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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346186
Recruitment Status : Enrolling by invitation
First Posted : April 15, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborators:
Nordsjaellands Hospital
Hvidovre University Hospital
Rigshospitalet, Denmark
Mental Health Services in the Capital Region, Denmark
University Hospital Bispebjerg and Frederiksberg
Information provided by (Responsible Party):
Kasper Iversen, Herlev Hospital

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.


Condition or disease Intervention/treatment
COVID Diagnostic Test: IgM and IgG diagnostic kits to SARS-CoV-2 Diagnostic Test: Elisa-test for IgM and IgG to SARS-CoV-2

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Study Type : Observational
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19: Investigation of Transmission and Immunisation Among Hospital Staff
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hospital Staff in the Capital Region of Denmark 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

Healthy volunteer blood donors 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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346186


Locations
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Denmark
Herlev Hospital
Herlev, Region Hovedstaden, Denmark, 2730
Bispebjerg Hospital
København NV, Region Hovedstaden, Denmark, 2400
Psykiatrisk Center Ballerup
Ballerup, Denmark, 2750
Psykiatrisk Center København
Copenhagen, Denmark, 2100
Rigshospitalet
Copenhagen, Denmark, 2100
Psykiatrisk Center Amager
Copenhagen, Denmark, 2300
Psykiatrisk Center Stolpegaard
Gentofte, Denmark, 2820
Børne- og Ungdomspsykiatrisk Center
Glostrup, Denmark, 2600
Psykiatrisk Center Glostrup
Glostrup, Denmark, 2700
Nordsjaellands Hospital
Hillerød, Denmark, 3400
Psykiatrisk Center Nordsjælland
Hillerød, Denmark, 3400
Psykiatrisk Center Sankt Hans
Roskilde, Denmark, 4000
Bornholms Hospital
Rønne, Denmark, 3700
Psykiatrisk Center Bornholm
Rønne, Denmark, 3700
Sponsors and Collaborators
Herlev Hospital
Nordsjaellands Hospital
Hvidovre University Hospital
Rigshospitalet, Denmark
Mental Health Services in the Capital Region, Denmark
University Hospital Bispebjerg and Frederiksberg
Investigators
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Principal Investigator: Kasper Iversen, Prof. Herlev-Gentofte Hospital
Principal Investigator: Henning Bundgaard, Prof. Rigshospitalet, Denmark
Principal Investigator: Henrik Ullum, Prof. Rigshospitalet, Denmark
Principal Investigator: Thomas Benfield, Prof. Hvidovre University Hospital
Principal Investigator: Susanne Dam Poulsen, Prof. Rigshospitalet, Denmark
Principal Investigator: Jørgen Rungby, Prof. Bispebjerg Hospital
Principal Investigator: Fredrik Folke, Associate prof. Akutberedskabet
Principal Investigator: Thea Kølsen Fischer Nordsjællands Hospital
Principal Investigator: Ove Andersen, Prof. Hvidovre University Hospital
Principal Investigator: Ida Hageman Mental Health Services in the Capital Region, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kasper Iversen, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT04346186    
Other Study ID Numbers: RegHCOVIDScreening
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Immunoglobulin G
Immunoglobulin M
Immunologic Factors
Physiological Effects of Drugs