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NCT Number: NCT04376476

Host-pathogen Interactions During SARS-CoV-2 Infection

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, responsible for a veritable global health crisis.

In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional.

Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response.

In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.

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Key information

Conditions

Infection, Coronavirus COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Coronavirus 2 Virus Diseases

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupement Hospitalier Nord-Daupine, Bourgoin, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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 criteria

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.

Treatment and study plan

Blood sample

Biological

blood samples will be taken as below: Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0

Low or upper respiratory tract sample

Biological

Low or upper respiratory tract sample will be collected in order to take virology measurements:

Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0

Stool collection or fecal swab

Biological

The stool collection or fecal swab will be collected in order to take virology measurements:

Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0

phone call

Other

phone calls will be performed to collect data regarding patients' symptoms at: Group E1: Day 14 Group E3: Day 14

Primary outcomes

  1. Initial biological profile of children with COVID-19 infection

    Time frame: Day 0

    Describe the immune response (biological profile in blood samples) of children and adults with COVID-19 infection and correlate it with the initial clinical presentation

    measurement of the following parameters in blood at time of inclusion: white blood cell count, C-reactive protein, procalcitonin, hepatic and renal functions, ferritin, vitamin C and D, fibrinogen, prothrombin time test and partial thromboplastin time in order to correlate them with the initial clinical presentation.

  2. Initial immunological profile of children with COVID-19 infection

    Time frame: Day 0

    measurement of the following parameters in blood at time of inclusion: interferon alpha and gamma, Tumor necrosis factor (TNF) alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte Human Leukocyte Antigen - DR isotype (HLA-DR) expression in order to correlate them with the initial clinical presentation.

Secondary outcomes

  1. Clinical worsening

    Time frame: Within 21 days following inclusion

    Determine whether the initial biological and immunological profiles (see primary outcome measures) are predictive of a secondary worsening (i.e., admission to intensive care unit, and/or increase in NEWS-2 score, and/or increase in oxygen dependence level) of COVID-19 infection

  2. Evolution of the immunological profile of children with COVID-19

    Time frame: Within 21 days following inclusion

    measurement of the following parameters in blood at day 7, and at time of worsening: interferon alpha and gamma, TNF alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte HLA-DR expression in order to correlate them with with the secondary worsening

  3. Nasopharyngeal swabs SARS-CoV-2 viral loads of children with COVID-19

    Time frame: Day 0

    Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured at day 0 and correlation to the initial clinical presentation

  4. titers in specific Immunoglobulin G (IgG) antibodies of children with COVID-19

    Time frame: Day 0

    Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured at day 0 and correlation to the initial clinical presentation

  5. titers in specific Immunoglobulin M (IgM) antibodies of children with COVID-19

    Time frame: Day 0

    Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured at day 0 and correlation to the initial clinical presentation

  6. Nasopharyngeal swabs SARS-CoV-2 viral loads of children with COVID-19

    Time frame: Within 21 days following inclusion

    Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured within 21 days following inclusion, and correlation to the secondary worsening

  7. titers in specific Immunoglobulin G (IgG) antibodies of children with COVID-19

    Time frame: Within 21 days following inclusion

    Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening

  8. titers in specific Immunoglobulin G (IgM) antibodies of children with COVID-19

    Time frame: Within 21 days following inclusion

    Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Host-pathogen Interactions During Paediatric and Adult SARS-CoV-2 Infection (COVID-19)

Acronym: HPI-COVID-19

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 6, 2020
Registry last updated
Apr 5, 2023

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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