Corona Virus InfectionImmuCoVNCT04707820
Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection
A study testing ELISPOT in people with Corona Virus Infection, run by University Hospital, Rouen at 1 site in France.
Trial summary
The SARS-CoV-2 (COVID-19) infection is causing a global pandemic and a major health crisis in France. Immunity is the body's ability to defend itself against infectious agents such as viruses. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- ELISPOT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2020to 1 Apr 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with an acute SARS-CoV-2 infection, confirmed by PCR or typical CT images, requiring hospitalization in a COVID unit at the Rouen University Hospital (pneumonic form requiring oxygen therapy < 4 L/min.)
- Rouen University Hospital staff free of any symptomatology compatible with an SARS-CoV-2 infection (fever, cough, fatigue, loss of taste, loss of smell) since February 1, 2020
- Age ≥ 18 years old
- Adult patient who has read and understood the information letter and signed the consent form
- Affiliation to a social security scheme
Who cannot join
- Patient with PCR-confirmed SARS-CoV-2 infection and hospitalized in intensive care units (acute respiratory distress and/or organ failure, whose pathogenesis may differ from the more frequently described forms with secondary aggravation (5)).
- Patient with PCR-confirmed but non-hospitalized SARS-CoV-2 infection (non-acute form, managed by confinement)
- A person participating in a therapeutic trial that may interfere with the procedures being investigated, including lymphocyte response prior to D+56±14 days.
- Known Pregnancy
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship
- Staff at the Rouen University Hospital with SARS-CoV-2 infection confirmed by PCR and/or typical scan images during the epidemic period.
- Hospital staff who were exposed to the virus (working in a Covid unit)
Trial locations and contacts
1 site in 1 country.
About this study
The SARS-CoV-2 (COVID-19) infection is causing a global pandemic and a major health crisis in France.
Immunity is the body's ability to defend itself against infectious agents such as viruses. The progressive acquisition by a large part of the population of immunity to defend itself against the COVID-19 virus is one of the main mechanisms by which a resolution of this pandemic is hoped for. Recovery from infection and protection from the virus is likely to depend on the development of antibodies (proteins produced by the body to neutralize infectious agents) and T-cells (a type of white blood cell in the immune system) that can stop the virus from multiplying and killing it.
Read more
To date, the way and speed at which the T-lymphocytes active against the virus appear are not known. The development of biological tests to detect T-cells active against the virus in the blood of infected patients is therefore necessary.
In this context, we propose you to participate in a study that will study the immune system's response against the sars-CoV-2 virus during and after COVID-19 infection.
- Conditions
- Corona Virus Infection
- Being tested
- ELISPOT
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISPOTDiagnostic test
The evolution of the number of gamma interferon (IFN) producing T lymphocytes in response to Spike glycoprotein (Spike glycoprotein) will be assessed by enumeration in ELISPOT method at 4 measurement times: D0 (confirmation of infection by PCR), D+7, D+14 or at hospital departure (D+Departure) and D+56±14 days.
The ELISPOT method consists in stimulating peripheral blood mononuclear cells (isolated by density gradient and containing a known CD3+ T lymphocyte count) over a short period of time (16 to 20 hours) with a pool of 15 amino acid peptides (overlapping on 11 amino acids) representative of the S protein.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | - Patient with an acute SARS-CoV-2 infection, confirmed by PCR or typical CT images, requiring hospitalization in a COVID unit at Rouen University Hospital. Receives: Diagnostic Test: ELISPOT |
| control group | No intervention | - Rouen University Hospital staff free of any symptomatology compatible with an SARS-CoV-2 infection (fever, cough, fatigue, loss of taste, loss of smell) since February 1, 2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the number of gamma interferon (IFN) producing T lymphocytes in response to the S protein
The evolution of the number of interferon-gamma producing T lymphocytes (IFN) in response to protein S (Spike glycoprotein) will be assessed by enumeration in ELISPOT method
Measured: for 56 days
Secondary outcomes (3)
Numbers of T lymphocytes producing IFN in response to other CoV-2-SARS viral
Numbers of T lymphocytes producing IFN in response to other CoV-2-SARS viral proteins (nucleoprotein, membrane proteins E (FEV1) and M (FEV1), proteins 3a, 9b, ORF10, non-structural proteins 6, 7a, 7b, 8, protein14) measured by ELISPOT
Measured: for 56 days
Anti-SARS-CoV-2 IgG and IgM levels
Anti-SARS-CoV-2 IgG and IgM levels
Measured: for 56 days
SARS-CoV-2 viral load in nasopharyngeal swab
SARS-CoV-2 viral load in nasopharyngeal swab
Measured: for 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start16 Apr 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707820
- Sponsor's protocol ID
- 2020/0100/HP
- Acronym
- ImmuCoV
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2020
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04707820
- Acronym / sponsor ID
- ImmuCoV / 2020/0100/HP
- Conditions
- Corona Virus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 13 Jan 2021 (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.
