Seroprevalence of SARS-CoV-2 in Strasbourg University Hospital, Strasbourg, France (COVID-19)
NCT ID: NCT04441684
Last Updated: 2026-01-20
Study Results
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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COMPLETED
NA
1466 participants
INTERVENTIONAL
2020-04-17
2021-07-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
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.
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.
PCR- group
This group includes any symptomatic person with a negative RT-PCR COVID 19 test carried out at least 10 days before inclusion.
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.
No PCR
This group includes any person, for which no COVID 19 RT- PCR testing was performed.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
* Person under safeguard of justice
* Person under guardianship or curatorship
18 Years
ALL
Yes
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Locations
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Hôpitaux Universitaires de Strasbourg - Centre d'Investigation Clinique - Nouvel Hôpital Civil et Hautepierre
Strasbourg, , France
Countries
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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.
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.
Other Identifiers
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7782
Identifier Type: -
Identifier Source: org_study_id
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