COVID-19: Investigation of Transmission and Immunisation Among Hospital Staff

Study Overview
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Brief Summary
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During the COVID-19 pandemic several countries have seen a high risk of transmission for health care personnel, with some countries having as many 20-25% of nurses and doctors either infected or showing symptoms of COVID-19. In this prospective cohort study, we will systematically screen all hospital staff in the Capital Region of Denmark for IgM and IgG antibodies against SARS-CoV-2 using a point of care tests and an Elisa kit. Testing will be offered 3 times: In April 2020, Maj 2020 and September 2020. All participants will submit a questionnaire regarding exposures, risk factors and symptoms of COVID-19 in relation to each testing. Follow-up will be through electronic patient records and national registries. We will compare the group of health care personnel with data from a control group of healthy volunteer blood donors from the Danish Blood Donor Study. The aim of the study is to investigate the proportion of hospital staff with SARS-CoV-2 antibodies during the study period compared to a control group representing the Danish population. We will compare the test characteristics of the two methods of testing, a point of care test and Elisa. Further, we will investigate the extent to which prior immunization or infection is protective for future infection with COVID-19.

Official Title
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COVID-19: Investigation of Transmission and Immunisation Among Hospital Staff

Conditions
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COVID

Intervention / Treatment
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* Diagnostic Test: IgM and IgG diagnostic kits to SARS-CoV-2
* Diagnostic Test: Elisa-test for IgM and IgG to SARS-CoV-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years old Consent to participation Employed at a Hospital in the Capitial Region of Denmark Exclusion Criteria: None
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospital Staff in the Capital Region of Denmark<br> | Diagnostic Test: IgM and IgG diagnostic kits to SARS-CoV-2<br>* Diagnostic kits for IgM/IgG antibodies to SARS-CoV-2<br>Diagnostic Test: Elisa-test for IgM and IgG to SARS-CoV-2<br>* Elisa-test for IgM and IgG to SARS-CoV-2<br>|
| Healthy volunteer blood donors<br> | Diagnostic Test: IgM and IgG diagnostic kits to SARS-CoV-2<br>* Diagnostic kits for IgM/IgG antibodies to SARS-CoV-2<br>Diagnostic Test: Elisa-test for IgM and IgG to SARS-CoV-2<br>* Elisa-test for IgM and IgG to SARS-CoV-2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive IgM/IgG tests | Proportion of hospital staff who have a positive IgM/IgG tests for antibodies to SARS-CoV-2 on point of care test and/or Elisa compared to the background population | At inclusion | 
| Positive IgM/IgG tests | Proportion of hospital staff who have a positive IgM/IgG tests for antibodies to SARS-CoV-2 on point of care test and/or Elisa compared to the background population | 1 month | 
| Positive IgM/IgG tests | Proportion of hospital staff who have a positive IgM/IgG tests for antibodies to SARS-CoV-2 on point of care test and/or Elisa compared to the background population | 5 month | 
| Comparison of the point of care test and Elisa | Comparison of the resultat from the point of care test and with results from Elisa | At inclusion | 
| Comparison of the point of care test and Elisa | Comparison of the resultat from the point of care test and with results from Elisa | 1 months | 
| Comparison of the point of care test and Elisa | Comparison of the resultat from the point of care test and with results from Elisa | 5 months | 
| Re-infection rate | Number of patients, who were tested positive for antibodies on an earlier test and later are infected with COVID-19 | 180 days | 
| Re-infection rate | Number of patients, who were tested positive for antibodies on an earlier test and later are infected with COVID-19 | 360 days | 
| IgM/IgG positive participants on follow-up test | Proportion of IgM/IgG positive participants with a lasting immune response. This will be the participants who are still positive on follow-up | 1 month | 
| IgM/IgG positive participants on follow-up test | Proportion of IgM/IgG positive participants with a lasting immune response. This will be the participants who are still positive on follow-up | 5 months |