CoronavirusCOVIDOCRECHENCT04413968
COVID-19 Infection and Transmission in Exposed, Confined and Community-based Infants
A study testing Rapid detection test, Nasopharyngeal swab and Stool collection in people with Coronavirus and Coronavirus Infection, run by Assistance Publique - Hôpitaux de Paris at 11 sites in France.
Trial summary
According to epidemiological models, the seroprevalence of SARS-CoV-2 infection in Île-de-France as of 11 May was between 10 and 15%. Preliminary data on the number of professionals evicted from nurseries on suspicion of COVID-19 (on clinical grounds) seem to be of the same order of magnitude, but need to be confirmed… Read more about this study
- Who is it for?
- Ages 1 month and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus, Coronavirus Infection, Covid19
- What is being tested?
- Rapid detection test, Nasopharyngeal swab and Stool collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 11 sitesFrance
- Study dates
- 2 Jun 2020to 2 Oct 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 1 month and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Population 1 :
- Children of priority staff welcomed in the crèche during the period of confinement, i.e. from 15 March to 9 May, regardless of the length of time they are in the crèche during this period and their "symptomatic or not" status during this period or on the day of inclusion.
- Consent of the holders of parental authority
- Affiliated to a social security system or entitled person
- Population 2 :
- Nursery staff, regardless of their status/occupation and having had contact with the children during the period of confinement regardless of how long they have been in the nursery during this period and their "symptomatic or not" status during this period or on the day of inclusion.
Show all 11Show fewer
- Consent to participate
- Affiliated to a social security system or entitled person
- Population 3 :
- Hospital staff not exposed to patients and/or children, with or without children in day care, working in the bacteriology, biochemistry and biological haematology laboratories or in an administrative department of the participating hospitals.
- Affiliated to a social security system or entitled person
Who cannot join
- Population 1 :
- Refusal to sign consent by parents
- Clinical condition requiring urgent medical assessment (attending physician or transfer to paediatric emergency)
- Population 2 and 3 :
- Refusal to sign consent for staff
- Clinical condition requiring urgent medical evaluation
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Hopital Avicenne
Bobigny, 93000
Hôpital Jean Verdier - Service de Pédiatrie
Bondy, 93143
Hôpital Jean Verdier
Bondy, 93143
Hôpital Antoine béclère
Clamart, 92140
Hôpital Louis Mourier
Colombes, 92700
CH intercommunal de Créteil
Créteil, 94000
Hôpital Annecy Genevois
Épagny
Hôpital Andé Mignot
Le Chesnay, 78150
Hôpital Trousseau
Paris, 75012
Hôpital Robert debré
Paris, 75019
CHU de Rouen
Rouen, 76000
About this study
Official title: Contamination and Transmission of the SARS-CoV-2 Virus in Exposed, Confined and Community-based Infants: A Cross-sectional, Multicentre, Interventional Seroprevalence Study
According to epidemiological models, the seroprevalence of SARS-CoV-2 infection in Île-de-France as of 11 May was between 10 and 15%. Preliminary data on the number of professionals evicted from nurseries on suspicion of COVID-19 (on clinical grounds) seem to be of the same order of magnitude, but need to be confirmed by a biological technique. Children would be susceptible to infection but often asymptomatic.
Read the detailed description
SARS-CoV-2, an emerging respiratory virus of the coronavirus family, is responsible for a global pandemic of which Europe has become the epicentre. Infection with the virus causes a disease called COVID-19, whose expression most often includes cough, fever, fatigue, myalgia, anosmia, ageusia and gastrointestinal symptoms, and which can be complicated by severe pneumonia requiring resuscitation and which can lead to death. Morbidity and mortality are clearly age-related and while illness and hospitalisations occur in all age groups, deaths occur mostly in the older age groups.
In the absence of curative treatment and vaccination, the only real measures capable of slowing the progression of the disease are large-scale social distancing measures. In analogy to community-based viral epidemics such as seasonal influenza, children were initially considered a potential vector of transmission, which led to the preventive measure of school closures. In France, this closure came into force on 14 March 2020.
