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

Poitiers University Hospital130 enrolled

Overview

Prospective study to describe the immunological, metabolic and serologic profile in the acute and post acute phases of Coronavirus disease (COVID-19)

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Covid19

Interventions

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

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 volunteersPROCEDURE

40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

C.H.U.de Poitiers

Poitiers, France

Outcomes

Primary Outcomes

Neutralizing antibodies

Serum titre of neutralizing antibodies

Time frame: Day 8 following the first SARS-CoV-2 symptoms for patients

Neutralizing antibodies

Serum titre of neutralizing antibodies

Time frame: Day 0 of the first injection of vaccine against COVID-19 for volunteers

T CD8 lymphocytes

Blood concentration of T CD8 lymphocytes

Time frame: Day 8 following the first SARS-CoV-2 symptoms for patients

T CD8 lymphocytes

Blood concentration of T CD8 lymphocytes

Time frame: Day 0 of the first injection of vaccine against COVID-19 for volunteers

Inflammatory markers

Blood levels of pro-inflammatory cytokines

Time frame: Day 8 following the first SARS-CoV-2 symptoms for patients

Inflammatory markers

Blood levels of pro-inflammatory cytokines

Time frame: Day 0 of the first injection of vaccine against COVID-19 for volunteers

Metabolic markers

Blood concentration of glucosidases

Time frame: Day 8 following the first SARS-CoV-2 symptoms for patients

Metabolic markers

Blood concentration of glucosidases

Time frame: Day 0 of the first injection of vaccine against COVID-19 for volunteers

Neutralizing antibodies

Data from ClinicalTrials.gov

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Serum titre of neutralizing antibodies

Time frame: Day 16 following the first SARS-CoV-2 symptoms for patients

Neutralizing antibodies

Serum titre of neutralizing antibodies

Time frame: Day 0 of the second injection of vaccine against COVID-19 for volunteers

T CD8 lymphocytes

Blood concentration of T CD8 lymphocytes

Time frame: Day 16 following the first SARS-CoV-2 symptoms for patients

T CD8 lymphocytes

Blood concentration of T CD8 lymphocytes

Time frame: Day 0 of the second injection of vaccine against COVID-19 for volunteers

Inflammatory markers

Blood levels of pro-inflammatory cytokines

Time frame: Day 16 following the first SARS-CoV-2 symptoms for patients

Inflammatory markers

Blood levels of pro-inflammatory cytokines

Time frame: Day 0 of the second injection of vaccine against COVID-19 for volunteers

Metabolic markers

Blood concentration of glucosidases

Time frame: Day 16 following the first SARS-CoV-2 symptoms for patients

Metabolic markers

Blood concentration of glucosidases

Time frame: Day 0 of the second injection of vaccine against COVID-19 for volunteers

Neutralizing antibodies

Serum titre of neutralizing antibodies

Time frame: Day 24 following the first SARS-CoV-2 symptoms for patients

Neutralizing antibodies

Serum titre of neutralizing antibodies

Time frame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers

T CD8 lymphocytes

Blood concentration of T CD8 lymphocytes

Time frame: Day 24 following the first SARS-CoV-2 symptoms for patients

T CD8 lymphocytes

Blood concentration of T CD8 lymphocytes

Time frame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers

Inflammatory markers

Blood levels of pro-inflammatory cytokines

Time frame: Day 24 following the first SARS-CoV-2 symptoms for patients

Inflammatory markers

Blood levels of pro-inflammatory cytokines

Time frame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers

Metabolic markers

Blood concentration of glucosidases

Time frame: Day 24 following the first SARS-CoV-2 symptoms for patients

Metabolic markers

Blood concentration of glucosidases

Time frame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers

Neutralizing antibodies

Serum titre of neutralizing antibodies

Time frame: 6 months following the first SARS-CoV-2 symptoms for patients

Neutralizing antibodies

Serum titre of neutralizing antibodies

Time frame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers

T CD8 lymphocytes

Blood concentration of T CD8 lymphocytes

Time frame: 6 months following the first SARS-CoV-2 symptoms for patients

T CD8 lymphocytes

Blood concentration of T CD8 lymphocytes

Time frame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers

Inflammatory markers

Blood levels of pro-inflammatory cytokines

Time frame: 6 months following the first SARS-CoV-2 symptoms for patients

Inflammatory markers

Blood levels of pro-inflammatory cytokines

Time frame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers

Metabolic markers

Blood concentration of glucosidases

Time frame: 6 months following the first SARS-CoV-2 symptoms for patients

Metabolic markers

Blood concentration of glucosidases

Time frame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers

Neutralizing antibodies

Serum titre of neutralizing antibodies

Time frame: 12 months following the first SARS-CoV-2 symptoms for patients

T CD8 lymphocytes

Blood concentration of T CD8 lymphocytes

Time frame: 12 months following the first SARS-CoV-2 symptoms for patients

T CD8 lymphocytes

Blood concentration of T CD8 lymphocytes

Time frame: At Month 6 after the second injection of vaccine against COVID-19 for volunteers

Inflammatory markers

Blood levels of pro-inflammatory cytokines

Time frame: 12 months following the first SARS-CoV-2 symptoms for patients

Inflammatory markers

Blood levels of pro-inflammatory cytokines

Time frame: At Month 6 after the second injection of vaccine against COVID-19 for volunteers

Metabolic markers

Blood concentration of glucosidases

Time frame: 12 months following the first SARS-CoV-2 symptoms for patients

Metabolic markers

Blood concentration of glucosidases

Time frame: At Month 6 after the second injection of vaccine against COVID-19 for volunteers

Neutralizing antibodies

Blood concentration of glucosidases

Time frame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers

T CD8 lymphocytes

Blood concentration of glucosidases

Time frame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers

Inflammatory markers

Blood concentration of glucosidases

Time frame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers

Metabolic markers

Blood concentration of glucosidases

Time frame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers