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

Covid19 Clinical Trial

— BIOMARK-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664023
• Other study ID #: BIOMARK-COVID
• Status: Completed
• Start date: December 9, 2020
• Est. completion date: June 19, 2023

Study information

• Verified date: June 2023
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 19, 2023
• Est. primary completion date: June 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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
• 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

Locations

Country	Name	City	State
France	C.H.U.de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutralizing antibodies	Serum titre of neutralizing antibodies	Day 8 following the first SARS-CoV-2 symptoms for patients
Primary	Neutralizing antibodies	Serum titre of neutralizing antibodies	Day 0 of the first injection of vaccine against COVID-19 for volunteers
Primary	T CD8 lymphocytes	Blood concentration of T CD8 lymphocytes	Day 8 following the first SARS-CoV-2 symptoms for patients
Primary	T CD8 lymphocytes	Blood concentration of T CD8 lymphocytes	Day 0 of the first injection of vaccine against COVID-19 for volunteers
Primary	Inflammatory markers	Blood levels of pro-inflammatory cytokines	Day 8 following the first SARS-CoV-2 symptoms for patients
Primary	Inflammatory markers	Blood levels of pro-inflammatory cytokines	Day 0 of the first injection of vaccine against COVID-19 for volunteers
Primary	Metabolic markers	Blood concentration of glucosidases	Day 8 following the first SARS-CoV-2 symptoms for patients
Primary	Metabolic markers	Blood concentration of glucosidases	Day 0 of the first injection of vaccine against COVID-19 for volunteers
Primary	Neutralizing antibodies	Serum titre of neutralizing antibodies	Day 16 following the first SARS-CoV-2 symptoms for patients
Primary	Neutralizing antibodies	Serum titre of neutralizing antibodies	Day 0 of the second injection of vaccine against COVID-19 for volunteers
Primary	T CD8 lymphocytes	Blood concentration of T CD8 lymphocytes	Day 16 following the first SARS-CoV-2 symptoms for patients
Primary	T CD8 lymphocytes	Blood concentration of T CD8 lymphocytes	Day 0 of the second injection of vaccine against COVID-19 for volunteers
Primary	Inflammatory markers	Blood levels of pro-inflammatory cytokines	Day 16 following the first SARS-CoV-2 symptoms for patients
Primary	Inflammatory markers	Blood levels of pro-inflammatory cytokines	Day 0 of the second injection of vaccine against COVID-19 for volunteers
Primary	Metabolic markers	Blood concentration of glucosidases	Day 16 following the first SARS-CoV-2 symptoms for patients
Primary	Metabolic markers	Blood concentration of glucosidases	Day 0 of the second injection of vaccine against COVID-19 for volunteers
Primary	Neutralizing antibodies	Serum titre of neutralizing antibodies	Day 24 following the first SARS-CoV-2 symptoms for patients
Primary	Neutralizing antibodies	Serum titre of neutralizing antibodies	At Month 1 after the second injection of vaccine against COVID-19 for volunteers
Primary	T CD8 lymphocytes	Blood concentration of T CD8 lymphocytes	Day 24 following the first SARS-CoV-2 symptoms for patients
Primary	T CD8 lymphocytes	Blood concentration of T CD8 lymphocytes	At Month 1 after the second injection of vaccine against COVID-19 for volunteers
Primary	Inflammatory markers	Blood levels of pro-inflammatory cytokines	Day 24 following the first SARS-CoV-2 symptoms for patients
Primary	Inflammatory markers	Blood levels of pro-inflammatory cytokines	At Month 1 after the second injection of vaccine against COVID-19 for volunteers
Primary	Metabolic markers	Blood concentration of glucosidases	Day 24 following the first SARS-CoV-2 symptoms for patients
Primary	Metabolic markers	Blood concentration of glucosidases	At Month 1 after the second injection of vaccine against COVID-19 for volunteers
Primary	Neutralizing antibodies	Serum titre of neutralizing antibodies	6 months following the first SARS-CoV-2 symptoms for patients
Primary	Neutralizing antibodies	Serum titre of neutralizing antibodies	At Month 2 after the second injection of vaccine against COVID-19 for volunteers
Primary	T CD8 lymphocytes	Blood concentration of T CD8 lymphocytes	6 months following the first SARS-CoV-2 symptoms for patients
Primary	T CD8 lymphocytes	Blood concentration of T CD8 lymphocytes	At Month 2 after the second injection of vaccine against COVID-19 for volunteers
Primary	Inflammatory markers	Blood levels of pro-inflammatory cytokines	6 months following the first SARS-CoV-2 symptoms for patients
Primary	Inflammatory markers	Blood levels of pro-inflammatory cytokines	At Month 2 after the second injection of vaccine against COVID-19 for volunteers
Primary	Metabolic markers	Blood concentration of glucosidases	6 months following the first SARS-CoV-2 symptoms for patients
Primary	Metabolic markers	Blood concentration of glucosidases	At Month 2 after the second injection of vaccine against COVID-19 for volunteers
Primary	Neutralizing antibodies	Serum titre of neutralizing antibodies	12 months following the first SARS-CoV-2 symptoms for patients
Primary	T CD8 lymphocytes	Blood concentration of T CD8 lymphocytes	12 months following the first SARS-CoV-2 symptoms for patients
Primary	T CD8 lymphocytes	Blood concentration of T CD8 lymphocytes	At Month 6 after the second injection of vaccine against COVID-19 for volunteers
Primary	Inflammatory markers	Blood levels of pro-inflammatory cytokines	12 months following the first SARS-CoV-2 symptoms for patients
Primary	Inflammatory markers	Blood levels of pro-inflammatory cytokines	At Month 6 after the second injection of vaccine against COVID-19 for volunteers
Primary	Metabolic markers	Blood concentration of glucosidases	12 months following the first SARS-CoV-2 symptoms for patients
Primary	Metabolic markers	Blood concentration of glucosidases	At Month 6 after the second injection of vaccine against COVID-19 for volunteers
Primary	Neutralizing antibodies	Blood concentration of glucosidases	At Month 12 after the second injection of vaccine against COVID-19 for volunteers
Primary	T CD8 lymphocytes	Blood concentration of glucosidases	At Month 12 after the second injection of vaccine against COVID-19 for volunteers
Primary	Inflammatory markers	Blood concentration of glucosidases	At Month 12 after the second injection of vaccine against COVID-19 for volunteers
Primary	Metabolic markers	Blood concentration of glucosidases	At Month 12 after the second injection of vaccine against COVID-19 for volunteers