COVID19COVILLE2NCT04416893
Part 2 on the Study Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children (COVILLE2) (WHO)
An observational study of COVID19, run by Centre Hospitalier Intercommunal Creteil.
Trial summary
France and in particular the paris area was one of the countries most affected by the pandemic Covid19. School closures and a generalized lockdown of the population were instituted in France from 17 March 2020 to 10 May 2020. Schools and nurseries have reopened partially since 11 May 2020. Read more about this study
- Who is it for?
- Ages Up to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID19
- What is being tested?
- RT-PCR SARS-Cov2 and Sars-Cov2 serology
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Apr 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children under 15 years of age in a community (kindergarten, school, college, holiday centre, etc.).
Who may be able to join
- Birth to 15 years old
- taking over the community (kindergarten, school, college, holiday centre, etc.) for at least 1 week
Who cannot join
- refusal to participate
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-Part 2 After the Lifting of the Lockdown
France and in particular the paris area was one of the countries most affected by the pandemic Covid19.
School closures and a generalized lockdown of the population were instituted in France from 17 March 2020 to 10 May 2020. Schools and nurseries have reopened partially since 11 May 2020. From 2 June, this reopening is more widespread. By combining the search for SARS-Cov2 viruses by PCR and micro-method serology we will be able to evaluate both the infection at a given time and also older contact with SARS-CoV2.
The temporal knowledge of the prevalence of SARS-Cov2 carriage and the serological status (IgM and IgG) after return to the community are crucial information to evaluate the speed of spread of the virus in children. This is the objective of COVILLE2, phase 2 of the COVILLE study.
- Conditions
- COVID19
- Being tested
- RT-PCR SARS-Cov2, Sars-Cov2 serology
- Keywords
- RT-PCR SARS-CoV-2, Serology SARS-CoV-2, 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.
RT-PCR SARS-Cov2Diagnostic test
nasopharyngeal swab will be taken for detection of SARS-CoV-2 by RT-PCR
Sars-Cov2 serologyDiagnostic test
A microsample of blood will be taken for serology
| Study group | Role | What they receive |
|---|---|---|
| Children under 15 years of age in a community | Children under 15 years of age in a community : kindergarten, school, college, holiday center, etc. Receives: Diagnostic Test: RT-PCR SARS-Cov2; Diagnostic Test: Sars-Cov2 serology |
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 Paris area
Measured: At inclusion
Secondary outcomes (4)
Cov2-SARS cases by age
Measured: At inclusion
Cov2-SARS cases by symptoms
Measured: At inclusion
Viral load
The viral load of children with SARS-Cov2 positive Reverse Transcriptase Polymerase Chain Reaction depending on the symptoms and the age of the patients
Measured: At inclusion
Presence of anti-SARS-CoV-2 antibodies (IgM and IgG) by the rapid serological test
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study startNov 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionApr 2021 (estimated)
Why it stopped: With the rapid evolution of COVID-19, the objective was no longer relevant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 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, Groupe de Pathologies Infectieuses Pédiatriques (GPIP), Francophone Pediatric Resuscitation and Emergency Group (GFRUP)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416893
- Sponsor's protocol ID
- COVILLE2
- Acronym
- COVILLE2
- Status last verified
- May 2021
- First submitted
- 2 Jun 2020
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. 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-Part 2 After the Lifting of the Lockdown
- ClinicalTrials.gov ID
- NCT04416893
- Acronym / sponsor ID
- COVILLE2 / COVILLE2
- Conditions
- COVID19
- Keywords
- RT-PCR SARS-CoV-2, Serology SARS-CoV-2, Children
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: With the rapid evolution of COVID-19, the objective was no longer relevant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Association Clinique Thérapeutique Infantile du val de Marne, Groupe de Pathologies Infectieuses Pédiatriques (GPIP), Francophone Pediatric Resuscitation and Emergency Group (GFRUP)
- Study start
- Nov 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 4 Jun 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.
France and in particular the paris area was one of the countries most affected by the pandemic Covid19.
School closures and a generalized lockdown of the population were instituted in France from 17 March 2020 to 10 May 2020. Schools and nurseries have reopened partially since 11 May 2020. From 2 June, this reopening is more widespread. By combining the search for SARS-Cov2 viruses by PCR and micro-method serology we will be able to evaluate both the infection at a given time and also older contact with SARS-CoV2.
The temporal knowledge of the prevalence of SARS-Cov2 carriage and the serological status (IgM and IgG) after return to the community are crucial information to evaluate the speed of spread of the virus in children. This is the objective of COVILLE2, phase 2 of the COVILLE study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children under 15 years of age in a community | – | Diagnostic Test: RT-PCR SARS-Cov2, Diagnostic Test: Sars-Cov2 serologyChildren under 15 years of age in a community : kindergarten, school, college, holiday center, etc. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children under 15 years of age in a community (kindergarten, school, college, holiday centre, etc.).
Key inclusion criteria (2 listed)
- Birth to 15 years old
- taking over the community (kindergarten, school, college, holiday centre, etc.) for at least 1 week
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| RT-PCR SARS-Cov2nasopharyngeal swab will be taken for detection of SARS-CoV-2 by RT-PCR | Diagnostic test | Children under 15 years of age in a community |
| Sars-Cov2 serologyA microsample of blood will be taken for serology | Diagnostic test | Children under 15 years of age in a community |
Primary outcome
Proportion of asymptomatic children or children with mild respiratory symptoms
Time frame: At inclusion
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 Paris area
4 secondary outcomes
Cov2-SARS cases by age
Time frame: At inclusion
Cov2-SARS cases by symptoms
Time frame: At inclusion
Viral load
Time frame: At inclusion
Presence of anti-SARS-CoV-2 antibodies (IgM and IgG) by the rapid serological test
Time frame: At inclusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID19, run by Centre Hospitalier Intercommunal Creteil.
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: withdrawn, as of the sponsor's last update on 27 May 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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: At inclusion). 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 May 2021.