SARS-CoV 2 in Personal Protective Equipment

Sponsor
Hospital de Clinicas José de San Martín (Other)
Overall Status
Unknown status
CT.gov ID
NCT04398043
Collaborator
Claudio Yaryour (Other), Fermepin Marcelo (Other), Luis Sarotto (Other), Federico Rodriguez Cairoli (Other), Angela Famiglieti (Other), Francisco Appiani (Other), Lucía Gallo Vaulet (Other)
16
2.5

Study Details

Study Description

Brief Summary

SARS-CoV-2 transmission is frequently occurring in hospital settings, with numerous reported cases of nosocomial transmission highlighting the vulnerability of healthcare workers.

If products proved to be efficacious against COVID-19, why are so many HCW getting COVID-19? Is it related to experience? Is it generated by the exhaustive job? Is there any degree of relationship to stress? These questions are still without fully correct answers. Achieving global benefits for HCW is still waiting.

Detailed Description

Objective: To assess the extent of surface contamination PPE doctors (personal protective equipment) with SARS-CoV-2, immediately after evaluating ill patients.

COVID-19 is a recently emerging disease, in which much scientific information is being generated, but in which there are few certainties. This is due to work of poor methodological quality, but also due to the fact that it is a recent infection, which has only been developing for a few months. Given that most cases of infection in health personnel in the workplace come from contamination with personal protective equipment, it is necessary to determine there is any degree of contamination of PPE by the virus, as the critical areas where it can be located in the PPE as well. That is why this investigation, when trying to determine the location and degree of contamination of PPE by COVID-19, will allow the implementation of exhaustive care that leads to greater care for health personnel.

Target population: patients with a diagnosis of COVID-19 in patients admitted to a service in the General Ward and Intensive Care Unit or Coronary Unit of a University Hospital of C.A.B.A- (Argentina) Accessible population of adults patients with a diagnosis of COVID-19 admitted to the CN / Intensive Care Unit / Coronary Unit, while the research is in progress.

Population Definition Criteria: PPE of medical personnel in contact with hospitalized patients with SARS-CoV-2 positive swab, hospitalized in CM / UTI / UC wards.

Inclusion Criteria: Samples of personal protective equipment of health personnel who have been in contact with patients with positive viral RNA results in RT-real time PCR (rtPCR +) test for SARS-CoV-2 will be used.

Exclusion criteria:

PPE of health personnel who have been in contact with patients without confirmation of COVID-19 diagnosis.

Elimination Criteria: those patients who change the result of the positive viral load to negative viral load.

Time-space coordinates:

The research will be carried out from May 15, 2020 and will be carried out in the CM / UTI / UC rooms of the Hospital de Clínicas José de San Martín, in those patients with confirmed pathology of COVID-19 until reaching the necessary number of 16 patients.

2.2. Ethical objections to the project. This project is carried out under the ethical standards that govern human research in accordance with the National Law on Protection of Personal Data No. 25,326 (Habeas Data Law) and the Declaration of Helsinki in its latest version (Fortaleza 2013). The Bioethics and Teaching and Research Committee of the José de San Martín Clinic Hospital have given their approval to carry out the study.

Study Design

Study Type:
Observational
Anticipated Enrollment :
16 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Searching for SARS-CoV 2 in Personal Protective Equipment in Physicians in a University Hospital
Anticipated Study Start Date :
May 15, 2020
Anticipated Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Jul 30, 2020

Outcome Measures

Primary Outcome Measures

  1. Asses surface contamination personel protective equipment [2 months]

    To assess the prevalence of surface contamination with COVID-19 from personal protective equipment (PPE) worn by medical doctors, immediately after evaluating sick patients

Secondary Outcome Measures

  1. Virus charge cuantification [2 months]

    Quantify the amount of COVID-19 in the PPE doctor´s in contact with infected patients.

  2. Place in PPE contamination [2 month]

    Determine the most frequent location of viruses inPPE

Other Outcome Measures

  1. Prevention risk advice [2 month]

    using the information found, carry out tips to reduce the risk of contagion

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • in patient with rtPCT possitive for SARSCoV-2 (interned in an intensive care unit, medical clinic room and coronary unit)
Exclusion Criteria:
  • in pattient with negattive rtPCT for SARSCoV-2

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospital de Clinicas José de San Martín
  • Claudio Yaryour
  • Fermepin Marcelo
  • Luis Sarotto
  • Federico Rodriguez Cairoli
  • Angela Famiglieti
  • Francisco Appiani
  • Lucía Gallo Vaulet

Investigators

  • Study Chair: Claudio Yaryour, MD, Hospital de Clínicas José de San Martín, UBA

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bernardo Bergroth, MD, Chief of medical informatics, Hospital de Clinicas José de San Martín
ClinicalTrials.gov Identifier:
NCT04398043
Other Study ID Numbers:
  • rt PCR en EPP
First Posted:
May 21, 2020
Last Update Posted:
May 21, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 21, 2020