Children are considered to be little affected by the coronavirus-19 epidemic because even if screening strategies differ, they represent less than 3% of the cases confirmed in the various studies.
In a period of confinement and reduction in the number of children cared for, in a crèche for children of healthcare workers, in a context of proximity and high risk of cross transmission, the frequency of symptomatic and asymptomatic forms of SARS-Cov-2 in children and staff would be comparable to the general population.
We hypothesize a susceptibility to infection in children but low transmission, which should lead to a cumulative prevalence of infection among daycare staff comparable to that obtained in a sample of professionals who do not come into contact with children in their work (here hospital laboratory and administrative staff).
- Conditions
- Coronavirus, Coronavirus Infection, Covid19, Sars-CoV2
- Being tested
- Rapid detection test, Nasopharyngeal swab, Stool collection
- Keywords
- Nursery, Child
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid detection testDiagnostic test
Rapid serological test by taking 3 drops of blood from the fingertip via the TDR device (rapid detection test) for children, supervising nursery staff and hospital laboratory and administrative staff
Nasopharyngeal swabDiagnostic test
Posterior nasopharyngeal swabbing in children
Stool collectionDiagnostic test
Stool collection in children
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | nasopharyngeal and blood sample Receives: Diagnostic Test: Rapid detection test; Diagnostic Test: Nasopharyngeal swab; Diagnostic Test: Stool collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the serological status/rate of past infections in the children of priority staff in the nursery during the containment period
Proportion of children with a positive rapid serological test (presence of anti-SARS-CoV2 antibodies (IgM or IgG)).
Measured: Day of intervention (1 day)
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 start2 Jun 2020
- Primary completion2 Jul 2020
- Study completion2 Oct 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 CoronavirusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cross-sectional, multi-center, non-randomized study
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric LACHASSINNE, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413968
- Sponsor's protocol ID
- APHP200587
- Other IDs
- 2020-A01540-39
- Acronym
- COVIDOCRECHE
- Status last verified
- May 2020
- First submitted
- 2 Jun 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lachassinne E, de Pontual L, Caseris M, Lorrot M, Guilluy C, Naud A, Dommergues MA, Pinquier D, Wannepain E, Hausherr E, Jung C, Gajdos V, Cohen R, Zahar JR, Brichler S, Basmaci R, Boelle PY, Bloch-Queyrat C, Aupiais C; COVIDOCRECHE collaborators. SARS-CoV-2 transmission among children and staff in daycare centres during a nationwide lockdown in France: a cross-sectional, multicentre, seroprevalence study. Lancet Child Adolesc Health. 2021 Apr;5(4):256-264. doi: 10.1016/S2352-4642(21)00024-9. Epub 2021 Feb 8.
PubMed 33571450
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contamination and Transmission of the SARS-CoV-2 Virus in Exposed, Confined and Community-based Infants: A Cross-sectional, Multicentre, Interventional Seroprevalence Study
- ClinicalTrials.gov ID
- NCT04413968
- Acronym / sponsor ID
- COVIDOCRECHE / APHP200587
- Conditions
- Coronavirus, Coronavirus Infection, Covid19, Sars-CoV2
- Keywords
- Nursery, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- 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.
According to epidemiological models, the seroprevalence of SARS-CoV-2 infection in Île-de-France as of 11 May was between 10 and 15%. Preliminary data on the number of professionals evicted from nurseries on suspicion of COVID-19 (on clinical grounds) seem to be of the same order of magnitude, but need to be confirmed by a biological technique. Children would be susceptible to infection but often asymptomatic.
Detailed description
SARS-CoV-2, an emerging respiratory virus of the coronavirus family, is responsible for a global pandemic of which Europe has become the epicentre. Infection with the virus causes a disease called COVID-19, whose expression most often includes cough, fever, fatigue, myalgia, anosmia, ageusia and gastrointestinal symptoms, and which can be complicated by severe pneumonia requiring resuscitation and which can lead to death. Morbidity and mortality are clearly age-related and while illness and hospitalisations occur in all age groups, deaths occur mostly in the older age groups.
