SARS Cov2, Immune ResponseNCT04410432
Immune Response and Risk of Serious Infection to SARS-Cov2
An observational study of SARS Cov2, Immune Response, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS Cov2, Immune Response
- What is being tested?
- Blood sample collection
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2020to 21 Jan 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for SARS-Cov-2 infection
Who may be able to join
- Person having given his or her non-opposition
- Patient hospitalized with an SARS-Cov2 infection proven by virological sampling (nasopharyngeal or sputum PCR) less than 8 days old.
Who cannot join
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to a safeguard measure of justice
- Pregnant, parturient or breastfeeding woman
- Major incapable or incapable of giving consent
- Minor
Trial locations and contacts
1 site in 1 country.
About this study
To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%.
Apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.
- Conditions
- SARS Cov2, Immune Response
- Being tested
- Blood sample collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionBiological
Additional blood volumes taken during a routine care blood test:
- 1 dry tube 5 mL for isolation and freezing of serum
- 1 x 5 mL EDTA tube to isolate and freeze plasma
- 8 heparinized 6 mL tubes for flow cytometry study
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patient hospitalized with SARS-Cov2 infection proven by virological sampling. Receives: Biological: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of circulating Th1 lymphocytes
Flow cytometry measurement of the percentage of circulating Th1 lymphocytes
Measured: Until the end of the study, about 12 months.
Secondary outcomes (1)
Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11
Immunofluorimetric measurement of serum concentrations of IFN-γ, CXCL9, CXCL10, CXCL11
Measured: Until the end of the study, about 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start29 Sep 2020
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS Cov2, Immune ResponseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410432
- Sponsor's protocol ID
- GHESQUIERE AOIc 2020
- Status last verified
- Jan 2026
- First submitted
- 29 May 2020
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Samson M, Nicolas B, Ciudad M, Greigert H, Guilhem A, Cladiere C, Straub C, Blot M, Piroth L, Rogier T, Devilliers H, Manckoundia P, Ghesquiere T, Francois S, Lakomy D, Audia S, Bonnotte B. T-cell immune response predicts the risk of critical SARS-Cov2 infection in hospitalized COVID-19 patients. Eur J Intern Med. 2022 Aug;102:104-109. doi: 10.1016/j.ejim.2022.06.001. Epub 2022 Jun 3.
PubMed 35690570
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response and Risk of Serious Infection to SARS-Cov2
- ClinicalTrials.gov ID
- NCT04410432
- Acronym / sponsor ID
- GHESQUIERE AOIc 2020
- Conditions
- SARS Cov2, Immune Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 1 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.
To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%.
Apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Biological: Blood sample collectionPatient hospitalized with SARS-Cov2 infection proven by virological sampling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for SARS-Cov-2 infection
Key inclusion criteria (2 listed)
- Person having given his or her non-opposition
- Patient hospitalized with an SARS-Cov2 infection proven by virological sampling (nasopharyngeal or sputum PCR) less than 8 days old.
Key exclusion criteria (5 listed)
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to a safeguard measure of justice
- Pregnant, parturient or breastfeeding woman
- Major incapable or incapable of giving consent
- Minor
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 sample collectionAdditional blood volumes taken during a routine care blood test: * 1 dry tube 5 mL for isolation and freezing of serum * 1 x 5 mL EDTA tube to isolate and freeze plasma * 8 heparinized 6 mL tubes for flow cytometry study | Biological | Patient |
Primary outcome
Percentage of circulating Th1 lymphocytes
Time frame: Until the end of the study, about 12 months.
Flow cytometry measurement of the percentage of circulating Th1 lymphocytes
1 secondary outcome
Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11
Time frame: Until the end of the study, about 12 months.
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 2 Feb 2026.
- Results publication: PubMed 35690570Samson M, Nicolas B, Ciudad M, Greigert H, Guilhem A, Cladiere C, Straub C, Blot M, Piroth L, Rogier T, Devilliers H, Manckoundia P, Ghesquiere T, Francois S, Lakomy D, Audia S, Bonnotte B. T-cell immune response predicts the risk of critical SARS-Cov2 infection in hospitalized COVID-19 patients. Eur J Intern Med. 2022 Aug;102:104-109. doi: 10.1016/j.ejim.2022.06.001. Epub 2022 Jun 3.
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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 SARS Cov2, Immune Response, run by Centre Hospitalier Universitaire Dijon 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 2 inclusion and 5 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 2 Feb 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?
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?
Percentage of circulating Th1 lymphocytes (time frame: Until the end of the study, about 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 NCT04410432, which also lists 1 linked publication.
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 2 Feb 2026.