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Covid19COVID-SeroPRIMNCT04808986

Seroprevalence of IgG Antibodies to SARS-CoV-2 (COVID-19) in Primary Health Care Workers and Their Household Contacts

A study testing Serological test for the detection of IgG anti-SARS-CoV-2 in people with Covid19, run by Institut National de la Santé Et de la Recherche Médicale, France 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

Many uncertainties remain regarding the epidemiological and clinical characteristics of COVID-19, including the number of people exposed to the disease, the persistence of the humoral response and its associated neutralisation capacity in recovered patients, and the long-term health consequences of the infection. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
Serological test for the detection of IgG anti-SARS-CoV-2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,817 participants
Where
1 siteFrance
Study dates
10 May 2021to 12 Oct 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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Health professionals in primary care :
  • General practitioners, paediatricians, pharmacists, pharmacy assistants, dental surgeons or dental assistants practising in metropolitan France at the time of inclusion (condition ensured by affiliation to one of the four networks);
  • Be affiliated to one of the following networks: Sentinelles, AFPA, IQVIA, ReCOL or work in a city pharmacy (for pharmacy assistants) or in a dental practice (dental assistants) whose owners are affiliated to these networks;
  • To be a volunteer to participate in the study;
  • To have given their agreement in principle to the collection of data (including personal data) necessary for recruitment;
  • Have given their consent to participate in the study;
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  • To be affiliated to a social security scheme or to be a beneficiary of such a scheme.
  • Members of health professionals' households :
  • Occupy the same dwelling as a healthcare professional included in PHASE 1 of the COVID-SeroPRIM study at least 2 days per week (including weekend attendees, every other week, etc.) at the time of inclusion in the study, without necessarily being related;
  • To have volunteered to participate in the study;
  • To have given their consent to participate in the study or, in the case of minors, consent given by the representative(s) of the parental authority;
  • To be able to understand the study process, to fill in the questionnaires and to take the planned samples (if the person included is old enough to understand).

Who cannot join

  • Persons subject to a legal protection measure (safeguard of justice, curatorship, guardianship);
  • Persons who have participated in clinical trials to test chemoprophylaxis to prevent infection with SARS-CoV-2.
  • Minors who do not have a parent or guardian in the health professional's household

Trial locations and contacts

1 site in 1 country.

France1 site
  • Institut Pierre Louis Epidemiologie Et Sante Publique

    Paris, 75012

Other trials in France

About this study

Official title: Séroprévalence Des IgG dirigés Contre le SARS-CoV-2 Chez Les Professionnels de santé en Soins Primaires et Leurs Contacts au Sein Des ménages

Many uncertainties remain regarding the epidemiological and clinical characteristics of COVID-19, including the number of people exposed to the disease, the persistence of the humoral response and its associated neutralisation capacity in recovered patients, and the long-term health consequences of the infection. The French national COVID-SeroPRIM survey aims to estimate the seroprevalence of IgG antibodies to SARS-CoV-2 in four populations of primary care health professionals: primary care physicians (general practitioners and paediatricians), health professionals working in city pharmacies (pharmacists and compounders) and in dental practices (dentists and dental assistants). Indeed, the majority of published studies target healthcare professionals in hospitals. It is therefore essential to provide new knowledge on the exposure of primary care workers to the virus in order to assess the impact of the pandemic, the level of immunity and the risk factors for exposure to the virus. These data will be very useful for public health decision makers to better adapt health protocols and provide useful information to better guide future vaccination campaigns. Assuming that vaccination against COVID-19 will start in January 2021, data on the vaccination rate of health professionals and their households will also be collected and made available to policy makers in a timely manner. This study will be conducted in collaboration with four primary care research and/or monitoring networks: the Sentinelles network (general practitioners), the Association de Formation Professionnelle en Pédiatrie (Association for Professional Training in Paediatrics), IQVIA (general practitioners and pharmacies), and the Réseau de Recherche Clinique en Odontologie Libérale (ReCOL, dental surgeons) Seroprevalence will be estimated using a high-sensitivity ELISA designed to detect SARS-CoV-2 specific IgG antibodies in humoral fluid and a high-specificity seroneutralisation test to assess seropositivity (i.e. excluding false positive ELISA results due to cross-reactivity with other coronaviruses) and to assess SARS-CoV-2 neutralising antibody levels. These techniques have already been used in two general population cohort studies (SAPRIS-SERO and EpiCoV) with the objective of describing SARS-CoV-2 seroprevalence and risk factors. The secondary objectives of the COVID-SeroPRIM study will be to assess the seroprevalence of IgG antibodies to SARS-CoV-2 in household contacts of health care workers, to identify risk factors for seropositivity to SARS-CoV-2, and to retrospectively describe the symptoms experienced by individuals diagnosed with COVID-19. Due to the use of the same methodology to assess seroprevalence, these results will be broadly complementary and comparable to those of seroepidemiological studies conducted in the general population, such as EpiCOV and SAPRIS-SERO. These surveys (EpiCOV, SAPRIS-SERO and COVID-SeroPRIM) as a whole are based on similar questionnaires and identical serological methods and will provide many health indicators such as the proportion of people who presented symptoms, who consulted for a suspicion of COVID-19, who were screened but also who did not seek care in the recent period. The COVID-SeroPRIM study, by targeting primary care health professionals and their households, will provide data to reinforce the knowledge from SAPRIS-SERO and EpiCOV and to better understand the dynamics of the epidemic in these four populations in order to guide public policy makers.

