Covid19BIOMARK-COVIDNCT04664023
Description of Immunologic, Enzymatic and Metabolic Biomarkers Associated to the Severity of COVID-19 (SARS-CoV-2) and Its Resolution
An observational study of Covid19, run by Poitiers University Hospital at 1 site in France.
Trial summary
Prospective study to describe the immunological, metabolic and serologic profile in the acute and post acute phases of Coronavirus disease (COVID-19) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection. and 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
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2020to 19 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
- 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
Who cannot join
- 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
- minor patient
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Description of Immunologic, Enzymatic and Metabolic Biomarkers Associated to the Severity of COVID-19 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)
- Conditions
- Covid19
- Being tested
- Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from 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 volunteers
- Keywords
- SARS-CoV-2, Immunologic biomarkers, Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection.Procedure or surgery
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 volunteersProcedure or surgery
40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe SARS-CoV-2 infection | Patients with severe SARS-CoV-2 infection hospitalised in intensive care unit Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing antibodies
Serum titre of neutralizing antibodies
Measured: Day 8 following the first SARS-CoV-2 symptoms for patients
Neutralizing antibodies
Serum titre of neutralizing antibodies
Measured: Day 0 of the first injection of vaccine against COVID-19 for volunteers
T CD8 lymphocytes
Blood concentration of T CD8 lymphocytes
Measured: Day 8 following the first SARS-CoV-2 symptoms for patients
T CD8 lymphocytes
Blood concentration of T CD8 lymphocytes
Measured: Day 0 of the first injection of vaccine against COVID-19 for volunteers
Inflammatory markers
Blood levels of pro-inflammatory cytokines
Measured: Day 8 following the first SARS-CoV-2 symptoms for patients
Inflammatory markers
Blood levels of pro-inflammatory cytokines
Measured: Day 0 of the first injection of vaccine against COVID-19 for volunteers
Metabolic markers
Blood concentration of glucosidases
Measured: Day 8 following the first SARS-CoV-2 symptoms for patients
Metabolic markers
Blood concentration of glucosidases
Measured: Day 0 of the first injection of vaccine against COVID-19 for volunteers
Neutralizing antibodies
Serum titre of neutralizing antibodies
Measured: Day 16 following the first SARS-CoV-2 symptoms for patients
Neutralizing antibodies
Serum titre of neutralizing antibodies
Measured: Day 0 of the second injection of vaccine against COVID-19 for volunteers
T CD8 lymphocytes
Blood concentration of T CD8 lymphocytes
Measured: Day 16 following the first SARS-CoV-2 symptoms for patients
T CD8 lymphocytes
Blood concentration of T CD8 lymphocytes
Measured: Day 0 of the second injection of vaccine against COVID-19 for volunteers
Inflammatory markers
Blood levels of pro-inflammatory cytokines
Measured: Day 16 following the first SARS-CoV-2 symptoms for patients
Inflammatory markers
Blood levels of pro-inflammatory cytokines
Measured: Day 0 of the second injection of vaccine against COVID-19 for volunteers
Metabolic markers
Blood concentration of glucosidases
Measured: Day 16 following the first SARS-CoV-2 symptoms for patients
Metabolic markers
Blood concentration of glucosidases
Measured: Day 0 of the second injection of vaccine against COVID-19 for volunteers
Neutralizing antibodies
Serum titre of neutralizing antibodies
Measured: Day 24 following the first SARS-CoV-2 symptoms for patients
Neutralizing antibodies
Serum titre of neutralizing antibodies
Measured: At Month 1 after the second injection of vaccine against COVID-19 for volunteers
T CD8 lymphocytes
Blood concentration of T CD8 lymphocytes
Measured: Day 24 following the first SARS-CoV-2 symptoms for patients
T CD8 lymphocytes
Blood concentration of T CD8 lymphocytes
Measured: At Month 1 after the second injection of vaccine against COVID-19 for volunteers
Inflammatory markers
Blood levels of pro-inflammatory cytokines
Measured: Day 24 following the first SARS-CoV-2 symptoms for patients
Inflammatory markers
Blood levels of pro-inflammatory cytokines
Measured: At Month 1 after the second injection of vaccine against COVID-19 for volunteers
Metabolic markers
Blood concentration of glucosidases
Measured: Day 24 following the first SARS-CoV-2 symptoms for patients
Metabolic markers
Blood concentration of glucosidases
Measured: At Month 1 after the second injection of vaccine against COVID-19 for volunteers
Neutralizing antibodies
Serum titre of neutralizing antibodies
Measured: 6 months following the first SARS-CoV-2 symptoms for patients
Neutralizing antibodies
Serum titre of neutralizing antibodies
Measured: At Month 2 after the second injection of vaccine against COVID-19 for volunteers
T CD8 lymphocytes
