Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children
COVILLE
2 other identifiers
interventional
605
1 country
22
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Apr 2020
Shorter than P25 for not_applicable covid19
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2020
CompletedStudy Start
First participant enrolled
April 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJuly 9, 2020
July 1, 2020
28 days
March 20, 2020
July 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
14 days
Secondary Outcomes (6)
Confirmed Cov2-SARS cases by age
14 days
Confirmed Cov2-SARS cases by symptoms
14 days
Viral load
14 days
Other respiratory viruses
14 days
Sars-Cov2 IgM
14 days
- +1 more secondary outcomes
Study Arms (1)
Data collection and rhinopharyngeal swab
OTHERAfter 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.
Interventions
Testing for SARS -Cov2 and other respiratory pathogens by PCR via nasopharyngeal swabbing and IgM/IgG rapid serology
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +2 more criteria
You may not qualify if:
- Refusal to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Cabinet du Dr Belaroussi
Boulogne, 92100, France
Cabinet du Dr Derkx
Champigny-sur-Marne, 94500, France
Cabinet du Dr Coicadan
Chennevières-sur-Marne, 94430, France
14 Av rené Samuel
Clamart, 92140, France
Cabinet du Dr Corrard
Combs-la-Ville, 77380, France
10 rue Delambre
Lagny-sur-Marne, 77400, France
157 Avenue du Général Leclerc
Maisons-Alfort, 94700, France
21 Grande Rue Charles de Gaulle
Nogent-sur-Marne, 94130, France
Cabinet du Dr Deberdt
Nogent-sur-Marne, 94130, France
Cabinet du Dr Wollner
Nogent-sur-Marne, 94130, France
4 allée des Norottes
Noisy-le-Grand, 93160, France
Cabinet du Dr D'acremont
Paris, 75009, France
146 Avenue Ledru Rollin
Paris, 75011, France
132 Boulevard du Montparnasse
Paris, 75014, France
Cabinet du Dr Romain
Paris, 75015, France
Cabinet du Dr Turberg-Romain
Paris, 75015, France
15 Quai Louis Blériot
Paris, 75016, France
Cabinet du Dr Michot
Paris, 75016, France
24 rue Volta
Puteaux, 92800, France
Cabinet du Dr Cohen
Saint-Maur-des-Fossés, 94100, France
Cabinet de Pédiatrie des Docteurs Ravilly et Bessa
Villejuif, 94800, France
13 Villa Beauséjour
Vincennes, 94300, France
Related Publications (1)
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.
PMID: 33665371DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2020
First Posted
March 24, 2020
Study Start
April 14, 2020
Primary Completion
May 12, 2020
Study Completion
June 1, 2020
Last Updated
July 9, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share