This project has received funding from the French National Research Agency (ANR) as part of the COVID-19 call for research projects, which aims to support urgent and rapid projects whose results could be implemented in society in the coming months.

Main objective To estimate the seroprevalence of IgG antibodies to SARS-CoV-2 in four distinct populations of primary care health professionals (general practitioners, paediatricians, health professionals practising in city pharmacies and dental practices) in metropolitan France.

Read the detailed description

Primary endpoint

  • Estimation of the prevalence of healthcare professionals with IgG antibodies to SARS-CoV-2 in each of the four study populations (general practitioners, paediatricians, healthcare professionals practising in community pharmacies and dental practices).

Secondary endpoint

  • Comparison of the estimated prevalence of IgG antibodies to SARS-CoV-2 between each healthcare professional population and the general population (EpiCOV and SAPRIS-SERO studies);
  • Comparison of the estimated prevalence of IgG antibodies to SARS-CoV-2 between the four healthcare worker populations studied;
  • Estimation of the prevalence of household contacts of healthcare workers with IgG antibodies to SARS-CoV-2;
  • Estimation of the prevalence of neutralising antibodies to SARS-CoV-2;
  • Estimating the prevalence of vaccine-acquired antibodies among health workers and their household contacts;
  • Measurement of the association between SARS-CoV-2 IgG seropositivity and the characteristics (socio-demographic data, implementation of hygiene measures, professional practices, etc.) of the health professionals participating in the study;
  • Measure of association between SARS-CoV-2 IgG seropositivity and characteristics (socio-demographics, adherence to hygiene measures, work practices, etc.) among members of health workers' households;
  • Proportion of a- and paucisymptomatic forms in study participants;
  • To retrospectively describe the symptoms reported by health workers and their household members with a biologically confirmed diagnosis of COVID-19.

Target populations First phase The target populations are all four of the following healthcare professional populations: general practitioners, paediatricians, healthcare professionals practising in city pharmacies (pharmacists and dispensing chemists) and in dental practices (dental surgeons and dental assistants) who are self-employed in metropolitan France at the time of their inclusion in the study (planned for January 2021) The source populations are general practitioners, paediatricians, health professionals practising in city pharmacies (pharmacists and dispensing chemists) and in dental practices (dental surgeons and dental assistants) who are self-employed in metropolitan France, and who are affiliated to the following four health professional networks at the time of their inclusion in the study: Sentinelles, AFPA, IQVIA, and ReCOL networks.

Second phase Household members of primary care health professionals The target population is all the members of the households of the following four populations of healthcare professionals: general practitioners, paediatricians, healthcare professionals practising in town pharmacies (pharmacists and dispensing chemists) and in dental practices (dental surgeons and dental assistants) who are self-employed in metropolitan France at the time of their inclusion in the study. The source population is made up of members of households of general practitioners, paediatricians, health professionals practising in city pharmacies (pharmacists and dispensing chemists) and in dental practices (dental surgeons and dental assistants) who are members of a network of health professionals listed below, and who are participating in phase 1 of the COVID-SeroPRIM study: Sentinelles, AFPA, IQVIA, and ReCOL networks.

Conditions
Covid19
Being tested
Serological test for the detection of IgG anti-SARS-CoV-2
Medical subject headings
COVID-19

What participants receive

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

  • Serological test for the detection of IgG anti-SARS-CoV-2Diagnostic test

    Self-sampling dried-blood spot (DBS) kits will be send to each participant including material (a DBS card, lancets, pad), detailed printed instructionson how to perform thetest, and a self-addressed stamped padded envelope to be returned with the card to the centralized biobank (CEPH Biobank, Paris, France). Tubes will be sent sent to the virology laboratory (Unité des virus Émergents, Marseille, France) for serological analysis.

