Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04913701
Acronym
COVID-19
Enrollment
500
Registered
2021-06-04
Start date
2020-03-21
Completion date
2020-12-31
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-Cov2

Keywords

SARS-Cov2, Covid-19, Epidemiological surveillance, Observational study, Healtcare workers, Real-life, Rehabilitation

Brief summary

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

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).

Interventions

OTHERObservation group 1

Subjects will be followed with 3 swabs and serological test

Sponsors

IRCCS San Raffaele Roma
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with positive RT-PCR against SARS-CoV215 daysAll subjects will have 3 swabs done and analyzed

Secondary

MeasureTime frameDescription
Number of participants with qualitative IgM/IgG positive results15 daysAll subjects will have 1 blood pick-test

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026