COVIDNCT04346186

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

An observational study of COVID, run by Herlev Hospital at 14 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: COVID
What is being tested?: IgM and IgG diagnostic kits to SARS-CoV-2 and Elisa-test for IgM and IgG to SARS-CoV-2
How many people: 44,698 participants
Where: 14 sitesDenmark
Study dates: 15 Apr 2020to 7 Oct 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Denmark14 sites

Psykiatrisk Center Ballerup
Ballerup Municipality, 2750
Psykiatrisk Center København
Copenhagen, 2100
Rigshospitalet
Copenhagen, 2100
Psykiatrisk Center Amager
Copenhagen, 2300
Psykiatrisk Center Stolpegaard
Gentofte Municipality, 2820
Børne- og Ungdomspsykiatrisk Center
Glostrup Municipality, 2600
Psykiatrisk Center Glostrup
Glostrup Municipality, 2700
Herlev Hospital
Herlev, Capital Region, 2730
Nordsjaellands Hospital
Hillerød, 3400
Psykiatrisk Center Nordsjælland
Hillerød, 3400
Bispebjerg Hospital
København NV, Capital Region, 2400
Bornholms Hospital
Rønne, 3700
Psykiatrisk Center Bornholm
Rønne, 3700
Psykiatrisk Center Sankt Hans
Roskilde, 4000

Other trials in Denmark

About this study

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.

Conditions: COVID
Being tested: IgM and IgG diagnostic kits to SARS-CoV-2, Elisa-test for IgM and IgG to SARS-CoV-2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04346186
Study group	Role	What they receive
Hospital Staff in the Capital Region of Denmark		Not described Receives: Diagnostic Test: IgM and IgG diagnostic kits to SARS-CoV-2; Diagnostic Test: Elisa-test for IgM and IgG to SARS-CoV-2
Healthy volunteer blood donors		Not described Receives: Diagnostic Test: IgM and IgG diagnostic kits to SARS-CoV-2; Diagnostic Test: Elisa-test for IgM and IgG to SARS-CoV-2

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: At inclusion
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
Measured: 1 month
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
Measured: 5 month
Comparison of the point of care test and Elisa
Comparison of the resultat from the point of care test and with results from Elisa
Measured: At inclusion
Comparison of the point of care test and Elisa
Comparison of the resultat from the point of care test and with results from Elisa
Measured: 1 months
Comparison of the point of care test and Elisa
Comparison of the resultat from the point of care test and with results from Elisa
Measured: 5 months
Re-infection rate
Number of patients, who were tested positive for antibodies on an earlier test and later are infected with COVID-19
Measured: 180 days
Re-infection rate
Number of patients, who were tested positive for antibodies on an earlier test and later are infected with COVID-19
Measured: 360 days
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
Measured: 1 month
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
Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 20207 Oct 2020

First posted15 Apr 2020
Study start15 Apr 2020
Primary completion7 Oct 2020
Study completion7 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for COVIDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 44,698 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04346186
Sponsor's protocol ID: RegHCOVIDScreening
Status last verified: Aug 2022
First submitted: 11 Apr 2020
Last updated: 25 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Iversen K, Kristensen JH, Hasselbalch RB, Pries-Heje M, Nielsen PB, Knudsen AD, Fogh K, Norsk JB, Andersen O, Fischer TK, Juul Jensen CA, Torp-Pedersen C, Rungby J, Ditlev SB, Hageman I, Mogelvang R, Gybel-Brask M, Dessau RB, Sorensen E, Harritshoj L, Folke F, Sten C, Engel Moller ME, Benfield T, Ullum H, Jorgensen CS, Erikstrup C, Ostrowski SR, Nielsen SD, Bundgaard H. Seroprevalence of SARS-CoV-2 antibodies and reduced risk of reinfection through 6 months: a Danish observational cohort study of 44 000 healthcare workers. Clin Microbiol Infect. 2022 May;28(5):710-717. doi: 10.1016/j.cmi.2021.09.005. Epub 2021 Sep 17.
PubMed 34543759
Iversen K, Bundgaard H, Hasselbalch RB, Kristensen JH, Nielsen PB, Pries-Heje M, Knudsen AD, Christensen CE, Fogh K, Norsk JB, Andersen O, Fischer TK, Jensen CAJ, Larsen M, Torp-Pedersen C, Rungby J, Ditlev SB, Hageman I, Mogelvang R, Hother CE, Gybel-Brask M, Sorensen E, Harritshoj L, Folke F, Sten C, Benfield T, Nielsen SD, Ullum H. Risk of COVID-19 in health-care workers in Denmark: an observational cohort study. Lancet Infect Dis. 2020 Dec;20(12):1401-1408. doi: 10.1016/S1473-3099(20)30589-2. Epub 2020 Aug 3.
PubMed 32758438

