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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 1, 2020

Interventions

  • 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

Arms, Groups and Cohorts

  • Hospital Staff in the Capital Region of Denmark
  • Healthy volunteer blood donors

Clinical Trial Outcome Measures

Primary Measures

  • Positive IgM/IgG tests
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 5 months
    • Comparison of the resultat from the point of care test and with results from Elisa
  • Re-infection rate
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

  • None

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Herlev Hospital
  • Collaborator
    • Nordsjaellands Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kasper Iversen, Professor – Herlev Hospital
  • Overall Official(s)
    • Kasper Iversen, Prof., Principal Investigator, Herlev-Gentofte Hospital
    • Henning Bundgaard, Prof., Principal Investigator, Rigshospitalet, Denmark
    • Henrik Ullum, Prof., Principal Investigator, Rigshospitalet, Denmark
    • Thomas Benfield, Prof., Principal Investigator, Hvidovre University Hospital
    • Susanne Dam Poulsen, Prof., Principal Investigator, Rigshospitalet, Denmark
    • Jørgen Rungby, Prof., Principal Investigator, Bispebjerg Hospital
    • Fredrik Folke, Associate prof., Principal Investigator, Akutberedskabet
    • Thea Kølsen Fischer, Principal Investigator, Nordsjællands Hospital
    • Ove Andersen, Prof., Principal Investigator, Hvidovre University Hospital
    • Ida Hageman, Principal Investigator, Mental Health Services in the Capital Region, Denmark
  • Overall Contact(s)
    • Rasmus Hasselbalch, MD, +4538686405, rasmus.bo.hasselbalch@regionh.dk

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