- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04416308
COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne (AntiCoV-HB) (AntiCoV-HB)
COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
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
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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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
---|---|
Other: Seroprevalence survey
NG Test + short self-questionnaire (except validation survey and detailed survey)
|
rapid diagnosis Covid 19
behavioral survey
|
Other: Validation test of the NG test survey
Blood test + NG test + detailed self-questionnaire
|
rapid diagnosis Covid 19
behavioral survey
sample
|
Other: Detailed Survey
NG test + self-questionnaire complementary to the short questionnaire
|
rapid diagnosis Covid 19
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 |
rapid diagnosis Covid 19
behavioral survey
sample
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Christophe PARIS, MD, CHU Rennes
Publications and helpful links
General Publications
- Garlantezec R, Heslan C, Tadie E, Tattevin P, Thibault V, Paris C. A lateral flow immunoassay test performance in SARS-CoV-2 seroprevalence surveys: a validation study among healthcare workers. Emerg Microbes Infect. 2020 Dec;9(1):2547-2549. doi: 10.1080/22221751.2020.1852893.
- Garlantezec R, Tadie E, Heslan C, Gary-Bobo P, Oumari S, Saade A, Sitruk A, Tattevin P, Thibault V, Paris C; AntiCOV-HB* working group. SARS-CoV-2 seroprevalence and antibodies persistence among health care workers after the first COVID-19 wave in nine hospitals in Western France. Infect Dis Now. 2022 Nov;52(8):447-452. doi: 10.1016/j.idnow.2022.09.004. Epub 2022 Sep 13.
- Paris C, Tadie E, Heslan C, Gary-Bobo P, Oumari S, Saade A, Sitruk A, Wild P, Thibault V, Tattevin P, Garlantezec R. Risk factors for SARS-CoV-2 infection among health care workers. Am J Infect Control. 2022 Apr;50(4):375-382. doi: 10.1016/j.ajic.2021.11.001. Epub 2021 Nov 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC20_9716
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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