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Completed

NCT Number: NCT04355533

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

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.

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Key information

Age range

7 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital necker Enfants-Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

For hospitalized children or consulting at hospital

  • child younger than 7 days
  • Refusal of parent
  • Refusal of child
  • No health insurance

Treatment and study plan

serology test

Biological

volume according to child weight

Nasopharyngeal swab

Biological

nasopharyngeal swab for PCR

rectal swab

Biological

rectal swab for PCR

Saliva sample

Biological

for biocollection

Primary outcomes

  1. Seroconversion against SARS-CoV2 in children

    Time frame: at inclusion

    serology

Secondary outcomes

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

    Time frame: at inclusion

    Serology in children

  2. Neutralization activity

    Time frame: at inclusion

    Serology in children

  3. Positive qPCR in children

    Time frame: at inclusion

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

  4. correlation between different Ab and qPCR and neutralization activity

    Time frame: at inclusion

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

  5. Protective immunity

    Time frame: Day 3

    Serology, measure of Ab in PCR positive children

  6. Protective immunity

    Time frame: Day 7

    Serology, measure of Ab in PCR positive children

  7. Protective immunity

    Time frame: Day 15

    Serology, measure of Ab in PCR positive children

  8. Protective immunity

    Time frame: Day 45

    Serology, measure of Ab in PCR positive children

  9. Protective immunity

    Time frame: At 6 months

    Serology, measure of Ab in PCR positive children

  10. Protective immunity

    Time frame: At 12 months

    Serology, measure of Ab in PCR positive children

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

    Time frame: until 45 days if persistence of positive qPCR

    Sars-Cov2 PCR in PCR positive children

  12. Correlation between antibody profile and viral clearance

    Time frame: until 45 days post onset

    Serology in PCR positive children

  13. Ab profile and memory of immunity

    Time frame: At Day 3

    Immune cells in positive PCR children

  14. Ab profile and memory of immunity

    Time frame: At Day 7

    Immune cells in positive PCR children

  15. Ab profile and memory of immunity

    Time frame: At Day 15

    Immune cells in positive PCR children

  16. Ab profile and memory of immunity

    Time frame: At Day 45

    Immune cells in positive PCR children

  17. Ab profile and memory of immunity

    Time frame: At 6 months

    Immune cells in positive PCR children

  18. Ab profile and memory of immunity

    Time frame: At 12 months

    Immune cells in positive PCR children

  19. saliva biofluid characteristics of COVID-19 infected

    Time frame: Until 1 year follow-up

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

  20. Presence of the virus

    Time frame: Until 1 year follow-up

    In PCR positive children: nasopharynx, saliva, stool

  21. Reinfection

    Time frame: Until 1 year follow-up

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

  22. Transmission of the virus to the family

    Time frame: until 45 days follow-up

    symptomatic, virological and serological follow-up

  23. Immune response

    Time frame: At inclusion

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

  24. Mucosal immunity

    Time frame: Until 1 year follow-up

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

  25. seroconversion against SARS-CoV2 in parents

    Time frame: at inclusion

    Ancillary study: Serology in parents

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

    Time frame: at inclusion

    Ancillary study: Serology in parents

  27. Positive qPCR in parents

    Time frame: at inclusion

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

  28. Correlation between different Ab and qPCR

    Time frame: at inclusion

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

  29. Correlation between antibody profile and viral clearance

    Time frame: until 45 days post onset

    Ancillary study: Serology in PCR positive parents

  30. Ab profile and memory of immunity

    Time frame: at Day 3

    Ancillary study: Immune cells in positive PCR parents

  31. Ab profile and memory of immunity

    Time frame: at Day 7

    Ancillary study: Immune cells in positive PCR parents

  32. Ab profile and memory of immunity

    Time frame: at Day 15

    Ancillary study: Immune cells in positive PCR parents

  33. Ab profile and memory of immunity

    Time frame: at Day 45

    Ancillary study: Immune cells in positive PCR parents

  34. Ab profile and memory of immunity

    Time frame: at 6 months

    Ancillary study: Immune cells in positive PCR parents

  35. Ab profile and memory of immunity

    Time frame: at 12 months

    Ancillary study: Immune cells in positive PCR parents

  36. Saliva biofluid characteristics of COVID-19 infected

    Time frame: Until 1 year follow-up

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

  37. Presence of the virus

    Time frame: Until 45 days follow-up

    in positive PCR parents: nasopharynx, saliva

  38. Mucosal immunity

    Time frame: Until 1 year follow-up

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

  39. Reinfection

    Time frame: Until 1 year follow-up

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Commissariat A L'energie Atomique
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Institut Pasteur
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: PED-COVID

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2020
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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