Seroprevalence of SARS-CoV-2 in Strasbourg University Hospital, Strasbourg, France (COVID-19)

NCT ID: NCT04441684

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1466 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-17

Study Completion Date

2021-07-16

Brief Summary

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COVID-19 is a new emerging disease caused by infection with the SARS-CoV-2 coronavirus, with no specific therapeutic options.

Since the end of February 2020, the Strasbourg University Hospital (HUS) had faced a sudden increase of patients with COVID-19 resulted from a SARS-CoV-2 superspreading event (religious meeting). Infected individuals went to regional hospitals, and this led to a cluster of infected healthcare workers at the Strasbourg University Hospitals from the first week of March. To date, several hundred Strasbourg hospital workers have presented a SARS-CoV-2 infection confirmed by the RT-PCR test from a nasopharyngeal sample. Most of them developed a mild form of COVID-19.

It is important to understand how far the infection has spread in the hospital staff, and to which extent the individuals who have been infected develop antibodies against SARS-CoV-2.

Detailed Description

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Conditions

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SARS-CoV-2 Serological Status SARS-CoV-2 Seroprevalence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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PCR+ group

This group includes any symptomatic person with a positive COVID result, with a RT-PCR test carried out at least 10 days before inclusion.

Group Type EXPERIMENTAL

Blood sample for serological test

Intervention Type DIAGNOSTIC_TEST

Serology tests:

* By LFA-ICT: BIOSYNEX COVID-19 BSS reference SW40005, BIOSYNEX SWISS SA, Fribourg, Switzerland
* ELISA: EDI™ Novel Coronavirus COVID-19 ELISA IgG Kit, Epitope Diagnostics, Inc., San Diego, USA

Confirmation test by seroneutralization tests developed at the Strasbourg Virology laboratory on whole virus (analyzes performed in a biosafety level 3 laboratory) and by the viral pseudoparticles system, will be performed.

PCR- group

This group includes any symptomatic person with a negative RT-PCR COVID 19 test carried out at least 10 days before inclusion.

Group Type EXPERIMENTAL

Blood sample for serological test

Intervention Type DIAGNOSTIC_TEST

Serology tests:

* By LFA-ICT: BIOSYNEX COVID-19 BSS reference SW40005, BIOSYNEX SWISS SA, Fribourg, Switzerland
* ELISA: EDI™ Novel Coronavirus COVID-19 ELISA IgG Kit, Epitope Diagnostics, Inc., San Diego, USA

Confirmation test by seroneutralization tests developed at the Strasbourg Virology laboratory on whole virus (analyzes performed in a biosafety level 3 laboratory) and by the viral pseudoparticles system, will be performed.

No PCR

This group includes any person, for which no COVID 19 RT- PCR testing was performed.

Group Type EXPERIMENTAL

Blood sample for serological test

Intervention Type DIAGNOSTIC_TEST

Serology tests:

* By LFA-ICT: BIOSYNEX COVID-19 BSS reference SW40005, BIOSYNEX SWISS SA, Fribourg, Switzerland
* ELISA: EDI™ Novel Coronavirus COVID-19 ELISA IgG Kit, Epitope Diagnostics, Inc., San Diego, USA

Confirmation test by seroneutralization tests developed at the Strasbourg Virology laboratory on whole virus (analyzes performed in a biosafety level 3 laboratory) and by the viral pseudoparticles system, will be performed.

Interventions

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Blood sample for serological test

Serology tests:

* By LFA-ICT: BIOSYNEX COVID-19 BSS reference SW40005, BIOSYNEX SWISS SA, Fribourg, Switzerland
* ELISA: EDI™ Novel Coronavirus COVID-19 ELISA IgG Kit, Epitope Diagnostics, Inc., San Diego, USA

Confirmation test by seroneutralization tests developed at the Strasbourg Virology laboratory on whole virus (analyzes performed in a biosafety level 3 laboratory) and by the viral pseudoparticles system, will be performed.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Any person, male or female, over 18 years of age at the time of signing the consent
* Any person affiliated to a social health insurance scheme
* Any person able to understand the objectives and risks related to research and to give an informed, dated and signed consent
* Any person who is part of HUS staff and working at HUS at the time of the pandemic, including residents affiliated with HUS and assigned to general hospitals in the region
* Any symptomatic person with a positive COVID result (PCR + group) or negative (PCR- group) with a RT-PCR test carried out at least 10 days before inclusion, or any person, for which no COVID PCR was performed (group " No PCR")

Exclusion Criteria

* Person in exclusion period (determined by a previous or ongoing study),
* Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
* Person under safeguard of justice
* Person under guardianship or curatorship
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpitaux Universitaires de Strasbourg - Centre d'Investigation Clinique - Nouvel Hôpital Civil et Hautepierre

Strasbourg, , France

Site Status

Countries

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France

References

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Garcia L, Woudenberg T, Rosado J, Dyer AH, Donnadieu F, Planas D, Bruel T, Schwartz O, Prazuck T, Velay A, Fafi-Kremer S, Batten I, Reddy C, Connolly E, McElheron M, Kennelly SP, Bourke NM, White MT, Pelleau S. Kinetics of the SARS-CoV-2 Antibody Avidity Response Following Infection and Vaccination. Viruses. 2022 Jul 8;14(7):1491. doi: 10.3390/v14071491.

Reference Type BACKGROUND
PMID: 35891471 (View on PubMed)

Gallais F, Gantner P, Bruel T, Velay A, Planas D, Wendling MJ, Bayer S, Solis M, Laugel E, Reix N, Schneider A, Glady L, Panaget B, Collongues N, Partisani M, Lessinger JM, Fontanet A, Rey D, Hansmann Y, Kling-Pillitteri L, Schwartz O, De Seze J, Meyer N, Gonzalez M, Schmidt-Mutter C, Fafi-Kremer S. Evolution of antibody responses up to 13 months after SARS-CoV-2 infection and risk of reinfection. EBioMedicine. 2021 Sep;71:103561. doi: 10.1016/j.ebiom.2021.103561. Epub 2021 Aug 27.

Reference Type RESULT
PMID: 34455390 (View on PubMed)

Other Identifiers

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7782

Identifier Type: -

Identifier Source: org_study_id

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