COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne (AntiCoV-HB) (AntiCoV-HB)

May 22, 2023 updated by: Rennes University Hospital

COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne

Since the start of this epidemic, numerous clinical and fundamental studies have been conducted to best adapt the individual management of COVID-19 cases [1-6]. In parallel with this work, it is necessary to better understand the characteristics of the epidemic in the general population but also in the population working in healthcare settings more exposed to SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand the collective immunization rate and the factors that can explain this immunization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The first cases of the new coronavirus disease 2019 (COVID-19) due to the SARS-CoV-2 virus were reported in December 2019 in Wuhan, China. Since that date, a significant circulation of the virus around the world has been observed, justifying that WHO described the situation as pandemic on March 11.

Since the start of this epidemic, numerous clinical and fundamental studies have been conducted to best adapt the individual management of COVID-19 cases. In parallel with this work, it is necessary to better understand the characteristics of the epidemic in the general population but also in the population working in healthcare settings more exposed to SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand the collective immunization rate and the factors that can explain this immunization. In the general population, only one recent study in France, in the Oise, one of the first clusters in France, reports a seroconversion rate of 35% in the area concerned [7]. This study used three different tests (ELISA, S-FLOW, LIPS assays) to define seroconversion (people were considered positive if at least one of the tests reported the presence of Anti SARS CoV 2 Antibodies).

The proportion of people infected in Brittany, estimated by modeling work, would be 1.8% [1.1% -3.3%]. At the present time, no data exist to our knowledge on the seroprevalence of anti SARS-CoV-2 antibodies in healthcare populations. Many serological tests are currently being validated. The Rennes University Hospital, thanks to the support of the NOMINOE fund, will offer all employees of the territory hospital group (GHT) Haute-Bretagne to participate in this seroprevalence study using the serological test from the company NG-Biotech. It is a device of the type "rapid serological diagnostic orientation test (TROD)" which can be carried out outside medical biology laboratories by a doctor / pharmacist who is not a biologist or a nurse. This test provides a result in about fifteen minutes. The NG-Biotech test has a CE / IVD mark (pending opinion from the Institut Pasteur). An assessment of the sensitivity and specificity of the test was carried out at the CHU Kremlin Bicêtre and CHU Paul Brousse. From a sample of 101 COVID-19 patients (diagnosed by RT-PCR on nasopharyngeal or pulmonary samples) and 50 negative controls (30 pre-pandemic sera from September and October 2017 and 20 sera from patients tested COVID- 19 negative by RT-PCR without any symptoms for more than 15 days) a sensitivity of 97% [88.7% - 99.4%] and a specificity of 100% [91.1% -100%] were obtained 15 days after the first signs of COVID-19 patients. If the validity of the test is very good in this study, its main limitation is that it was carried out with a group of COVID-19 patients who were in the vast majority hospitalized (84% of patients) and therefore not representative of pauci or asymptomatic patients .

Consequently, given the absence of consolidated data on the immune response based on clinical pictures, it is relevant to continue validation in a population of employees in which we wish to carry out this seroprevalence study and where the majority of infections did not lead to hospitalization. In addition, it is also necessary to obtain other data, in particular concerning the inter-observer reproducibility of the test which has not yet been studied. The need to validate the test in pauci or asymptomatic populations and to obtain reproducibility data was underlined in the opinion of the HAS on the methods for evaluating the performance of serological tests detecting antibodies directed against SARS-CoV -2.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9453

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Fougères, France, 35300
        • Centre Hospitalier de Fougères
      • Grand-Fougeray, France, 35390
        • Centre Hospitalier Grand Fougeray
      • Janzé, France, 35150
        • Centre Hospitalier de La Roche Aux Fees
      • Montfort sur Meu, France, 35162
        • Centre Hospitalier Montfort-Sur-Meu
      • Redon, France, 35603
        • Centre Hospitalier de Redon Carentoir
      • Rennes, France, 35000
        • Chu Rennes
      • Saint-Méen-le-Grand, France, 35290
        • Centre Hospitalier St Meen Le Grand
      • Vitré, France, 35506
        • CENTRE HOSPITALIER VITRE_Simone Veil
    • La Guerche-de-Bretagne
      • La Guerche de Bretagne, La Guerche-de-Bretagne, France, 35130
        • CENTRE HOSPITALIER de VITRE_ Saint Jean (La Guerche)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Employees of voluntary establishments of GHT Haute-Bretagne
  • Employees over the age of 18
  • Having signed a free, informed and written consent.

