CoV2 Positive CaregiversCOVID-SERNCT04341142

Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER

A study testing Serological tests will be applied on patients blood sampling in people with CoV2 Positive Caregivers, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: CoV2 Positive Caregivers
What is being tested?: Serological tests will be applied on patients blood sampling
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 517 participants
Where: 1 siteFrance
Study dates: 10 Apr 2020to 5 Jan 2026
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

Seropositive caregivers screened for anti-SARS CoV2 antibodies during their consultation at the occupational medicine of HCL.
Age: ≥ 18 years old
Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months.
Persons affiliated to a social security scheme or beneficiary of such a scheme.

Who cannot join

Pregnant or lactating woman

Trial locations and contacts

1 site in 1 country.

France1 site

Hôpital Lyon Sud,Sainte Eugénie bat 4M,5, Chemin du Grand Revoyet
Pierre-Bénite, 69495

Other trials in France

About this study

Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests

Conditions: CoV2 Positive Caregivers
Being tested: Serological tests will be applied on patients blood sampling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Serological tests will be applied on patients blood samplingDiagnostic test
Application of tests on patients' serum

Study groups in NCT04341142
Study group	Role	What they receive
Serological tests will be applied on patients blood sampling	Experimental	Serological tests will be applied on patients blood sampling Receives: Diagnostic Test: Serological tests will be applied on patients blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

The positivity (Yes/No) of the serological test.
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Measured: Day 0
The positivity (Yes/No) of the serological test.
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Measured: Day 3
The positivity (Yes/No) of the serological test.
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Measured: Day 7
The positivity (Yes/No) of the serological test.
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Measured: Day 14
The positivity (Yes/No) of the serological test.
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Measured: Day 21
The positivity (Yes/No) of the serological test.
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Measured: Day 28
The positivity (Yes/No) of the serological test.
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Measured: Day 35
The positivity (Yes/No) of the serological test.
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Measured: Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 20205 Jan 2026

