Efficacy and feasibility of a novel semi-facial respirator with chitosan nanoparticles on the incidence of SARS-CoV-2 infection in healthcare professionals: randomized controlled trial

Aline Midori Adati Kubota; Mário Fabrício Fleury Rosa; Solange Baraldi; Janine Araújo Montefusco Vale; Joana D Arc Gonçalves da Silva; Marcella Lemos Brettas Carneiro; Rosimeire Simprini Padula; Rodrigo Haddad; Graziella Anselmo Joanitti; Glécia Virgolino da Silva Luz; Marcus Vinícius Lia Fook; Ivan Ricardo Zimmermann; Suélia de Siqueira Rodrigues Fleury Rosa; Henry Maia Peixoto; Rodrigo Luiz Carregaro

doi:10.1186/s12879-024-09966-x

Efficacy and feasibility of a novel semi-facial respirator with chitosan nanoparticles on the incidence of SARS-CoV-2 infection in healthcare professionals: randomized controlled trial

Aline Midori Adati Kubota, Mário Fabrício Fleury Rosa, Solange Baraldi, Janine Araújo Montefusco Vale, Joana D Arc Gonçalves da Silva, Marcella Lemos Brettas Carneiro, Rosimeire Simprini Padula, Rodrigo Haddad, Graziella Anselmo Joanitti, Glécia Virgolino da Silva Luz, Marcus Vinícius Lia Fook, Ivan Ricardo Zimmermann, Suélia de Siqueira Rodrigues Fleury Rosa, Henry Maia Peixoto, Rodrigo Luiz Carregaro

Health Sciences

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

BACKGROUND: Evidence suggests that semi-facial respirators provide protection against contamination in high-risk environments, although the COVID-19 pandemic called for greater protection and viral inactivation capacity. Thus, the aim of this study was to investigate the efficacy of a novel semi-facial respirator containing chitosan nanoparticles, compared with a conventional N95 respirator on the incidence of laboratory-confirmed SARS-CoV-2 in healthcare professionals. The secondary outcomes were influenza infection, usability and comfort.

METHODS: Randomized controlled trial within a large public hospital (reference for COVID-19 patients) carried out between March 2021 and June 2023. We included 230 healthcare professionals exposed to SARS-Cov-2 and influenza, working in emergency departments, hospital wards, and intensive care units. Participants were assessed at baseline, after 10 days, and 21 days of follow-up. Researchers, participants, and outcome assessors were blinded to the allocated groups. Outcomes were analyzed by bivariate and multivariate comparisons using logistic regression. Crude (cOR) and adjusted odds ratios (aOR) were estimated, followed by 95% confidence intervals (CIs 95%). We adopted intention-to-treat (ITT) and complete-case (CC) analyses.

RESULTS: Baseline characteristics were considered homogeneous between groups, and usability and comfort were reported as excellent in both groups. Non-significant differences were found for all outcomes, both in the ITT and CC analyses. The incidence of COVID-19 and influenza were, respectively, cOR: 0.96 [CI95%: 0.21-4.42] and cOR: 1.25 [CI95%: 0.34-4.62]; and aOR: 1.08 [CI95%: 0.21-5.47] and aOR: 1.11 [CI95%: 0.17-7.01].

CONCLUSIONS: We found that the incidence of SARS-Cov-2 and influenza infections were similar between the new respirator compared to the conventional respirator. Furthermore, we observed that usability and comfort were similar and considered excellent for both respirators.

TRIAL REGISTRATION: Clinicaltrials.gov (NCT04490200, 29/07/2020).

Original language	English
Article number	1061
Pages (from-to)	1061
Journal	BMC Infectious Diseases
Volume	24
Issue number	1
DOIs	https://doi.org/10.1186/s12879-024-09966-x
Publication status	Published - 27 Sept 2024

Bibliographical note

Funding

The study was funded by the National Council for Scientific and Technological Development (CNPq) process number 307885/2020-8 and 403472/2020-2; Foundation for Research Support of the Federal District (FAPDF) process number 00193–00000736/2021-64; UnB/DPI/FAPDF (COVID-19) process number 6913; Online crowdfunding (VAKINHA) ID 964530; Brasília Department of the Institute of Electrical and Electronic Engineers (IEEE); Federal Institute of Education, Science, and Technology of Brasília - Ceilândia Campus (IFT); National Conference of Bishops of Brazil (CNBB). The funding sources were not involved in the study design, in the collection, analysis, and interpretation of data, in the writing of the report or in the decision to submit the article for publication.

