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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; Vale, Janine Araújo Montefusco; da Silva, Joana D Arc Gonçalves; Carneiro, Marcella Lemos Brettas; Padula, Rosimeire Simprini; Haddad, Rodrigo; Joanitti, Graziella Anselmo; da Silva Luz, Glécia Virgolino; Fook, Marcus Vinícius Lia; Zimmermann, Ivan Ricardo; Rosa, Suélia de Siqueira Rodrigues Fleury; Peixoto, Henry Maia; Luiz Carregaro, Rodrigo.
Affiliation
  • Kubota AMA; Universidade de Brasília (UnB), Brasília, Brazil.
  • Rosa MFF; Universidade de Brasília (UnB), Brasília, Brazil.
  • Baraldi S; Universidade de Brasília (UnB), Brasília, Brazil.
  • Vale JAM; Hospital Regional da Asa Norte (HRAN), Brasília, DF, Brazil.
  • da Silva JDAG; Hospital Regional da Asa Norte (HRAN), Brasília, DF, Brazil.
  • Carneiro MLB; Universidade de Brasília (UnB), Brasília, Brazil.
  • Padula RS; Universidade Cidade de São Paulo (UNICID), São Paulo, DF, Brazil.
  • Haddad R; Universidade de Brasília (UnB), Brasília, Brazil.
  • Joanitti GA; Universidade de Brasília (UnB), Brasília, Brazil.
  • da Silva Luz GV; Universidade de Brasília (UnB), Brasília, Brazil.
  • Fook MVL; Universidade Federal de Campina Grande (UFCG), Northeastern Biomaterials Evaluation and Development Laboratory (CERTBIO), Campina Grande, PB, Brazil.
  • Zimmermann IR; Universidade de Brasília (UnB), Brasília, Brazil.
  • Rosa SSRF; Universidade de Brasília (UnB), Brasília, Brazil.
  • Peixoto HM; Universidade de Brasília (UnB), Brasília, Brazil.
  • Luiz Carregaro R; Universidade de Brasília (UnB), Brasília, Brazil. rodrigocarregaro@unb.br.
BMC Infect Dis ; 24(1): 1061, 2024 Sep 27.
Article in En | MEDLINE | ID: mdl-39333902
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).
Subject(s)
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Health Personnel / Chitosan / Nanoparticles / SARS-CoV-2 / COVID-19 Limits: Adult / Female / Humans / Male / Middle aged Language: En Journal: BMC Infect Dis Journal subject: DOENCAS TRANSMISSIVEIS Year: 2024 Document type: Article Affiliation country: Brazil Country of publication: United kingdom

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Health Personnel / Chitosan / Nanoparticles / SARS-CoV-2 / COVID-19 Limits: Adult / Female / Humans / Male / Middle aged Language: En Journal: BMC Infect Dis Journal subject: DOENCAS TRANSMISSIVEIS Year: 2024 Document type: Article Affiliation country: Brazil Country of publication: United kingdom