Seroconversion Among Staff at a Large Acute Care Hospital in Denmark During the COVID-19 Pandemic

Study Overview
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Brief Summary
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The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital. This will enable the identification of those who are protected and non-infectious for SARS-CoV2 and those who are seronegative and therefore potentially susceptible and infectious on patient contact. Prospective testing will provide data on the acquisition of SARS-CoV2 infections among HCWs and associated risk factors for transmission during a pandemic at an acute care hospital facility in the capital region of Denmark. Hypothesis: Serial seroconversion measurements in hospital employees improve the organization of the clinical treatment and care during the COVID-19 pandemic at Nordsjællands Hospital and Nykøbing Falster County Hospital.

Detailed Description
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The study is a prospective cohort study. Weekly (in the first phase) and bi-weekly (in the second phase) serum samples will be drawn and shipped bi-weekly to laboratory collaborators in United Kingdom for antibody analyses during the course of the local epidemic, expected to last 10-12 weeks or more. After the cease of the epidemic serum will be drawn in 3-monthly intervals in a smaller group of seroconverted volunteers to follow the long-lasting immunity of SARS-CoV-2 infection up to 5 years post-pandemic. Nurses, medical doctors, biomedical laboratory scientists, social health care assistants, and few healthcare administrators (as controls) will be invited for enrolment. In hospitals, all departments with staff that are in physical contact with patients during the pandemic will be invited to participate in the study.

Official Title
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Seroconversion Among Staff at a Large Acute Care Hospital in Denmark During the COVID-19 Pandemic

Conditions
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Covid-19, Health Personnel, Personnel, Hospital

Intervention / Treatment
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* Other: Serial seroconversion measurements in hospital employees during the COVID-19 pandemic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hospital employee - Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Serial seroconversion measurements in hospital employees<br>Serial seroconversion measurements in hospital employees during the COVID-19 pandemic | Other: Serial seroconversion measurements in hospital employees during the COVID-19 pandemic<br>* The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serology testing for specific COVID-19 | IgM and IgG (Covid-19 antibodies) | From baseline to follow up at four years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 infection | Swab, SARS-CoV-2 | From baseline to follow up at three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthcare workers, health care workers, hcw, seroconversion