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CompletedNCT04664023BIOMARK-COVIDUpdated Jun 23, 2023

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

An observational study in Covid19, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-23.

Sponsored by Poitiers University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Covid19

Browse trials for

Keywords

  • SARS-CoV-2
  • Immunologic biomarkers
  • Vaccine
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 130 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

    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

  • 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

    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

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

06

What researchers measure

Primary outcomes

  1. Neutralizing antibodies

    Serum titre of neutralizing antibodies

    Time frame: Day 8 following the first SARS-CoV-2 symptoms for patients

  2. Neutralizing antibodies

    Serum titre of neutralizing antibodies

    Time frame: Day 0 of the first injection of vaccine against COVID-19 for volunteers

  3. T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

    Time frame: Day 8 following the first SARS-CoV-2 symptoms for patients

  4. T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

    Time frame: Day 0 of the first injection of vaccine against COVID-19 for volunteers

  5. Inflammatory markers

    Blood levels of pro-inflammatory cytokines

    Time frame: Day 8 following the first SARS-CoV-2 symptoms for patients

  6. Inflammatory markers

    Blood levels of pro-inflammatory cytokines

    Time frame: Day 0 of the first injection of vaccine against COVID-19 for volunteers

  7. Metabolic markers

    Blood concentration of glucosidases

    Time frame: Day 8 following the first SARS-CoV-2 symptoms for patients

  8. Metabolic markers

    Blood concentration of glucosidases

    Time frame: Day 0 of the first injection of vaccine against COVID-19 for volunteers

  9. Neutralizing antibodies

    Serum titre of neutralizing antibodies

    Time frame: Day 16 following the first SARS-CoV-2 symptoms for patients

  10. Neutralizing antibodies

    Serum titre of neutralizing antibodies

    Time frame: Day 0 of the second injection of vaccine against COVID-19 for volunteers

  11. T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

    Time frame: Day 16 following the first SARS-CoV-2 symptoms for patients

  12. T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

    Time frame: Day 0 of the second injection of vaccine against COVID-19 for volunteers

  13. Inflammatory markers

    Blood levels of pro-inflammatory cytokines

    Time frame: Day 16 following the first SARS-CoV-2 symptoms for patients

  14. Inflammatory markers

    Blood levels of pro-inflammatory cytokines

    Time frame: Day 0 of the second injection of vaccine against COVID-19 for volunteers

  15. Metabolic markers

    Blood concentration of glucosidases

    Time frame: Day 16 following the first SARS-CoV-2 symptoms for patients

  16. Metabolic markers

    Blood concentration of glucosidases

    Time frame: Day 0 of the second injection of vaccine against COVID-19 for volunteers

  17. Neutralizing antibodies

    Serum titre of neutralizing antibodies

    Time frame: Day 24 following the first SARS-CoV-2 symptoms for patients

  18. Neutralizing antibodies

    Serum titre of neutralizing antibodies

    Time frame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers

  19. T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

    Time frame: Day 24 following the first SARS-CoV-2 symptoms for patients

  20. T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

    Time frame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers

  21. Inflammatory markers

    Blood levels of pro-inflammatory cytokines

    Time frame: Day 24 following the first SARS-CoV-2 symptoms for patients

  22. Inflammatory markers

    Blood levels of pro-inflammatory cytokines

    Time frame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers

  23. Metabolic markers

    Blood concentration of glucosidases

    Time frame: Day 24 following the first SARS-CoV-2 symptoms for patients

  24. Metabolic markers

    Blood concentration of glucosidases

    Time frame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers

  25. Neutralizing antibodies

    Serum titre of neutralizing antibodies

    Time frame: 6 months following the first SARS-CoV-2 symptoms for patients

  26. Neutralizing antibodies

    Serum titre of neutralizing antibodies

    Time frame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers

  27. T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

    Time frame: 6 months following the first SARS-CoV-2 symptoms for patients

  28. T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

    Time frame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers

  29. Inflammatory markers

    Blood levels of pro-inflammatory cytokines

    Time frame: 6 months following the first SARS-CoV-2 symptoms for patients

  30. Inflammatory markers

    Blood levels of pro-inflammatory cytokines

    Time frame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers

  31. Metabolic markers

    Blood concentration of glucosidases

    Time frame: 6 months following the first SARS-CoV-2 symptoms for patients

  32. Metabolic markers

    Blood concentration of glucosidases

    Time frame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers

  33. Neutralizing antibodies

    Serum titre of neutralizing antibodies

    Time frame: 12 months following the first SARS-CoV-2 symptoms for patients

  34. T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

    Time frame: 12 months following the first SARS-CoV-2 symptoms for patients

  35. T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

    Time frame: At Month 6 after the second injection of vaccine against COVID-19 for volunteers

  36. Inflammatory markers

    Blood levels of pro-inflammatory cytokines

    Time frame: 12 months following the first SARS-CoV-2 symptoms for patients

  37. Inflammatory markers

    Blood levels of pro-inflammatory cytokines

    Time frame: At Month 6 after the second injection of vaccine against COVID-19 for volunteers

  38. Metabolic markers

    Blood concentration of glucosidases

    Time frame: 12 months following the first SARS-CoV-2 symptoms for patients

  39. Metabolic markers

    Blood concentration of glucosidases

    Time frame: At Month 6 after the second injection of vaccine against COVID-19 for volunteers

  40. Neutralizing antibodies

    Blood concentration of glucosidases

    Time frame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers

  41. T CD8 lymphocytes

    Blood concentration of glucosidases

    Time frame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers

  42. Inflammatory markers

    Blood concentration of glucosidases

    Time frame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers

  43. Metabolic markers

    Blood concentration of glucosidases

    Time frame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers

07

Study locations

1 site
  • C.H.U.de Poitiers
    Poitiers, 86000, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04664023
Lead sponsor
Poitiers University Hospital
Responsible party
Sponsor
First posted
Dec 11, 2020
Start date
Dec 9, 2020
Primary completion
Jun 19, 2023
Completion
Jun 19, 2023
Last update
Jun 23, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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