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rt PCRNCT04398043

SARS-CoV 2 in Personal Protective Equipment

An observational study of rt PCR and COVID, run by Hospital de Clinicas José de San Martín.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
rt PCR, COVID, Personal Protective Equipment PPE
How many people
16 participants
Where
No sites listed yet
Study dates
15 May 2020to 30 Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: In patients in a University Hospital with COVID 19 desease

Who may be able to join

  • in patient with rtPCT possitive for SARSCoV-2 (interned in an intensive care unit, medical clinic room and coronary unit)

Who cannot join

  • in pattient with negattive rtPCT for SARSCoV-2

Trial locations and contacts

No sites are listed yet.

bernardo bergroth, MD contact

+5491137047513

bernibergroth@gmail.com

Claudio Yaryour, MD contact

chyaryour@hotmail.com

About this study

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

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.

Read the 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.

Medical subject headings
Virus Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 months

Secondary outcomes (2)

  1. Virus charge cuantification

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

    Measured: 2 months

  2. Place in PPE contamination

    Determine the most frequent location of viruses inPPE

    Measured: 2 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start15 May 2020 (estimated)
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion30 Jul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04398043
Sponsor's protocol ID
rt PCR en EPP
Status last verified
May 2020
First submitted
19 May 2020
Last updated
21 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: It depnds on formulations

Publications

  • 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.

    PubMed 32199474

  • 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.

    PubMed 32294574

  • 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.

    PubMed 32294374

  • 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.

    PubMed 32196430

  • 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.

    PubMed 32292826

Questions about this trial

What is this clinical trial studying?

An observational study of rt PCR and COVID, run by Hospital de Clinicas José de San Martín.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact bernardo bergroth, MD (+5491137047513, bernibergroth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asses surface contamination personel protective equipment (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04398043, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.

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