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

Completed

• Conditions: Covid19
• Interventions: 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

• Registration Number: NCT04664023
• Lead Sponsor: Poitiers University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-03
• Study Start: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-11
• Status Verified: 2023-06
• Primary Completion: 2023-06-19
• Study Completion: 2023-06-19
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Little symptomatic patients with SARS-CoV-2 infection	Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection.	Little symptomatic ambulatory patients with SARS-CoV-2 infection
Patients with severe SARS-CoV-2 infection	Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection.	Patients with severe SARS-CoV-2 infection hospitalised in intensive care unit
Patients with intermediate SARS-CoV-2 infection	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 hospitalised in infectious and tropical diseases department
Patients with SARS-CoV-2 infection hospitalised in geriatry department	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 to study influence of age on the studied mechanisms
Subjects below 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine	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
Subjects above 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine	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 above 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine

Primary Outcome Measures

Name	Time	Method
Metabolic markers	At Month 12 after the second injection of vaccine against COVID-19 for volunteers	Blood concentration of glucosidases
T CD8 lymphocytes	At Month 12 after the second injection of vaccine against COVID-19 for volunteers	Blood concentration of glucosidases
Inflammatory markers	At Month 12 after the second injection of vaccine against COVID-19 for volunteers	Blood concentration of glucosidases
Neutralizing antibodies	At Month 12 after the second injection of vaccine against COVID-19 for volunteers	Blood concentration of glucosidases

Trial Locations

Locations (1)

C.H.U.de Poitiers; 🇫🇷 Poitiers, France