Covid-19VIGILNCT04412317
Use of PCR-Sars-CoV-2 in Children
An observational study of Covid-19, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
Trial summary
The VIGIL study was set up at the beginning of the pandemic, in the spring of 2020, at a time when diagnostic testing for SARS-CoV-2 had to be performed according to specific clinical criteria (even if no clinical picture suggestive of COVID had been clearly identified). Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Covid-19
- How many people
- 12,000 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Jun 2020to 30 May 2024
- How long will I take part?
- 12 Months
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Child from birth to 14 years of age consulting their doctor
Who may be able to join
- Children under 15 years of age
- Prescription of a PCR-Sars-CoV-2
- VIGIL information note given to parents
Who cannot join
- Refusal to participate by the patient, family member or legal representative (depending on the situation)
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
ACTIV network
Créteil
Corinne LEVY, MD, 148850404 ext. 33, corinne.levy@activ-france.fr
- Recruiting
PARI network
Créteil
Corinne Levy, MD, corinne.levy@activ-france.fr
About this study
Official title: National Observatory of the Care of Young Sick Children in Community or Not, Indications and Cost-effectiveness of PCR-Sars-CoV-2 - VIGIL Study
The VIGIL study was set up at the beginning of the pandemic, in the spring of 2020, at a time when diagnostic testing for SARS-CoV-2 had to be performed according to specific clinical criteria (even if no clinical picture suggestive of COVID had been clearly identified). The management of sick young children (with respiratory tract infection that could be attributed to COVID) by pediatricians (infectious diseases specialists, emergency physicians, general practitioners, and outpatients) was facilitated by an algorithm whose objective was to help define the indications for SARS-CoV-2 PCR and subsequently for antigenic testing. The current technique of deep nasopharyngeal swabbing (for PCR or antigenic testing) is delicate and difficult in children, and is therefore a serious handicap for community-based screening, especially since infectious episodes are frequent in children. Since then, nasal self-tests that can be easily used in children have been commercialized and have facilitated screening.
Because of the similarity between the clinical signs of respiratory tract infections in children, it is often impossible to distinguish between different viral respiratory infections and epidemics may overlap in time. However, the identification of the pathogen is the key to improve management of these infectious diseases. The VIGIL study is therefore continuing, still facilitated by the existence of an active pediatric network existing for 20 years. ACTIV AFPA and GPIP have created networks of hospital and ambulatory pediatricians who actively participate in various observatories https://www.jpeds.com/article/S0022-3476(17)31606-2/fulltext To date, these observatories have resulted in the publication of more than 80 articles in international journals (https://www.activ-france.com/fr/publications).
- Conditions
- Covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children < 15 years old | Patients under 15 years old who consults a physician on an outpatient basis or in the emergency room and who requires a Sars-CoV-2 RT- PCR (nucleic acid using real-time reverse-transcriptase polymerase-chain-reaction) diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children screened with a positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test
Number of positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test on total number of PCR
Measured: At inclusion
Secondary outcomes (4)
Number of symptomatic children
Number of positive PCR result in the sick child in the presence of a Covid contagion in the family environment or not on total number of PCR
Measured: the day of PCR or RAD result
presence or absence of positive people in close contacts
Number of RAD-Sars-CoV-2 positive in the sick child in the presence of a Covid contagion in the family environment or not on number of negative RAD-Sars-CoV-2
Measured: the day of PCR or RAD result
Percentage of RAD RSV and Flu positive in children with respiratory tract infection
Number of RAD RSV and Flu positive in children with respiratory tract infection on total number of tests
Measured: the day of PCR or RAD result
Accuracy of antigen test compared to PCR
Sensibility and specificity of the test
Measured: the day of PCR or RAD result
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start3 Jun 2020
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies 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
- 12,000 participants (estimated)
- Target duration
- 12 Months
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), AFPA, Francophone Pediatric Resuscitation and Emergency Group (GFRUP)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412317
- Sponsor's protocol ID
- VIGIL
- Acronym
- VIGIL
- Status last verified
- Feb 2023
- First submitted
- 30 May 2020
- Last updated
- 8 Feb 2023
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Observatory of the Care of Young Sick Children in Community or Not, Indications and Cost-effectiveness of PCR-Sars-CoV-2 - VIGIL Study
- ClinicalTrials.gov ID
- NCT04412317
- Acronym / sponsor ID
- VIGIL / VIGIL
- Conditions
- Covid-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Association Clinique Thérapeutique Infantile du val de Marne, Groupe de Pathologies Infectieuses Pédiatriques (GPIP), AFPA, Francophone Pediatric Resuscitation and Emergency Group (GFRUP)
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 2 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.