Funders	Funder number
Institute of Electrical and Electronics Engineers
Federal Institute of Education, Science, and Technology of Brasília - Ceilândia Campus
Institute of Food Technologists
Occupational Health and Safety Department
VAKINHA	964530
Conselho Nacional de Desenvolvimento Científico e Tecnológico	403472/2020-2, 307885/2020-8
Fundação de Apoio à Pesquisa do Distrito Federal	6913, 00193–00000736/2021-64

Keywords

Humans
COVID-19/prevention & control
Chitosan
Female
Male
Health Personnel
Adult
Nanoparticles
Incidence
SARS-CoV-2
Middle Aged
Respiratory Protective Devices
Influenza, Human/prevention & control
N95 Respirators
Feasibility Studies

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Kubota, A. M. A., Rosa, M. F. F., Baraldi, S., Vale, J. A. M., da Silva, J. D. A. G., Carneiro, M. L. B., Padula, R. S., Haddad, R., Joanitti, G. A., da Silva Luz, G. V., Fook, M. V. L., Zimmermann, I. R., Rosa, S. D. S. R. F., Peixoto, H. M., & Luiz Carregaro, R. (2024). Efficacy and feasibility of a novel semi-facial respirator with chitosan nanoparticles on the incidence of SARS-CoV-2 infection in healthcare professionals: randomized controlled trial. BMC Infectious Diseases, 24(1), 1061. Article 1061. https://doi.org/10.1186/s12879-024-09966-x

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abstract = "BACKGROUND: Evidence suggests that semi-facial respirators provide protection against contamination in high-risk environments, although the COVID-19 pandemic called for greater protection and viral inactivation capacity. Thus, the aim of this study was to investigate the efficacy of a novel semi-facial respirator containing chitosan nanoparticles, compared with a conventional N95 respirator on the incidence of laboratory-confirmed SARS-CoV-2 in healthcare professionals. The secondary outcomes were influenza infection, usability and comfort.METHODS: Randomized controlled trial within a large public hospital (reference for COVID-19 patients) carried out between March 2021 and June 2023. We included 230 healthcare professionals exposed to SARS-Cov-2 and influenza, working in emergency departments, hospital wards, and intensive care units. Participants were assessed at baseline, after 10 days, and 21 days of follow-up. Researchers, participants, and outcome assessors were blinded to the allocated groups. Outcomes were analyzed by bivariate and multivariate comparisons using logistic regression. Crude (cOR) and adjusted odds ratios (aOR) were estimated, followed by 95% confidence intervals (CIs 95%). We adopted intention-to-treat (ITT) and complete-case (CC) analyses.RESULTS: Baseline characteristics were considered homogeneous between groups, and usability and comfort were reported as excellent in both groups. Non-significant differences were found for all outcomes, both in the ITT and CC analyses. The incidence of COVID-19 and influenza were, respectively, cOR: 0.96 [CI95%: 0.21-4.42] and cOR: 1.25 [CI95%: 0.34-4.62]; and aOR: 1.08 [CI95%: 0.21-5.47] and aOR: 1.11 [CI95%: 0.17-7.01].CONCLUSIONS: We found that the incidence of SARS-Cov-2 and influenza infections were similar between the new respirator compared to the conventional respirator. Furthermore, we observed that usability and comfort were similar and considered excellent for both respirators.TRIAL REGISTRATION: Clinicaltrials.gov (NCT04490200, 29/07/2020).",

keywords = "Humans, COVID-19/prevention & control, Chitosan, Female, Male, Health Personnel, Adult, Nanoparticles, Incidence, SARS-CoV-2, Middle Aged, Respiratory Protective Devices, Influenza, Human/prevention & control, N95 Respirators, Feasibility Studies",

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doi = "10.1186/s12879-024-09966-x",

language = "English",

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Kubota, AMA, Rosa, MFF, Baraldi, S, Vale, JAM, da Silva, JDAG, Carneiro, MLB, Padula, RS, Haddad, R, Joanitti, GA, da Silva Luz, GV, Fook, MVL, Zimmermann, IR, Rosa, SDSRF, Peixoto, HM & Luiz Carregaro, R 2024, 'Efficacy and feasibility of a novel semi-facial respirator with chitosan nanoparticles on the incidence of SARS-CoV-2 infection in healthcare professionals: randomized controlled trial', BMC Infectious Diseases, vol. 24, no. 1, 1061, pp. 1061. https://doi.org/10.1186/s12879-024-09966-x

Efficacy and feasibility of a novel semi-facial respirator with chitosan nanoparticles on the incidence of SARS-CoV-2 infection in healthcare professionals: randomized controlled trial. / Kubota, Aline Midori Adati; Rosa, Mário Fabrício Fleury; Baraldi, Solange et al.
In: BMC Infectious Diseases, Vol. 24, No. 1, 1061, 27.09.2024, p. 1061.

Research output: Contribution to Journal › Article › Academic › peer-review

TY - JOUR

T1 - Efficacy and feasibility of a novel semi-facial respirator with chitosan nanoparticles on the incidence of SARS-CoV-2 infection in healthcare professionals

