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

NCT04441684 | Completed

• 1 other identifier: 7782
• Study Type: interventional
• Target: 1,466
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

COVID-19; SARS-CoV-2; Humoral response; T-cell response

Outcome Measures

Primary Outcomes (1)

• Presence of specific SARS-CoV2 antibodies in the serum in the 3 groups of subjects studied, at the inclusion visit (D0).

  Presence of specific SARS-CoV2 antibodies in the serum in the 3 groups of subjects studied, at the inclusion visit (D0).

  inclusion visit (Day 0).

Secondary Outcomes (5)

• Detection and titration of neutralizing antibodies anti-SARS-CoV-2

  At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).

• Kinetics of antibodies and their persistence over a period of 1 year

  At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).

• Number of asymptomatic subjects in the PCR - and -PCR groups

  At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).

• Number of people with positive Sars-CoV-2 serology

  At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).

• Questionnaire (Type of health care personnel, Contact history, medical operation and respect of hygiene standards)

  At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).

Other Outcomes (3)

• Analysis of the T cell response by the ELISPOT technique

  At one of the follow up visit : Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) or Month 12 (Day 0+12 months).

• B cell repertoire sequencing

  At one of the follow up visit : Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) or Month 12 (Day 0+12 months).

• Sequencing of cellular SARS-CoV2 receptors

  At one of the follow up visit : Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) or Month 12 (Day 0+12 months).

Study Arms (3)

PCR+ group

EXPERIMENTAL

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

Diagnostic Test: Blood sample for serological test

PCR- group

EXPERIMENTAL

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

Diagnostic Test: Blood sample for serological test

No PCR

EXPERIMENTAL

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

Diagnostic Test: Blood sample for serological test

Interventions

Blood sample for serological test 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; PCR+ group; PCR- group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
• Person under safeguard of justice
• Person under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, France

Location

Related Publications (2)

• 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.

  PMID: 35891471 BACKGROUND

• 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.

  PMID: 34455390 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection; Serologic Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Immunologic Tests; Immunologic Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 22, 2020
• Study Start: April 17, 2020
• Primary Completion: May 7, 2020
• Study Completion: July 16, 2021
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

FR (1)