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COVID-19 InfectionPED-COVIDNCT04355533

Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19

A study testing serology test, nasopharyngeal swab and rectal swab in people with COVID-19 Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to provide data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study. Read more about this study

Who is it for?
Ages 7 days and older
Conditions the study is for
COVID-19 Infection
What is being tested?
serology test, nasopharyngeal swab and rectal swab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,056 participants
Where
1 siteFrance
Study dates
29 Jul 2020to 24 May 2022
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 7 days and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • For hospitalized children or consulting at hospital
  • any child over 7 days old and under 17 years old in consultation or hospitalized for at most 4 days at AP-HP or CH Cayenne; Or any child over 7 days old and under 17 years old with a positive PCR at home, with an attending physician in a participating centre
  • Parent's agreement for blood, saliva and stool samples
  • Optional parent's agreement for nasopharynx swab
  • Optional parent's agreement for follow-up if PCR+
  • With an Health insurance
Show all 25Show fewer
  • For children with potential COVID disease during the first wave
  • Any child over 7 days old and under 17 years, seropositive during the first wave
  • Or any child over 7 days old and under 17 years, with a previous inflammatory clinical disease potentially linked to SARS-cov2
  • With an Health insurance
  • Parent of the enrolled child
  • One parent of the enrolled child on ped-covid
  • Agreement for blood and saliva samples
  • Optional agreement for nasopharynx swab
  • Optional parent's agreement for follow-up if PCR+
  • With an Health insurance
  • For children SARS-coV2 positive
  • any child less then 18 years old
  • infected by SARS-coV2
  • Parent's agreement for blood, saliva samples
  • Optional parent's agreement for nasopharynx swab
  • With health insurance
  • For people living under the same roof of a child included in the study
  • any child or adult living under the same roof of a child SARS-coV2 positive and included in the study
  • With health insurance

Who cannot join

  • For hospitalized children or consulting at hospital
  • child younger than 7 days
  • Refusal of parent
  • Refusal of child
  • No health insurance

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital necker Enfants-Malades

    Paris, 75015

Other trials in France

About this study

Official title: Seroprevalence and Antibody Profiling Against SARS-CoV2 in Children and Their Parents

The purpose of this study is to provide data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.

Read the detailed description

The fraction of undiagnosed but likely to transmit the virus is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV2. To adapt the epidemy control, it is essential to study the immunoprotection of the general population. A crucial question is the study of pauci or asymptomatic subjects, and in particular children who make mild forms, because they could act as a real reservoir for the spread of the virus. The serological study is essential in this context.

The serologic test Abbott will be used to study immunoprevalence. Institut Pasteur has validated test using neutralizing Ab. CEA will used a antibodies and antigen test.

Being tested
serology test, nasopharyngeal swab, rectal swab, saliva sample
Keywords
Child, COVID-19 infection, immune response, healthy carrier
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • serology testBiological

    volume according to child weight

  • nasopharyngeal swabBiological

    nasopharyngeal swab for PCR

  • rectal swabBiological

    rectal swab for PCR

  • saliva sampleBiological

    for biocollection

Study groups in NCT04355533
Study groupRoleWhat they receive
Hospitalized children or consulting at hospitalExperimentalNot described
Receives: Biological: serology test; Biological: nasopharyngeal swab; Biological: rectal swab; Biological: saliva sample
Parents of one included childExperimentalNot described
Receives: Biological: serology test; Biological: nasopharyngeal swab; Biological: saliva sample
Children with potential COVID disease during the first waveExperimentalNot described
Receives: Biological: serology test; Biological: nasopharyngeal swab; Biological: rectal swab; Biological: saliva sample
Children SARS-coV2 positiveExperimentalNot described
Receives: Biological: serology test; Biological: nasopharyngeal swab; Biological: rectal swab; Biological: saliva sample
Person living under the same roof as children included in the studyExperimentalNot described
Receives: Biological: serology test; Biological: nasopharyngeal swab; Biological: rectal swab; Biological: saliva sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Seroconversion against SARS-CoV2 in children

    serology

    Measured: at inclusion

Secondary outcomes (39)

  1. Measure of Ab antiN and Ab anti-S1/2

    Serology in children

    Measured: at inclusion

  2. Neutralization activity

    Serology in children

    Measured: at inclusion

  3. Positive qPCR in children

    in children, qualitative and quantitative measure , in nasopharynx, saliva and stool

    Measured: at inclusion

  4. correlation between different Ab and qPCR and neutralization activity

    in children, qualitative and quantitative measure , in nasopharynx, saliva and stool, Ab anti-N, Ab anti-S1/2, neutralization serum

