Clinical trial NCT04664023: Description of Immunologic, Enzymatic and Metabolic Biomarkers Associated to the Severity of COVID-19 (SARS-CoV-2) and Its Resolution
Official title: Description of Immunologic, Enzymatic and Metabolic Biomarkers Associated to the Severity of COVID-19 and Its Resolution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: SARS-CoV-2
Immunologic biomarkers
Vaccine
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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


Eligibility criteria: 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

Primary outcomes:
measure: Neutralizing antibodies
timeFrame: Day 8 following the first SARS-CoV-2 symptoms for patients
measure: Neutralizing antibodies
timeFrame: Day 0 of the first injection of vaccine against COVID-19 for volunteers
measure: T CD8 lymphocytes
timeFrame: Day 8 following the first SARS-CoV-2 symptoms for patients
measure: T CD8 lymphocytes
timeFrame: Day 0 of the first injection of vaccine against COVID-19 for volunteers
measure: Inflammatory markers
timeFrame: Day 8 following the first SARS-CoV-2 symptoms for patients
measure: Inflammatory markers
timeFrame: Day 0 of the first injection of vaccine against COVID-19 for volunteers
measure: Metabolic markers
timeFrame: Day 8 following the first SARS-CoV-2 symptoms for patients
measure: Metabolic markers
timeFrame: Day 0 of the first injection of vaccine against COVID-19 for volunteers
measure: Neutralizing antibodies
timeFrame: Day 16 following the first SARS-CoV-2 symptoms for patients
measure: Neutralizing antibodies
timeFrame: Day 0 of the second injection of vaccine against COVID-19 for volunteers
measure: T CD8 lymphocytes
timeFrame: Day 16 following the first SARS-CoV-2 symptoms for patients
measure: T CD8 lymphocytes
timeFrame: Day 0 of the second injection of vaccine against COVID-19 for volunteers
measure: Inflammatory markers
timeFrame: Day 16 following the first SARS-CoV-2 symptoms for patients
measure: Inflammatory markers
timeFrame: Day 0 of the second injection of vaccine against COVID-19 for volunteers
measure: Metabolic markers
timeFrame: Day 16 following the first SARS-CoV-2 symptoms for patients
measure: Metabolic markers
timeFrame: Day 0 of the second injection of vaccine against COVID-19 for volunteers
measure: Neutralizing antibodies
timeFrame: Day 24 following the first SARS-CoV-2 symptoms for patients
measure: Neutralizing antibodies
timeFrame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers
measure: T CD8 lymphocytes
timeFrame: Day 24 following the first SARS-CoV-2 symptoms for patients
measure: T CD8 lymphocytes
timeFrame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers
measure: Inflammatory markers
timeFrame: Day 24 following the first SARS-CoV-2 symptoms for patients
measure: Inflammatory markers
timeFrame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers
measure: Metabolic markers
timeFrame: Day 24 following the first SARS-CoV-2 symptoms for patients
measure: Metabolic markers
timeFrame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers
measure: Neutralizing antibodies
timeFrame: 6 months following the first SARS-CoV-2 symptoms for patients
measure: Neutralizing antibodies
timeFrame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers
measure: T CD8 lymphocytes
timeFrame: 6 months following the first SARS-CoV-2 symptoms for patients
measure: T CD8 lymphocytes
timeFrame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers
measure: Inflammatory markers
timeFrame: 6 months following the first SARS-CoV-2 symptoms for patients
measure: Inflammatory markers
timeFrame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers
measure: Metabolic markers
timeFrame: 6 months following the first SARS-CoV-2 symptoms for patients
measure: Metabolic markers
timeFrame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers
measure: Neutralizing antibodies
timeFrame: 12 months following the first SARS-CoV-2 symptoms for patients
measure: T CD8 lymphocytes
timeFrame: 12 months following the first SARS-CoV-2 symptoms for patients
measure: T CD8 lymphocytes
timeFrame: At Month 6 after the second injection of vaccine against COVID-19 for volunteers
measure: Inflammatory markers
timeFrame: 12 months following the first SARS-CoV-2 symptoms for patients
measure: Inflammatory markers
timeFrame: At Month 6 after the second injection of vaccine against COVID-19 for volunteers
measure: Metabolic markers
timeFrame: 12 months following the first SARS-CoV-2 symptoms for patients
measure: Metabolic markers
timeFrame: At Month 6 after the second injection of vaccine against COVID-19 for volunteers
measure: Neutralizing antibodies
timeFrame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers
measure: T CD8 lymphocytes
timeFrame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers
measure: Inflammatory markers
timeFrame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers
measure: Metabolic markers
timeFrame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: C.H.U.de Poitiers
Study officials:
References: