs Ravilly et Bessa
Villejuif, 94800
13 Villa Beauséjour
Vincennes, 94300
About this study
Official title: Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care.
This study is expected to provide, for the first time, data on Cov2-SARS circulation in asymptomatic children and children with moderate respiratory symptoms in order to construct the severity pyramid of this novel pathogen. This information will be essential in the coming weeks to understand the dynamics of the transmission of this pathogen at the population level and to highlight the relevance of public health interventions, particularly with regard to the systematic closure of schools and childcare facilities.
Read the detailed description
Cov2-SARS is an emerging respiratory virus of the coronavirus family responsible for a global epidemic since November 2019. As of March 10, 2020, it had caused more than 160,000 cases of corona virus disease (COVID-19), including more than 6,500 deaths worldwide. France is one of the main epidemic outbreaks with more than 5,000 confirmed cases and the number of diagnosed patients is increasing every day.
The number of confirmed paediatric cases is relatively low, and the mortality rate in children is close to zero. This contrast suggests that children are more likely to present pauci-symptomatic or even asymptomatic forms of the disease, which are therefore undiagnosed in most cases. Given the rapid spread of this virus, and the fact that indigenous cases without an obvious chain of transmission now appear to be frequent in France, it is possible that the pauci-symptomatic or asymptomatic child may play a role in the transmission of the pathogen and the dynamics of the epidemic, as documented for other respiratory pathogens such as influenza. Based on this hypothesis, the closure of children's communities has been organized in France and other highly endemic countries.
- Conditions
- Covid19
- Being tested
- Data collection and rhinopharyngeal swab
- Keywords
- Sars-Cov2 rhino-pharyngeal carriage, primary care, children
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection and rhinopharyngeal swabDiagnostic test
Also called IgM/IgG rapid serology
Testing for SARS -Cov2 and other respiratory pathogens by PCR via nasopharyngeal swabbing and IgM/IgG rapid serology
| Study group | Role | What they receive |
|---|---|---|
| Data collection and rhinopharyngeal swab | Other | After information, the collection of consent will be carried out. A clinical information sheet will be completed by the investigator in order to collect socio-demographic data, history, clinical symptoms and signs, and complementary examinations performed.
During the same consultation, a rhinopharyngeal swab will be taken for the detection of SARS -Cov2 and other respiratory pathogens by PCR. Receives: Diagnostic Test: Data collection and rhinopharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of asymptomatic children or children with mild respiratory symptoms
Proportion of asymptomatic children or children with mild respiratory symptoms (mildly-symptomatic children) with a positive SARS-Cov2 Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on rhino pharyngeal swab or/and IgM/IgG positive serology in the Ile-de-France region during an epidemic period.
Measured: 14 days
Secondary outcomes (6)
Confirmed Cov2-SARS cases by age
The proportion of confirmed Cov2-SARS cases in mildly-symptomatic and asymptomatic children in different age groups (defined as 6-23 months, 2-4 years, 5-9 years, 10-15 years).
Measured: 14 days
Confirmed Cov2-SARS cases by symptoms
The proportion of confirmed Cov2-SARS cases based on the symptoms presented by the patients
Measured: 14 days
Viral load
The viral load of children with SARS-Cov2 positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) depending on the symptoms and the age of the patients
Measured: 14 days
Other respiratory viruses
The proportion of co-infection with other respiratory viruses among children with SARS -Cov2 RT-PCR positive
Measured: 14 days
Sars-Cov2 IgM
Proportion of patients with Sars-Cov2 IgM +
Measured: 14 days
Sars-Cov2 IgG
Proportion of patients with Sars-Cov2 IgG +
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start14 Apr 2020
- Primary completion12 May 2020
- Study completion1 Jun 2020
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 Covid19Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Association Clinique Thérapeutique Infantile du val de Marne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318431
- Sponsor's protocol ID
- COVILLE
- Other IDs
- 2020-A00724-35
- Acronym
- COVILLE
- Status last verified
- Jul 2020
- First submitted
- 20 Mar 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen R, Jung C, Ouldali N, Sellam A, Batard C, Cahn-Sellem F, Elbez A, Wollner A, Romain O, Corrard F, Aberrane S, Soismier N, Creidy R, Smati-Lafarge M, Launay O, Bechet S, Varon E, Levy C. Assessment of SARS-CoV-2 infection by Reverse transcription-PCR and serology in the Paris area: a cross-sectional study. BMJ Paediatr Open. 2020 Dec 29;4(1):e000887. doi: 10.1136/bmjpo-2020-000887. eCollection 2020.
