Corona Virus InfectionSeroCOVNCT04707833
Evaluation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen
A study testing Serological testing for COVID-19 infection in people with Corona Virus Infection, run by University Hospital, Rouen at 1 site in France.
Trial summary
At present, the offer of tests for the serological diagnosis of CoVID-19 (detection of IgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of a very large number of rapid diagnostic unit tests, a few dedicated high throughput automated systems or reagents on existing open systems. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- Serological testing for COVID-19 infection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2020to 10 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria in the retrospective "Negative/Potentially Interfering" group are as follows :
- Adult patient sampled prior to the onset of the COVID-19 epidemic (before January 2020)
- Patient presenting a coronavirus infection other than SARS-CoV-2, or other respiratory viral infections (influenza, metapneumovirus)
- Patients for whom a serum is kept in the biocollection declared under the number AC-2014-2293 and kept in the Institute of Clinical Biology, University Hospital of Rouen.
- The criteria for inclusion in the "acute point infection" group are as follows:
- Patients screened by a positive RT-PCR for an SARS-CoV-2 infection
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- Patients aged ≥ 18 years old
- Patients taken in charge in the emergency room / in a unit / in COVID resuscitation at the Rouen University Hospital.
- Patients having read and understood the briefing note
- Non-opposition to participation in the study
- The criteria for inclusion in the "Sequential acute infection" group are as follows:
- Patients with positive RT-PCR for CoV-2-SARS infection
- Patients aged ≥ 18 years old
- Taken care of in a COVID unit at the Rouen University Hospital
- Having read and understood the briefing note and signed the informed consent form
- The criteria for inclusion in the "Convalescent" group are as follows:
- Caregivers working at the UH of Rouen
- Screened by positive RT-PCR for SARS-CoV-2 infection,
- Healed for at least one month at the time of inclusion
- Having read and understood the briefing note and signed the informed consent form
Who cannot join
- Minor person
- Known Pregnancy
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship
- Person not affiliated with social security
- Person who does not understand and speak French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol for the Collection of Clinical Samples for Evaluation and Implementation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen
At present, the offer of tests for the serological diagnosis of CoVID-19 (detection of IgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of a very large number of rapid diagnostic unit tests, a few dedicated high throughput automated systems or reagents on existing open systems. The offer will continue to expand in the coming months.
In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HAS report of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific council concerning the potential use of these serological tests at the end of the COVID-19 epidemic, the Virology laboratory wishes to validate the sensitivity and specificity of the tests it intends to use.
- Conditions
- Corona Virus Infection
- Being tested
- Serological testing for COVID-19 infection
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological testing for COVID-19 infectionDiagnostic test
The tests used will be the following:
EUROIMMUN SARS-CoV-2(IgA) ELISA ELISA SARS-CoV-2 (IgG) EUROIMMUN WANTAI SARS-CoV-2 Ab ELISA WANTAI SARS-CoV-2 IgM ELISA Abbott Architect SARS-CoV-2 IgG Diasorin SARS LINK CoV-2 S1/S2 IgG Roche ECL anti-SARS-Cov-2 (combined IgG IgM IgA)
| Study group | Role | What they receive |
|---|---|---|
| Patient infected or cured from covid19 | Experimental | * Patients with an acute SARS-CoV-2 infection confirmed by a positive RT-PCR, hospitalized in COVID units or in COVID resuscitations,
* Nurses at the Rouen University Hospital infected with COVID 19, and cured,
* Patients with a high suggestive clinic for COVID-19 infection but with negative COVID-19 RT-PCR Receives: Diagnostic Test: Serological testing for COVID-19 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of immunological Abbott Architect SARS-CoV-2 IgG Assay
Measurement of antibodies against COVID-19 infection (Sensitivity and specificity )
Measured: 24 months
Secondary outcomes (1)
Evaluation of immunological of EUROIMMUN SARS-CoV-2(IgA) ELISA, EUROIMMUN SARS-CoV-2 (IgG) ELISA, WANTAI SARS-CoV-2 Ab ELISA, WANTAI SARS-CoV-2 IgM ELISA, Diasorin LIAISON SARS CoV-2 S1/S2 IgG, Roche ECL anti-SARS-Cov-2 (combined IgG IgA)
Measurement of antibodies against COVID-19 infection (Sensitivity and specificity )
Measured: 24 months
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 start26 Nov 2020
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Why it stopped: The inclusion and exclusion criteria have become very restrictive, resulting in a very limited eligible population
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 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
- NCT04707833
- Sponsor's protocol ID
- 2020/0126/HP
- Acronym
- SeroCOV
- Status last verified
- Feb 2026
- First submitted
- 29 Dec 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Collection of Clinical Samples for Evaluation and Implementation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen
- ClinicalTrials.gov ID
- NCT04707833
- Acronym / sponsor ID
- SeroCOV / 2020/0126/HP
- Conditions
- Corona Virus Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The inclusion and exclusion criteria have become very restrictive, resulting in a very limited eligible population
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 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.
