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

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346186
• Other study ID #: RegHCOVIDScreening
• Status: Completed
• Start date: April 15, 2020
• Est. completion date: October 7, 2020

Study information

• Verified date: August 2022
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44698
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• >18 years old

• Consent to participation

• Employed at a Hospital in the Capitial Region of Denmark

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• COVID

Intervention

Diagnostic Test:
• IgM and IgG diagnostic kits to SARS-CoV-2
Diagnostic kits for IgM/IgG antibodies to SARS-CoV-2
• Elisa-test for IgM and IgG to SARS-CoV-2
Elisa-test for IgM and IgG to SARS-CoV-2

Locations

Country	Name	City	State
Denmark	Psykiatrisk Center Ballerup	Ballerup
Denmark	Psykiatrisk Center Amager	Copenhagen
Denmark	Psykiatrisk Center København	Copenhagen
Denmark	Rigshospitalet	Copenhagen
Denmark	Psykiatrisk Center Stolpegaard	Gentofte
Denmark	Børne- og Ungdomspsykiatrisk Center	Glostrup
Denmark	Psykiatrisk Center Glostrup	Glostrup
Denmark	Herlev Hospital	Herlev	Region Hovedstaden
Denmark	Nordsjaellands Hospital	Hillerød
Denmark	Psykiatrisk Center Nordsjælland	Hillerød
Denmark	Bispebjerg Hospital	København NV	Region Hovedstaden
Denmark	Bornholms Hospital	Rønne
Denmark	Psykiatrisk Center Bornholm	Rønne
Denmark	Psykiatrisk Center Sankt Hans	Roskilde

Sponsors (6)

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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive IgM/IgG tests	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	At inclusion
Primary	Positive IgM/IgG tests	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	1 month
Primary	Positive IgM/IgG tests	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	5 month
Primary	Comparison of the point of care test and Elisa	Comparison of the resultat from the point of care test and with results from Elisa	At inclusion
Primary	Comparison of the point of care test and Elisa	Comparison of the resultat from the point of care test and with results from Elisa	1 months
Primary	Comparison of the point of care test and Elisa	Comparison of the resultat from the point of care test and with results from Elisa	5 months
Primary	Re-infection rate	Number of patients, who were tested positive for antibodies on an earlier test and later are infected with COVID-19	180 days
Primary	Re-infection rate	Number of patients, who were tested positive for antibodies on an earlier test and later are infected with COVID-19	360 days
Primary	IgM/IgG positive participants on follow-up test	Proportion of IgM/IgG positive participants with a lasting immune response. This will be the participants who are still positive on follow-up	1 month
Primary	IgM/IgG positive participants on follow-up test	Proportion of IgM/IgG positive participants with a lasting immune response. This will be the participants who are still positive on follow-up	5 months