Clinical trial NCT04431310: Seroconversion Among Staff at a Large Acute Care Hospital in Denmark During the COVID-19 Pandemic
Official title: Seroconversion Among Staff at a Large Acute Care Hospital in Denmark During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid-19
Health Personnel
Personnel, Hospital
Keywords: healthcare workers
health care workers
hcw
seroconversion
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: Nykøbing Falster County Hospital
First posted: 2020-06-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care workers at two Danish hospitals

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.

Eligibility criteria: Inclusion Criteria: hospital employee

-

Exclusion Criteria: none

Primary outcomes:
measure: Serology testing for specific COVID-19
timeFrame: From baseline to follow up at four years
Secondary outcomes:
measure: SARS-CoV-2 infection
timeFrame: From baseline to follow up at three months
Other outcomes:
measure: Co-variates
timeFrame: At baseline
Locations:
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
state: Capital Region
city: Nykøbing Falster
country: Denmark
facility: Nykøbing Falster County Hospital
state: Southern Region
Study officials:
affiliation: Nordsjællands Hospital
name: Thea K Fischer, professor
role: PRINCIPAL_INVESTIGATOR
References: