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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04431310
Other study ID # Journal-nr.: H-20022312
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 27, 2020
Est. completion date August 1, 2025

Study information

Verified date June 2020
Source Nordsjaellands Hospital
Contact Fischer
Phone +45 2440 1718
Email thea.koelsen.fischer@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: hospital employee

-

Exclusion Criteria: none

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Serial 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.

Locations

Country Name City State
Denmark Nordsjællands Hospital Hillerød Capital Region
Denmark Nykøbing Falster County Hospital Nykøbing Falster Southern Region

Sponsors (3)

Lead Sponsor Collaborator
Nordsjaellands Hospital Nykøbing Falster County Hospital, University of Oxford

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Co-variates Age, gender, employment details, smoking, chronic diseases At baseline
Primary Serology testing for specific COVID-19 IgM and IgG (Covid-19 antibodies) From baseline to follow up at four years
Secondary SARS-CoV-2 infection Swab, SARS-CoV-2 From baseline to follow up at three months
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