In the absence of curative treatment and vaccination, the only real measures capable of slowing the progression of the disease are large-scale social distancing measures. In analogy to community-based viral epidemics such as seasonal influenza, children were initially considered a potential vector of transmission, which led to the preventive measure of school closures. In France, this closure came into force on 14 March 2020.
Children are considered to be little affected by the coronavirus-19 epidemic because even if screening strategies differ, they represent less than 3% of the cases confirmed in the various studies.
In a period of confinement and reduction in the number of children cared for, in a crèche for children of healthcare workers, in a context of proximity and high risk of cross transmission, the frequency of symptomatic and asymptomatic forms of SARS-Cov-2 in children and staff would be comparable to the general population.
We hypothesize a susceptibility to infection in children but low transmission, which should lead to a cumulative prevalence of infection among daycare staff comparable to that obtained in a sample of professionals who do not come into contact with children in their work (here hospital laboratory and administrative staff).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross-sectional, multi-center, non-randomized study
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Diagnostic Test: Rapid detection test, Diagnostic Test: Nasopharyngeal swab, Diagnostic Test: Stool collectionnasopharyngeal and blood sample |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Children of priority staff welcomed in the crèche during the period of confinement, i.e. from 15 March to 9 May, regardless of the length of time they are in the crèche during this period and their "symptomatic or not" status during this period or on the day of inclusion.
- Consent of the holders of parental authority
- Affiliated to a social security system or entitled person
- Nursery staff, regardless of their status/occupation and having had contact with the children during the period of confinement regardless of how long they have been in the nursery during this period and their "symptomatic or not" status during this period or on the day of inclusion.
- Consent to participate
Key exclusion criteria (6 listed)
- Refusal to sign consent by parents
- Clinical condition requiring urgent medical assessment (attending physician or transfer to paediatric emergency)
- Refusal to sign consent for staff
- Clinical condition requiring urgent medical evaluation
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 |
|---|---|---|
| Rapid detection testRapid serological test by taking 3 drops of blood from the fingertip via the TDR device (rapid detection test) for children, supervising nursery staff and hospital laboratory and administrative staff | Diagnostic test | Interventional |
| Nasopharyngeal swabPosterior nasopharyngeal swabbing in children | Diagnostic test | Interventional |
| Stool collectionStool collection in children | Diagnostic test | Interventional |
Primary outcome
Assess the serological status/rate of past infections in the children of priority staff in the nursery during the containment period
Time frame: Day of intervention (1 day)
Proportion of children with a positive rapid serological test (presence of anti-SARS-CoV2 antibodies (IgM or IgG)).
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 26 Oct 2020.
- Derived from this study: PubMed 33571450Lachassinne E, de Pontual L, Caseris M, Lorrot M, Guilluy C, Naud A, Dommergues MA, Pinquier D, Wannepain E, Hausherr E, Jung C, Gajdos V, Cohen R, Zahar JR, Brichler S, Basmaci R, Boelle PY, Bloch-Queyrat C, Aupiais C; COVIDOCRECHE collaborators. SARS-CoV-2 transmission among children and staff in daycare centres during a nationwide lockdown in France: a cross-sectional, multicentre, seroprevalence study. Lancet Child Adolesc Health. 2021 Apr;5(4):256-264. doi: 10.1016/S2352-4642(21)00024-9. Epub 2021 Feb 8.
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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.
Eric LACHASSINNE, MD principal investigator
Assistance Publique - Hôpitaux de Paris
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid detection test, Nasopharyngeal swab and Stool collection in people with Coronavirus and Coronavirus Infection, run by Assistance Publique - Hôpitaux de Paris at 11 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 11 inclusion and 6 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 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Assess the serological status/rate of past infections in the children of priority staff in the nursery during the containment period (time frame: Day of intervention (1 day)). 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 NCT04413968, 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 26 Oct 2020.