Coronavirus InfectionsCovImmune 2NCT04429594
Study of the Incidence of SARS-CoV-2 Infection (COVID-19)
A study testing blood sampling in people with Coronavirus Infections, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infections
- What is being tested?
- blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2020to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Any major subject, voluntary, exposed to the public from 11 May 2020 informed of the study by partner institutions (Departmental Council 06), affiliated to a social security scheme,
Who cannot join
- Subject protected by law under tutorship or guardianship, or who cannot participate in a clinical study under the terms of Article L. 1121-16 of the French Public Health Code
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Nice Hospital
Nice, 06000
Barbara SEITZ- POLSKI, 334.92.03.55.02, seitz-polski.b@chu-nice.fr
barbara SEITZ POLSKI
About this study
Official title: Study of the Incidence of SARS-CoV-2 Infection in the Alpes-Maritimes Department by Analysis of the Specific Humoral and Cellular Response During Deconfinement
This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study.
The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality.
The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.
- Conditions
- Coronavirus Infections
- Being tested
- blood sampling
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
blood sampling at J0, M6, M12, M24, M36, M48, M60
| Study group | Role | What they receive |
|---|---|---|
| volonteers | Other | Not described Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive serologies
number of positive serologies
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start28 Jul 2020
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429594
- Sponsor's protocol ID
- 20-PP-14
- Acronym
- CovImmune 2
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2020
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Graca D, Brglez V, Allouche J, Zorzi K, Fernandez C, Teisseyre M, Cremoni M, Benzaken S, Pradier C, Seitz-Polski B. Both Humoral and Cellular Immune Responses to SARS-CoV-2 Are Essential to Prevent Infection: a Prospective Study in a Working Vaccinated Population from Southern France. J Clin Immunol. 2023 Nov;43(8):1724-1739. doi: 10.1007/s10875-023-01558-9. Epub 2023 Aug 22.
PubMed 37606852Buscot M, Cremoni M, Graca D, Brglez V, Courjon J, Allouche J, Teisseyre M, Boyer L, Barriere J, Chamorey E, Carles M, Seitz-Polski B. Breakthrough infections due to SARS-CoV-2 Delta variant: relation to humoral and cellular vaccine responses. Front Immunol. 2023 Mar 30;14:1145652. doi: 10.3389/fimmu.2023.1145652. eCollection 2023.
PubMed 37063916
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Incidence of SARS-CoV-2 Infection in the Alpes-Maritimes Department by Analysis of the Specific Humoral and Cellular Response During Deconfinement
- ClinicalTrials.gov ID
- NCT04429594
- Acronym / sponsor ID
- CovImmune 2 / 20-PP-14
- Conditions
- Coronavirus Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Jun 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.
This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study.
The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality.
The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volonteers | Other | Other: blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any major subject, voluntary, exposed to the public from 11 May 2020 informed of the study by partner institutions (Departmental Council 06), affiliated to a social security scheme,
Key exclusion criteria (1 listed)
- Subject protected by law under tutorship or guardianship, or who cannot participate in a clinical study under the terms of Article L. 1121-16 of the French Public Health Code
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 samplingblood sampling at J0, M6, M12, M24, M36, M48, M60 | Other | volonteers |
Primary outcome
positive serologies
Time frame: 12 months
number of positive serologies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Derived from this study: PubMed 37606852Graca D, Brglez V, Allouche J, Zorzi K, Fernandez C, Teisseyre M, Cremoni M, Benzaken S, Pradier C, Seitz-Polski B. Both Humoral and Cellular Immune Responses to SARS-CoV-2 Are Essential to Prevent Infection: a Prospective Study in a Working Vaccinated Population from Southern France. J Clin Immunol. 2023 Nov;43(8):1724-1739. doi: 10.1007/s10875-023-01558-9. Epub 2023 Aug 22.
- Derived from this study: PubMed 37063916Buscot M, Cremoni M, Graca D, Brglez V, Courjon J, Allouche J, Teisseyre M, Boyer L, Barriere J, Chamorey E, Carles M, Seitz-Polski B. Breakthrough infections due to SARS-CoV-2 Delta variant: relation to humoral and cellular vaccine responses. Front Immunol. 2023 Mar 30;14:1145652. doi: 10.3389/fimmu.2023.1145652. eCollection 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Coronavirus Infections, run by Centre Hospitalier Universitaire de Nice 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara SEITZ, MCUPH (334 92 03 55 02, seitz-polski.b@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive serologies (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04429594, which also lists 2 linked publications.
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 22 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.