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Screening of Health-care Workers in an University Hospital for SARS-CoV-2 (STORM-HCW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04567836
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca

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.

Condition or disease Intervention/treatment
Covid19 Other: Investigation of the prevalence of test positivity

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening of Health-care Workers in an University Hospital: an Observational Prospective Study on the Screening of Hospital Workers for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020


Group/Cohort Intervention/treatment
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 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 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

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 .





Primary Outcome Measures :
  1. Prevalence of test positivity [ Time Frame: Until the end of the study (approximately 6 months). ]
    Desciption of the prevalence of test positivity (swab or serological examination) in relation to the duties and related occupational risk

  2. Correlation of the positive result of the test with the manifestations of the signs [ Time Frame: Until the end of the study (approximately 6 months). ]
    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.

  3. Development of COVID [ Time Frame: Until the end of the study (approximately 6 months). ]
    Description of the outcome of positive serological and swab test operators in terms of development of COVID-related symptomatology


Secondary Outcome Measures :
  1. Analysis of genomic sequences of the virus [ Time Frame: Until the end of the study (approximately 6 months). ]
    to correlate the virus genomic sequence of asymptomatic but positive serological and swab operators with the available data of the SARS-CoV-2 virus sequences.

  2. Evaluation of the test relevance [ Time Frame: Until the end of the study (approximately 6 months). ]
    Evaluate the relevance of tests with greater sensitivity and specificity in the population negative for the throat swab but positive for the serological investigation;

  3. Evaluation of predictive biomolecular markers [ Time Frame: Until the end of the study (approximately 6 months). ]
    Evaluation biomolecular markers that are predictive of susceptibility to infection and predictive of symptomatic infection

  4. The trend over time of the antibody response in subjects positive [ Time Frame: Until the end of the study (approximately 6 months). ]
    Evaluate the trend over time of the antibody response in subjects positive to the serological test and to the swab (both symptomatic and asymptomatic).

  5. The frequency of re-infection [ Time Frame: Until the end of the study (approximately 6 months). ]
    Evaluate the frequency of re-infection (symptomatology compatible with COVID and positive swab) in operators who tested positive for serological and swab tests.

  6. Evaluation of the mode of transmission relatively anamnestic data [ Time Frame: Until the end of the study (approximately 6 months). ]
    Evaluate the mode of transmission between relatives by collecting anamnestic data.

  7. The relation between mode of transmission and the available clinical documentation [ Time Frame: Until the end of the study (approximately 6 months). ]
    Assess the mode of transmission between relatives by collecting the available clinical documentation

  8. Evaluation of the mode of transmission for the use of barriers [ Time Frame: Until the end of the study (approximately 6 months). ]
    Evaluate the mode of transmission between relatives by collecting the barriers used in the home: none, mask and spacing, voluntary isolation.


Biospecimen Retention:   Samples With DNA
serological samples and nasopharyngeal swab


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567836


Contacts
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Contact: Paolo Bonfanti +39 039 233 9310 paolo.bonfanti@unimib.it

Locations
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Italy
ASST Monza-Ospedale San Gerardo Recruiting
Monza, Italy
Sponsors and Collaborators
University of Milano Bicocca
Publications:
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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT04567836    
Other Study ID Numbers: STORM-HCW
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Milano Bicocca:
sars-covid-2
coronavirus infection
coronavirus