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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04431310
• Other study ID #: Journal-nr.: H-20022312
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Covid-19
• Health Personnel
• Personnel, Hospital

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