COVILLE: Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children

• Sponsor: Centre Hospitalier Intercommunal Creteil (Other)
• Overall Status: Completed
• CT.gov ID: NCT04318431
• Collaborator: Association Clinique Thérapeutique Infantile du val de Marne (Other)
• Enrollment: 605
• Locations: 22
• Arm: 1
• Actual Duration (Months): 1.6
• Patients Per Site: 27.5
• Patients Per Site Per Month: 17.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Diagnostic Test: Data collection and rhinopharyngeal swab	N/A

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

• Study Type: Interventional
• Actual Enrollment: 605 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care.
• Actual Study Start Date: Apr 14, 2020
• Actual Primary Completion Date: May 12, 2020
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm

Intervention/Treatment

Other: Data collection and rhinopharyngeal swab 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.

Diagnostic Test: Data collection and rhinopharyngeal swab; Testing for SARS -Cov2 and other respiratory pathogens by PCR via nasopharyngeal swabbing and IgM/IgG rapid serology; Other Names: IgM/IgG rapid serology

Outcome Measures

Primary Outcome Measures

1. Proportion of asymptomatic children or children with mild respiratory symptoms [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.

Secondary Outcome Measures

1. Confirmed Cov2-SARS cases by age [14 days]

   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).

2. Confirmed Cov2-SARS cases by symptoms [14 days]

   The proportion of confirmed Cov2-SARS cases based on the symptoms presented by the patients

3. Viral load [14 days]

   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

4. Other respiratory viruses [14 days]

   The proportion of co-infection with other respiratory viruses among children with SARS -Cov2 RT-PCR positive

5. Sars-Cov2 IgM [14 days]

   Proportion of patients with Sars-Cov2 IgM +

6. Sars-Cov2 IgG [14 days]

   Proportion of patients with Sars-Cov2 IgG +

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

• Acceptance to participate in the protocol by one of the holders of parental authority

• Affiliated to a social security

Exclusion Criteria:

• Refusal to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cabinet du Dr Belaroussi	Boulogne		France	92100
2	Cabinet du Dr Derkx	Champigny-sur-Marne		France	94500
3	Cabinet du Dr Coicadan	Chennevières-sur-Marne		France	94430
4	14 Av rené Samuel	Clamart		France	92140
5	Cabinet du Dr Corrard	Combs-la-Ville		France	77380
6	10 rue Delambre	Lagny-sur-Marne		France	77400
7	157 Avenue du Général Leclerc	Maisons-Alfort		France	94700
8	21 Grande Rue Charles de Gaulle	Nogent-sur-Marne		France	94130
9	Cabinet du Dr Deberdt	Nogent-sur-Marne		France	94130
10	Cabinet du Dr Wollner	Nogent-sur-Marne		France	94130
11	4 allée des Norottes	Noisy-le-Grand		France	93160
12	Cabinet du Dr D'acremont	Paris		France	75009
13	146 Avenue Ledru Rollin	Paris		France	75011
14	132 Boulevard du Montparnasse	Paris		France	75014
15	Cabinet du Dr Romain	Paris		France	75015
16	Cabinet du Dr Turberg-Romain	Paris		France	75015
17	15 Quai Louis Blériot	Paris		France	75016
18	Cabinet du Dr Michot	Paris		France	75016
19	24 rue Volta	Puteaux		France	92800
20	Cabinet du Dr Cohen	Saint-Maur-des-Fossés		France	94100
21	Cabinet de Pédiatrie des Docteurs Ravilly et Bessa	Villejuif		France	94800
22	13 Villa Beauséjour	Vincennes		France	94300

Sponsors and Collaborators

• Centre Hospitalier Intercommunal Creteil
• Association Clinique Thérapeutique Infantile du val de Marne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Intercommunal Creteil
• ClinicalTrials.gov Identifier: NCT04318431
• Other Study ID Numbers: COVILLE; 2020-A00724-35
• First Posted: Mar 24, 2020
• Last Update Posted: Jul 9, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Intercommunal Creteil: Sars-Cov2 rhino-pharyngeal carriage; primary care; children

Study Results

No Results Posted as of Jul 9, 2020