T2 - randomized controlled trial

AU - Kubota, Aline Midori Adati

AU - Rosa, Mário Fabrício Fleury

AU - Baraldi, Solange

AU - Vale, Janine Araújo Montefusco

AU - da Silva, Joana D Arc Gonçalves

AU - Carneiro, Marcella Lemos Brettas

AU - Padula, Rosimeire Simprini

AU - Haddad, Rodrigo

AU - Joanitti, Graziella Anselmo

AU - da Silva Luz, Glécia Virgolino

AU - Fook, Marcus Vinícius Lia

AU - Zimmermann, Ivan Ricardo

AU - Rosa, Suélia de Siqueira Rodrigues Fleury

AU - Peixoto, Henry Maia

AU - Luiz Carregaro, Rodrigo

PY - 2024/9/27

Y1 - 2024/9/27

N2 - BACKGROUND: Evidence suggests that semi-facial respirators provide protection against contamination in high-risk environments, although the COVID-19 pandemic called for greater protection and viral inactivation capacity. Thus, the aim of this study was to investigate the efficacy of a novel semi-facial respirator containing chitosan nanoparticles, compared with a conventional N95 respirator on the incidence of laboratory-confirmed SARS-CoV-2 in healthcare professionals. The secondary outcomes were influenza infection, usability and comfort.METHODS: Randomized controlled trial within a large public hospital (reference for COVID-19 patients) carried out between March 2021 and June 2023. We included 230 healthcare professionals exposed to SARS-Cov-2 and influenza, working in emergency departments, hospital wards, and intensive care units. Participants were assessed at baseline, after 10 days, and 21 days of follow-up. Researchers, participants, and outcome assessors were blinded to the allocated groups. Outcomes were analyzed by bivariate and multivariate comparisons using logistic regression. Crude (cOR) and adjusted odds ratios (aOR) were estimated, followed by 95% confidence intervals (CIs 95%). We adopted intention-to-treat (ITT) and complete-case (CC) analyses.RESULTS: Baseline characteristics were considered homogeneous between groups, and usability and comfort were reported as excellent in both groups. Non-significant differences were found for all outcomes, both in the ITT and CC analyses. The incidence of COVID-19 and influenza were, respectively, cOR: 0.96 [CI95%: 0.21-4.42] and cOR: 1.25 [CI95%: 0.34-4.62]; and aOR: 1.08 [CI95%: 0.21-5.47] and aOR: 1.11 [CI95%: 0.17-7.01].CONCLUSIONS: We found that the incidence of SARS-Cov-2 and influenza infections were similar between the new respirator compared to the conventional respirator. Furthermore, we observed that usability and comfort were similar and considered excellent for both respirators.TRIAL REGISTRATION: Clinicaltrials.gov (NCT04490200, 29/07/2020).

AB - BACKGROUND: Evidence suggests that semi-facial respirators provide protection against contamination in high-risk environments, although the COVID-19 pandemic called for greater protection and viral inactivation capacity. Thus, the aim of this study was to investigate the efficacy of a novel semi-facial respirator containing chitosan nanoparticles, compared with a conventional N95 respirator on the incidence of laboratory-confirmed SARS-CoV-2 in healthcare professionals. The secondary outcomes were influenza infection, usability and comfort.METHODS: Randomized controlled trial within a large public hospital (reference for COVID-19 patients) carried out between March 2021 and June 2023. We included 230 healthcare professionals exposed to SARS-Cov-2 and influenza, working in emergency departments, hospital wards, and intensive care units. Participants were assessed at baseline, after 10 days, and 21 days of follow-up. Researchers, participants, and outcome assessors were blinded to the allocated groups. Outcomes were analyzed by bivariate and multivariate comparisons using logistic regression. Crude (cOR) and adjusted odds ratios (aOR) were estimated, followed by 95% confidence intervals (CIs 95%). We adopted intention-to-treat (ITT) and complete-case (CC) analyses.RESULTS: Baseline characteristics were considered homogeneous between groups, and usability and comfort were reported as excellent in both groups. Non-significant differences were found for all outcomes, both in the ITT and CC analyses. The incidence of COVID-19 and influenza were, respectively, cOR: 0.96 [CI95%: 0.21-4.42] and cOR: 1.25 [CI95%: 0.34-4.62]; and aOR: 1.08 [CI95%: 0.21-5.47] and aOR: 1.11 [CI95%: 0.17-7.01].CONCLUSIONS: We found that the incidence of SARS-Cov-2 and influenza infections were similar between the new respirator compared to the conventional respirator. Furthermore, we observed that usability and comfort were similar and considered excellent for both respirators.TRIAL REGISTRATION: Clinicaltrials.gov (NCT04490200, 29/07/2020).

KW - Humans

KW - COVID-19/prevention & control

KW - Chitosan

KW - Female

KW - Male

KW - Health Personnel

KW - Adult

KW - Nanoparticles

KW - Incidence

KW - SARS-CoV-2

KW - Middle Aged

KW - Respiratory Protective Devices

KW - Influenza, Human/prevention & control

KW - N95 Respirators

KW - Feasibility Studies

U2 - 10.1186/s12879-024-09966-x

DO - 10.1186/s12879-024-09966-x

M3 - Article

C2 - 39333902

SN - 1471-2334

VL - 24

SP - 1061

JO - BMC Infectious Diseases

JF - BMC Infectious Diseases

IS - 1

M1 - 1061

ER -

Efficacy and feasibility of a novel semi-facial respirator with chitosan nanoparticles on the incidence of SARS-CoV-2 infection in healthcare professionals: randomized controlled trial

Abstract

Bibliographical note

Funding

Keywords

UN SDGs

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