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

Recruiting

• Conditions: Covid-19; Health Personnel; Personnel, Hospital
• Interventions: Other: Serial seroconversion measurements in hospital employees during the COVID-19 pandemic

• Registration Number: NCT04431310
• Lead Sponsor: Nordsjaellands Hospital

Brief 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.

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 Timeline

• Study Start: 2020-03-27
• Study First Submitted: 2020-05-11
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-12
• Last Update Submitted: 2020-06-12
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

hospital employee

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Serology testing for specific COVID-19	From baseline to follow up at four years	IgM and IgG (Covid-19 antibodies)

Secondary Outcome Measures

Name	Time	Method
SARS-CoV-2 infection	From baseline to follow up at three months	Swab, SARS-CoV-2

Trial Locations

Locations (2)

Nordsjællands Hospital; 🇩🇰 Hillerød, Capital Region, Denmark

Nykøbing Falster County Hospital; 🇩🇰 Nykøbing Falster, Southern Region, Denmark