COVID-19: Investigation of Transmission and Immunisation Among Hospital Staff
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Hospital Staff in the Capital Region of Denmark
|
Diagnostic Test: IgM and IgG diagnostic kits to SARS-CoV-2
Diagnostic kits for IgM/IgG antibodies to SARS-CoV-2
Diagnostic Test: Elisa-test for IgM and IgG to SARS-CoV-2
Elisa-test for IgM and IgG to SARS-CoV-2
|
| Healthy volunteer blood donors
|
Diagnostic Test: IgM and IgG diagnostic kits to SARS-CoV-2
Diagnostic kits for IgM/IgG antibodies to SARS-CoV-2
Diagnostic Test: Elisa-test for IgM and IgG to SARS-CoV-2
Elisa-test for IgM and IgG to SARS-CoV-2
|
Outcome Measures
Primary Outcome Measures
- Positive IgM/IgG tests [At inclusion]
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
- Positive IgM/IgG tests [1 month]
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
- Positive IgM/IgG tests [5 month]
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
- Comparison of the point of care test and Elisa [At inclusion]
Comparison of the resultat from the point of care test and with results from Elisa
- Comparison of the point of care test and Elisa [1 months]
Comparison of the resultat from the point of care test and with results from Elisa
- Comparison of the point of care test and Elisa [5 months]
Comparison of the resultat from the point of care test and with results from Elisa
- Re-infection rate [180 days]
Number of patients, who were tested positive for antibodies on an earlier test and later are infected with COVID-19
- Re-infection rate [360 days]
Number of patients, who were tested positive for antibodies on an earlier test and later are infected with COVID-19
- IgM/IgG positive participants on follow-up test [1 month]
Proportion of IgM/IgG positive participants with a lasting immune response. This will be the participants who are still positive on follow-up
- IgM/IgG positive participants on follow-up test [5 months]
Proportion of IgM/IgG positive participants with a lasting immune response. This will be the participants who are still positive on follow-up
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years old
-
Consent to participation
-
Employed at a Hospital in the Capitial Region of Denmark
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herlev Hospital | Herlev | Region Hovedstaden | Denmark | 2730 |
| 2 | Bispebjerg Hospital | København NV | Region Hovedstaden | Denmark | 2400 |
| 3 | Psykiatrisk Center Ballerup | Ballerup | Denmark | 2750 | |
| 4 | Psykiatrisk Center København | Copenhagen | Denmark | 2100 | |
| 5 | Rigshospitalet | Copenhagen | Denmark | 2100 | |
| 6 | Psykiatrisk Center Amager | Copenhagen | Denmark | 2300 | |
| 7 | Psykiatrisk Center Stolpegaard | Gentofte | Denmark | 2820 | |
| 8 | Børne- og Ungdomspsykiatrisk Center | Glostrup | Denmark | 2600 | |
| 9 | Psykiatrisk Center Glostrup | Glostrup | Denmark | 2700 | |
| 10 | Nordsjaellands Hospital | Hillerød | Denmark | 3400 | |
| 11 | Psykiatrisk Center Nordsjælland | Hillerød | Denmark | 3400 | |
| 12 | Psykiatrisk Center Sankt Hans | Roskilde | Denmark | 4000 | |
| 13 | Bornholms Hospital | Rønne | Denmark | 3700 | |
| 14 | Psykiatrisk Center Bornholm | Rønne | Denmark | 3700 |
Sponsors and Collaborators
- Herlev Hospital
- Nordsjaellands Hospital
- Hvidovre University Hospital
- Rigshospitalet, Denmark
- Mental Health Services in the Capital Region, Denmark
- University Hospital Bispebjerg and Frederiksberg
Investigators
- Principal Investigator: 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, Nordsjællands Hospital
- Principal Investigator: Ove Andersen, Prof., Hvidovre University Hospital
- Principal Investigator: Ida Hageman, Mental Health Services in the Capital Region, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RegHCOVIDScreening