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Prospective study to describe the immunological, metabolic and serologic profile in the acute and post acute phases of Coronavirus disease (COVID-19)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with severe SARS-CoV-2 infection | Patients with severe SARS-CoV-2 infection hospitalised in intensive care unit |
| |
| Patients with intermediate SARS-CoV-2 infection | Patients with intermediate SARS-CoV-2 infection hospitalised in infectious and tropical diseases department |
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| Little symptomatic patients with SARS-CoV-2 infection | Little symptomatic ambulatory patients with SARS-CoV-2 infection |
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| Patients with SARS-CoV-2 infection hospitalised in geriatry department | Patients with SARS-CoV-2 infection hospitalised in geriatry department to study influence of age on the studied mechanisms |
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| Subjects above 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine | Subjects above 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection. | Procedure | 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibodies | Serum titre of neutralizing antibodies | Day 8 following the first SARS-CoV-2 symptoms for patients |
| Neutralizing antibodies | Serum titre of neutralizing antibodies | Day 0 of the first injection of vaccine against COVID-19 for volunteers |
| T CD8 lymphocytes | Blood concentration of T CD8 lymphocytes | Day 8 following the first SARS-CoV-2 symptoms for patients |
| T CD8 lymphocytes | Blood concentration of T CD8 lymphocytes | Day 0 of the first injection of vaccine against COVID-19 for volunteers |
| Inflammatory markers | Blood levels of pro-inflammatory cytokines | Day 8 following the first SARS-CoV-2 symptoms for patients |
| Inflammatory markers | Blood levels of pro-inflammatory cytokines | Day 0 of the first injection of vaccine against COVID-19 for volunteers |
| Metabolic markers | Blood concentration of glucosidases | Day 8 following the first SARS-CoV-2 symptoms for patients |
| Metabolic markers | Blood concentration of glucosidases |
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Inclusion Criteria for patients:
Exclusion Criteria for patients:
Inclusion Criteria for volunteers:
Exclusion Criteria for volunteers:
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Patients with severe SARS-CoV-2 infection hospitalised in intensive care unit
Patients with intermediate SARS-CoV-2 infection hospitalised in infectious and tropical diseases department
Little symptomatic ambulatory patients with SARS-CoV-2 infection
Patients with SARS-CoV-2 infection hospitalised in geriatry department
Subjects wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.H.U.de Poitiers | Poitiers | 86000 | France |
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Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection for patients with COVID-19.
Blood collection at first injection of vaccine against COVID-19, at second injection of vaccine, at Month 1, Month 2, Month 6 and Month 12 after second injection of vaccine for volunteers.
40mL blood sample will be collected at each blood collection.
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| Subjects below 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine | Subjects below 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine |
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| Blood collection at 1st injection of vaccine against COVID-19, at at second injection of vaccine, at Month 1, Month 2, Month 6 and Month 12 after second injection of vaccine for volunteers | Procedure | 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis |
|
| Day 0 of the first injection of vaccine against COVID-19 for volunteers |
| Neutralizing antibodies | Serum titre of neutralizing antibodies | Day 16 following the first SARS-CoV-2 symptoms for patients |
| Neutralizing antibodies | Serum titre of neutralizing antibodies | Day 0 of the second injection of vaccine against COVID-19 for volunteers |
| T CD8 lymphocytes | Blood concentration of T CD8 lymphocytes | Day 16 following the first SARS-CoV-2 symptoms for patients |
| T CD8 lymphocytes | Blood concentration of T CD8 lymphocytes | Day 0 of the second injection of vaccine against COVID-19 for volunteers |