PubMed 33665371
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care.
- ClinicalTrials.gov ID
- NCT04318431
- Acronym / sponsor ID
- COVILLE / COVILLE
- Conditions
- Covid19
- Keywords
- Sars-Cov2 rhino-pharyngeal carriage, primary care, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Association Clinique Thérapeutique Infantile du val de Marne
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 24 Mar 2020 (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.
This study is expected to provide, for the first time, data on Cov2-SARS circulation in asymptomatic children and children with moderate respiratory symptoms in order to construct the severity pyramid of this novel pathogen. This information will be essential in the coming weeks to understand the dynamics of the transmission of this pathogen at the population level and to highlight the relevance of public health interventions, particularly with regard to the systematic closure of schools and childcare facilities.
Detailed description
Cov2-SARS is an emerging respiratory virus of the coronavirus family responsible for a global epidemic since November 2019. As of March 10, 2020, it had caused more than 160,000 cases of corona virus disease (COVID-19), including more than 6,500 deaths worldwide. France is one of the main epidemic outbreaks with more than 5,000 confirmed cases and the number of diagnosed patients is increasing every day.
The number of confirmed paediatric cases is relatively low, and the mortality rate in children is close to zero. This contrast suggests that children are more likely to present pauci-symptomatic or even asymptomatic forms of the disease, which are therefore undiagnosed in most cases. Given the rapid spread of this virus, and the fact that indigenous cases without an obvious chain of transmission now appear to be frequent in France, it is possible that the pauci-symptomatic or asymptomatic child may play a role in the transmission of the pathogen and the dynamics of the epidemic, as documented for other respiratory pathogens such as influenza. Based on this hypothesis, the closure of children's communities has been organized in France and other highly endemic countries.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data collection and rhinopharyngeal swab | Other | Diagnostic Test: Data collection and rhinopharyngeal swabAfter information, the collection of consent will be carried out. A clinical information sheet will be completed by the investigator in order to collect socio-demographic data, history, clinical symptoms and signs, and complementary examinations performed. During the same consultation, a rhinopharyngeal swab will be taken for the detection of SARS -Cov2 and other respiratory pathogens by PCR. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- Asymptomatic children:
- Age between birth and 15 years
- Carrying out a visit within the framework defined by the learned societies and professional organisations representative of paediatrics in France, i.e. :
- The consultation of the first month and all consultations involving compulsory vaccinations (2, 4, 5, 11, 12, 16 months).
- Consultations for acute pathologies, infectious or not.
Key exclusion criteria (1 listed)
- Refusal to participate in the study
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 |
|---|---|---|
| Data collection and rhinopharyngeal swabAlso: IgM/IgG rapid serologyTesting for SARS -Cov2 and other respiratory pathogens by PCR via nasopharyngeal swabbing and IgM/IgG rapid serology | Diagnostic test | Data collection and rhinopharyngeal swab |
Primary outcome
Proportion of asymptomatic children or children with mild respiratory symptoms
Time frame: 14 days
Proportion of asymptomatic children or children with mild respiratory symptoms (mildly-symptomatic children) with a positive SARS-Cov2 Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on rhino pharyngeal swab or/and IgM/IgG positive serology in the Ile-de-France region during an epidemic period.
6 secondary outcomes
Confirmed Cov2-SARS cases by age
Time frame: 14 days
Confirmed Cov2-SARS cases by symptoms
Time frame: 14 days
Viral load
Time frame: 14 days
Other respiratory viruses
Time frame: 14 days
Sars-Cov2 IgM
Time frame: 14 days
Sars-Cov2 IgG
Time frame: 14 days
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 9 Jul 2020.
- Derived from this study: PubMed 33665371Cohen R, Jung C, Ouldali N, Sellam A, Batard C, Cahn-Sellem F, Elbez A, Wollner A, Romain O, Corrard F, Aberrane S, Soismier N, Creidy R, Smati-Lafarge M, Launay O, Bechet S, Varon E, Levy C. Assessment of SARS-CoV-2 infection by Reverse transcription-PCR and serology in the Paris area: a cross-sectional study. BMJ Paediatr Open. 2020 Dec 29;4(1):e000887. doi: 10.1136/bmjpo-2020-000887. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data collection and rhinopharyngeal swab in people with Covid19, run by Centre Hospitalier Intercommunal Creteil at 22 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 17 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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
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?
Proportion of asymptomatic children or children with mild respiratory symptoms (time frame: 14 days). 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 NCT04318431, 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 9 Jul 2020.