Skip to main content
OpenTrials
Completed

NCT Number: NCT04346186

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID

Sex eligibility

All sexes

Study type

Observational

Primary location

Herlev Hospital, Herlev, Capital Region, Denmark

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

IgM and IgG diagnostic kits to SARS-CoV-2

Diagnostic Test

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

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

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Hvidovre University Hospital
  • Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
  • Nordsjaellands Hospital
  • Rigshospitalet, Denmark
  • University Hospital Bispebjerg and Frederiksberg

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2020
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.