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

NCT04913701 | Completed

• 1 other identifier: RP 20/09 main
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-Cov2

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with positive RT-PCR against SARS-CoV2

  All subjects will have 3 swabs done and analyzed

  15 days

Secondary Outcomes (1)

• Number of participants with qualitative IgM/IgG positive results

  15 days

Study Arms (3)

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

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

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

Interventions

Observation group 1 OTHER

Subjects will be followed with 3 swabs and serological test

1 - Health workers; 2 - Patients; 3 - Real life participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients/Participants \> 18 years
• Subjects who agree with the study signing the informed consent

You may not qualify if:

• Age \<18 years;
• Pregnancy in progress;
• Simultaneous participation in another clinical study
• Ongoing immunosuppressive therapy or during the last month

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele Pisana

Rome, I-00166, Italy

Location

Related Publications (12)

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  PMID: 32141279 BACKGROUND

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  PMID: 32109012 BACKGROUND

• Heymann DL. Data sharing and outbreaks: best practice exemplified. Lancet. 2020 Feb 15;395(10223):469-470. doi: 10.1016/S0140-6736(20)30184-7. Epub 2020 Jan 24. No abstract available.

  PMID: 31986258 BACKGROUND

• Hellewell J, Abbott S, Gimma A, Bosse NI, Jarvis CI, Russell TW, Munday JD, Kucharski AJ, Edmunds WJ; Centre for the Mathematical Modelling of Infectious Diseases COVID-19 Working Group; Funk S, Eggo RM. Feasibility of controlling COVID-19 outbreaks by isolation of cases and contacts. Lancet Glob Health. 2020 Apr;8(4):e488-e496. doi: 10.1016/S2214-109X(20)30074-7. Epub 2020 Feb 28.

  PMID: 32119825 BACKGROUND

• Huh S. How to train health personnel to protect themselves from SARS-CoV-2 (novel coronavirus) infection when caring for a patient or suspected case. J Educ Eval Health Prof. 2020 Jan;17:10. doi: 10.3352/jeehp.2020.17.10. Epub 2020 Mar 7. No abstract available.

  PMID: 32150796 BACKGROUND

• Jones DS. History in a Crisis - Lessons for Covid-19. N Engl J Med. 2020 Apr 30;382(18):1681-1683. doi: 10.1056/NEJMp2004361. Epub 2020 Mar 12. No abstract available.

  PMID: 32163699 BACKGROUND

• Lipsitch M, Swerdlow DL, Finelli L. Defining the Epidemiology of Covid-19 - Studies Needed. N Engl J Med. 2020 Mar 26;382(13):1194-1196. doi: 10.1056/NEJMp2002125. Epub 2020 Feb 19. No abstract available.

  PMID: 32074416 BACKGROUND

• Rothe C, Schunk M, Sothmann P, Bretzel G, Froeschl G, Wallrauch C, Zimmer T, Thiel V, Janke C, Guggemos W, Seilmaier M, Drosten C, Vollmar P, Zwirglmaier K, Zange S, Wolfel R, Hoelscher M. Transmission of 2019-nCoV Infection from an Asymptomatic Contact in Germany. N Engl J Med. 2020 Mar 5;382(10):970-971. doi: 10.1056/NEJMc2001468. Epub 2020 Jan 30. No abstract available.

  PMID: 32003551 BACKGROUND

• Reusken CBEM, Broberg EK, Haagmans B, Meijer A, Corman VM, Papa A, Charrel R, Drosten C, Koopmans M, Leitmeyer K; EVD-LabNet and ERLI-Net. Laboratory readiness and response for novel coronavirus (2019-nCoV) in expert laboratories in 30 EU/EEA countries, January 2020. Euro Surveill. 2020 Feb;25(6):2000082. doi: 10.2807/1560-7917.ES.2020.25.6.2000082. Epub 2020 Feb 11.

  PMID: 32046815 BACKGROUND

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  PMID: 32145766 BACKGROUND

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  PMID: 32074444 BACKGROUND

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  PMID: 32087115 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Carlo Tomino, PhD

  IRCCS San Raffaele Pisana

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 4, 2021
• Study Start: March 21, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

IT (1)