NCT04431310

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

5.4 years

First QC Date

May 11, 2020

Last Update Submit

June 12, 2020

Conditions

Keywords

healthcare workershealth care workershcwseroconversion

Outcome Measures

Primary Outcomes (1)

  • Serology testing for specific COVID-19

    IgM and IgG (Covid-19 antibodies)

    From baseline to follow up at four years

Secondary Outcomes (1)

  • SARS-CoV-2 infection

    From baseline to follow up at three months

Other Outcomes (1)

  • Co-variates

    At baseline

Study Arms (1)

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

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

Serial seroconversion measurements in hospital employees

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health care workers at two Danish hospitals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nordsjællands Hospital

Hillerød, Capital Region, 3400, Denmark

RECRUITING

Nykøbing Falster County Hospital

Nykøbing Falster, Southern Region, 4800, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Full blood samples

MeSH Terms

Conditions

COVID-19HIV Seropositivity

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Thea K Fischer, professor

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2020

First Posted

June 16, 2020

Study Start

March 27, 2020

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations