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

Recruiting
Infection, Coronavirus
Severe Acute Respiratory Syndrome Coronavirus 2

Biological: Blood sample
blood samples will be taken as below: Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0
Adult group A1
Adult group A2
Adult group A3
Children group E1
Children group E2
Children group E3

Biological: Low or upper respiratory tract sample
Low or upper respiratory tract sample will be collected in order to take virology measurements:
Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0
Adult group A1
Adult group A2
Adult group A3
Children group E1
Children group E2
Children group E3

Biological: Stool collection or fecal swab
The stool collection or fecal swab will be collected in order to take virology measurements:
Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0
Adult group A1
Adult group A2
Adult group A3
Children group E2
Children group E3

Genetic: Blood sample for whole genome sequencing
The blood sample for whole genome sequencing will be performed at day 0 for group A1 and A2.
Adult group A1
Adult group A2

Other: phone call
phone calls will be performed to collect data regarding patients' symptoms at: Group A1 : Day 10 Group A2 : Day 10 Group A3 : Day 10 Group E1: Day 14 Group E3: Day 14
Adult group A1
Adult group A2
Adult group A3
Children group E1
Children group E3

Eligibility Criteria

Inclusion Criteria:

Group A1:

- Age ≥ 18 years and ≤ 70 years;

- Infection with the SARS-CoV-2 virus confirmed by Reverse transcription polymerase chain reaction (RT-PCR) on a upper or low respiratory tract sample

- Clinical evolution ≤ 5 days at inclusion;

- No hospitalization criteria (National Early Warning Score (NEWS-2 score) ≤ 4);

- No risk factor for serious outcome;

- Absence of therapeutic limitation decided a priori (level of care = 1);

- Patients having been informed of the study, not objecting to participating in it and having signed the consent;

- Beneficiary of a social security scheme.

Group A2:

- Age ≥ 18 years and ≤ 70 years;

- Infection with the SARS-CoV-2 virus confirmed by RT-PCR on a upper or low respiratory tract sample

- Clinical evolution ≤ 5 days at inclusion;

- Hospitalization in medical unit with oxygen dependence (need for oxygen to reach an peripheral oxygen saturation (SpO2) ≥ 94%) but flow ≤ 3 liter/minute (L / min);

- Absence of therapeutic limitation decided a priori (level of care = 1);

- Patients having been informed of the study, not objecting to participating in it and having signed the consent;

- Beneficiary of a social security scheme.

Group A3:

- Age ≥ 18 years and ≤ 70 years;

- Negative SARS-CoV-2 PCR on at least one respiratory sample, and other confirmed viral infection

- Clinical evolution ≤ 5 days at inclusion;

- No hospitalization criteria (NEWS-2 score ≤ 4);

- No risk factor for serious outcome

- Absence of therapeutic limitation decided a priori (level of care = 1);

- Patients having been informed of the study, not objecting to participating in it and having signed the consent;

- Beneficiary of a social security scheme.

Group E1:

- Age from birth to 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;

- 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 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 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 A1:

- Proven or suspected bacterial or viral co-infection;

- Presence of a hospitalization criterion: respiratory, neurological or hemodynamic distress (NEWS-2 score > 4);

- Presence of a serious risk factor

- Patients treated or going to be treated with an immunomodulator (including interferon);

- Patients who have received immunosuppressive therapy, biotherapy and / or corticosteroid therapy at a dose greater than 10 milligram per day (mg/d) of prednisone equivalent for more than 2 weeks in the 3 months preceding the virological diagnosis;

- Patients who have been treated with rituximab;

- Patients who received systemic anti-cancer chemotherapy for solid tumor or hemopathy in the 6 months preceding the virological diagnosis;

- Patients with splenectomy or asplenia

- Infection with the human immunodeficiency virus (HIV);

- Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;

- Pregnancy

- Levels of care ≥ 2 (therapeutic limitation posed a priori, whatever its extent);

- Patient under legal protection measure or unable to consent to the study.

Group A2:

- Proven or suspected bacterial or viral co-infection;

- Patients treated or going to be treated with an immunomodulator (including interferon);

- Patients who have received immunosuppressive therapy, biotherapy and / or corticosteroid therapy at a dose greater than 10 mg / d of prednisone equivalent for more than 2 weeks in the 3 months preceding the virological diagnosis;

- Patients who have been treated with rituximab;

- Patients who received systemic anti-cancer chemotherapy for solid tumor or hemopathy in the 6 months preceding the virological diagnosis;

- Patients with splenectomy or asplenia

- Infection with the human immunodeficiency virus (HIV);

- Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;

- Pregnancy ;

- Levels of care ≥ 2 (therapeutic limitation posed a priori, whatever its extent);

- Patient under legal protection measure or unable to consent to the study

Group A3:

- Presence of a hospitalization criterion: respiratory, neurological or hemodynamic distress (NEWS-2 score> 4);

- Presence of a serious risk factor

- Patients treated or going to be treated with an immunomodulator (including interferon);

- Patients who have received immunosuppressive therapy, biotherapy and / or corticosteroid therapy at a dose greater than 10 mg / d of prednisone equivalent for more than 2 weeks in the 3 months preceding the virological diagnosis;

- Patients who have been treated with rituximab;

- Patients who received systemic anti-cancer chemotherapy for solid tumor or hemopathy in the 6 months preceding the virological diagnosis;

- Patients with splenectomy or asplenia

- Infection with the human immunodeficiency virus (HIV);

- Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;

- Pregnancy ;

- Levels of care ≥ 2 (therapeutic limitation posed a priori, whatever its extent);

- Patient under legal protection measure or unable to consent to the study

Group E1:

- Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;

- 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.

Eligibility Gender
All
Eligibility Age
Maximum: 70 Years
Countries
France
Contacts

Florent VALOUR, PhD
0472 071 107 +33
florent.valour@chu-lyon.fr

Tiphanie Ginhoux
0427 857 723 +33
tiphanie.ginhoux01@chu-lyon.fr

Hospices Civils de Lyon
NCT Number
Keywords
Severe acute respiratory syndrome coronavirus 2
Covid-19
immunology
Interferon
Coronavirus
MeSH Terms
Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome