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

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

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

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: 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
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • C.H.U.de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with severe SARS-CoV-2 infection; 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.; 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis
Patients with intermediate SARS-CoV-2 infection; 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.; 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis
Little symptomatic patients with SARS-CoV-2 infection; 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.; 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis
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	Procedure: Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection.; 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis
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; 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis
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; 40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2020
• Primary Completion (Actual): June 19, 2023
• Study Completion (Actual): June 19, 2023

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Vaccine; Immunologic biomarkers
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BIOMARK-COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No