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RecruitingNCT04431310Updated Jun 16, 2020

Seroconversion Among Staff at a Large Acute Care Hospital in Denmark During the COVID-19 Pandemic

An observational study in Covid-19, Health Personnel and Personnel, Hospital, sponsored by Nordsjaellands Hospital. Recruiting at 2 sites in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Nordsjaellands Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Mar 2020; still recruiting 6 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Covid-19
  • Health Personnel
  • Personnel, Hospital

Browse trials for

Keywords

  • healthcare workers
  • health care workers
  • hcw
  • seroconversion
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 300 is above the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Nordsjaellands Hospital is the lead sponsor of 88 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Health care workers at two Danish hospitals

Eligibility criteria

Inclusion Criteria: hospital employee

-

Exclusion Criteria: none

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Serial seroconversion measurements in hospital employees

    Serial seroconversion measurements in hospital employees during the COVID-19 pandemic

    Other: Serial seroconversion measurements in hospital employees during the COVID-19 pandemic

Interventions

  • OtherSerial seroconversion measurements in hospital employees during the COVID-19 pandemic

    The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital.

06

What researchers measure

Primary outcomes

  1. Serology testing for specific COVID-19

    IgM and IgG (Covid-19 antibodies)

    Time frame: From baseline to follow up at four years

Secondary outcomes

  1. SARS-CoV-2 infection

    Swab, SARS-CoV-2

    Time frame: From baseline to follow up at three months

Other outcomes

  1. Co-variates

    Age, gender, employment details, smoking, chronic diseases

    Time frame: At baseline

07

Study locations

2 of 2 sites recruiting
  • Nordsjællands Hospital
    Hillerød, Capital Region 3400, Denmark
    Recruiting
  • Nykøbing Falster County Hospital
    Nykøbing Falster, Southern Region 4800, Denmark
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04431310
Lead sponsor
Nordsjaellands Hospital
Collaborators
University of Oxford, Nykøbing Falster County Hospital
Responsible party
Thea Kølsen Fischer (Professor, Nordsjaellands Hospital) — Principal investigator
First posted
Jun 16, 2020
Start date
Mar 27, 2020
Primary completion
Aug 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Jun 16, 2020

Study contacts

Fischer
Contact
thea.koelsen.fischer@regionh.dk
+45 2440 1718
Thea K Fischer, professor
principal investigator · Nordsjællands Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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