First posted10 Apr 2020
Study start10 Apr 2020
Primary completion10 Apr 2023
Study completion5 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for CoV2 Positive CaregiversStudies of the same condition, open and under way.
More trials run by Hospices Civils de LyonThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 517 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04341142
Sponsor's protocol ID: 69HCL20_0329
Acronym: COVID-SER
Status last verified: Oct 2026
First submitted: 8 Apr 2020
Last updated: 16 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bal A, Trabaud MA, Fassier JB, Rabilloud M, Saker K, Langlois-Jacques C, Guibert N, Paul A, Alfaiate D, Massardier-Pilonchery A, Pitiot V, Morfin-Sherpa F, Lina B, Pozzetto B, Trouillet-Assant S; COVID SER Study Group. Six-month antibody response to SARS-CoV-2 in healthcare workers assessed by virus neutralization and commercial assays. Clin Microbiol Infect. 2021 Jun;27(6):933-935. doi: 10.1016/j.cmi.2021.01.003. Epub 2021 Jan 13. No abstract available.
PubMed 33450388
Bal A, Brengel-Pesce K, Gaymard A, Queromes G, Guibert N, Frobert E, Bouscambert M, Trabaud MA, Allantaz-Frager F, Oriol G, Cheynet V, d'Aubarede C, Massardier-Pilonchery A, Buisson M, Lupo J, Pozzetto B, Poignard P, Lina B, Fassier JB, Morfin F, Trouillet-Assant S; COVID-SER Study group. Clinical and laboratory characteristics of symptomatic healthcare workers with suspected COVID-19: a prospective cohort study. Sci Rep. 2021 Jul 22;11(1):14977. doi: 10.1038/s41598-021-93828-y.
PubMed 34294751
Pozzetto B, Legros V, Djebali S, Barateau V, Guibert N, Villard M, Peyrot L, Allatif O, Fassier JB, Massardier-Pilonchery A, Brengel-Pesce K, Yaugel-Novoa M, Denolly S, Boson B, Bourlet T, Bal A, Valette M, Andrieu T, Lina B; Covid-Ser study group; Cosset FL, Paul S, Defrance T, Marvel J, Walzer T, Trouillet-Assant S. Immunogenicity and efficacy of heterologous ChAdOx1-BNT162b2 vaccination. Nature. 2021 Dec;600(7890):701-706. doi: 10.1038/s41586-021-04120-y. Epub 2021 Oct 21.
PubMed 34673755
Trouillet-Assant S, Albert Vega C, Bal A, Nazare JA, Fascia P, Paul A, Massardier-Pilonchery A, D Aubarede C, Guibert N, Pitiot V, Lahousse M, Boibieux A, Makhloufi D, Simon C, Rabilloud M, Trabaud MA, Gueyffier F, Fassier JB; COVID-SER study group. Assessment of serological techniques for screening patients for COVID-19 (COVID-SER): a prospective, multicentric study. BMJ Open. 2020 Nov 24;10(11):e041268. doi: 10.1136/bmjopen-2020-041268.
PubMed 33234651
de Boer J, Saade U, Granjon E, Trouillet-Assant S, Saade C, Pottel H, Zrein M; Covid ser study group. A novel assessment method for COVID-19 humoral immunity duration using serial measurements in naturally infected and vaccinated subjects. PLoS One. 2022 Sep 29;17(9):e0274553. doi: 10.1371/journal.pone.0274553. eCollection 2022.
PubMed 36173972
Bal A, Pozzetto B, Trabaud MA, Escuret V, Rabilloud M, Langlois-Jacques C, Paul A, Guibert N, D'Aubarede-Frieh C, Massardier-Pilonchery A, Fabien N, Goncalves D, Boibieux A, Morfin-Sherpa F, Pitiot V, Gueyffier F, Lina B, Fassier JB, Trouillet-Assant S; COVID SER Study Group. Evaluation of High-Throughput SARS-CoV-2 Serological Assays in a Longitudinal Cohort of Patients with Mild COVID-19: Clinical Sensitivity, Specificity, and Association with Virus Neutralization Test. Clin Chem. 2021 Apr 29;67(5):742-752. doi: 10.1093/clinchem/hvaa336.
PubMed 33399823

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER
ClinicalTrials.gov ID: NCT04341142
Acronym / sponsor ID: COVID-SER / 69HCL20_0329
Conditions: CoV2 Positive Caregivers
Study type: Interventional
Recruitment status: Completed
Enrolment: 517 participants (actual)
Lead sponsor: Hospices Civils de LyonUniversity, hospital or other
Study start: 10 Apr 2020 (actual)
Primary completion: 10 Apr 2023 (actual)
Study completion: 5 Jan 2026 (actual)
First posted: 10 Apr 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.

Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Serological tests will be applied on patients blood sampling	Experimental	Diagnostic Test: Serological tests will be applied on patients blood samplingSerological tests will be applied on patients blood sampling

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Seropositive caregivers screened for anti-SARS CoV2 antibodies during their consultation at the occupational medicine of HCL.
Age: ≥ 18 years old
Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months.
Persons affiliated to a social security scheme or beneficiary of such a scheme.

Key exclusion criteria (1 listed)

Pregnant or lactating woman

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 tests will be applied on patients blood samplingApplication of tests on patients' serum	Diagnostic test	Serological tests will be applied on patients blood sampling

Primary outcome

The positivity (Yes/No) of the serological test.
Time frame: Day 0
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time frame: Day 3
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time frame: Day 7
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time frame: Day 14
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time frame: Day 21
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time frame: Day 28
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time frame: Day 35
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time frame: Day 42
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

