Status:

COMPLETED

Effectiveness of a Novel Respirator With Chitosan Nanoparticles

Lead Sponsor:

University of Brasilia

Collaborating Sponsors:

University of Campinas, Brazil

Centro de Pesquisa em Biotecnologia Ltda

Conditions:

Covid19

SARS-CoV Infection

Eligibility:

All Genders

20-59 years

Phase:

NA

Brief Summary

The use of nanomaterials in semi-facial respirators could decrease the permeability of particles and promote a biocidal effect compared to conventional respirators (N95) and, therefore, to enhance the...

Detailed Description

Context for the latest register update (May, 2022): Our randomized controlled pilot trial was conducted from February until April 2021, following the same methodological procedures described within th...

Eligibility Criteria

Inclusion

  • Full-time employees (defined as direct patient care for more than 24 hours weekly) and work primarily at the study site or co-participants (more than 75% of working hours).
  • Professionals working in emergency departments, ICUs, and other hospital settings exposed to SARS-Cov-2.
  • Negative clinical and laboratory results for SARS-Cov-2 infection (negative RT-PCR).
  • Have previous experience using N95 PFF2 respirators.

Exclusion

  • Pregnant or breastfeeding women.
  • History of high-risk comorbidities, such as high-risk heart disease or respiratory diseases.
  • Presence of heterogeneous facial anatomical characteristics such as bulky beard, facial deformities, or facial dimensions incompatible with the respirators.

Key Trial Info

Start Date :

March 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 28 2023

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT04490200

Start Date

March 1 2021

End Date

June 28 2023

Last Update

July 3 2023

Active Locations (1)

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1

HRAN (Hospital Regional da Asa Norte)

Brasília, Brazil