    Measured: at inclusion

  5. Protective immunity

    Serology, measure of Ab in PCR positive children

    Measured: Day 3

  6. Protective immunity

    Serology, measure of Ab in PCR positive children

    Measured: Day 7

  7. Protective immunity

    Serology, measure of Ab in PCR positive children

    Measured: Day 15

  8. Protective immunity

    Serology, measure of Ab in PCR positive children

    Measured: Day 45

  9. Protective immunity

    Serology, measure of Ab in PCR positive children

    Measured: At 6 months

  10. Protective immunity

    Serology, measure of Ab in PCR positive children

    Measured: At 12 months

  11. Duration of viral carriage in stool, saliva and or nasopharynx

    Sars-Cov2 PCR in PCR positive children

    Measured: until 45 days if persistence of positive qPCR

  12. Correlation between antibody profile and viral clearance

    Serology in PCR positive children

    Measured: until 45 days post onset

  13. Ab profile and memory of immunity

    Immune cells in positive PCR children

    Measured: At Day 3

  14. Ab profile and memory of immunity

    Immune cells in positive PCR children

    Measured: At Day 7

  15. Ab profile and memory of immunity

    Immune cells in positive PCR children

    Measured: At Day 15

  16. Ab profile and memory of immunity

    Immune cells in positive PCR children

    Measured: At Day 45

  17. Ab profile and memory of immunity

    Immune cells in positive PCR children

    Measured: At 6 months

  18. Ab profile and memory of immunity

    Immune cells in positive PCR children

    Measured: At 12 months

  19. saliva biofluid characteristics of COVID-19 infected

    viral content (qPCR and immunodetection); presence of IgG, M, and A

    Measured: Until 1 year follow-up

  20. Presence of the virus

    In PCR positive children: nasopharynx, saliva, stool

    Measured: Until 1 year follow-up

  21. Reinfection

    In PCR positive children: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus

    Measured: Until 1 year follow-up

  22. Transmission of the virus to the family

    symptomatic, virological and serological follow-up

    Measured: until 45 days follow-up

  23. Immune response

    In children COVID+ during the first wave :immune response few months after the infection

    Measured: At inclusion

  24. Mucosal immunity

    In PCR positive children: Ab anti-SARS-cov2 in nasopharynx samples

    Measured: Until 1 year follow-up

  25. seroconversion against SARS-CoV2 in parents

    Ancillary study: Serology in parents

    Measured: at inclusion

  26. Measure of Ab antiN and Ab anti-S1 and neutralization activity

    Ancillary study: Serology in parents

    Measured: at inclusion

  27. Positive qPCR in parents

    Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva

    Measured: at inclusion

  28. Correlation between different Ab and qPCR

    Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva, Ab anti-N, Ab anti-S1, neutralization serum

    Measured: at inclusion

  29. Correlation between antibody profile and viral clearance

    Ancillary study: Serology in PCR positive parents

    Measured: until 45 days post onset

  30. Ab profile and memory of immunity

    Ancillary study: Immune cells in positive PCR parents

    Measured: at Day 3

  31. Ab profile and memory of immunity

    Ancillary study: Immune cells in positive PCR parents

    Measured: at Day 7

  32. Ab profile and memory of immunity

    Ancillary study: Immune cells in positive PCR parents

    Measured: at Day 15

  33. Ab profile and memory of immunity

    Ancillary study: Immune cells in positive PCR parents

    Measured: at Day 45

  34. Ab profile and memory of immunity

    Ancillary study: Immune cells in positive PCR parents

    Measured: at 6 months

  35. Ab profile and memory of immunity

    Ancillary study: Immune cells in positive PCR parents

    Measured: at 12 months

  36. Saliva biofluid characteristics of COVID-19 infected

    in positive PCR parents: viral content (qPCR and immunodetection); presence of IgG, M, and A

    Measured: Until 1 year follow-up

  37. Presence of the virus

    in positive PCR parents: nasopharynx, saliva

    Measured: Until 45 days follow-up

  38. Mucosal immunity

    in positive PCR parents: Ab anti-SARS-cov2 in nasopharynx samples

    Measured: Until 1 year follow-up

  39. Reinfection

    in positive PCR parents: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus

    Measured: Until 1 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study start29 Jul 2020
  3. Primary completion20 May 2022
  4. Study completion24 May 2022

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,056 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04355533
Sponsor's protocol ID
APHP200467
Other IDs
2020-A00999-30
Acronym
PED-COVID
Status last verified
Dec 2025
First submitted
17 Apr 2020
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Delaunay-Moisan A, Guilleminot T, Semeraro M, Briand N, Bader-Meunier B, Berthaud R, Morelle G, Quartier P, Galeotti C, Basmaci R, Benoist G, Gajdos V, Lorrot M, Rifai M, Crespin M, M'Sakni Z, Padavia F, Savetier-Leroy C, Lorenzi M, Maurin C, Behillil S, de Pontual L, Elenga N, Bouazza N, Moltrecht B, van der Werf S, Leruez-Ville M, Sermet-Gaudelus I. Saliva for molecular detection of SARS-CoV-2 in pre-school and school-age children. Environ Microbiol. 2022 Oct;24(10):4725-4737. doi: 10.1111/1462-2920.16151. Epub 2022 Aug 12.

    PubMed 36065993

Questions about this trial

What is this clinical trial studying?

A study testing serology test, nasopharyngeal swab and rectal swab in people with COVID-19 Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 25 inclusion and 5 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 6 Jan 2026. 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 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?

Seroconversion against SARS-CoV2 in children (time frame: at inclusion). 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 NCT04355533, 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 6 Jan 2026.

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