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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01102-37 | Other Identifier | ID-RCB |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children group E1 | Experimental | 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. |
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| Children group E2 | Experimental | 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). |
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| Children group E3 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 |
| 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. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 21 days following inclusion |
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Inclusion Criteria:
Group E1:
Group E2:
Group E3:
Exclusion Criteria:
Group E1:
Group E2:
Group E3:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupement Hospitalier Nord-Daupine | Bourgoin | 38300 | France | |||
| Hôpital femme-mère-enfant |
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| 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 |
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| 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 |
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| phone call | Other | phone calls will be performed to collect data regarding patients' symptoms at: Group E1: Day 14 Group E3: Day 14 |
|
| 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 |
| Within 21 days following inclusion |
| 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 | Day 0 |
| 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 | Day 0 |
| 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 | Day 0 |
| 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 | Within 21 days following inclusion |
| 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 | Within 21 days following inclusion |
| 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 | Within 21 days following inclusion |
| Bron |
| 69677 |
| France |
| Hôpital Louis Pradel | Bron | 69677 | France |
| Hôpital Louis Mourier | Colombes | 92700 | France |
| Centre Hospitalier D'Annecy-Genevois | Épagny | 74370 | France |
| Centre Hospitalo-Universitaire de Grenoble | La Tronche | 38700 | France |
| Hopital de la Croix-Rousse | Lyon | 69317 | France |
| Hôpital Edouard Herriot | Lyon | 69437 | France |
| Hôpital mère - enfant Nantes | Nantes | 44093 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Hôpital Nord de Saint Etienne | Saint-Priest-en-Jarez | 42270 | France |
| Hôpital Nord-Ouest | Villefranche-sur-Saône | 69655 | France |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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