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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04664023
Acronym
BIOMARK-COVID
Enrollment
130
Registered
2020-12-11
Start date
2020-12-09
Completion date
2023-06-19
Last updated
2023-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

SARS-CoV-2, Immunologic biomarkers, Vaccine

Brief summary

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

Interventions

PROCEDUREBlood 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

PROCEDUREBlood 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

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neutralizing antibodiesDay 8 following the first SARS-CoV-2 symptoms for patientsSerum titre of neutralizing antibodies
T CD8 lymphocytesDay 8 following the first SARS-CoV-2 symptoms for patientsBlood concentration of T CD8 lymphocytes
Inflammatory markersDay 8 following the first SARS-CoV-2 symptoms for patientsBlood levels of pro-inflammatory cytokines
Metabolic markersDay 8 following the first SARS-CoV-2 symptoms for patientsBlood concentration of glucosidases

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026