| Inflammatory markers | Blood levels of pro-inflammatory cytokines | Day 16 following the first SARS-CoV-2 symptoms for patients |
| Inflammatory markers | Blood levels of pro-inflammatory cytokines | Day 0 of the second injection of vaccine against COVID-19 for volunteers |
| Metabolic markers | Blood concentration of glucosidases | Day 16 following the first SARS-CoV-2 symptoms for patients |
| Metabolic markers | Blood concentration of glucosidases | Day 0 of the second injection of vaccine against COVID-19 for volunteers |
| Neutralizing antibodies | Serum titre of neutralizing antibodies | Day 24 following the first SARS-CoV-2 symptoms for patients |
| Neutralizing antibodies | Serum titre of neutralizing antibodies | At Month 1 after the second injection of vaccine against COVID-19 for volunteers |
| T CD8 lymphocytes | Blood concentration of T CD8 lymphocytes | Day 24 following the first SARS-CoV-2 symptoms for patients |
| T CD8 lymphocytes | Blood concentration of T CD8 lymphocytes | At Month 1 after the second injection of vaccine against COVID-19 for volunteers |
| Inflammatory markers | Blood levels of pro-inflammatory cytokines | Day 24 following the first SARS-CoV-2 symptoms for patients |
| Inflammatory markers | Blood levels of pro-inflammatory cytokines | At Month 1 after the second injection of vaccine against COVID-19 for volunteers |
| Metabolic markers | Blood concentration of glucosidases | Day 24 following the first SARS-CoV-2 symptoms for patients |
| Metabolic markers | Blood concentration of glucosidases | At Month 1 after the second injection of vaccine against COVID-19 for volunteers |
| Neutralizing antibodies | Serum titre of neutralizing antibodies | 6 months following the first SARS-CoV-2 symptoms for patients |
| Neutralizing antibodies | Serum titre of neutralizing antibodies | At Month 2 after the second injection of vaccine against COVID-19 for volunteers |
| T CD8 lymphocytes | Blood concentration of T CD8 lymphocytes | 6 months following the first SARS-CoV-2 symptoms for patients |
| T CD8 lymphocytes | Blood concentration of T CD8 lymphocytes | At Month 2 after the second injection of vaccine against COVID-19 for volunteers |
| Inflammatory markers | Blood levels of pro-inflammatory cytokines | 6 months following the first SARS-CoV-2 symptoms for patients |
| Inflammatory markers | Blood levels of pro-inflammatory cytokines | At Month 2 after the second injection of vaccine against COVID-19 for volunteers |
| Metabolic markers | Blood concentration of glucosidases | 6 months following the first SARS-CoV-2 symptoms for patients |
| Metabolic markers | Blood concentration of glucosidases | At Month 2 after the second injection of vaccine against COVID-19 for volunteers |
| Neutralizing antibodies | Serum titre of neutralizing antibodies | 12 months following the first SARS-CoV-2 symptoms for patients |
| T CD8 lymphocytes | Blood concentration of T CD8 lymphocytes | 12 months following the first SARS-CoV-2 symptoms for patients |
| T CD8 lymphocytes | Blood concentration of T CD8 lymphocytes | At Month 6 after the second injection of vaccine against COVID-19 for volunteers |
| Inflammatory markers | Blood levels of pro-inflammatory cytokines | 12 months following the first SARS-CoV-2 symptoms for patients |
| Inflammatory markers | Blood levels of pro-inflammatory cytokines | At Month 6 after the second injection of vaccine against COVID-19 for volunteers |
| Metabolic markers | Blood concentration of glucosidases | 12 months following the first SARS-CoV-2 symptoms for patients |
| Metabolic markers | Blood concentration of glucosidases | At Month 6 after the second injection of vaccine against COVID-19 for volunteers |
| Neutralizing antibodies | Blood concentration of glucosidases | At Month 12 after the second injection of vaccine against COVID-19 for volunteers |
| T CD8 lymphocytes | Blood concentration of glucosidases | At Month 12 after the second injection of vaccine against COVID-19 for volunteers |
| Inflammatory markers | Blood concentration of glucosidases | At Month 12 after the second injection of vaccine against COVID-19 for volunteers |
| Metabolic markers | Blood concentration of glucosidases | At Month 12 after the second injection of vaccine against COVID-19 for volunteers |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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