The SARS-CoV-2 (COVID-19) infection is causing a global pandemic and a major health crisis in France.
Immunity is the body's ability to defend itself against infectious agents such as viruses. The progressive acquisition by a large part of the population of immunity to defend itself against the COVID-19 virus is one of the main mechanisms by which a resolution of this pandemic is hoped for. Recovery from infection and protection from the virus is likely to depend on the development of antibodies (proteins produced by the body to neutralize infectious agents) and T-cells (a type of white blood cell in the immune system) that can stop the virus from multiplying and killing it.
To date, the way and speed at which the T-lymphocytes active against the virus appear are not known. The development of biological tests to detect T-cells active against the virus in the blood of infected patients is therefore necessary.
In this context, we propose you to participate in a study that will study the immune system's response against the sars-CoV-2 virus during and after COVID-19 infection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Diagnostic Test: ELISPOT- Patient with an acute SARS-CoV-2 infection, confirmed by PCR or typical CT images, requiring hospitalization in a COVID unit at Rouen University Hospital. |
| control group | No intervention | –- Rouen University Hospital staff free of any symptomatology compatible with an SARS-CoV-2 infection (fever, cough, fatigue, loss of taste, loss of smell) since February 1, 2020 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with an acute SARS-CoV-2 infection, confirmed by PCR or typical CT images, requiring hospitalization in a COVID unit at the Rouen University Hospital (pneumonic form requiring oxygen therapy < 4 L/min.)
- Rouen University Hospital staff free of any symptomatology compatible with an SARS-CoV-2 infection (fever, cough, fatigue, loss of taste, loss of smell) since February 1, 2020
- Age ≥ 18 years old
- Adult patient who has read and understood the information letter and signed the consent form
- Affiliation to a social security scheme
Key exclusion criteria (7 listed)
- Patient with PCR-confirmed SARS-CoV-2 infection and hospitalized in intensive care units (acute respiratory distress and/or organ failure, whose pathogenesis may differ from the more frequently described forms with secondary aggravation (5)).
- Patient with PCR-confirmed but non-hospitalized SARS-CoV-2 infection (non-acute form, managed by confinement)
- A person participating in a therapeutic trial that may interfere with the procedures being investigated, including lymphocyte response prior to D+56±14 days.
- Known Pregnancy
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship
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 |
|---|---|---|
| ELISPOTThe evolution of the number of gamma interferon (IFN) producing T lymphocytes in response to Spike glycoprotein (Spike glycoprotein) will be assessed by enumeration in ELISPOT method at 4 measurement times: D0 (confirmation of infection by PCR), D+7, D+14 or at hospital departure (D+Departure) and D+56±14 days. The ELISPOT method consists in stimulating peripheral blood mononuclear cells (isolated by density gradient and containing a known CD3+ T lymphocyte count) over a short period of time (16 to 20 hours) with a pool of 15 amino acid peptides (overlapping on 11 amino acids) representative of the S protein. | Diagnostic test | Patient group |
Primary outcome
Evolution of the number of gamma interferon (IFN) producing T lymphocytes in response to the S protein
Time frame: for 56 days
The evolution of the number of interferon-gamma producing T lymphocytes (IFN) in response to protein S (Spike glycoprotein) will be assessed by enumeration in ELISPOT method
3 secondary outcomes
Numbers of T lymphocytes producing IFN in response to other CoV-2-SARS viral
Time frame: for 56 days
Anti-SARS-CoV-2 IgG and IgM levels
Time frame: for 56 days
SARS-CoV-2 viral load in nasopharyngeal swab
Time frame: for 56 days
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 22 Jan 2026.
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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?
A study testing ELISPOT in people with Corona Virus Infection, run by University Hospital, Rouen 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 5 inclusion and 7 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 22 Jan 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?
Evolution of the number of gamma interferon (IFN) producing T lymphocytes in response to the S protein (time frame: for 56 days). 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 22 Jan 2026.