Clinical trial NCT04416308: COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne (AntiCoV-HB)
Official title: COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus
Keywords: Covid 19, SRAS-CoV-2
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Fonds NOMINOE
First posted: 2020-06-04
Enrollment: 9453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi-center cross-sectional survey at risk and minimal constraints, among GHT Haute Bretagne employees in order to know the prevalence of the presence of anti-SARS-CoV-2 antibodies.

For a sample of employees with no additional prospective follow-up will be done on D30 and D90.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: rate of presence of anti-SARS-CoV-2 antibodies (Ig G _ Ig M) among employees working in a GHT Haute Bretagne health establishment.
timeFrame: at inclusion visit
Secondary outcomes:
measure: a) Validation of the Biotech NG test:
timeFrame: at inclusion visit
measure: a) Validation of the Biotech NG test:
timeFrame: at inclusion visit
measure: a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgG
timeFrame: at inclusion visit
measure: a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgM.
timeFrame: at inclusion visit
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
timeFrame: At inclusion visit
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
timeFrame: At inclusion visit
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
timeFrame: At inclusion visit
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
timeFrame: At inclusion visit
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
timeFrame: At inclusion visit
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
timeFrame: At inclusion visit
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
timeFrame: At inclusion visit
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
timeFrame: At inclusion visit
measure: c) Risk of presence of anti SARS-CoV-2 antibodies in function:
timeFrame: At inclusion visit
measure: c) Risk of presence of anti SARS-CoV-2 antibodies in function:
timeFrame: At inclusion visit
measure: d) Description of the experience and behavioral changes related to the epidemic,
timeFrame: at Day 0
measure: d) Description of the experience and behavioral changes related to the epidemic,
timeFrame: at Day 0
measure: d) Description of the experience and behavioral changes related to the epidemic,
timeFrame: at Day 0
measure: d) Description of the experience and behavioral changes related to the epidemic,
timeFrame: at Day 0
measure: d) Description of the experience and behavioral changes related to the epidemic,
timeFrame: at Day 0
measure: d) Description of the experience and behavioral changes related to the epidemic,
timeFrame: at Day 0
measure: d) Description of the experience and behavioral changes related to the epidemic,
timeFrame: at Day 0
measure: e) Evolution of seroprevalence over time:
timeFrame: At Day30
measure: e) Evolution of seroprevalence over time:
timeFrame: At Day 90
measure: e) Evolution of seroprevalence over time:
timeFrame: At Day 90
Other outcomes:
Locations:
city: La Guerche de Bretagne
country: France
facility: CENTRE HOSPITALIER de VITRE_ Saint Jean (La Guerche)
state: La Guerche-de-Bretagne
city: Fougères
country: France
facility: Centre Hospitalier de Fougeres
city: Grand-Fougeray
country: France
facility: Centre Hospitalier Grand Fougeray
city: Janzé
country: France
facility: Centre Hospitalier de La Roche Aux Fees
city: Montfort sur Meu
country: France
facility: Centre Hospitalier Montfort-Sur-Meu
city: Redon
country: France
facility: Centre Hospitalier de Redon Carentoir
city: Rennes
country: France
facility: Chu Rennes
city: Saint-Méen-le-Grand
country: France
facility: Centre Hospitalier St Meen Le Grand
city: Vitré
country: France
facility: CENTRE HOSPITALIER VITRE_Simone Veil
Study officials:
affiliation: CHU Rennes
name: Christophe PARIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.