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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

44,698

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach

1 country

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

First Submitted

Initial submission to the registry

April 11, 2020

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed

Same day until next milestone

Study Start

First participant enrolled

April 15, 2020

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2020

Completed

Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

April 11, 2020

Last Update Submit

August 24, 2022

Conditions

COVID

Outcome Measures

Primary Outcomes (10)

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

Study Arms (2)

Hospital Staff in the Capital Region of Denmark

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

Healthy volunteer blood donors

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

Interventions

IgM and IgG diagnostic kits to SARS-CoV-2DIAGNOSTIC_TEST

Diagnostic kits for IgM/IgG antibodies to SARS-CoV-2

Healthy volunteer blood donorsHospital Staff in the Capital Region of Denmark

Elisa-test for IgM and IgG to SARS-CoV-2DIAGNOSTIC_TEST

Elisa-test for IgM and IgG to SARS-CoV-2

Healthy volunteer blood donorsHospital Staff in the Capital Region of Denmark

Eligibility Criteria

Sexall

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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.

You may qualify if:

\>18 years old
Consent to participation
Employed at a Hospital in the Capitial Region of Denmark

You may not qualify if:

None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Herlev Hospitallead
Nordsjaellands Hospitalcollaborator
Hvidovre University Hospitalcollaborator
Rigshospitalet, Denmarkcollaborator
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospitalcollaborator
University Hospital Bispebjerg and Frederiksbergcollaborator

Study Sites (14)

Herlev Hospital

Herlev, Capital Region, 2730, Denmark

Location

Bispebjerg Hospital

København NV, Capital Region, 2400, Denmark

Location

Psykiatrisk Center Ballerup

Ballerup Municipality, 2750, Denmark

Location

Psykiatrisk Center København

Copenhagen, 2100, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Psykiatrisk Center Amager

Copenhagen, 2300, Denmark

Location

Psykiatrisk Center Stolpegaard

Gentofte Municipality, 2820, Denmark

Location

Børne- og Ungdomspsykiatrisk Center

Glostrup Municipality, 2600, Denmark

Location

Psykiatrisk Center Glostrup

Glostrup Municipality, 2700, Denmark

Location

Nordsjaellands Hospital

Hillerød, 3400, Denmark

Location

Psykiatrisk Center Nordsjælland

Hillerød, 3400, Denmark

Location

Psykiatrisk Center Sankt Hans

Roskilde, 4000, Denmark

Location

Bornholms Hospital

Rønne, 3700, Denmark

Location

Psykiatrisk Center Bornholm

Rønne, 3700, Denmark

Location

Related Publications (2)

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.
PMID: 34543759DERIVED
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.
PMID: 32758438DERIVED

Study Officials

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
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

April 11, 2020

First Posted

April 15, 2020

Study Start

April 15, 2020

Primary Completion

October 7, 2020

Study Completion

October 7, 2020

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing: Will not share

Locations

DK(14)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (10)

Study Arms (2)

Hospital Staff in the Capital Region of Denmark

Healthy volunteer blood donors

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (14)

Related Publications (2)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations