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Host-pathogen Interactions During SARS-CoV-2 Infection (HPI-COVID-19)

Primary Purpose

Infection, Coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Low or upper respiratory tract sample
Stool collection or fecal swab
phone call
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infection, Coronavirus focused on measuring Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19, immunology, interferon, coronavirus

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Groupement Hospitalier Nord-Daupine
  • Hôpital femme-mère-enfant
  • Hôpital Louis Pradel
  • Hôpital Louis Mourier
  • Centre Hospitalo-Universitaire de Grenoble
  • Hopital de la Croix-Rousse
  • Hôpital Edouard Herriot
  • Hôpital mère - enfant Nantes
  • Centre Hospitalier Lyon Sud
  • Hôpital Nord de Saint Etienne
  • Hôpital Nord-Ouest
  • Centre Hospitalier D'Annecy-Genevois

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Children group E1

Children group E2

Children group E3

Arm Description

Children with confirmed asymptomatic or pauci-symptomatic COVID infection will be recruited in pediatric emergency departments, among siblings of COVID-19+ pediatric patients or through the blood collection centers set up by the occupational health services. A single visit will be scheduled at the hospital (for clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14.

Children with confirmed COVID-19 infection requiring hospitalization will be recruited within participating centers (mostly in emergency and intensive care units). Data will be recorded (clinical examination, biology, immunology, virology measurements) during their hospital stay (day 0, day 7, in case of worsening) and a phone call performed at day 14 (or onsite visit if patient still hospitalized).

Children with confirmed non-COVID-19 viral infection requiring hospitalization will be recruited within participating centers (mostly in intensive care units). At inclusion, data will be recorded (clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14.

Outcomes

Primary Outcome Measures

Initial biological profile of children with COVID-19 infection
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.
Initial immunological profile of children with COVID-19 infection
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 Outcome Measures

Clinical worsening
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
Evolution of the immunological profile of children with COVID-19
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
Nasopharyngeal swabs SARS-CoV-2 viral loads of children with COVID-19
Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured at day 0 and correlation to the initial clinical presentation
titers in specific Immunoglobulin G (IgG) antibodies of children with COVID-19
Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured at day 0 and correlation to the initial clinical presentation
titers in specific Immunoglobulin M (IgM) antibodies of children with COVID-19
Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured at day 0 and correlation to the initial clinical presentation
Nasopharyngeal swabs SARS-CoV-2 viral loads of children with COVID-19
Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured within 21 days following inclusion, and correlation to the secondary worsening
titers in specific Immunoglobulin G (IgG) antibodies of children with COVID-19
Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening
titers in specific Immunoglobulin G (IgM) antibodies of children with COVID-19
Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening

Full Information

First Posted
April 28, 2020
Last Updated
April 4, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04376476
Brief Title
Host-pathogen Interactions During SARS-CoV-2 Infection
Acronym
HPI-COVID-19
Official Title
Host-pathogen Interactions During Paediatric and Adult SARS-CoV-2 Infection (COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
May 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2
Keywords
Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19, immunology, interferon, coronavirus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children group E1
Arm Type
Experimental
Arm Description
Children with confirmed asymptomatic or pauci-symptomatic COVID infection will be recruited in pediatric emergency departments, among siblings of COVID-19+ pediatric patients or through the blood collection centers set up by the occupational health services. A single visit will be scheduled at the hospital (for clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14.
Arm Title
Children group E2
Arm Type
Experimental
Arm Description
Children with confirmed COVID-19 infection requiring hospitalization will be recruited within participating centers (mostly in emergency and intensive care units). Data will be recorded (clinical examination, biology, immunology, virology measurements) during their hospital stay (day 0, day 7, in case of worsening) and a phone call performed at day 14 (or onsite visit if patient still hospitalized).
Arm Title
Children group E3
Arm Type
Experimental
Arm Description
Children with confirmed non-COVID-19 viral infection requiring hospitalization will be recruited within participating centers (mostly in intensive care units). At inclusion, data will be recorded (clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14.
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Low or upper respiratory tract sample
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Stool collection or fecal swab
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
phone call
Intervention Description
phone calls will be performed to collect data regarding patients' symptoms at: Group E1: Day 14 Group E3: Day 14
Primary Outcome Measure Information:
Title
Initial biological profile of children with COVID-19 infection
Description
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.
Time Frame
Day 0
Title
Initial immunological profile of children with COVID-19 infection
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Clinical worsening
Description
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
Time Frame
Within 21 days following inclusion
Title
Evolution of the immunological profile of children with COVID-19
Description
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
Time Frame
Within 21 days following inclusion
Title
Nasopharyngeal swabs SARS-CoV-2 viral loads of children with COVID-19
Description
Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured at day 0 and correlation to the initial clinical presentation
Time Frame
Day 0
Title
titers in specific Immunoglobulin G (IgG) antibodies of children with COVID-19
Description
Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured at day 0 and correlation to the initial clinical presentation
Time Frame
Day 0
Title
titers in specific Immunoglobulin M (IgM) antibodies of children with COVID-19
Description
Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured at day 0 and correlation to the initial clinical presentation
Time Frame
Day 0
Title
Nasopharyngeal swabs SARS-CoV-2 viral loads of children with COVID-19
Description
Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured within 21 days following inclusion, and correlation to the secondary worsening
Time Frame
Within 21 days following inclusion
Title
titers in specific Immunoglobulin G (IgG) antibodies of children with COVID-19
Description
Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening
Time Frame
Within 21 days following inclusion
Title
titers in specific Immunoglobulin G (IgM) antibodies of children with COVID-19
Description
Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening
Time Frame
Within 21 days following inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Groupement Hospitalier Nord-Daupine
City
Bourgoin-Jallieu
ZIP/Postal Code
38300
Country
France
Facility Name
Hôpital femme-mère-enfant
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hôpital Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
Centre Hospitalo-Universitaire de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hopital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hôpital mère - enfant Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Hôpital Nord de Saint Etienne
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Hôpital Nord-Ouest
City
Villefranche-sur-Saône
ZIP/Postal Code
69655
Country
France
Facility Name
Centre Hospitalier D'Annecy-Genevois
City
Épagny
ZIP/Postal Code
74370
Country
France

12. IPD Sharing Statement

Learn more about this trial

Host-pathogen Interactions During SARS-CoV-2 Infection

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