SARS-CoV 2 in Personal Protective Equipment

NCT ID: NCT04398043

Last Updated: 2020-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-15

Study Completion Date

2020-07-30

Brief Summary

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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

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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.

Conditions

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rt PCR COVID Personal Protective Equipment PPE SARS-CoV 2 Health Personnel Attitude Virus Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Claudio Yaryour

UNKNOWN

Sponsor Role collaborator

Fermepin Marcelo

UNKNOWN

Sponsor Role collaborator

Luis Sarotto

UNKNOWN

Sponsor Role collaborator

Federico Rodriguez Cairoli

UNKNOWN

Sponsor Role collaborator

Angela Famiglieti

UNKNOWN

Sponsor Role collaborator

Francisco Appiani

UNKNOWN

Sponsor Role collaborator

Lucía Gallo Vaulet

UNKNOWN

Sponsor Role collaborator

Hospital de Clinicas José de San Martín

OTHER

Sponsor Role lead

Responsible Party

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Bernardo Bergroth

MD, Chief of medical informatics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudio Yaryour, MD

Role: STUDY_CHAIR

Hospital de Clínicas José de San Martín, UBA

Central Contacts

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bernardo bergroth, MD

Role: CONTACT

+5491137047513

Claudio Yaryour, MD

Role: CONTACT

References

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The Lancet. COVID-19: protecting health-care workers. Lancet. 2020 Mar 21;395(10228):922. doi: 10.1016/S0140-6736(20)30644-9. No abstract available.

Reference Type BACKGROUND
PMID: 32199474 (View on PubMed)

Morawska L, Cao J. Airborne transmission of SARS-CoV-2: The world should face the reality. Environ Int. 2020 Jun;139:105730. doi: 10.1016/j.envint.2020.105730. Epub 2020 Apr 10.

Reference Type BACKGROUND
PMID: 32294574 (View on PubMed)

Meselson M. Droplets and Aerosols in the Transmission of SARS-CoV-2. N Engl J Med. 2020 May 21;382(21):2063. doi: 10.1056/NEJMc2009324. Epub 2020 Apr 15. No abstract available.

Reference Type BACKGROUND
PMID: 32294374 (View on PubMed)

Assessment of N95 respirator decontamination and re-use for SARS-CoV-2 Robert Fischer, View ORCID ProfileDylan H Morris, Neeltje van Doremalen, Shanda Sarchette, Jeremiah Matson, Trenton Bushmaker, Claude Kwe Yinda, Stephanie Seifert, Amandine Gamble, Brandi Williamson, Seth Judson, Emmie de Wit, Jamie Lloyd-Smith, View ORCID ProfileVincent Munster doi: https://doi.org/10.1101/2020.04.11.20062018

Reference Type BACKGROUND

Loeffelholz MJ, Tang YW. Laboratory diagnosis of emerging human coronavirus infections - the state of the art. Emerg Microbes Infect. 2020 Dec;9(1):747-756. doi: 10.1080/22221751.2020.1745095.

Reference Type BACKGROUND
PMID: 32196430 (View on PubMed)

Maguire BJ, Guerin PJ. A living systematic review protocol for COVID-19 clinical trial registrations. Wellcome Open Res. 2020 Apr 2;5:60. doi: 10.12688/wellcomeopenres.15821.1. eCollection 2020.

Reference Type BACKGROUND
PMID: 32292826 (View on PubMed)

Other Identifiers

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rt PCR en EPP

Identifier Type: -

Identifier Source: org_study_id

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