We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04441684
Recruitment Status : Completed
First Posted : June 22, 2020
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
SARS-CoV-2 Serological Status SARS-CoV-2 Seroprevalence Diagnostic Test: Blood sample for serological test Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1466 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Study of the Seroprevalence of SARS-CoV-2 in Hospital Staff in Strasbourg University Hospital, Strasbourg, France
Actual Study Start Date : April 17, 2020
Actual Primary Completion Date : May 7, 2020
Actual Study Completion Date : July 16, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.


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.
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.


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





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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). ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441684


Locations
Layout table for location information
France
Hôpitaux Universitaires de Strasbourg - Centre d'Investigation Clinique - Nouvel Hôpital Civil et Hautepierre
Strasbourg, France
Sponsors and Collaborators
University Hospital, Strasbourg, France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04441684    
Other Study ID Numbers: 7782
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
COVID-19
SARS-CoV-2
Humoral response
T-cell response