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

June 23, 2023 updated by: IRCCS San Raffaele Roma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, I-00166
        • IRCCS San Raffaele Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Study will be on healthcare workers in direct contact with patients (pts). Surveillance will be done on new admitted pts to evaluate prevalence of infection among pts in pulmonary, or cardiac rehabilitation.

Data will allow to reconstruct eventual transmission and compare values observed in healthcare and real life. Random samples will be done in subjects from the population without obvious risk factors.

Study will have 3 groups:

  • 200-300 healthcare workers in direct patients contact, incl. staff at registration desk. 100-200 pts admitted to rehabilitation at the Institute, referred from other health facilities will be enrolled in the study.
  • 100 volunteers in Real-life will be other employees, staff not in contact with patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 - Health workers
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
Subjects will be followed with 3 swabs and serological test
2 - Patients
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
Subjects will be followed with 3 swabs and serological test
3 - Real life participants
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
Subjects will be followed with 3 swabs and serological test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with positive RT-PCR against SARS-CoV2
Time Frame: 15 days
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
Time Frame: 15 days
All subjects will have 1 blood pick-test
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele Roma

Investigators

  • Study Director: Carlo Tomino, PhD, IRCCS San Raffaele Pisana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

June 3, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RP 20/09 main

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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