Clinical trial NCT04346186: COVID-19: Investigation of Transmission and Immunisation Among Hospital Staff
Official title: COVID-19: Investigation of Transmission and Immunisation Among Hospital Staff
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Nordsjaellands Hospital
name: Hvidovre University Hospital
name: Rigshospitalet, Denmark
name: Mental Health Services in the Capital Region, Denmark
name: University Hospital Bispebjerg and Frederiksberg
First posted: 2020-04-15
Enrollment: 44698
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Positive IgM/IgG tests
timeFrame: At inclusion
measure: Positive IgM/IgG tests
timeFrame: 1 month
measure: Positive IgM/IgG tests
timeFrame: 5 month
measure: Comparison of the point of care test and Elisa
timeFrame: At inclusion
measure: Comparison of the point of care test and Elisa
timeFrame: 1 months
measure: Comparison of the point of care test and Elisa
timeFrame: 5 months
measure: Re-infection rate
timeFrame: 180 days
measure: Re-infection rate
timeFrame: 360 days
measure: IgM/IgG positive participants on follow-up test
timeFrame: 1 month
measure: IgM/IgG positive participants on follow-up test
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Region Hovedstaden
city: København NV
country: Denmark
facility: Bispebjerg Hospital
state: Region Hovedstaden
city: Ballerup
country: Denmark
facility: Psykiatrisk Center Ballerup
city: Copenhagen
country: Denmark
facility: Psykiatrisk Center København
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Copenhagen
country: Denmark
facility: Psykiatrisk Center Amager
city: Gentofte
country: Denmark
facility: Psykiatrisk Center Stolpegaard
city: Glostrup
country: Denmark
facility: Børne- og Ungdomspsykiatrisk Center
city: Glostrup
country: Denmark
facility: Psykiatrisk Center Glostrup
city: Hillerød
country: Denmark
facility: Nordsjaellands Hospital
city: Hillerød
country: Denmark
facility: Psykiatrisk Center Nordsjælland
city: Roskilde
country: Denmark
facility: Psykiatrisk Center Sankt Hans
city: Rønne
country: Denmark
facility: Bornholms Hospital
city: Rønne
country: Denmark
facility: Psykiatrisk Center Bornholm
Study officials:
affiliation: Herlev-Gentofte Hospital
name: Kasper Iversen, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Henning Bundgaard, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Henrik Ullum, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Thomas Benfield, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Susanne Dam Poulsen, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Jørgen Rungby, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Akutberedskabet
name: Fredrik Folke, Associate prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nordsjællands Hospital
name: Thea Kølsen Fischer
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Ove Andersen, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mental Health Services in the Capital Region, Denmark
name: Ida Hageman
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.