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

Completed

• Conditions: COVID
• Interventions: Diagnostic Test: IgM and IgG diagnostic kits to SARS-CoV-2; Diagnostic Test: Elisa-test for IgM and IgG to SARS-CoV-2

• Registration Number: NCT04346186
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-11
• Study First Submitted QC: 2020-04-13
• Study Start: 2020-04-15
• Study First Posted: 2020-04-15
• Primary Completion: 2020-10-07
• Study Completion: 2020-10-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44698

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospital Staff in the Capital Region of Denmark	IgM and IgG diagnostic kits to SARS-CoV-2	-
Healthy volunteer blood donors	IgM and IgG diagnostic kits to SARS-CoV-2	-
Healthy volunteer blood donors	Elisa-test for IgM and IgG to SARS-CoV-2	-
Hospital Staff in the Capital Region of Denmark	Elisa-test for IgM and IgG to SARS-CoV-2	-

Primary Outcome Measures

Name	Time	Method
Comparison of the point of care test and Elisa	5 months	Comparison of the resultat from the point of care test and with results from Elisa
Re-infection rate	360 days	Number of patients, who were tested positive for antibodies on an earlier test and later are infected with COVID-19
Positive IgM/IgG tests	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
IgM/IgG positive participants on follow-up test	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

Trial Locations

Locations (14)

Psykiatrisk Center Sankt Hans; 🇩🇰 Roskilde, Denmark

Psykiatrisk Center Amager; 🇩🇰 Copenhagen, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Bornholms Hospital; 🇩🇰 Rønne, Denmark

Psykiatrisk Center Bornholm; 🇩🇰 Rønne, Denmark

Psykiatrisk Center Ballerup; 🇩🇰 Ballerup, Denmark

Psykiatrisk Center Stolpegaard; 🇩🇰 Gentofte, Denmark

Herlev Hospital; 🇩🇰 Herlev, Region Hovedstaden, Denmark

Bispebjerg Hospital; 🇩🇰 København NV, Region Hovedstaden, Denmark

Psykiatrisk Center København; 🇩🇰 Copenhagen, Denmark

Børne- og Ungdomspsykiatrisk Center; 🇩🇰 Glostrup, Denmark

Psykiatrisk Center Glostrup; 🇩🇰 Glostrup, Denmark

Nordsjaellands Hospital; 🇩🇰 Hillerød, Denmark

Psykiatrisk Center Nordsjælland; 🇩🇰 Hillerød, Denmark