Covid19COVIMMUNITYNCT04648709
Evaluation and Longitudinal Follow-up of Biomarkers Predictive of Severe Forms of COVID-19
An observational study of Covid19, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Current data in the literature demonstrate that the immune response to CoV-2-SARS is much more complex than initially assumed. In fact, beyond the humoral response, including the existence of neutralizing CAs, the adaptive lymphocyte T-type immune response also appears to play an important role in controlling the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- ELISPOT and QUANTIFERON
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2021to 11 Dec 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
- Adult, Older adult
Study population: Patients with COVID infection documented by PCR and/or antigenic testing will be included.
Who may be able to join
- Social security affiliation
- Signed informed consent
- Patients with COVID infection documented by PCR and/or antigenic testing
- Patients belonging to the following groups:
- asymptomatic patients with PCR-positive PCR
- patients with mild symptoms and PCR positive
Show all 9Show fewer
- seriously symptomatic patients with PCR positive
- patients in resuscitation with positive PCR
- Healthy individuals as controls
Who cannot join
- haemoglobin < 8g/dL
- Pregnancy, breastfeeding woman
- Patient vaccinated within 15 days prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Current data in the literature demonstrate that the immune response to CoV-2-SARS is much more complex than initially assumed. In fact, beyond the humoral response, including the existence of neutralizing CAs, the adaptive lymphocyte T-type immune response also appears to play an important role in controlling the infection and reducing the severity of the disease. At this stage, the analysis of this T response is still rudimentary and underdeveloped, but it seems crucial to be able to analyze it effectively in COVID-19 patients, which could help predict the evolution of the infection. It is also currently difficult to know the evolution of this response over time and especially after the resolution of the infection.
To this end, we will analyze the T lymphocyte response (ELISPOT and QUANTIFERON) based on the secretion of IFN (Th1) and IL-4 (Th2) by CoV-2-SARS specific T cells from COVID-19 patients. We will compare the T response to the quality of the systemic and mucosal humoral response. Finally, we will evaluate in parallel two new biomarkers of the severity of COVID-19: plasma calprotectin and the presence of antibodies to type 1 IFN antibodies.
- Conditions
- Covid19
- Being tested
- ELISPOT, QUANTIFERON
- Keywords
- T cells, B cells, immune response, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISPOTDiagnostic test
measure of immune response by ELISPOT
QUANTIFERONDiagnostic test
measure of immune response by QUANTIFERON
| Study group | Role | What they receive |
|---|---|---|
| asymptomatic patients | asymptomatic patients with PCR-positive PCR Receives: Diagnostic Test: ELISPOT; Diagnostic Test: QUANTIFERON | |
| mild symptoms patients | patients with mild symptoms and PCR positive Receives: Diagnostic Test: ELISPOT; Diagnostic Test: QUANTIFERON | |
| seriously symptomatic patients | seriously symptomatic patients with PCR positive Receives: Diagnostic Test: ELISPOT; Diagnostic Test: QUANTIFERON | |
| patients in resuscitation | patients in resuscitation with positive PCR Receives: Diagnostic Test: ELISPOT; Diagnostic Test: QUANTIFERON | |
| heathly volunteer | heathly volunteer as control Receives: Diagnostic Test: ELISPOT; Diagnostic Test: QUANTIFERON |
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell immune response
Characterize T-cell immune response in patient with COVID 19 infection
Measured: from baseline to 18 months
Secondary outcomes (3)
B cell immune response
Characterize B-cell immune response in patient with COVID 19 infection
Measured: from baseline to 18 months
Platelet immune response
Characterize platelet immune response in patient with COVID 19 infection
Measured: from baseline to 18 months
Immune response and chronic forms
Determine if there is a correlation between the pattern of immune response and the risk of reinfection or with persistence of symptoms in chronic forms of COVID-19.
Measured: from baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start9 Mar 2021
- Primary completion26 Sep 2022
- Study completion11 Dec 2023
Why it stopped: The development and generalisation of vaccination led to a significant drop in the number of patients meeting the inclusion criteria.
