NCT05766111

Brief Summary

Healthcare workers are at the forefront against COVID-19, worldwide. Since Fondazione Policlinico Universitario A. Gemelli (FPG) IRCCS was enlisted as a COVID-19 hospital, the healthcare workers deployed to COVID-19 wards were separated from those with limited/no exposure, whereas the administrative staff were designated to work from home. Between June and July 2020, an investigation will conduct to evaluate the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin (IgG) antibodies among the employees of the FPG using point-of-care (POC) and venous blood tests. Sensitivity, specificity, and predictive values were determined with reverse-transcription polymerase chain reaction on nasal/oropharyngeal swabs as the diagnostic gold standard.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,888

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

1 month

First QC Date

March 10, 2023

Last Update Submit

September 26, 2024

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Detection of Anti-SARS-CoV-2 Antibodies in Blood Samples

    Prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection based on the serological tests and stratified by age, sex, professional category, and direct assistance to COVID-19 patients or not (COVID-19 care, Yes/No)

    1 month

Secondary Outcomes (2)

  • Number of Healthcare Workers with Confirmed COVID-19 Infection

    1 month

  • Sensitivity and Specificity of Serological Tests

    1 month

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

medical, non-medical HCW, and administrative staff (AS) of the Fondazione Policlinico Gemelli Hospital

You may qualify if:

  • employees of the Fondazione Policlinico Gemelli Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 13, 2023

Study Start

June 1, 2020

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)