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

Poitiers University Hospital

Status: Completed

Conditions: Covid19

Treatments: 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

Study type: Observational

Funder types: Other

Identifiers

NCT04664023

BIOMARK-COVID

Details and patient eligibility

About

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

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

130 participants in 6 patient groups

Patients with severe SARS-CoV-2 infection

Description:

Patients with severe SARS-CoV-2 infection hospitalised in intensive care unit

Treatment:

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

Patients with intermediate SARS-CoV-2 infection

Description:

Patients with intermediate SARS-CoV-2 infection hospitalised in infectious and tropical diseases department

Treatment:

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

Little symptomatic patients with SARS-CoV-2 infection

Description:

Little symptomatic ambulatory patients with SARS-CoV-2 infection

Treatment:

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

Patients with SARS-CoV-2 infection hospitalised in geriatry department

Description:

Patients with SARS-CoV-2 infection hospitalised in geriatry department to study influence of age on the studied mechanisms

Treatment:

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

Subjects above 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine

Description:

Subjects above 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine

Treatment:

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

Subjects below 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine

Description:

Subjects below 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine

Treatment:

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