Description of Immunologic, Enzymatic and Metabolic Biomarkers Associated to the Severity of COVID-19 (SARS-CoV-2) and Its Resolution
NCT ID: NCT04664023
Last Updated: 2023-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
130 participants
OBSERVATIONAL
2020-12-09
2023-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with severe SARS-CoV-2 infection
Patients with severe SARS-CoV-2 infection hospitalised in intensive care unit
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
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
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
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
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
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
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
40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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C.H.U.de Poitiers
Poitiers, , France
Countries
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Other Identifiers
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BIOMARK-COVID
Identifier Type: -
Identifier Source: org_study_id
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