Covid-19NCT04431310
Seroconversion Among Staff at a Large Acute Care Hospital in Denmark During the COVID-19 Pandemic
An observational study of Covid-19 and Health Personnel, run by Nordsjaellands Hospital at 2 sites in Denmark.
Trial summary
The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital. This will enable the identification of those who are protected and non-infectious for SARS-CoV2 and those who are seronegative and therefore potentially susceptible and infectious on… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid-19, Health Personnel, Personnel, Hospital
- What is being tested?
- Serial seroconversion measurements in hospital employees during the COVID-19 pandemic
- How many people
- 300 participants
- Where
- 2 sitesDenmark
- Study dates
- 27 Mar 2020to 1 Aug 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health care workers at two Danish hospitals
Who may be able to join
- -
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Nordsjællands Hospital
Hillerød, Capital Region, 3400
Thea K Fischer, +45 2440 1718, thea.koelsen.fischer@regionh.dk
- Recruiting
Nykøbing Falster County Hospital
Nykøbing Falster, Southern Region, 4800
Gry St-Martin, md, +45 20537137, grys@regionsjaelland.dk
About this study
The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital. This will enable the identification of those who are protected and non-infectious for SARS-CoV2 and those who are seronegative and therefore potentially susceptible and infectious on patient contact. Prospective testing will provide data on the acquisition of SARS-CoV2 infections among HCWs and associated risk factors for transmission during a pandemic at an acute care hospital facility in the capital region of Denmark.
Hypothesis: Serial seroconversion measurements in hospital employees improve the organization of the clinical treatment and care during the COVID-19 pandemic at Nordsjællands Hospital and Nykøbing Falster County Hospital.
Read the detailed description
The study is a prospective cohort study. Weekly (in the first phase) and bi-weekly (in the second phase) serum samples will be drawn and shipped bi-weekly to laboratory collaborators in United Kingdom for antibody analyses during the course of the local epidemic, expected to last 10-12 weeks or more. After the cease of the epidemic serum will be drawn in 3-monthly intervals in a smaller group of seroconverted volunteers to follow the long-lasting immunity of SARS-CoV-2 infection up to 5 years post-pandemic.
Nurses, medical doctors, biomedical laboratory scientists, social health care assistants, and few healthcare administrators (as controls) will be invited for enrolment. In hospitals, all departments with staff that are in physical contact with patients during the pandemic will be invited to participate in the study.
- Conditions
- Covid-19, Health Personnel, Personnel, Hospital
- Being tested
- Serial seroconversion measurements in hospital employees during the COVID-19 pandemic
- Keywords
- healthcare workers, health care workers, hcw, seroconversion
- Medical subject headings
- COVID-19, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial seroconversion measurements in hospital employees during the COVID-19 pandemicOther
The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital.
| Study group | Role | What they receive |
|---|---|---|
| Serial seroconversion measurements in hospital employees | Serial seroconversion measurements in hospital employees during the COVID-19 pandemic Receives: Other: Serial seroconversion measurements in hospital employees during the COVID-19 pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serology testing for specific COVID-19
IgM and IgG (Covid-19 antibodies)
Measured: From baseline to follow up at four years
Secondary outcomes (1)
SARS-CoV-2 infection
Swab, SARS-CoV-2
Measured: From baseline to follow up at three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start27 Mar 2020
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Nykøbing Falster County Hospital
- Responsible party
- Principal investigator, Thea Kølsen Fischer, Nordsjaellands Hospital
- Investigators
- Thea K Fischer, professor, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431310
- Sponsor's protocol ID
- Journal-nr.: H-20022312
- Status last verified
- Jun 2020
- First submitted
- 11 May 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroconversion Among Staff at a Large Acute Care Hospital in Denmark During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04431310
- Acronym / sponsor ID
- Journal-nr.: H-20022312
- Conditions
- Covid-19, Health Personnel, Personnel, Hospital
- Keywords
- healthcare workers, health care workers, hcw, seroconversion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- University of Oxford, Nykøbing Falster County Hospital
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 16 Jun 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.
The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital. This will enable the identification of those who are protected and non-infectious for SARS-CoV2 and those who are seronegative and therefore potentially susceptible and infectious on patient contact. Prospective testing will provide data on the acquisition of SARS-CoV2 infections among HCWs and associated risk factors for transmission during a pandemic at an acute care hospital facility in the capital region of Denmark.
Hypothesis: Serial seroconversion measurements in hospital employees improve the organization of the clinical treatment and care during the COVID-19 pandemic at Nordsjællands Hospital and Nykøbing Falster County Hospital.
Detailed description
The study is a prospective cohort study. Weekly (in the first phase) and bi-weekly (in the second phase) serum samples will be drawn and shipped bi-weekly to laboratory collaborators in United Kingdom for antibody analyses during the course of the local epidemic, expected to last 10-12 weeks or more. After the cease of the epidemic serum will be drawn in 3-monthly intervals in a smaller group of seroconverted volunteers to follow the long-lasting immunity of SARS-CoV-2 infection up to 5 years post-pandemic.
Nurses, medical doctors, biomedical laboratory scientists, social health care assistants, and few healthcare administrators (as controls) will be invited for enrolment. In hospitals, all departments with staff that are in physical contact with patients during the pandemic will be invited to participate in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serial seroconversion measurements in hospital employees | – | Other: Serial seroconversion measurements in hospital employees during the COVID-19 pandemicSerial seroconversion measurements in hospital employees during the COVID-19 pandemic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health care workers at two Danish hospitals
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Serial seroconversion measurements in hospital employees during the COVID-19 pandemicThe aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital. | Other | Serial seroconversion measurements in hospital employees |
Primary outcome
Serology testing for specific COVID-19
Time frame: From baseline to follow up at four years
IgM and IgG (Covid-19 antibodies)
1 secondary outcome
SARS-CoV-2 infection
Time frame: From baseline to follow up at three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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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.
Thea K Fischer, professor principal investigator
Nordsjaellands Hospital
2 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-19 and Health Personnel, run by Nordsjaellands Hospital at 2 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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fischer (+45 2440 1718, thea.koelsen.fischer@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serology testing for specific COVID-19 (time frame: From baseline to follow up at four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2020.