Exclusion Criteria:

  • Employees subject to legal protection (safeguard of justice, guardianship, curatorship)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Seroprevalence survey
NG Test + short self-questionnaire (except validation survey and detailed survey)
Diagnostic test: NG test
rapid diagnosis Covid 19
Behavioral: Self-questionnary
behavioral survey
Other: Validation test of the NG test survey
Blood test + NG test + detailed self-questionnaire
Diagnostic test: NG test
rapid diagnosis Covid 19
Behavioral: Self-questionnary
behavioral survey
Diagnostic test: Blood test
sample
Other: Detailed Survey
NG test + self-questionnaire complementary to the short questionnaire
Diagnostic test: NG test
rapid diagnosis Covid 19
Behavioral: Self-questionnary
behavioral survey
Other: Prevalence monitoring (2 population samples)

Participants having presented a certain or probable COVID: acts of the validation test survey, + follow-up questionnaire,+ blood test + NG test, on D30 and D90

Others Participants : drawn by lot: acts of the seroprevalence survey, + follow-up questionnaire + NG test, on D90
Diagnostic test: NG test
rapid diagnosis Covid 19
Behavioral: Self-questionnary
behavioral survey
Diagnostic test: Blood test
sample

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
rate of presence of anti-SARS-CoV-2 antibodies (Ig G _ Ig M) among employees working in a GHT Haute Bretagne health establishment.
Time Frame: at inclusion visit
Rate of presence
at inclusion visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
a) Validation of the Biotech NG test:
Time Frame: at inclusion visit
Sensitivity
at inclusion visit
a) Validation of the Biotech NG test:
Time Frame: at inclusion visit
Specificity
at inclusion visit
a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgG
Time Frame: at inclusion visit
agreement between observers (kappa coefficient)
at inclusion visit
a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgM.
Time Frame: at inclusion visit
agreement between observers (kappa coefficient)
at inclusion visit
b) Risk of presence of anti SARS-CoV-2 antibodies in function:
Time Frame: At inclusion visit
Demographic characteristics (age, sex)
At inclusion visit
b) Risk of presence of anti SARS-CoV-2 antibodies in function:
Time Frame: At inclusion visit
- Professional characteristics (establishment, profession, service).
At inclusion visit
b) Risk of presence of anti SARS-CoV-2 antibodies in function:
Time Frame: At inclusion visit
- Management of confirmed or probable COVID-19 patients
At inclusion visit
b) Risk of presence of anti SARS-CoV-2 antibodies in function:
Time Frame: At inclusion visit
- From contact with confirmed or probable COVID-19 professionals.
At inclusion visit
b) Risk of presence of anti SARS-CoV-2 antibodies in function:
Time Frame: At inclusion visit
- From contact in his personal circle with COVID-19 confirmed or probable persons.
At inclusion visit
b) Risk of presence of anti SARS-CoV-2 antibodies in function:
Time Frame: At inclusion visit
- Episodes of symptoms suggestive of COVID-19
At inclusion visit
b) Risk of presence of anti SARS-CoV-2 antibodies in function:
Time Frame: At inclusion visit
- The existence of a chronic immunomodulatory pathology
At inclusion visit
b) Risk of presence of anti SARS-CoV-2 antibodies in function:
Time Frame: At inclusion visit
- The existence of smoking
At inclusion visit
c) Risk of presence of anti SARS-CoV-2 antibodies in function:
Time Frame: At inclusion visit
- The use of materials adapted to good hygiene practices
At inclusion visit
c) Risk of presence of anti SARS-CoV-2 antibodies in function:
Time Frame: At inclusion visit
- Service organization
At inclusion visit
d) Description of the experience and behavioral changes related to the epidemic,
Time Frame: at Day 0

depending on the work sector (COVID dedicated or not) and depending on the profession:

- Rate of employees who changed their tobacco consumption
at Day 0
d) Description of the experience and behavioral changes related to the epidemic,
Time Frame: at Day 0

depending on the work sector (COVID dedicated or not) and depending on the profession:

- Description of the reasons for modifying tobacco consumption
at Day 0
d) Description of the experience and behavioral changes related to the epidemic,
Time Frame: at Day 0

depending on the work sector (COVID dedicated or not) and depending on the profession:

- Rate of employees who changed their alcohol consumption
at Day 0
d) Description of the experience and behavioral changes related to the epidemic,
Time Frame: at Day 0

depending on the work sector (COVID dedicated or not) and depending on the profession:

- Description of the reasons for modification of alcohol consumption
at Day 0
d) Description of the experience and behavioral changes related to the epidemic,
Time Frame: at Day 0

depending on the work sector (COVID dedicated or not) and depending on the profession:

- Rate of employees who have changed their eating habits
at Day 0
d) Description of the experience and behavioral changes related to the epidemic,
Time Frame: at Day 0

depending on the work sector (COVID dedicated or not) and depending on the profession:

- Description of sleep changes
at Day 0
d) Description of the experience and behavioral changes related to the epidemic,
Time Frame: at Day 0

depending on the work sector (COVID dedicated or not) and depending on the profession:

- Description of lived experience and perceived stress
at Day 0
e) Evolution of seroprevalence over time:
Time Frame: At Day30

For employees identified as COVID "certain or probable"

* Percentage of employees with antibodies (IgG and IgM) against SARS CoV-2 on D30 and D90.
At Day30
e) Evolution of seroprevalence over time:
Time Frame: At Day 90

For employees identified as COVID "certain or probable"

* Evolution of the kinetics of antibodies (IgG and IgM) against SARS CoV-2 on D30 and D90.
At Day 90
e) Evolution of seroprevalence over time:
Time Frame: At Day 90
For the random sample of employees with follow-up on D90: Percentage of employees with antibodies (IgG and IgM) against SARS CoV-2
At Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rennes University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fonds NOMINOE

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christophe PARIS, MD, Chu Rennes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 35RC20_9716

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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