NCT04664023

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

December 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

2.5 years

First QC Date

December 3, 2020

Last Update Submit

June 22, 2023

Conditions

Covid19

Keywords

SARS-CoV-2Immunologic biomarkersVaccine

Outcome Measures

Primary Outcomes (43)

  • Neutralizing antibodies

    Serum titre of neutralizing antibodies

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

  • Neutralizing antibodies

    Serum titre of neutralizing antibodies

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

  • T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

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

  • T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

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

  • Inflammatory markers

    Blood levels of pro-inflammatory cytokines

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

  • Inflammatory markers

    Blood levels of pro-inflammatory cytokines

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

  • Metabolic markers

    Blood concentration of glucosidases

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

  • Metabolic markers

    Blood concentration of glucosidases

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

  • Neutralizing antibodies

    Serum titre of neutralizing antibodies

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

  • Neutralizing antibodies

    Serum titre of neutralizing antibodies

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

  • T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

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

  • T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

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

  • Inflammatory markers

    Blood levels of pro-inflammatory cytokines

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

  • Inflammatory markers

    Blood levels of pro-inflammatory cytokines

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

  • Metabolic markers

    Blood concentration of glucosidases

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

  • Metabolic markers

    Blood concentration of glucosidases

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

  • Neutralizing antibodies

    Serum titre of neutralizing antibodies

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

  • Neutralizing antibodies

    Serum titre of neutralizing antibodies

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

  • T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

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

  • T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

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

  • Inflammatory markers

    Blood levels of pro-inflammatory cytokines

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

  • Inflammatory markers

    Blood levels of pro-inflammatory cytokines

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

  • Metabolic markers

    Blood concentration of glucosidases

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

  • Metabolic markers

    Blood concentration of glucosidases

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

  • Neutralizing antibodies

    Serum titre of neutralizing antibodies

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

  • Neutralizing antibodies

    Serum titre of neutralizing antibodies

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

  • T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

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

  • T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

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

  • Inflammatory markers

    Blood levels of pro-inflammatory cytokines

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

  • Inflammatory markers

    Blood levels of pro-inflammatory cytokines

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

  • Metabolic markers

    Blood concentration of glucosidases

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

  • Metabolic markers

    Blood concentration of glucosidases

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

  • Neutralizing antibodies

    Serum titre of neutralizing antibodies

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

  • T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

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

  • T CD8 lymphocytes

    Blood concentration of T CD8 lymphocytes

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

  • Inflammatory markers

    Blood levels of pro-inflammatory cytokines

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

  • Inflammatory markers

    Blood levels of pro-inflammatory cytokines

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

  • Metabolic markers

    Blood concentration of glucosidases

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

  • Metabolic markers

    Blood concentration of glucosidases

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

  • Neutralizing antibodies

    Blood concentration of glucosidases

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

  • T CD8 lymphocytes

    Blood concentration of glucosidases

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

  • Inflammatory markers

    Blood concentration of glucosidases

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

  • Metabolic markers

    Blood concentration of glucosidases

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

Study Arms (6)

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

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

Little symptomatic patients with SARS-CoV-2 infectionPatients with SARS-CoV-2 infection hospitalised in geriatry departmentPatients with intermediate SARS-CoV-2 infectionPatients with severe SARS-CoV-2 infection
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 volunteersPROCEDURE

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 vaccineSubjects below 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

C.H.U.de Poitiers

Poitiers, 86000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection for patients with COVID-19. Blood collection at first injection of vaccine against COVID-19, 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 11, 2020

Study Start

December 9, 2020

Primary Completion

June 19, 2023

Study Completion

June 19, 2023

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations

FR(1)