At present, the offer of tests for the serological diagnosis of CoVID-19 (detection of IgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of a very large number of rapid diagnostic unit tests, a few dedicated high throughput automated systems or reagents on existing open systems. The offer will continue to expand in the coming months.
In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HAS report of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific council concerning the potential use of these serological tests at the end of the COVID-19 epidemic, the Virology laboratory wishes to validate the sensitivity and specificity of the tests it intends to use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient infected or cured from covid19 | Experimental | Diagnostic Test: Serological testing for COVID-19 infection* Patients with an acute SARS-CoV-2 infection confirmed by a positive RT-PCR, hospitalized in COVID units or in COVID resuscitations, * Nurses at the Rouen University Hospital infected with COVID 19, and cured, * Patients with a high suggestive clinic for COVID-19 infection but with negative COVID-19 RT-PCR |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- The inclusion criteria in the retrospective "Negative/Potentially Interfering" group are as follows :
- Adult patient sampled prior to the onset of the COVID-19 epidemic (before January 2020)
- Patient presenting a coronavirus infection other than SARS-CoV-2, or other respiratory viral infections (influenza, metapneumovirus)
- Patients for whom a serum is kept in the biocollection declared under the number AC-2014-2293 and kept in the Institute of Clinical Biology, University Hospital of Rouen.
- Patients screened by a positive RT-PCR for an SARS-CoV-2 infection
Key exclusion criteria (5 listed)
- Minor person
- Known Pregnancy
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship
- Person not affiliated with social security
- Person who does not understand and speak French
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 |
|---|---|---|
| Serological testing for COVID-19 infectionThe tests used will be the following: EUROIMMUN SARS-CoV-2(IgA) ELISA ELISA SARS-CoV-2 (IgG) EUROIMMUN WANTAI SARS-CoV-2 Ab ELISA WANTAI SARS-CoV-2 IgM ELISA Abbott Architect SARS-CoV-2 IgG Diasorin SARS LINK CoV-2 S1/S2 IgG Roche ECL anti-SARS-Cov-2 (combined IgG IgM IgA) | Diagnostic test | Patient infected or cured from covid19 |
Primary outcome
Evaluation of immunological Abbott Architect SARS-CoV-2 IgG Assay
Time frame: 24 months
Measurement of antibodies against COVID-19 infection (Sensitivity and specificity )
1 secondary outcome
Evaluation of immunological of EUROIMMUN SARS-CoV-2(IgA) ELISA, EUROIMMUN SARS-CoV-2 (IgG) ELISA, WANTAI SARS-CoV-2 Ab ELISA, WANTAI SARS-CoV-2 IgM ELISA, Diasorin LIAISON SARS CoV-2 S1/S2 IgG, Roche ECL anti-SARS-Cov-2 (combined IgG IgA)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: The inclusion and exclusion criteria have become very restrictive, resulting in a very limited eligible population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 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 Serological testing for COVID-19 infection 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 20 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: stopped early, as of the sponsor's last update on 29 Apr 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 was stopped early (reason given: The inclusion and exclusion criteria have become very restrictive, resulting in a very limited eligible population). 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?
Evaluation of immunological Abbott Architect SARS-CoV-2 IgG Assay (time frame: 24 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 29 Apr 2026.