Skip to main content
OpenTrials
Completed

NCT Number: NCT04441684

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

SARS-CoV-2 Serological Status COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Seroprevalence Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Strasbourg, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

Other outcomes

  1. Analysis of the T cell response by the ELISPOT technique

    Time frame: 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).

  2. B cell repertoire sequencing

    Time frame: 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).

  3. Sequencing of cellular SARS-CoV2 receptors

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Study of the Seroprevalence of SARS-CoV-2 in Hospital Staff in Strasbourg University Hospital, Strasbourg, France

Acronym: SeroCoV-HUS

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 22, 2020
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.