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| Name | Class |
|---|---|
| Nordsjaellands Hospital | OTHER |
| Hvidovre University Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospital Staff in the Capital Region of Denmark |
| ||
| Healthy volunteer blood donors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgM and IgG diagnostic kits to SARS-CoV-2 | Diagnostic Test | Diagnostic kits for IgM/IgG antibodies to SARS-CoV-2 |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All staff with any form of contact with patients, employed at any hospital in the Capital Region of Denmark will be offered to participate at their place of employment.
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| Name | Affiliation | Role |
|---|---|---|
| Kasper Iversen, Prof. | Herlev-Gentofte Hospital | Principal Investigator |
| Henning Bundgaard, Prof. | Rigshospitalet, Denmark | Principal Investigator |
| Henrik Ullum, Prof. | Rigshospitalet, Denmark | Principal Investigator |
| Thomas Benfield, Prof. | Hvidovre University Hospital | Principal Investigator |
| Susanne Dam Poulsen, Prof. | Rigshospitalet, Denmark | Principal Investigator |
| Jørgen Rungby, Prof. | Bispebjerg Hospital | Principal Investigator |
| Fredrik Folke, Associate prof. | Akutberedskabet | Principal Investigator |
| Thea Kølsen Fischer | Nordsjaellands Hospital | Principal Investigator |
| Ove Andersen, Prof. | Hvidovre University Hospital | Principal Investigator |
| Ida Hageman |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | Capital Region | 2730 | Denmark | ||
| Bispebjerg Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34543759 | Derived | Iversen K, Kristensen JH, Hasselbalch RB, Pries-Heje M, Nielsen PB, Knudsen AD, Fogh K, Norsk JB, Andersen O, Fischer TK, Juul Jensen CA, Torp-Pedersen C, Rungby J, Ditlev SB, Hageman I, Mogelvang R, Gybel-Brask M, Dessau RB, Sorensen E, Harritshoj L, Folke F, Sten C, Engel Moller ME, Benfield T, Ullum H, Jorgensen CS, Erikstrup C, Ostrowski SR, Nielsen SD, Bundgaard H. Seroprevalence of SARS-CoV-2 antibodies and reduced risk of reinfection through 6 months: a Danish observational cohort study of 44 000 healthcare workers. Clin Microbiol Infect. 2022 May;28(5):710-717. doi: 10.1016/j.cmi.2021.09.005. Epub 2021 Sep 17. | |
| 32758438 |
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| OTHER |
| University Hospital Bispebjerg and Frederiksberg | OTHER |
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| Elisa-test for IgM and IgG to SARS-CoV-2 | Diagnostic Test | Elisa-test for IgM and IgG to SARS-CoV-2 |
|
| 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 |
| Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital |
| Principal Investigator |
| København NV |
| Capital Region |
| 2400 |
| Denmark |
| Psykiatrisk Center Ballerup | Ballerup Municipality | 2750 | Denmark |
| Psykiatrisk Center København | Copenhagen | 2100 | Denmark |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Psykiatrisk Center Amager | Copenhagen | 2300 | Denmark |
| Psykiatrisk Center Stolpegaard | Gentofte Municipality | 2820 | Denmark |
| Børne- og Ungdomspsykiatrisk Center | Glostrup Municipality | 2600 | Denmark |
| Psykiatrisk Center Glostrup | Glostrup Municipality | 2700 | Denmark |
| Nordsjaellands Hospital | Hillerød | 3400 | Denmark |
| Psykiatrisk Center Nordsjælland | Hillerød | 3400 | Denmark |
| Psykiatrisk Center Sankt Hans | Roskilde | 4000 | Denmark |
| Bornholms Hospital | Rønne | 3700 | Denmark |
| Psykiatrisk Center Bornholm | Rønne | 3700 | Denmark |
| Derived |
| Iversen K, Bundgaard H, Hasselbalch RB, Kristensen JH, Nielsen PB, Pries-Heje M, Knudsen AD, Christensen CE, Fogh K, Norsk JB, Andersen O, Fischer TK, Jensen CAJ, Larsen M, Torp-Pedersen C, Rungby J, Ditlev SB, Hageman I, Mogelvang R, Hother CE, Gybel-Brask M, Sorensen E, Harritshoj L, Folke F, Sten C, Benfield T, Nielsen SD, Ullum H. Risk of COVID-19 in health-care workers in Denmark: an observational cohort study. Lancet Infect Dis. 2020 Dec;20(12):1401-1408. doi: 10.1016/S1473-3099(20)30589-2. Epub 2020 Aug 3. |