Covid19NCT05137535
A Study of the Infection and Transmission of SARS-CoV-2 in Paediatric Patients
An observational study of Covid19, run by University of Padova at 1 site in Italy.
Trial summary
Covid-19 disease, originated by SARS-Cov-2 Coronavirus, officially appeared in Italy in February 2020. Children and adolescents, in most cases, have an asymptomatic or paucisymptomatic clinical picture and are very rarely hospitalized. Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Covid19
- What is being tested?
- Questionnaire
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 3 Nov 2021to 30 Jun 2022
- 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 1 day to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients enrolled by the family pediatricians participating in this study, affected by Covid-19 disease whose diagnosis was confirmed by SARS-Cov-2 molecular test
Pediatric patients affected by Covid-19 disease whose diagnosis was confirmed by SARS-Cov-2 molecular test enrolled by the family pediatricians participating in this study from February 1 2020 to December 31 2021
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AULSS 5 Polesana
Rovigo, RO
Emanuela Frascella, PhD, ela.frascella@gmail.com
Alessandra R Brazzale, PhD, alessandra.brazzale@unipd.it
About this study
Covid-19 disease, originated by SARS-Cov-2 Coronavirus, officially appeared in Italy in February 2020. Children and adolescents, in most cases, have an asymptomatic or paucisymptomatic clinical picture and are very rarely hospitalized. Precisely because of the modest symptoms presented, information on the natural history of Covid19 disease and its symptomatology is still limited.
Because almost all children with Covid19 are treated by community medicine, family pediatricians are the most suitable figures to collect the clinical history of these patients.
Read more
Information regarding the mode of infection and spread at both the intrafamily and school levels is also poor, and the role that the opening of schools may have on the spread of infection is not yet well established. However, scientific evidence supports the adverse effect of school closures on the physical and mental health of children and adolescents.
Analysis of school spread in a specific area can therefore contribute to increased knowledge about the role of schools, and such information may be useful in guiding health policy choices.
Read the detailed description
Covid-19 disease, caused by the coronavirus Sars-Cov-2, officially appeared in Italy in February 2020. As of January 2020, the first pediatric cases had already been described, initially in China and then in other countries. Clinical studies suggest that children are susceptible at any age and can transmit the SARS-CoV-2 virus; for the most part pediatric studies analyzed hospitalized patients.
Mainly children and young people present asymptomatic or paucisymptomatic symptoms, and very rarely require hospitalization: the biological reasons for this different clinical picture compared to the adult population are not clear. Just because of the modest symptomatology presented in pediatric age, the natural history of Covid-19 disease and its clinical features in pediatric age are not well known and the disease may be underdiagnosed. Equally scarce is information about Covid-19 spread both within the family and in school communities. These data depend on the availability of tests for the identification of Sars-CoV-2 infection and on how population screenings are organized.
However, knowledge about clinical aspects and diffusion of Covid-19 within the family and at school are fundamental to orient health policy choices such as the opening of schools and of social, educational and sports spaces for children and young people. It is known that transmission of SARS-CoV-2 can occur in school settings, but there are still no definitive data on the impact that this transmission may have on the spread of the infection within the population, because school closures always coincide with closures of other activities and often with general restrictions on the movement of people. Several studies suggest that transmission of SARS-CoV-2 at school is not frequent. School contributes a modest number to the total number of cases and in many cases the infection is attributable to the school staff. Also, the presence of multiple cases in the same school may depend on a greater spread of the virus in the community.
Scientific evidence confirms adverse effect of school closures on the physical and mental health of children and young people, with a very high cost considering impact on learning and reduction of skills in the long term: any reduction in school hours has negative effects on students' cognitive abilities, on the probability of dropping out of school, on college enrollment, and on employment outcomes. In addition, distance learning has exacerbated inequality, because access to computers and the internet is much more complicated for lower class families. Moreover, in some contexts, school closure has generated increases in domestic violence and situations of toxic prolonged stress for children.
The network of community medicine, formed by family pediatricians, represents a unique resource to study Covid-19 natural history in children and spread of disease in their family and at school within a specific territory.
