Description of Immunologic, Enzymatic and Metabolic Biomarkers Associated to the Severity of COVID-19 (SARS-CoV-2) and Its Resolution

Study Overview
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Brief Summary
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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)

Official Title
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Description of Immunologic, Enzymatic and Metabolic Biomarkers Associated to the Severity of COVID-19 and Its Resolution

Conditions
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Covid19

Intervention / Treatment
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* Procedure: Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection.
* Procedure: 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for patients: adult patient Patient with Covid-19 confirmed by RT-PCR, supported by Poitiers hospital Patient came for RT-PCR test at the drive of the hospital, or hospitalised in one of the Covid-19 departments of the Poitiers hospital (geriatry, infectious and tropical diseases, medical resuscitation and continuous care unit) informed consent signed by the patient or a trusted or immediate person after clear and loyal information on the study Exclusion Criteria for patients: minor patient patient having had syptoms for more than 8 days patient already enrolled in another study regarding immunomodulators patient not benefiting from a Social Security scheme or not benefiting from it through a third party patient benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adult under legal protection Inclusion Criteria for volunteers: adult patient subject wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine informed consent signed by the volunteer after clear and loyal information on the study Exclusion Criteria for volunteers: minor patient subject having had COVID-19 documented by a positive RT-PCR test or serology subject already vaccinated against COVID-19 (complete or partial vaccinal scheme) patient not benefiting from a Social Security scheme or not benefiting from it through a third party patient benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adult under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with severe SARS-CoV-2 infection<br>Patients with severe SARS-CoV-2 infection hospitalised in intensive care unit | Procedure: Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection.<br>* 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis<br>|
| Patients with intermediate SARS-CoV-2 infection<br>Patients with intermediate SARS-CoV-2 infection hospitalised in infectious and tropical diseases department | Procedure: Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection.<br>* 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis<br>|
| Little symptomatic patients with SARS-CoV-2 infection<br>Little symptomatic ambulatory patients with SARS-CoV-2 infection | Procedure: Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection.<br>* 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis<br>|
| Patients with SARS-CoV-2 infection hospitalised in geriatry department<br>Patients with SARS-CoV-2 infection hospitalised in geriatry department to study influence of age on the studied mechanisms | Procedure: Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection.<br>* 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis<br>|
| Subjects above 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine<br>Subjects above 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine | Procedure: 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<br>* 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis<br>|
| Subjects below 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine<br>Subjects below 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine | Procedure: 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<br>* 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, Immunologic biomarkers, Vaccine