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

NCT04346186 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44698

Last updated 2022-08-25

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Nordsjaellands Hospital

    collaborator OTHER
  • Hvidovre University Hospital

    collaborator OTHER
  • Rigshospitalet, Denmark

    collaborator OTHER
  • Mental Health Services in the Capital Region, Denmark

    collaborator OTHER
  • University Hospital Bispebjerg and Frederiksberg

    collaborator OTHER
  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Kasper Iversen, Prof. · Herlev-Gentofte Hospital

  • Henning Bundgaard, Prof. · Rigshospitalet, Denmark

  • Henrik Ullum, Prof. · Rigshospitalet, Denmark

  • Thomas Benfield, Prof. · Hvidovre University Hospital

  • Susanne Dam Poulsen, Prof. · Rigshospitalet, Denmark

  • Jørgen Rungby, Prof. · Bispebjerg Hospital

  • Fredrik Folke, Associate prof. · Akutberedskabet

  • Thea Kølsen Fischer · Nordsjaellands Hospital

  • Ove Andersen, Prof. · Hvidovre University Hospital

  • Ida Hageman · Mental Health Services in the Capital Region, Denmark

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2020-10-07
Completion
2020-10-07

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04346186 on ClinicalTrials.gov