COVID-19 Epidemiological Surveillance on Healthcare Workers and Patients in a Rehabilitation Medicine Facility

Study Overview
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Brief Summary
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The recent SARS-CoV2 pandemic has highlighted that the transmission of the virus within health care facilities plays a fundamental role in its propagation and, therefore, in the increase in COVID-19 cases registered among patients and healthcare workers. This study, original for the current lack of data on nosocomial transmission mechanisms compared to what happens in the community, proposes to conduct a study in patients, health workers and people in real-life setting. The study will be monocentric and performed at the San Raffaele Pisana Institute in Rome, that is able to guarantee the necessary number and the right case-mix that will allow to evaluate any possible correlations between infection and pre-existing disease.

Detailed Description
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Furthermore, hospitals, especially those dedicated to chronic patients, as well as other communities that are not completely closed (such as school and work communities), are also at greater risk of small outbreaks that also affect healthcare professionals. It is therefore necessary to carry out periodic checks on all healthcare professionals who work in healthcare facilities both to ensure their health and avoid the risk of possible contamination and to prevent the possible transmission of infection from the community to the hospital. Another essential aspect to prevent infection in such facilities is the control of colonization in admitted patients. Negativity from SARS-CoV2 should be carefully monitored in these patients prior to their placement in different departments. On this basis, the study aims to determine the presence of SARS-CoV2 by monitoring with serial nasopharyngeal swabs carried out on healthcare professionals working within the facility and on new patients admitted. In order to exclude the possibility of false negatives due to low viral load found in the early stages of infection (incubation time) or any exposure that may occur in the days following the execution of the swab, the study will i provide for the repetition of the swab examination, 3 times, at weekly intervals. In order to verify the correspondence between the presence of IgM and IgG antibodies against the virus and the positivity to the swabs, the healthcare professionals and patients who undergoing nasopharyngeal swab will be previously subjected to the rapid antibody detection test (prick test for IgG and IgM).

Official Title
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Observational Study for SARS-Cov2 Epidemiological Surveillance on Healthcare Workers and Patients in a Rehabilitation Medicine Facility

Conditions
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SARS-Cov2

Intervention / Treatment
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* Other: Observation group 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients/Participants > 18 years Subjects who agree with the study signing the informed consent Exclusion Criteria: Age <18 years; Pregnancy in progress; Simultaneous participation in another clinical study Ongoing immunosuppressive therapy or during the last month

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 - Health workers<br>A total number of 200-300 healthcare workers, exposed to close contact with patients, will be asked to participate to the study and will be asked to sign the informed consent. | Other: Observation group 1<br>* Subjects will be followed with 3 swabs and serological test<br>|
| 2 - Patients<br>A total number of 100-200 patients admitted to the rehabilitation facility, referred from other healthcare facilities or from their own home, will be asked to participate to the study. | Other: Observation group 1<br>* Subjects will be followed with 3 swabs and serological test<br>|
| 3 - Real life participants<br>A total number of 100 real-life participants, will be represented by volunteers (other employees, staff not in contact with patients | Other: Observation group 1<br>* Subjects will be followed with 3 swabs and serological test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with positive RT-PCR against SARS-CoV2 | All subjects will have 3 swabs done and analyzed | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with qualitative IgM/IgG positive results | All subjects will have 1 blood pick-test | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-Cov2, Covid-19, Epidemiological surveillance, Observational study, Healtcare workers, Real-life, Rehabilitation