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Completed

NCT Number: NCT04664023

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

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

C.H.U.de Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection.

Procedure

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

Procedure

40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis

Primary outcomes

  1. Neutralizing antibodies

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

    Serum titre of neutralizing antibodies

  2. Neutralizing antibodies

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

    Serum titre of neutralizing antibodies

  3. T CD8 lymphocytes

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

    Blood concentration of T CD8 lymphocytes

  4. T CD8 lymphocytes

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

    Blood concentration of T CD8 lymphocytes

  5. Inflammatory markers

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

    Blood levels of pro-inflammatory cytokines

  6. Inflammatory markers

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

    Blood levels of pro-inflammatory cytokines

  7. Metabolic markers

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

    Blood concentration of glucosidases

  8. Metabolic markers

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

    Blood concentration of glucosidases

  9. Neutralizing antibodies

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

    Serum titre of neutralizing antibodies

  10. Neutralizing antibodies

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

    Serum titre of neutralizing antibodies

  11. T CD8 lymphocytes

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

    Blood concentration of T CD8 lymphocytes

  12. T CD8 lymphocytes

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

    Blood concentration of T CD8 lymphocytes

  13. Inflammatory markers

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

    Blood levels of pro-inflammatory cytokines

  14. Inflammatory markers

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

    Blood levels of pro-inflammatory cytokines

  15. Metabolic markers

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

    Blood concentration of glucosidases

  16. Metabolic markers

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

    Blood concentration of glucosidases

  17. Neutralizing antibodies

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

    Serum titre of neutralizing antibodies

  18. Neutralizing antibodies

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

    Serum titre of neutralizing antibodies

  19. T CD8 lymphocytes

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

    Blood concentration of T CD8 lymphocytes

  20. T CD8 lymphocytes

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

    Blood concentration of T CD8 lymphocytes

  21. Inflammatory markers

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

    Blood levels of pro-inflammatory cytokines

  22. Inflammatory markers

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

    Blood levels of pro-inflammatory cytokines

  23. Metabolic markers

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

    Blood concentration of glucosidases

  24. Metabolic markers

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

    Blood concentration of glucosidases

  25. Neutralizing antibodies

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

    Serum titre of neutralizing antibodies

  26. Neutralizing antibodies

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

    Serum titre of neutralizing antibodies

  27. T CD8 lymphocytes

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

    Blood concentration of T CD8 lymphocytes

  28. T CD8 lymphocytes

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

    Blood concentration of T CD8 lymphocytes

  29. Inflammatory markers

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

    Blood levels of pro-inflammatory cytokines

  30. Inflammatory markers

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

    Blood levels of pro-inflammatory cytokines

  31. Metabolic markers

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

    Blood concentration of glucosidases

  32. Metabolic markers

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

    Blood concentration of glucosidases

  33. Neutralizing antibodies

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

    Serum titre of neutralizing antibodies

  34. T CD8 lymphocytes

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

    Blood concentration of T CD8 lymphocytes

  35. T CD8 lymphocytes

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

    Blood concentration of T CD8 lymphocytes

  36. Inflammatory markers

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

    Blood levels of pro-inflammatory cytokines

  37. Inflammatory markers

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

    Blood levels of pro-inflammatory cytokines

  38. Metabolic markers

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

    Blood concentration of glucosidases

  39. Metabolic markers

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

    Blood concentration of glucosidases

  40. Neutralizing antibodies

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

    Blood concentration of glucosidases

  41. T CD8 lymphocytes

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

    Blood concentration of glucosidases

  42. Inflammatory markers

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

    Blood concentration of glucosidases

  43. Metabolic markers

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

    Blood concentration of glucosidases

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: BIOMARK-COVID

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2020
Registry last updated
Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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