Status:

COMPLETED

Host-pathogen Interactions During SARS-CoV-2 Infection

Lead Sponsor:

Hospices Civils de Lyon

Conditions:

Infection, Coronavirus

Severe Acute Respiratory Syndrome Coronavirus 2

Eligibility:

All Genders

1-18 years

Phase:

NA

Brief Summary

The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsib...

Eligibility Criteria

Inclusion

  • Group E1:
  • Age from birth to \<18 years old;
  • Weight\> 3 kilogram (kg);
  • Infection with SARS-CoV-2 virus confirmed by RT-PCR on upper respiratory tract sample
  • No fever or respiratory symptoms;
  • Not requiring hospitalization (or hospitalization not related to a SARS-CoV-2 infection);
  • Consent signed by at least one parent / holder of parental authority and assent of the child (if applicable);
  • Beneficiary of a social security scheme
  • Group E2:
  • Age from birth to \<18 years old;
  • Weight\> 3kg;
  • Infection with the SARS-CoV-2 virus confirmed by RT-PCR on a upper or low respiratory tract sample or pneumonia with scanner suggesting SARS-CoV-2 infection;
  • Hospitalized in a pediatric intensive care unit or in a general pediatrics unit
  • Consent signed by at least one parent / holder of parental authority and assent of the child (if applicable);
  • Beneficiary of a social security scheme
  • Group E3:
  • Age from birth to \<18 years old;
  • Weight\> 3 kg;
  • Negative SARS-CoV-2 PCR on at least one respiratory sample, and other confirmed viral infection
  • Hospitalized in a pediatric intensive care unit or in a general pediatrics unit, for a respiratory reason;
  • Consent signed by at least one parent / holder of parental authority and assent of the child (if applicable);
  • Beneficiary of a social security scheme

Exclusion

  • Group E1:
  • Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
  • Other Suspected or proved infection
  • Pregnancy.
  • Group E2:
  • Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
  • Pregnancy.
  • Group E3:
  • Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
  • Infection with the SARS-CoV-2 virus known among the relatives
  • Pregnancy.

Key Trial Info

Start Date :

May 5 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 13 2022

Estimated Enrollment :

140 Patients enrolled

Trial Details

Trial ID

NCT04376476

Start Date

May 5 2020

End Date

May 13 2022

Last Update

April 5 2023

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Groupement Hospitalier Nord-Daupine

Bourgoin, France, 38300

2

Hôpital femme-mère-enfant

Bron, France, 69677

3

Hôpital Louis Pradel

Bron, France, 69677

4

Hôpital Louis Mourier

Colombes, France, 92700