NCT04567836

Brief Summary

This is an observational prospective study. The aim is to assess the prevalence of test positivity (swab or serological examination) to Coronavirus Disease-2019 (Covid-19) in relation to the duties and related occupational risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 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

July 9, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

September 22, 2020

Last Update Submit

April 28, 2022

Conditions

Covid19

Keywords

sars-covid-2coronavirus infectioncoronavirus

Outcome Measures

Primary Outcomes (3)

  • Prevalence of test positivity

    Desciption of the prevalence of test positivity (swab or serological examination) in relation to the duties and related occupational risk

    Until the end of the study (approximately 6 months).

  • Correlation of the positive result of the test with the manifestations of the signs

    Description of the positive result of the test (swab or serological examination) with the manifestations of the signs / symptoms collected in the previous months from the attached form in the cohort of positive cases and related negative controls.

    Until the end of the study (approximately 6 months).

  • Development of COVID

    Description of the outcome of positive serological and swab test operators in terms of development of COVID-related symptomatology

    Until the end of the study (approximately 6 months).

Secondary Outcomes (8)

  • Analysis of genomic sequences of the virus

    Until the end of the study (approximately 6 months).

  • Evaluation of the test relevance

    Until the end of the study (approximately 6 months).

  • Evaluation of predictive biomolecular markers

    Until the end of the study (approximately 6 months).

  • The trend over time of the antibody response in subjects positive

    Until the end of the study (approximately 6 months).

  • The frequency of re-infection

    Until the end of the study (approximately 6 months).

  • +3 more secondary outcomes

Study Arms (2)

The asymptomatic medical staff cohort

The cohort of asymptomatic / paucisymptomatic operators will include the cohort of operators who will test positive in the serological analysis. From the entire population of hospital workers (over 3000), three controls will be identified for each operator who tested positive for the serological test that were analyzed on the same day and were negative for the serological test.

Other: Investigation of the prevalence of test positivity

The symptomatic medical staff cohort

The cohort of symptomatic hospital workers who tested positive for the swab includes 250 operators.

Other: Investigation of the prevalence of test positivity

Interventions

Investigation of the prevalence of test positivityOTHER

The study consists of an investigation by means of a prospective observational study with the aim of assess the prevalence of test positivity (swab or serological examination) ti covid-19 in relation to the duties and related occupational risk. It is used CLIA method test designed to recognize IgG antibodies directed against the S1 and S2 domains of the SARS-CoV-2 virus "spike" protein, selected for their ability to provide specificity for SARS-CoV-2 compared to other Coronaviruses .

The asymptomatic medical staff cohortThe symptomatic medical staff cohort

Eligibility Criteria

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

The study population consists of: 1. Hospital workers employed by the ASST of Monza (principals of Monza and Desio) who, in the presence of symptoms suggestive of SARS-CoV-2 infection or asymptomatic but positive on the surveillance check list, carried out nasopharyngeal swabs and tested positive. The surveillance provided by the Occupational Medicine service of the ASST of Monza involves the execution of a double negative nasopharyngeal swab before readmission to work. This cohort of operators (over 250 at ASST of Monza) will be offered the possibility of performing the serological test on a voluntary basis; 2. Asymptomatic or paucisymptomatic hospital workers employed by the ASST of Monza (garrisons of Monza and Desio) as indicated by the DG Welfare of the Lombardy region.

You may qualify if:

  • Hospital staff on active duty;
  • Age greater than or equal to 18 years;

You may not qualify if:

  • Failure to consent to serological screening or failure to consent to study participation (there are two different consent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Monza-Ospedale San Gerardo

Monza, Italy

Location

Related Publications (4)

  • Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

    PMID: 32091533BACKGROUND

  • Hunter E, Price DA, Murphy E, Schim van der Loeff I, Baker KF, Lendrem D, Lendrem C, Schmid ML, Pareja-Cebrian L, Welch A, Payne BAI, Duncan CJA. First experience of COVID-19 screening of health-care workers in England. Lancet. 2020 May 2;395(10234):e77-e78. doi: 10.1016/S0140-6736(20)30970-3. Epub 2020 Apr 22. No abstract available.

    PMID: 32333843BACKGROUND

  • Sethuraman N, Jeremiah SS, Ryo A. Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. 2020 Jun 9;323(22):2249-2251. doi: 10.1001/jama.2020.8259. No abstract available.

    PMID: 32374370BACKGROUND

  • Civra A, Colzani M, Cagno V, Francese R, Leoni V, Aldini G, Lembo D, Poli G. Modulation of cell proteome by 25-hydroxycholesterol and 27-hydroxycholesterol: A link between cholesterol metabolism and antiviral defense. Free Radic Biol Med. 2020 Mar;149:30-36. doi: 10.1016/j.freeradbiomed.2019.08.031. Epub 2019 Sep 13.

    PMID: 31525455BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

serological samples and nasopharyngeal swab

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 29, 2020

Study Start

July 9, 2020

Primary Completion

September 18, 2020

Study Completion

September 18, 2020

Last Updated

April 29, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)