Study groups in NCT04808986
Study groupRoleWhat they receive
serology COVID-19OtherSerology of COVID-19 will be proposed to all health professionels and household members included in the study
Receives: Diagnostic Test: Serological test for the detection of IgG anti-SARS-CoV-2

What is being measured

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

  1. Seroprevalence estimates in health care professionals

    Seroprevalence estimates of healthcare professionals with IgG antibodies to SARS-CoV-2 in each of the four study populations (general practitioners, paediatricians, healthcare professionals working in community pharmacies and dental practices).

    Measured: 3 months

Timeline

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

  1. First posted22 Mar 2021
  2. Study start10 May 2021
  3. Primary completion12 Oct 2021
  4. Study completion12 Oct 2021

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
This is a monocentric cross-sectional epidemiological study, with descriptive and analytical aims, carried out in metropolitan France. This study is qualified as research involving the human person of category 2 (RIPH2) as defined in the 2nd of article L. 1121-1 of the public health code, i.e. interventional research that involves only minimal risks and constraints, the list of which is set by order of 12 April 2018 of the minister in charge of health, after the opinion of the director general of the National Agency for the Safety of Medicines and Health Products (ANSM).
Masking
None (open label)
Enrolment
2,817 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04808986
Sponsor's protocol ID
C20-72
Other IDs
ID RCB : 2020-A03298-31
Acronym
COVID-SeroPRIM
Status last verified
Nov 2023
First submitted
17 Mar 2021
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pouquet M, Decarreaux D, Di Domenico L, Sabbatini CE, Prevot-Monsacre P, Fourie T, Villarroel PMS, Priet S, Blanche H, Sebaoun JM, Deleuze JF, Turbelin C, Rossignol L, Werner A, Kochert F, Grosgogeat B, Rabiega P, Laupie J, Abraham N, Noel H, van der Werf S, Colizza V, Carrat F, Charrel R, de Lamballerie X, Blanchon T, Falchi A. SARS-CoV-2 infection prevalence and associated factors among primary healthcare workers in France after the third COVID-19 wave. Sci Rep. 2024 Mar 5;14(1):5418. doi: 10.1038/s41598-024-55477-9.

    PubMed 38443618
  • Decarreaux D, Pouquet M, Souty C, Vilcu AM, Prevot-Monsacre P, Fourie T, Villarroel PMS, Priet S, Blanche H, Sebaoun JM, Deleuze JF, Turbelin C, Werner A, Kochert F, Grosgogeat B, Rabiega P, Laupie J, Abraham N, Guerrisi C, Noel H, Van der Werf S, Carrat F, Hanslik T, Charrel R, De Lamballerie X, Blanchon T, Falchi A. Seroprevalence of SARS-CoV-2 IgG Antibodies and Factors Associated with SARS-CoV-2 IgG Neutralizing Activity among Primary Health Care Workers 6 Months after Vaccination Rollout in France. Viruses. 2022 May 3;14(5):957. doi: 10.3390/v14050957.

    PubMed 35632699
  • Pouquet M, Decarreaux D, Prevot-Monsacre P, Herve C, Werner A, Grosgogeat B, Blanche H, Rabiega P, Laupie J, Kochert F, Abraham N, Sebaoun JM, de Lamballerie X, Charrel R, Souty C, Camara I, Pergeline J, Noel H, Guerrisi C, Werf SV, Carrat F, Hanslik T, Blanchon T, Falchi A. Nationwide Seroprevalence of SARS-CoV-2 IgG Antibodies among Four Groups of Primary Health-Care Workers and Their Household Contacts 6 Months after the Initiation of the COVID-19 Vaccination Campaign in France: SeroPRIM Study Protocol. Pathogens. 2021 Jul 20;10(7):911. doi: 10.3390/pathogens10070911.

    PubMed 34358061

Questions about this trial

What is this clinical trial studying?

A study testing Serological test for the detection of IgG anti-SARS-CoV-2 in people with Covid19, run by Institut National de la Santé Et de la Recherche Médicale, France 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 12 inclusion and 3 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 4 Sep 2025. 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?

Seroprevalence estimates in health care professionals (time frame: 3 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 NCT04808986, which also lists 3 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 4 Sep 2025.

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