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

Overview

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.

Full Title of Study: “Study of the Seroprevalence of SARS-CoV-2 in Hospital Staff in Strasbourg University Hospital, Strasbourg, France”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 7, 2020

Interventions

  • Diagnostic Test: 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Experimental: PCR- group
    • This group includes any symptomatic person with a negative RT-PCR COVID 19 test carried out at least 10 days before inclusion.
  • Experimental: No PCR
    • This group includes any person, for which no COVID 19 RT- PCR testing was performed.

Clinical Trial Outcome Measures

Primary Measures

  • Presence of specific SARS-CoV2 antibodies in the serum in the 3 groups of subjects studied, at the inclusion visit (D0).
    • Time Frame: inclusion visit (Day 0).
    • Presence of specific SARS-CoV2 antibodies in the serum in the 3 groups of subjects studied, at the inclusion visit (D0).

Secondary Measures

  • Detection and titration of neutralizing antibodies anti-SARS-CoV-2
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Strasbourg, France
  • Provider of Information About this Clinical Study
    • Sponsor

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