- Conditions
- Covid19
- Being tested
- Questionnaire
- Keywords
- Covid-19, SARS-CoV-2, children, pediatric, transmission, clinical features
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Family-based questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Children diagnosed with Covid-19 | Pediatric patients enrolled by the family pediatricians participating in this study, affected by Covid-19 disease whose diagnosis was confirmed by SARS-Cov-2 molecular test Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural history
Description of the natural history of Covid19 in paediatric patients in terms of length, severity and symptoms
Measured: Feb. 1, 2020 - Dec. 31, 2021
Infection and spread
Description of the mode of infection and spread at both the intrafamily and school levels using suitable statistical models
Measured: Feb. 1, 2020 - Dec. 31, 2021
Secondary outcomes (2)
School opening
Study of the impact of school opening on the infection spread using suitable statistical models
Measured: Feb. 1, 2020 - Dec. 31, 2021
Monitoring
Development of a monitoring tool of the spread of infection at school level using GIS technology
Measured: Feb. 1, 2020 - Dec. 31, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start3 Nov 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Family based
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda ULSS 5 Polesana, Imperial College London
- Responsible party
- Principal investigator, BRAZZALE ALESSANDRA ROSALBA, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137535
- Sponsor's protocol ID
- PLS COVID 19 - Prog. 3401CESC
- Status last verified
- Nov 2021
- First submitted
- 24 Nov 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta NS, Mytton OT, Mullins EWS, Fowler TA, Falconer CL, Murphy OB, Langenberg C, Jayatunga WJP, Eddy DH, Nguyen-Van-Tam JS. SARS-CoV-2 (COVID-19): What Do We Know About Children? A Systematic Review. Clin Infect Dis. 2020 Dec 3;71(9):2469-2479. doi: 10.1093/cid/ciaa556.
PubMed 32392337Posfay-Barbe KM, Wagner N, Gauthey M, Moussaoui D, Loevy N, Diana A, L'Huillier AG. COVID-19 in Children and the Dynamics of Infection in Families. Pediatrics. 2020 Aug;146(2):e20201576. doi: 10.1542/peds.2020-1576. Epub 2020 May 26. No abstract available.
PubMed 32457213Dorigatti I, Lavezzo E, Manuto L, Ciavarella C, Pacenti M, Boldrin C, Cattai M, Saluzzo F, Franchin E, Del Vecchio C, Caldart F, Castelli G, Nicoletti M, Nieddu E, Salvadoretti E, Labella B, Fava L, Guglielmo S, Fascina M, Grazioli M, Alvisi G, Vanuzzo MC, Zupo T, Calandrin R, Lisi V, Rossi L, Castagliuolo I, Merigliano S, Unwin HJT, Plebani M, Padoan A, Brazzale AR, Toppo S, Ferguson NM, Donnelly CA, Crisanti A. SARS-CoV-2 antibody dynamics and transmission from community-wide serological testing in the Italian municipality of Vo'. Nat Commun. 2021 Jul 19;12(1):4383. doi: 10.1038/s41467-021-24622-7.
PubMed 34282139European Centre for Disease Prevention and Control. TECHNICAL REPORT COVID-19 in children and the role of school settings in transmission - update 23 December 2020.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Infection and Transmission of SARS-CoV-2 in Paediatric Patients
- ClinicalTrials.gov ID
- NCT05137535
- Acronym / sponsor ID
- PLS COVID 19 - Prog. 3401CESC
- Conditions
- Covid19
- Keywords
- Covid-19, SARS-CoV-2, children, pediatric, transmission, clinical features
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Azienda ULSS 5 Polesana, Imperial College London
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 30 Nov 2021 (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.
Covid-19 disease, originated by SARS-Cov-2 Coronavirus, officially appeared in Italy in February 2020. Children and adolescents, in most cases, have an asymptomatic or paucisymptomatic clinical picture and are very rarely hospitalized. Precisely because of the modest symptoms presented, information on the natural history of Covid19 disease and its symptomatology is still limited.
Because almost all children with Covid19 are treated by community medicine, family pediatricians are the most suitable figures to collect the clinical history of these patients.
Information regarding the mode of infection and spread at both the intrafamily and school levels is also poor, and the role that the opening of schools may have on the spread of infection is not yet well established. However, scientific evidence supports the adverse effect of school closures on the physical and mental health of children and adolescents.
Analysis of school spread in a specific area can therefore contribute to increased knowledge about the role of schools, and such information may be useful in guiding health policy choices.
Detailed description
Covid-19 disease, caused by the coronavirus Sars-Cov-2, officially appeared in Italy in February 2020. As of January 2020, the first pediatric cases had already been described, initially in China and then in other countries. Clinical studies suggest that children are susceptible at any age and can transmit the SARS-CoV-2 virus; for the most part pediatric studies analyzed hospitalized patients.
Mainly children and young people present asymptomatic or paucisymptomatic symptoms, and very rarely require hospitalization: the biological reasons for this different clinical picture compared to the adult population are not clear. Just because of the modest symptomatology presented in pediatric age, the natural history of Covid-19 disease and its clinical features in pediatric age are not well known and the disease may be underdiagnosed. Equally scarce is information about Covid-19 spread both within the family and in school communities. These data depend on the availability of tests for the identification of Sars-CoV-2 infection and on how population screenings are organized.
