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

NCT04416308 | Completed

• 1 other identifier: 35RC20_9716
• Study Type: interventional
• Target: 9,453
• Locations: 1 country
• Sites: 9

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.

Conditions

Coronavirus

Keywords

Covid 19, SRAS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• a) Validation of the Biotech NG test:

  at inclusion visit

• a) Validation of the Biotech NG test:

  at inclusion visit

• a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgG

  at inclusion visit

• a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgM.

  at inclusion visit

• b) Risk of presence of anti SARS-CoV-2 antibodies in function:

  At inclusion visit

Study Arms (4)

Seroprevalence survey

OTHER

NG Test + short self-questionnaire (except validation survey and detailed survey)

Diagnostic Test: NG test; Behavioral: Self-questionnary

Validation test of the NG test survey

OTHER

Blood test + NG test + detailed self-questionnaire

Diagnostic Test: NG test; Diagnostic Test: Blood test; Behavioral: Self-questionnary

Detailed Survey

OTHER

NG test + self-questionnaire complementary to the short questionnaire

Diagnostic Test: NG test; Behavioral: Self-questionnary

Prevalence monitoring (2 population samples)

OTHER

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; Diagnostic Test: Blood test; Behavioral: Self-questionnary

Interventions

NG test DIAGNOSTIC_TEST

rapid diagnosis Covid 19

Detailed Survey; Prevalence monitoring (2 population samples); Seroprevalence survey; Validation test of the NG test survey

Blood test DIAGNOSTIC_TEST

sample

Prevalence monitoring (2 population samples); Validation test of the NG test survey

Self-questionnary BEHAVIORAL

behavioral survey

Detailed Survey; Prevalence monitoring (2 population samples); Seroprevalence survey; Validation test of the NG test survey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rennes University Hospital: lead
• Fonds NOMINOE: collaborator

Study Sites (9)

CENTRE HOSPITALIER de VITRE_ Saint Jean (La Guerche)

La Guerche-de-Bretagne, La Guerche-de-Bretagne, 35130, France

Location

Centre Hospitalier de Fougeres

Fougères, 35300, France

Location

Centre Hospitalier Grand Fougeray

Grand-Fougeray, 35390, France

Location

Centre Hospitalier de La Roche Aux Fees

Janzé, 35150, France

Location

Centre Hospitalier Montfort-Sur-Meu

Montfort-sur-Meu, 35162, France

Location

Centre Hospitalier de Redon Carentoir

Redon, 35603, France

Location

Chu Rennes

Rennes, 35000, France

Location

Centre Hospitalier St Meen Le Grand

Saint-Méen-le-Grand, 35290, France

Location

CENTRE HOSPITALIER VITRE_Simone Veil

Vitré, 35506, France

Location

Related 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: 10.1080/22221751.2020.1852893.

  PMID: 33206004 RESULT

• 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.

  PMID: 36108975 RESULT

• 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.

  PMID: 34774895 RESULT

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Christophe PARIS, MD

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For the first 30 employees a second test will be carried out a few minutes after the first test by another nurse blinded to the result of the first test in order to estimate the agreement between - observers.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 4, 2020
• Study Start: May 29, 2020
• Primary Completion: July 10, 2020
• Study Completion: October 12, 2020
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

FR (9)