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

University Hospital, Strasbourg, France

Status: Completed

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

Treatments: Diagnostic Test: Blood sample for serological test

Study type: Interventional

Funder types: Other

Identifiers

NCT04441684

7782

Details and patient eligibility

About

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.

Enrollment: 1,466 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,466 participants in 3 patient groups

PCR+ group

Experimental group

Description:

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

Treatment:

Diagnostic Test: Blood sample for serological test

PCR- group

Experimental group

Description:

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

Treatment:

Diagnostic Test: Blood sample for serological test

No PCR

Experimental group

Description:

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

Treatment:

Diagnostic Test: Blood sample for serological test