Blood concentration of T CD8 lymphocytes
Measured: 6 months following the first SARS-CoV-2 symptoms for patients
T CD8 lymphocytes
Blood concentration of T CD8 lymphocytes
Measured: At Month 2 after the second injection of vaccine against COVID-19 for volunteers
Inflammatory markers
Blood levels of pro-inflammatory cytokines
Measured: 6 months following the first SARS-CoV-2 symptoms for patients
Inflammatory markers
Blood levels of pro-inflammatory cytokines
Measured: At Month 2 after the second injection of vaccine against COVID-19 for volunteers
Metabolic markers
Blood concentration of glucosidases
Measured: 6 months following the first SARS-CoV-2 symptoms for patients
Metabolic markers
Blood concentration of glucosidases
Measured: At Month 2 after the second injection of vaccine against COVID-19 for volunteers
Neutralizing antibodies
Serum titre of neutralizing antibodies
Measured: 12 months following the first SARS-CoV-2 symptoms for patients
T CD8 lymphocytes
Blood concentration of T CD8 lymphocytes
Measured: 12 months following the first SARS-CoV-2 symptoms for patients
T CD8 lymphocytes
Blood concentration of T CD8 lymphocytes
Measured: At Month 6 after the second injection of vaccine against COVID-19 for volunteers
Inflammatory markers
Blood levels of pro-inflammatory cytokines
Measured: 12 months following the first SARS-CoV-2 symptoms for patients
Inflammatory markers
Blood levels of pro-inflammatory cytokines
Measured: At Month 6 after the second injection of vaccine against COVID-19 for volunteers
Metabolic markers
Blood concentration of glucosidases
Measured: 12 months following the first SARS-CoV-2 symptoms for patients
Metabolic markers
Blood concentration of glucosidases
Measured: At Month 6 after the second injection of vaccine against COVID-19 for volunteers
Neutralizing antibodies
Blood concentration of glucosidases
Measured: At Month 12 after the second injection of vaccine against COVID-19 for volunteers
T CD8 lymphocytes
Blood concentration of glucosidases
Measured: At Month 12 after the second injection of vaccine against COVID-19 for volunteers
Inflammatory markers
Blood concentration of glucosidases
Measured: At Month 12 after the second injection of vaccine against COVID-19 for volunteers
Metabolic markers
Blood concentration of glucosidases
Measured: At Month 12 after the second injection of vaccine against COVID-19 for volunteers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start9 Dec 2020
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664023
- Sponsor's protocol ID
- BIOMARK-COVID
- Acronym
- BIOMARK-COVID
- Status last verified
- Jun 2023
- First submitted
- 3 Dec 2020
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Immunologic, Enzymatic and Metabolic Biomarkers Associated to the Severity of COVID-19 and Its Resolution
- ClinicalTrials.gov ID
- NCT04664023
- Acronym / sponsor ID
- BIOMARK-COVID / BIOMARK-COVID
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, Immunologic biomarkers, Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective study to describe the immunological, metabolic and serologic profile in the acute and post acute phases of Coronavirus disease (COVID-19)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patients with severe 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 severe SARS-CoV-2 infection hospitalised in intensive care unit |
| Patients with intermediate 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 intermediate SARS-CoV-2 infection hospitalised in infectious and tropical diseases department |
| Little symptomatic 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.Little symptomatic ambulatory patients with SARS-CoV-2 infection |
| Patients with SARS-CoV-2 infection hospitalised in geriatry department | – | 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 to study influence of age on the studied mechanisms |
| 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 volunteersSubjects above 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 volunteersSubjects below 65 years wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
- adult patient
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Little symptomatic patients with SARS-CoV-2 infection, Patients with SARS-CoV-2 infection hospitalised in geriatry department, Patients with intermediate SARS-CoV-2 infection, Patients 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 volunteers40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis | Procedure or surgery | Subjects above 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 |
Primary outcome
Neutralizing antibodies
Time frame: Day 8 following the first SARS-CoV-2 symptoms for patients
Serum titre of neutralizing antibodies
Neutralizing antibodies
Time frame: Day 0 of the first injection of vaccine against COVID-19 for volunteers
Serum titre of neutralizing antibodies
T CD8 lymphocytes
Time frame: Day 8 following the first SARS-CoV-2 symptoms for patients
Blood concentration of T CD8 lymphocytes
T CD8 lymphocytes
Time frame: Day 0 of the first injection of vaccine against COVID-19 for volunteers
Blood concentration of T CD8 lymphocytes
Inflammatory markers
Time frame: Day 8 following the first SARS-CoV-2 symptoms for patients