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 Centre Hospitalier Universitaire de Saint EtienneThe 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
- 73 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Paul, PHD, Study director, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648709
- Sponsor's protocol ID
- 20CH207
- Other IDs
- 2020-A02943-36
- Acronym
- COVIMMUNITY
- Status last verified
- Feb 2023
- First submitted
- 27 Nov 2020
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Longitudinal Follow-up of Biomarkers Predictive of Severe Forms of COVID-19
- ClinicalTrials.gov ID
- NCT04648709
- Acronym / sponsor ID
- COVIMMUNITY / 20CH207
- Conditions
- Covid19
- Keywords
- T cells, B cells, immune response, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The development and generalisation of vaccination led to a significant drop in the number of patients meeting the inclusion criteria.
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 1 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.
Current data in the literature demonstrate that the immune response to CoV-2-SARS is much more complex than initially assumed. In fact, beyond the humoral response, including the existence of neutralizing CAs, the adaptive lymphocyte T-type immune response also appears to play an important role in controlling the infection and reducing the severity of the disease. At this stage, the analysis of this T response is still rudimentary and underdeveloped, but it seems crucial to be able to analyze it effectively in COVID-19 patients, which could help predict the evolution of the infection. It is also currently difficult to know the evolution of this response over time and especially after the resolution of the infection.
To this end, we will analyze the T lymphocyte response (ELISPOT and QUANTIFERON) based on the secretion of IFN (Th1) and IL-4 (Th2) by CoV-2-SARS specific T cells from COVID-19 patients. We will compare the T response to the quality of the systemic and mucosal humoral response. Finally, we will evaluate in parallel two new biomarkers of the severity of COVID-19: plasma calprotectin and the presence of antibodies to type 1 IFN antibodies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| asymptomatic patients | – | Diagnostic Test: ELISPOT, Diagnostic Test: QUANTIFERONasymptomatic patients with PCR-positive PCR |
| mild symptoms patients | – | Diagnostic Test: ELISPOT, Diagnostic Test: QUANTIFERONpatients with mild symptoms and PCR positive |
| seriously symptomatic patients | – | Diagnostic Test: ELISPOT, Diagnostic Test: QUANTIFERONseriously symptomatic patients with PCR positive |
| patients in resuscitation | – | Diagnostic Test: ELISPOT, Diagnostic Test: QUANTIFERONpatients in resuscitation with positive PCR |
| heathly volunteer | – | Diagnostic Test: ELISPOT, Diagnostic Test: QUANTIFERONheathly volunteer as control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with COVID infection documented by PCR and/or antigenic testing will be included.
Key inclusion criteria (9 listed)
- Social security affiliation
- Signed informed consent
- Patients with COVID infection documented by PCR and/or antigenic testing
- Patients belonging to the following groups:
Key exclusion criteria (3 listed)
- haemoglobin < 8g/dL
- Pregnancy, breastfeeding woman
- Patient vaccinated within 15 days prior to inclusion
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 |
|---|---|---|
| ELISPOTmeasure of immune response by ELISPOT | Diagnostic test | asymptomatic patients, heathly volunteer, mild symptoms patients, patients in resuscitation, seriously symptomatic patients |
| QUANTIFERONmeasure of immune response by QUANTIFERON | Diagnostic test | asymptomatic patients, heathly volunteer, mild symptoms patients, patients in resuscitation, seriously symptomatic patients |
Primary outcome
T cell immune response
Time frame: from baseline to 18 months
Characterize T-cell immune response in patient with COVID 19 infection
3 secondary outcomes
B cell immune response
Time frame: from baseline to 18 months
Platelet immune response
Time frame: from baseline to 18 months
Immune response and chronic forms
Time frame: from baseline to 18 months
Results and safety
The study was stopped early (reason given: The development and generalisation of vaccination led to a significant drop in the number of patients meeting the inclusion criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Stéphane Paul, PHD study director
Centre Hospitalier Universitaire de Saint Etienne
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 Centre Hospitalier Universitaire de Saint Etienne 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 9 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Dec 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 was stopped early (reason given: The development and generalisation of vaccination led to a significant drop in the number of patients meeting the inclusion criteria.). Results are not available in the source record.
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?
T cell immune response (time frame: from baseline to 18 months). 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 20 Dec 2023.