SARS-CoV 2 in Personal Protective Equipment

COVID Clinical Trial

Official title:

Searching for SARS-CoV 2 in Personal Protective Equipment in Physicians in a University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04398043
• Other study ID #: rt PCR en EPP
• Status: Not yet recruiting
• Start date: May 15, 2020
• Est. completion date: July 30, 2020

Study information

• Verified date: May 2020
• Source: Hospital de Clinicas José de San Martín
• Contact: bernardo bergroth, MD
• Phone: +5491137047513
• Email: bernibergroth[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: July 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (8)

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

References & Publications (6)

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

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. Review. — View Citation

Maguire BJ, Guérin 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. — View Citation

Meselson M. Droplets and Aerosols in the Transmission of SARS-CoV-2. N Engl J Med. 2020 Apr 15. doi: 10.1056/NEJMc2009324. [Epub ahead of print] — View Citation

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

The Lancet. COVID-19: protecting health-care workers. Lancet. 2020 Mar 21;395(10228):922. doi: 10.1016/S0140-6736(20)30644-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevention risk advice	using the information found, carry out tips to reduce the risk of contagion	2 month
Primary	Asses surface contamination personel protective equipment	To assess the prevalence of surface contamination with COVID-19 from personal protective equipment (PPE) worn by medical doctors, immediately after evaluating sick patients	2 months
Secondary	Virus charge cuantification	Quantify the amount of COVID-19 in the PPE doctor´s in contact with infected patients.	2 months
Secondary	Place in PPE contamination	Determine the most frequent location of viruses inPPE	2 month