CoronavirusINCOVPEDNCT04336761
Prevalence of Covid-19 in Children Admitted to Paediatric Emergency Departments During the Pandemic Period in France
An observational study of Coronavirus and COVID, run by University Hospital, Lille at 6 sites in France.
Trial summary
Arriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Coronavirus, COVID, Infection Viral
- What is being tested?
- nasopharyngeal swab
- How many people
- 901 participants
- Where
- 6 sitesFrance
- Study dates
- 15 Apr 2020to 1 Jan 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children admitted to hospital pediatric emergencies in France during the pandemic period.
Who may be able to join
- 1st Line Consultation in Pediatric Emergencies
- All reasons for consultation during working hours
- Informed and written consent of a parent holder (only 1 authorized companion) and a child of understanding age
Who cannot join
- Refusal of participation by parents/child of decision age
- No membership of a social security scheme (beneficiary or entitled)
- No understanding of French
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CH Louis MOURIER
Colombes
Hôpital Jeanne de Flandres, CHU
Lille, 59037
Hôpital Mère Enfant CHU
Nantes
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice
Hôpital des enfants - CHU
Toulouse
CHU de Tours
Tours
About this study
Arriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. It is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. For this reason, measures have been taken to close schools and contain populations in a large number of countries, including France. However, there are no data on the prevalence of COVID-19 in children.
- Conditions
- Coronavirus, COVID, Infection Viral
- Being tested
- nasopharyngeal swab
- Keywords
- pediatric emergencies, pandemia
- Medical subject headings
- Coronavirus Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal swabDiagnostic test
Data collection and nasopharyngeal swab
| Study group | Role | What they receive |
|---|---|---|
| Child suspected of infection with COVID-19. | Child included with positive included Receives: Diagnostic Test: nasopharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of positivity of COVID-19 virus measured by rt-PCR
Measured: At 28 days
Secondary outcomes (5)
Prevalence of positivity of COVID-19 virus measured by rt-PCR in the following subpopulations of emergency patients
children admitted to pediatric emergencies for respiratory signs
- Children hospitalized as a result of travelling to pediatric emergency departments for respiratory signs
- Respiratory asymptomatic children admitted to pediatric emergencies
Measured: at the end an average 28 days
Respiratory signs of children tested within 28 day
Measured: through study completion, an average 28 days
Percentage of children hospitalized tested within 28 day
Measured: through study completion, an average 28 days
Contact frequency
the degree of relationship with these contacts and the time spent in contact with them within 24 hours before emergency
Measured: At inclusion
Prevalence of positivity of other respiratory viruses measured by rt-PCR
Measured: at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start15 Apr 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Dubos, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336761
- Sponsor's protocol ID
- 2020_21
- Other IDs
- 2020-A00811-38
- Acronym
- INCOVPED
- Status last verified
- Mar 2021
- First submitted
- 3 Apr 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Covid-19 in Children Admitted to Paediatric Emergency Departments During the Pandemic Period in France
- ClinicalTrials.gov ID
- NCT04336761
- Acronym / sponsor ID
- INCOVPED / 2020_21
- Conditions
- Coronavirus, COVID, Infection Viral
- Keywords
- pediatric emergencies, pandemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 7 Apr 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.
Arriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. It is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. For this reason, measures have been taken to close schools and contain populations in a large number of countries, including France. However, there are no data on the prevalence of COVID-19 in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Child suspected of infection with COVID-19. | – | Diagnostic Test: nasopharyngeal swabChild included with positive included |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children admitted to hospital pediatric emergencies in France during the pandemic period.
Key inclusion criteria (3 listed)
- 1st Line Consultation in Pediatric Emergencies
- All reasons for consultation during working hours
- Informed and written consent of a parent holder (only 1 authorized companion) and a child of understanding age
Key exclusion criteria (3 listed)
- Refusal of participation by parents/child of decision age
- No membership of a social security scheme (beneficiary or entitled)
- No understanding of French
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 |
|---|---|---|
| nasopharyngeal swabData collection and nasopharyngeal swab | Diagnostic test | Child suspected of infection with COVID-19. |
Primary outcome
Prevalence of positivity of COVID-19 virus measured by rt-PCR
Time frame: At 28 days
5 secondary outcomes
Prevalence of positivity of COVID-19 virus measured by rt-PCR in the following subpopulations of emergency patients
Time frame: at the end an average 28 days
Respiratory signs of children tested within 28 day
Time frame: through study completion, an average 28 days
Percentage of children hospitalized tested within 28 day
Time frame: through study completion, an average 28 days
Contact frequency
Time frame: At inclusion
Prevalence of positivity of other respiratory viruses measured by rt-PCR
Time frame: at 28 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 11 Mar 2021.
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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.
François Dubos, MD,PhD principal investigator
University Hospital, Lille
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus and COVID, run by University Hospital, Lille at 6 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 3 inclusion and 3 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Prevalence of positivity of COVID-19 virus measured by rt-PCR (time frame: At 28 days). 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 11 Mar 2021.