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19

All COVID trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: COVID-19: Investigation of Transmission and Immunisation Among Hospital Staff
ClinicalTrials.gov ID: NCT04346186
Acronym / sponsor ID: RegHCOVIDScreening
Conditions: COVID
Study type: Observational
Recruitment status: Completed
Enrolment: 44,698 participants (actual)
Lead sponsor: Herlev HospitalUniversity, hospital or other
Collaborators: Nordsjaellands Hospital, Hvidovre University Hospital, Copenhagen University Hospital, Rigshospitalet, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, University Hospital Bispebjerg and Frederiksberg
Study start: 15 Apr 2020 (actual)
Primary completion: 7 Oct 2020 (actual)
Study completion: 7 Oct 2020 (actual)
First posted: 15 Apr 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Further, we will investigate the extent to which prior immunization or infection is protective for future infection with COVID-19.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Hospital Staff in the Capital Region of Denmark	–	Diagnostic Test: IgM and IgG diagnostic kits to SARS-CoV-2, Diagnostic Test: 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 Test: Elisa-test for IgM and IgG to SARS-CoV-2

Who may qualify

Sex: All
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IgM and IgG diagnostic kits to SARS-CoV-2Diagnostic kits for IgM/IgG antibodies to SARS-CoV-2	Diagnostic test	Healthy volunteer blood donors, Hospital Staff in the Capital Region of Denmark
Elisa-test for IgM and IgG to SARS-CoV-2Elisa-test for IgM and IgG to SARS-CoV-2	Diagnostic test	Healthy volunteer blood donors, Hospital Staff in the Capital Region of Denmark

Primary outcome

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
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
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
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
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
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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
Derived from this study: PubMed 34543759Iversen K, Kristensen JH, Hasselbalch RB, Pries-Heje M, Nielsen PB, Knudsen AD, Fogh K, Norsk JB, Andersen O, Fischer TK, Juul Jensen CA, Torp-Pedersen C, Rungby J, Ditlev SB, Hageman I, Mogelvang R, Gybel-Brask M, Dessau RB, Sorensen E, Harritshoj L, Folke F, Sten C, Engel Moller ME, Benfield T, Ullum H, Jorgensen CS, Erikstrup C, Ostrowski SR, Nielsen SD, Bundgaard H. Seroprevalence of SARS-CoV-2 antibodies and reduced risk of reinfection through 6 months: a Danish observational cohort study of 44 000 healthcare workers. Clin Microbiol Infect. 2022 May;28(5):710-717. doi: 10.1016/j.cmi.2021.09.005. Epub 2021 Sep 17.
Derived from this study: PubMed 32758438Iversen K, Bundgaard H, Hasselbalch RB, Kristensen JH, Nielsen PB, Pries-Heje M, Knudsen AD, Christensen CE, Fogh K, Norsk JB, Andersen O, Fischer TK, Jensen CAJ, Larsen M, Torp-Pedersen C, Rungby J, Ditlev SB, Hageman I, Mogelvang R, Hother CE, Gybel-Brask M, Sorensen E, Harritshoj L, Folke F, Sten C, Benfield T, Nielsen SD, Ullum H. Risk of COVID-19 in health-care workers in Denmark: an observational cohort study. Lancet Infect Dis. 2020 Dec;20(12):1401-1408. doi: 10.1016/S1473-3099(20)30589-2. Epub 2020 Aug 3.
Individual participant dataSharing planned: No

Related trials for COVID

Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kasper Iversen, Prof. principal investigator

Herlev-Gentofte Hospital

Henning Bundgaard, Prof. principal investigator

Copenhagen University Hospital, Rigshospitalet

Henrik Ullum, Prof. principal investigator

Copenhagen University Hospital, Rigshospitalet

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID, run by Herlev Hospital at 14 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive IgM/IgG tests (time frame: At inclusion). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04346186, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.