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

Not Applicable

Completed

• Conditions: SARS-CoV-2 Seroprevalence; SARS-CoV-2 Serological Status
• Interventions: Diagnostic Test: Blood sample for serological test

• Registration Number: NCT04441684
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-17
• Primary Completion: 2020-05-07
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-22
• Status Verified: 2021-07
• Study Completion: 2021-07-16
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1466

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCR- group	Blood sample for serological test	This group includes any symptomatic person with a negative RT-PCR COVID 19 test carried out at least 10 days before inclusion.
No PCR	Blood sample for serological test	This group includes any person, for which no COVID 19 RT- PCR testing was performed.
PCR+ group	Blood sample for serological test	This group includes any symptomatic person with a positive COVID result, with a RT-PCR test carried out at least 10 days before inclusion.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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).
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).
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).
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).

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg - Centre d'Investigation Clinique - Nouvel Hôpital Civil et Hautepierre; 🇫🇷 Strasbourg, France