NCT04346186

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

Completed Last updated 25 August 2022

What this trial tests

trial testing IgM and IgG diagnostic kits to SARS-CoV-2 in COVID in 44,698 participants. Completed in 7 October 2020.

Timeline

15 April 2020

Primary endpoint
7 October 2020

7 October 2020

Quick facts

Lead sponsor	Herlev Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	44,698
Start date	15 April 2020
Primary completion	7 October 2020
Estimated completion	7 October 2020
Sites	14 locations across Denmark

Drugs / interventions tested

• IgM and IgG diagnostic kits to SARS-CoV-2
• Elisa-test for IgM and IgG to SARS-CoV-2

Conditions studied

• COVID — all drugs for COVID →

Sponsor

Herlev Hospital

Who can join

Eligibility, any sex, with COVID. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Risk of COVID-19 in health-care workers in Denmark: an observational cohort study.
   Iversen K, Bundgaard H, Hasselbalch RB, Kristensen JH, et al · · 2020 · cited 315× · PMID 32758438 · DOI 10.1016/s1473-3099(20)30589-2
2. Risk Factors for Being Seronegative following SARS-CoV-2 Infection in a Large Cohort of Health Care Workers in Denmark.
   Johannesen CK, Rezahosseini O, Gybel-Brask M, Kristensen JH, et al · · 2021 · cited 13× · PMID 34668738 · DOI 10.1128/spectrum.00904-21
3. Seroprevalence of SARS-CoV-2 antibodies and reduced risk of reinfection through 6 months: a Danish observational cohort study of 44 000 healthcare workers.
   Iversen K, Kristensen JH, Hasselbalch RB, Pries-Heje M, et al · · 2022 · cited 13× · PMID 34543759 · DOI 10.1016/j.cmi.2021.09.005
4. Effect of Influenza Vaccination on Risk of Coronavirus Disease 2019: A Prospective Cohort Study of 46 000 Healthcare Workers.
   Kristensen JH, Bo Hasselbalch R, Pries-Heje M, Nielsen PB, et al · · 2022 · cited 5× · PMID 34989811 · DOI 10.1093/infdis/jiac001
5. Coronavirus Disease 2019 Related Clinical Studies: A Cross-Sectional Analysis.
   Ma LL, Yin X, Li BH, Yang JY, et al · · 2020 · cited 5× · PMID 32982751 · DOI 10.3389/fphar.2020.540187
6. Correction to Lancet Infect Dis 2020; published online Aug 3. https://doi.org/10.1016/S1473-3099(20)30589-2.
   · 2020 · cited 1× · PMID 32805199 · DOI 10.1016/s1473-3099(20)30652-6