Covid 19EliSpotNCT04418206
Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
A study testing patients COVID 19 in people with Covid 19, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
Trial summary
The RT-PCR on rhino-pharynge sampling highlights the genetic material of the virus and indicates that a subject is infected with SARS-CoV-2. This test can be in about 30% of false negative cases, it does not allow to date the infection, nor to predict the asymptomatic, mild, moderate or severe evolution of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid 19
- What is being tested?
- patients COVID 19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Jun 2020to 19 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years,
- patients with confirmed SARS-Cov2 infection (RT PCR positive)
- or patients suspected (evocative chest scanner)
- OR patients exposure to SARS-CoV2 but no symptoms (patient's family, caregivers)
- OR patients Non exposure to SARS-Cov2 volunteer subjects (general population)
Who cannot join
- pregnant or breastfeeding female
Trial locations and contacts
4 sites in 1 country.
France4 sites
CH Antibes
Antibes, Alpes Maritimes, 06606
Ch Cannes, Pneumologie
Cannes, Alpes Maritimes, 06414
Ch Grasse
Grasse, Alpes Maritimes, 06355
CHU de nice
Nice, Alpes-Maritimes, 06001
About this study
The RT-PCR on rhino-pharynge sampling highlights the genetic material of the virus and indicates that a subject is infected with SARS-CoV-2. This test can be in about 30% of false negative cases, it does not allow to date the infection, nor to predict the asymptomatic, mild, moderate or severe evolution of the disease. In terms of public health, we need 1/ to better understand the chronology of the immune response to the virus in the general population and in contacts of index cases; 2/ To know which characteristics of the immune response are protective of future reinfections. Finally, in symptomatic subjects, we need biomarkers that predict the evolutionary mode of the disease (moderate vs. severe form).
- Conditions
- Covid 19
- Being tested
- patients COVID 19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients COVID 19Other
Exposure to SARS-Cov2 but no symptoms (patient's family, medical staff) and General population (volunteers not exposed to SARS-Cov2)
| Study group | Role | What they receive |
|---|---|---|
| Samples With DNA | Other | Nasopharyngal swab and blood samples Receives: Other: patients COVID 19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgA specific cells of SARS
Proportion of subjects with IgA-specific cells of SARS-CoV-2's Spike 1 protein at inclusion and 7 +/-2 days later
Measured: At 7 days
Secondary outcomes (1)
OMS progression scale
The scale is 7-point ordinal.
Measured: At 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Jun 2020
- Primary completion10 Feb 2022
- Study completion19 Jul 2022
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 Covid 19Studies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- COVID-19 patients will be selected in the 4 participating centres Contact subjects and healthy volunteers will be selected only in the coordinating centre (Centre Hospitalier Universitaire de Nice)
- Masking
- None (open label)
- Enrolment
- 950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LEROY Sylvie, Principal investigator, CHU de Nice, pneumologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418206
- Sponsor's protocol ID
- 20-PP-10
- Acronym
- EliSpot
- Status last verified
- Mar 2026
- First submitted
- 18 May 2020
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hofman P, Allegra M, Salah M, Benzaquen J, Tanga V, Bordone O, Fayada J, Long-Mira E, Lassalle S, Lanteri E, Lespinet-Fabre V, Brest P, Mograbi B, Maniel C, Boutros J, Leroy S, Heeke S, Hofman V, Marquette CH, Ilie M. Evaluation of Sample Pooling for SARS-CoV-2 Detection in Nasopharyngeal Swab and Saliva Samples with the Idylla SARS-CoV-2 Test. Microbiol Spectr. 2021 Dec 22;9(3):e0099621. doi: 10.1128/Spectrum.00996-21. Epub 2021 Nov 10.
PubMed 34756076
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
- ClinicalTrials.gov ID
- NCT04418206
- Acronym / sponsor ID
- EliSpot / 20-PP-10
- Conditions
- Covid 19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 950 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 5 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.
The RT-PCR on rhino-pharynge sampling highlights the genetic material of the virus and indicates that a subject is infected with SARS-CoV-2. This test can be in about 30% of false negative cases, it does not allow to date the infection, nor to predict the asymptomatic, mild, moderate or severe evolution of the disease. In terms of public health, we need 1/ to better understand the chronology of the immune response to the virus in the general population and in contacts of index cases; 2/ To know which characteristics of the immune response are protective of future reinfections. Finally, in symptomatic subjects, we need biomarkers that predict the evolutionary mode of the disease (moderate vs. severe form).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- COVID-19 patients will be selected in the 4 participating centres Contact subjects and healthy volunteers will be selected only in the coordinating centre (Centre Hospitalier Universitaire de Nice)
| Arm | Type | Receives |
|---|---|---|
| Samples With DNA | Other | Other: patients COVID 19Nasopharyngal swab and blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years,
- patients with confirmed SARS-Cov2 infection (RT PCR positive)
- or patients suspected (evocative chest scanner)
- OR patients exposure to SARS-CoV2 but no symptoms (patient's family, caregivers)
- OR patients Non exposure to SARS-Cov2 volunteer subjects (general population)
Key exclusion criteria (1 listed)
- pregnant or breastfeeding female
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 |
|---|---|---|
| patients COVID 19Exposure to SARS-Cov2 but no symptoms (patient's family, medical staff) and General population (volunteers not exposed to SARS-Cov2) | Other | Samples With DNA |
Primary outcome
IgA specific cells of SARS
Time frame: At 7 days
Proportion of subjects with IgA-specific cells of SARS-CoV-2's Spike 1 protein at inclusion and 7 +/-2 days later
1 secondary outcome
OMS progression scale
Time frame: At 7 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 24 Mar 2026.
- Results publication: PubMed 34756076Hofman P, Allegra M, Salah M, Benzaquen J, Tanga V, Bordone O, Fayada J, Long-Mira E, Lassalle S, Lanteri E, Lespinet-Fabre V, Brest P, Mograbi B, Maniel C, Boutros J, Leroy S, Heeke S, Hofman V, Marquette CH, Ilie M. Evaluation of Sample Pooling for SARS-CoV-2 Detection in Nasopharyngeal Swab and Saliva Samples with the Idylla SARS-CoV-2 Test. Microbiol Spectr. 2021 Dec 22;9(3):e0099621. doi: 10.1128/Spectrum.00996-21. Epub 2021 Nov 10.
- 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.
LEROY Sylvie principal investigator
CHU de Nice, pneumologie
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patients COVID 19 in people with Covid 19, run by Centre Hospitalier Universitaire de Nice at 4 sites 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 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: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
IgA specific cells of SARS (time frame: At 7 days). 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 NCT04418206, 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 24 Mar 2026.