The VIGIL study was set up at the beginning of the pandemic, in the spring of 2020, at a time when diagnostic testing for SARS-CoV-2 had to be performed according to specific clinical criteria (even if no clinical picture suggestive of COVID had been clearly identified). The management of sick young children (with respiratory tract infection that could be attributed to COVID) by pediatricians (infectious diseases specialists, emergency physicians, general practitioners, and outpatients) was facilitated by an algorithm whose objective was to help define the indications for SARS-CoV-2 PCR and subsequently for antigenic testing. The current technique of deep nasopharyngeal swabbing (for PCR or antigenic testing) is delicate and difficult in children, and is therefore a serious handicap for community-based screening, especially since infectious episodes are frequent in children. Since then, nasal self-tests that can be easily used in children have been commercialized and have facilitated screening.
Because of the similarity between the clinical signs of respiratory tract infections in children, it is often impossible to distinguish between different viral respiratory infections and epidemics may overlap in time. However, the identification of the pathogen is the key to improve management of these infectious diseases. The VIGIL study is therefore continuing, still facilitated by the existence of an active pediatric network existing for 20 years. ACTIV AFPA and GPIP have created networks of hospital and ambulatory pediatricians who actively participate in various observatories https://www.jpeds.com/article/S0022-3476(17)31606-2/fulltext To date, these observatories have resulted in the publication of more than 80 articles in international journals (https://www.activ-france.com/fr/publications).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children < 15 years old | – | –Patients under 15 years old who consults a physician on an outpatient basis or in the emergency room and who requires a Sars-CoV-2 RT- PCR (nucleic acid using real-time reverse-transcriptase polymerase-chain-reaction) diagnostic |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Child from birth to 14 years of age consulting their doctor
Key inclusion criteria (3 listed)
- Children under 15 years of age
- Prescription of a PCR-Sars-CoV-2
- VIGIL information note given to parents
Key exclusion criteria (1 listed)
- Refusal to participate by the patient, family member or legal representative (depending on the situation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of children screened with a positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test
Time frame: At inclusion
Number of positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test on total number of PCR
4 secondary outcomes
Number of symptomatic children
Time frame: the day of PCR or RAD result
presence or absence of positive people in close contacts
Time frame: the day of PCR or RAD result
Percentage of RAD RSV and Flu positive in children with respiratory tract infection
Time frame: the day of PCR or RAD result
Accuracy of antigen test compared to PCR
Time frame: the day of PCR or RAD result
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- From the original SARS-CoV-2 strain to the Omicron variant: Predictors of COVID-19 in ambulatory symptomatic childrenLink provided by the sponsor.
- Diagnostic accuracy of SARS-CoV-2 rapid antigen test from self-collected anterior nasal swabs in children compared to rapid antigen test and RT-PCR from nasopharyngeal swabs collected by healthcare workers: A multicentric prospective studyLink provided by the sponsor.
- Assessment of SARS-CoV-2 testing in children during a low prevalence period (VIGIL study 1)Link provided by the sponsor.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, run by Centre Hospitalier Intercommunal Creteil at 2 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 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Corinne Levy, MD (148850404 ext. 33, corinne.levy@activ-france.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of children screened with a positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test (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 8 Feb 2023.