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

Coronavirus Clinical Trial

— AntiCoV-HB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416308
• Other study ID #: 35RC20_9716
• Status: Completed
• Phase: N/A
• Start date: May 29, 2020
• Est. completion date: October 12, 2020

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9453
• Est. completion date: October 12, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronavirus
• COVID-19

Intervention

Diagnostic Test:
• NG test
rapid diagnosis Covid 19
• Blood test
sample

Behavioral:
• Self-questionnary
behavioral survey

Locations

Country	Name	City	State
France	Centre Hospitalier de Fougeres	Fougères
France	Centre Hospitalier Grand Fougeray	Grand-Fougeray
France	Centre Hospitalier de La Roche Aux Fees	Janzé
France	CENTRE HOSPITALIER de VITRE_ Saint Jean (La Guerche)	La Guerche de Bretagne	La Guerche-de-Bretagne
France	Centre Hospitalier Montfort-Sur-Meu	Montfort sur Meu
France	Centre Hospitalier de Redon Carentoir	Redon
France	Chu Rennes	Rennes
France	Centre Hospitalier St Meen Le Grand	Saint-Méen-le-Grand
France	CENTRE HOSPITALIER VITRE_Simone Veil	Vitré

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Fonds NOMINOE

Country where clinical trial is conducted

France, 

References & Publications (3)

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/ — View 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 ho — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of presence of anti-SARS-CoV-2 antibodies (Ig G _ Ig M) among employees working in a GHT Haute Bretagne health establishment.	Rate of presence	at inclusion visit
Secondary	a) Validation of the Biotech NG test:	Sensitivity	at inclusion visit
Secondary	a) Validation of the Biotech NG test:	Specificity	at inclusion visit
Secondary	a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgG	agreement between observers (kappa coefficient)	at inclusion visit
Secondary	a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgM.	agreement between observers (kappa coefficient)	at inclusion visit
Secondary	b) Risk of presence of anti SARS-CoV-2 antibodies in function:	Demographic characteristics (age, sex)	At inclusion visit
Secondary	b) Risk of presence of anti SARS-CoV-2 antibodies in function:	- Professional characteristics (establishment, profession, service).	At inclusion visit
Secondary	b) Risk of presence of anti SARS-CoV-2 antibodies in function:	- Management of confirmed or probable COVID-19 patients	At inclusion visit
Secondary	b) Risk of presence of anti SARS-CoV-2 antibodies in function:	- From contact with confirmed or probable COVID-19 professionals.	At inclusion visit
Secondary	b) Risk of presence of anti SARS-CoV-2 antibodies in function:	- From contact in his personal circle with COVID-19 confirmed or probable persons.	At inclusion visit
Secondary	b) Risk of presence of anti SARS-CoV-2 antibodies in function:	- Episodes of symptoms suggestive of COVID-19	At inclusion visit
Secondary	b) Risk of presence of anti SARS-CoV-2 antibodies in function:	- The existence of a chronic immunomodulatory pathology	At inclusion visit
Secondary	b) Risk of presence of anti SARS-CoV-2 antibodies in function:	- The existence of smoking	At inclusion visit
Secondary	c) Risk of presence of anti SARS-CoV-2 antibodies in function:	- The use of materials adapted to good hygiene practices	At inclusion visit
Secondary	c) Risk of presence of anti SARS-CoV-2 antibodies in function:	- Service organization	At inclusion visit
Secondary	d) Description of the experience and behavioral changes related to the epidemic,	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
Secondary	d) Description of the experience and behavioral changes related to the epidemic,	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
Secondary	d) Description of the experience and behavioral changes related to the epidemic,	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
Secondary	d) Description of the experience and behavioral changes related to the epidemic,	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
Secondary	d) Description of the experience and behavioral changes related to the epidemic,	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
Secondary	d) Description of the experience and behavioral changes related to the epidemic,	depending on the work sector (COVID dedicated or not) and depending on the profession: - Description of sleep changes	at Day 0
Secondary	d) Description of the experience and behavioral changes related to the epidemic,	depending on the work sector (COVID dedicated or not) and depending on the profession: - Description of lived experience and perceived stress	at Day 0
Secondary	e) Evolution of seroprevalence over time:	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
Secondary	e) Evolution of seroprevalence over time:	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
Secondary	e) Evolution of seroprevalence over time:	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