Blood levels of pro-inflammatory cytokines
Inflammatory markers
Time frame: Day 0 of the first injection of vaccine against COVID-19 for volunteers
Blood levels of pro-inflammatory cytokines
Metabolic markers
Time frame: Day 8 following the first SARS-CoV-2 symptoms for patients
Blood concentration of glucosidases
Metabolic markers
Time frame: Day 0 of the first injection of vaccine against COVID-19 for volunteers
Blood concentration of glucosidases
Neutralizing antibodies
Time frame: Day 16 following the first SARS-CoV-2 symptoms for patients
Serum titre of neutralizing antibodies
Neutralizing antibodies
Time frame: Day 0 of the second injection of vaccine against COVID-19 for volunteers
Serum titre of neutralizing antibodies
T CD8 lymphocytes
Time frame: Day 16 following the first SARS-CoV-2 symptoms for patients
Blood concentration of T CD8 lymphocytes
T CD8 lymphocytes
Time frame: Day 0 of the second injection of vaccine against COVID-19 for volunteers
Blood concentration of T CD8 lymphocytes
Inflammatory markers
Time frame: Day 16 following the first SARS-CoV-2 symptoms for patients
Blood levels of pro-inflammatory cytokines
Inflammatory markers
Time frame: Day 0 of the second injection of vaccine against COVID-19 for volunteers
Blood levels of pro-inflammatory cytokines
Metabolic markers
Time frame: Day 16 following the first SARS-CoV-2 symptoms for patients
Blood concentration of glucosidases
Metabolic markers
Time frame: Day 0 of the second injection of vaccine against COVID-19 for volunteers
Blood concentration of glucosidases
Neutralizing antibodies
Time frame: Day 24 following the first SARS-CoV-2 symptoms for patients
Serum titre of neutralizing antibodies
Neutralizing antibodies
Time frame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers
Serum titre of neutralizing antibodies
T CD8 lymphocytes
Time frame: Day 24 following the first SARS-CoV-2 symptoms for patients
Blood concentration of T CD8 lymphocytes
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
Inflammatory markers
Time frame: Day 24 following the first SARS-CoV-2 symptoms for patients
Blood levels of pro-inflammatory cytokines
Inflammatory markers
Time frame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers
Blood levels of pro-inflammatory cytokines
Metabolic markers
Time frame: Day 24 following the first SARS-CoV-2 symptoms for patients
Blood concentration of glucosidases
Metabolic markers
Time frame: At Month 1 after the second injection of vaccine against COVID-19 for volunteers
Blood concentration of glucosidases
Neutralizing antibodies
Time frame: 6 months following the first SARS-CoV-2 symptoms for patients
Serum titre of neutralizing antibodies
Neutralizing antibodies
Time frame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers
Serum titre of neutralizing antibodies
T CD8 lymphocytes
Time frame: 6 months following the first SARS-CoV-2 symptoms for patients
Blood concentration of T CD8 lymphocytes
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
Inflammatory markers
Time frame: 6 months following the first SARS-CoV-2 symptoms for patients
Blood levels of pro-inflammatory cytokines
Inflammatory markers
Time frame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers
Blood levels of pro-inflammatory cytokines
Metabolic markers
Time frame: 6 months following the first SARS-CoV-2 symptoms for patients
Blood concentration of glucosidases
Metabolic markers
Time frame: At Month 2 after the second injection of vaccine against COVID-19 for volunteers
Blood concentration of glucosidases
Neutralizing antibodies
Time frame: 12 months following the first SARS-CoV-2 symptoms for patients
Serum titre of neutralizing antibodies
T CD8 lymphocytes
Time frame: 12 months following the first SARS-CoV-2 symptoms for patients
Blood concentration of T CD8 lymphocytes
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
Inflammatory markers
Time frame: 12 months following the first SARS-CoV-2 symptoms for patients
Blood levels of pro-inflammatory cytokines
Inflammatory markers
Time frame: At Month 6 after the second injection of vaccine against COVID-19 for volunteers
Blood levels of pro-inflammatory cytokines
Metabolic markers
Time frame: 12 months following the first SARS-CoV-2 symptoms for patients
Blood concentration of glucosidases
Metabolic markers
Time frame: At Month 6 after the second injection of vaccine against COVID-19 for volunteers
Blood concentration of glucosidases
Neutralizing antibodies
Time frame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers
Blood concentration of glucosidases
T CD8 lymphocytes
Time frame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers
Blood concentration of glucosidases
Inflammatory markers
Time frame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers
Blood concentration of glucosidases
Metabolic markers
Time frame: At Month 12 after the second injection of vaccine against COVID-19 for volunteers
Blood concentration of glucosidases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutralizing antibodies (time frame: Day 8 following the first SARS-CoV-2 symptoms for patients). The study lists 43 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.