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 16 Oct 2026.
Results publication: PubMed 33450388Bal A, Trabaud MA, Fassier JB, Rabilloud M, Saker K, Langlois-Jacques C, Guibert N, Paul A, Alfaiate D, Massardier-Pilonchery A, Pitiot V, Morfin-Sherpa F, Lina B, Pozzetto B, Trouillet-Assant S; COVID SER Study Group. Six-month antibody response to SARS-CoV-2 in healthcare workers assessed by virus neutralization and commercial assays. Clin Microbiol Infect. 2021 Jun;27(6):933-935. doi: 10.1016/j.cmi.2021.01.003. Epub 2021 Jan 13. No abstract available.
Results publication: PubMed 34294751Bal A, Brengel-Pesce K, Gaymard A, Queromes G, Guibert N, Frobert E, Bouscambert M, Trabaud MA, Allantaz-Frager F, Oriol G, Cheynet V, d'Aubarede C, Massardier-Pilonchery A, Buisson M, Lupo J, Pozzetto B, Poignard P, Lina B, Fassier JB, Morfin F, Trouillet-Assant S; COVID-SER Study group. Clinical and laboratory characteristics of symptomatic healthcare workers with suspected COVID-19: a prospective cohort study. Sci Rep. 2021 Jul 22;11(1):14977. doi: 10.1038/s41598-021-93828-y.
Results publication: PubMed 34673755Pozzetto B, Legros V, Djebali S, Barateau V, Guibert N, Villard M, Peyrot L, Allatif O, Fassier JB, Massardier-Pilonchery A, Brengel-Pesce K, Yaugel-Novoa M, Denolly S, Boson B, Bourlet T, Bal A, Valette M, Andrieu T, Lina B; Covid-Ser study group; Cosset FL, Paul S, Defrance T, Marvel J, Walzer T, Trouillet-Assant S. Immunogenicity and efficacy of heterologous ChAdOx1-BNT162b2 vaccination. Nature. 2021 Dec;600(7890):701-706. doi: 10.1038/s41586-021-04120-y. Epub 2021 Oct 21.
Results publication: PubMed 33234651Trouillet-Assant S, Albert Vega C, Bal A, Nazare JA, Fascia P, Paul A, Massardier-Pilonchery A, D Aubarede C, Guibert N, Pitiot V, Lahousse M, Boibieux A, Makhloufi D, Simon C, Rabilloud M, Trabaud MA, Gueyffier F, Fassier JB; COVID-SER study group. Assessment of serological techniques for screening patients for COVID-19 (COVID-SER): a prospective, multicentric study. BMJ Open. 2020 Nov 24;10(11):e041268. doi: 10.1136/bmjopen-2020-041268.
Results publication: PubMed 36173972de Boer J, Saade U, Granjon E, Trouillet-Assant S, Saade C, Pottel H, Zrein M; Covid ser study group. A novel assessment method for COVID-19 humoral immunity duration using serial measurements in naturally infected and vaccinated subjects. PLoS One. 2022 Sep 29;17(9):e0274553. doi: 10.1371/journal.pone.0274553. eCollection 2022.
Results publication: PubMed 33399823Bal A, Pozzetto B, Trabaud MA, Escuret V, Rabilloud M, Langlois-Jacques C, Paul A, Guibert N, D'Aubarede-Frieh C, Massardier-Pilonchery A, Fabien N, Goncalves D, Boibieux A, Morfin-Sherpa F, Pitiot V, Gueyffier F, Lina B, Fassier JB, Trouillet-Assant S; COVID SER Study Group. Evaluation of High-Throughput SARS-CoV-2 Serological Assays in a Longitudinal Cohort of Patients with Mild COVID-19: Clinical Sensitivity, Specificity, and Association with Virus Neutralization Test. Clin Chem. 2021 Apr 29;67(5):742-752. doi: 10.1093/clinchem/hvaa336.
Individual participant dataSharing planned: No

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 tests will be applied on patients blood sampling in people with CoV2 Positive Caregivers, run by Hospices Civils de Lyon 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 4 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 16 Oct 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?

The positivity (Yes/No) of the serological test. (time frame: Day 0). The study lists 8 primary outcomes in all. 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 NCT04341142, which also lists 6 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 16 Oct 2026.