NCT04387929

Brief Summary

COVID-19 (SARS-CoV-2) infection in health professionals represent a significant criticality both for the risk of spreading the disease and for the organizational aspects that follow. The objective of the study is to evaluate the spread of COVID-19 virus within the hospital population of Humanitas through the monitoring of the levels of IgG antibodies. Moreover, viral load will be measured by RT-PCR in the subgroup positive to IgG antibodies.

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
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

May 4, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

May 13, 2020

Last Update Submit

May 13, 2020

Conditions

COVID-19

Keywords

COVID-19Antibody titerSerological testsHospital personnel

Outcome Measures

Primary Outcomes (1)

  • SARS-CoV-2 levels of IgG antibodies

    Measurement of the temporal trend of the antibody value of anti-SARS-CoV-2 neutralizing IgG.

    1 year

Secondary Outcomes (2)

  • SARS-CoV-2 viral load in nasopharyngeal swab of IgG positive subjects

    1 year

  • Epidemiology correlations

    1 year

Study Arms (3)

IgG negative

No intervantion. Only antibody mesurment from blood sample

Diagnostic Test: Detection of anti-COVID-19 antibody level

IgG positive, viral load negative

No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs

Diagnostic Test: Detection of anti-COVID-19 antibody level

IgG positive, viral load positive

No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs

Diagnostic Test: Detection of anti-COVID-19 antibody level

Interventions

Detection of anti-COVID-19 antibody levelDIAGNOSTIC_TEST

Detection of anti-COVID-19 antibody level form blood samples. If positive, viral load will be measured by RT-PCR of nasopharyngeal swab.

IgG negativeIgG positive, viral load negativeIgG positive, viral load positive

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Personnel of Humanitas Group including: Healthcare Staff (Doctors, Nurses, OSS) Technical Staff (Biologists, Radiology Technicians, Laboratory Technicians, etc.) PARC staff and Staff Staff Research Internship students of Hunimed Contract staff (e.g. transport and sanitation services)

You may qualify if:

  • Age\> 18 years old
  • work for the Humanitas Group (Rozzano / San Pio X, Humanitas Gavazzeni, Humanitas Mater Domini, Humanitas University, Humanitas Medical Care)
  • Work activity in the Humanitas Group for at least 3 months among which, for example:
  • Healthcare Staff (Doctors, Nurses, OSS) Technical Staff (Biologists, Radiology Technicians, Laboratory Technicians, etc.) PARC staff and Staff Staff Research Internship students of Hunimed Contract staff (e.g. transport and sanitation services)
  • Signature of informed consent
  • Compilation of the anamnestic questionnaire

You may not qualify if:

  • Subjects absent for any reason during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanitas Rozzano/San Pio X

Rozzano, Lombardy, 20089, Italy

RECRUITING

Related Publications (1)

  • Levi R, Azzolini E, Pozzi C, Ubaldi L, Lagioia M, Mantovani A, Rescigno M. One dose of SARS-CoV-2 vaccine exponentially increases antibodies in individuals who have recovered from symptomatic COVID-19. J Clin Invest. 2021 Jun 15;131(12):e149154. doi: 10.1172/JCI149154.

    PMID: 33956667DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Patrizia Meroni, MD

CONTACT

02 82241patrizia.meroni@humanitas.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 14, 2020

Study Start

May 4, 2020

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

May 15, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)