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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04346186
Enrollment
44698
Registered
2020-04-15
Start date
2020-04-15
Completion date
2020-10-07
Last updated
2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID

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.

Interventions

DIAGNOSTIC_TESTIgM and IgG diagnostic kits to SARS-CoV-2

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

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

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

Sponsors

Nordsjaellands Hospital
CollaboratorOTHER
Hvidovre University Hospital
CollaboratorOTHER
Rigshospitalet, Denmark
CollaboratorOTHER
Mental Health Services in the Capital Region, Denmark
CollaboratorOTHER
University Hospital Bispebjerg and Frederiksberg
CollaboratorOTHER
Herlev Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Positive IgM/IgG testsAt inclusionProportion 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 ElisaAt inclusionComparison of the resultat from the point of care test and with results from Elisa
Re-infection rate180 daysNumber 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 test1 monthProportion of IgM/IgG positive participants with a lasting immune response. This will be the participants who are still positive on follow-up

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026