However, knowledge about clinical aspects and diffusion of Covid-19 within the family and at school are fundamental to orient health policy choices such as the opening of schools and of social, educational and sports spaces for children and young people. It is known that transmission of SARS-CoV-2 can occur in school settings, but there are still no definitive data on the impact that this transmission may have on the spread of the infection within the population, because school closures always coincide with closures of other activities and often with general restrictions on the movement of people. Several studies suggest that transmission of SARS-CoV-2 at school is not frequent. School contributes a modest number to the total number of cases and in many cases the infection is attributable to the school staff. Also, the presence of multiple cases in the same school may depend on a greater spread of the virus in the community.
Scientific evidence confirms adverse effect of school closures on the physical and mental health of children and young people, with a very high cost considering impact on learning and reduction of skills in the long term: any reduction in school hours has negative effects on students' cognitive abilities, on the probability of dropping out of school, on college enrollment, and on employment outcomes. In addition, distance learning has exacerbated inequality, because access to computers and the internet is much more complicated for lower class families. Moreover, in some contexts, school closure has generated increases in domestic violence and situations of toxic prolonged stress for children.
The network of community medicine, formed by family pediatricians, represents a unique resource to study Covid-19 natural history in children and spread of disease in their family and at school within a specific territory.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children diagnosed with Covid-19 | – | Other: QuestionnairePediatric patients enrolled by the family pediatricians participating in this study, affected by Covid-19 disease whose diagnosis was confirmed by SARS-Cov-2 molecular test |
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients enrolled by the family pediatricians participating in this study, affected by Covid-19 disease whose diagnosis was confirmed by SARS-Cov-2 molecular test
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 |
|---|---|---|
| QuestionnaireFamily-based questionnaire | Other | Children diagnosed with Covid-19 |
Primary outcome
Natural history
Time frame: Feb. 1, 2020 - Dec. 31, 2021
Description of the natural history of Covid19 in paediatric patients in terms of length, severity and symptoms
Infection and spread
Time frame: Feb. 1, 2020 - Dec. 31, 2021
Description of the mode of infection and spread at both the intrafamily and school levels using suitable statistical models
2 secondary outcomes
School opening
Time frame: Feb. 1, 2020 - Dec. 31, 2021
Monitoring
Time frame: Feb. 1, 2020 - Dec. 31, 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Background: PubMed 32392337Mehta NS, Mytton OT, Mullins EWS, Fowler TA, Falconer CL, Murphy OB, Langenberg C, Jayatunga WJP, Eddy DH, Nguyen-Van-Tam JS. SARS-CoV-2 (COVID-19): What Do We Know About Children? A Systematic Review. Clin Infect Dis. 2020 Dec 3;71(9):2469-2479. doi: 10.1093/cid/ciaa556.
- Background: PubMed 32457213Posfay-Barbe KM, Wagner N, Gauthey M, Moussaoui D, Loevy N, Diana A, L'Huillier AG. COVID-19 in Children and the Dynamics of Infection in Families. Pediatrics. 2020 Aug;146(2):e20201576. doi: 10.1542/peds.2020-1576. Epub 2020 May 26. No abstract available.
- Background: PubMed 34282139Dorigatti I, Lavezzo E, Manuto L, Ciavarella C, Pacenti M, Boldrin C, Cattai M, Saluzzo F, Franchin E, Del Vecchio C, Caldart F, Castelli G, Nicoletti M, Nieddu E, Salvadoretti E, Labella B, Fava L, Guglielmo S, Fascina M, Grazioli M, Alvisi G, Vanuzzo MC, Zupo T, Calandrin R, Lisi V, Rossi L, Castagliuolo I, Merigliano S, Unwin HJT, Plebani M, Padoan A, Brazzale AR, Toppo S, Ferguson NM, Donnelly CA, Crisanti A. SARS-CoV-2 antibody dynamics and transmission from community-wide serological testing in the Italian municipality of Vo'. Nat Commun. 2021 Jul 19;12(1):4383. doi: 10.1038/s41467-021-24622-7.
- BackgroundEuropean Centre for Disease Prevention and Control. TECHNICAL REPORT COVID-19 in children and the role of school settings in transmission - update 23 December 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 Alessandra R. Brazzale, PhD (+39 049 827 4136, alessandra.brazzale@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural history (time frame: Feb. 1, 2020 - Dec. 31, 2021). The study lists 2 primary outcomes in all. 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 NCT05137535, which also lists 4 linked publications.
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 30 Nov 2021.