Effectiveness of a Novel Respirator With Chitosan Nanoparticles

NCT04490200 | Completed

• 2 other identifiers: VESTA Trial32862320.0.0000.0030
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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 filtering power, aiming to mitigate harmful effects of bacteria and viruses. Chitosan is a natural cationic polymer derived from chitin, with characteristics such as being biodegradable, biocompatible, non-toxic, and presenting antimicrobial activity. This polymer has virucidal activity in several types of viruses, including other coronaviruses, given the attractive factor of its cationic charge for negative charges. The effectiveness of a novel individual protection semi-facial respirator (called VESTA) will be investigated, compared to a conventional N95 respirator. The respirators will be tested in healthcare professionals working in hospital environments and the effectiveness will be attributed to the lower incidence rate of infection by the SARS-CoV-2, and to the ability to filter these viruses after use by healthcare professionals exposed to potentially contaminated environments. The study will be carried out in two stages: i) Randomized Controlled Trial with reduced sample to confirm the sample size calculation (pilot trial), and ii) Randomized Controlled Trial (RCT). The RCT will be conducted with healthcare professionals who have contact with environments/patients infected by SARS-CoV-2 in hospital sectors with greater vulnerability to infection (urgency, emergency and intensive care units). The RCT will be conducted initially with a group of sixty participants (n = 30 in each group) for initial investigation of the potential for efficacy with the use of the respirators (VESTA and conventional N95) in two sectors (emergency and ICU) in a reference Hospital for COVID-19. The RCT will consist of two parallel groups: (1) Experimental Group (GExp) that will use the novel respirator (VESTA) and (2) Control Group (CG) that will use the standard respirator (N95). Participants will be recruited from participating hospitals and will be accompanied by 21 days in approximately eight consecutive shifts (ranging from shifts lasting 6 to 12 hours each, followed by approximately 36 hours of rest). Participants will be assessed at baseline (T0), at the end of the 10th day (T1), and at the end of the 21st day (T2).

Conditions

Covid19; SARS-CoV Infection; Worker-Patient Transmission, Healthcare

Keywords

Protective personal equipment; SARS-Cov-2; Chitosan; Occupational health; Prevention

Outcome Measures

Primary Outcomes (1)

• Incidence of laboratory-confirmed COVID-19

  Number of professionals infected, confirmed by reverse-transcription polymerase chain reaction (RT-PCR)

  21 days (Assessments at T1 - day 10, and T2 - day 21)

Secondary Outcomes (3)

• Usability and comfort of the respirator

  Assessments at T1 (day 10) and T2 (day 21)

• Adherence to the use of the Respirator

  Assessments at T1 (day 10) and T2 (day 21)

• Incidence of acute respiratory illness

  Change from Pre-Intervention (T0), compared to T1 (day 10), and T2 (day 21)

Study Arms (2)

Novel chitosan semi facial respirator (VESTA)

EXPERIMENTAL

VESTA is a semi facial respirator that follows the same technical specifications of a N95 class PFF2 respirator. However, the VESTA respirator has nanoparticles in the filtering element, which is manufactured with a product of 50 gsm melt blown polypropylene-treated with an electrostatic charge. This filtering element deposits nanoparticles of polymeric biodegradable material known as chitosan. Chitosan can act as a surface for adsorption and viral inactivation.

Device: VESTA respirator

Conventional N95 semi facial respirator

ACTIVE COMPARATOR

The N95 PFF2 respirators are manufactured from TNT as defined in ABNT NBR 15052: 2004 and in the resolution of ANVISA RDC No. 356. The filtering element is usually formed by a layer of thin polypropylene fibers arranged at random. This configuration influences the particles (which constitute aerosols) to move along an extensive and tortuous path in relation to their size; thus, increasing the probability of them coming into contact with the fibers and being retained. A number of mechanisms influence the interception of particles by the fibers of the filter element. In addition to the mechanical interception mechanisms, the presence of charges on the surface of the filter material can enhance the association of particles with its fibers and optimize the efficiency of the respirator.

Device: Conventional N95 respirator

Interventions

VESTA respirator DEVICE

The protocol will be composed by the use of the VESTA respirator for 21 days (approximately 8 consecutive shifts lasting 6 to 12 hours, followed by approximately 36 hours of rest). Each participant will receive a total of approximately 8 respirators, with instructions for a maximum usage time of 6 hours. Therefore, participants will receive 1 respirator to be used in each shift of 6 hours, and 2 respirators in shifts of 12 hours. All participants will receive a booklet with guidelines and training in the use and proper handling of the respirator. All respirators will be sterilized and packaged in the laboratory, to ensure that they are not contaminated before use by the participants. The intervention will not change the participants' routine, considering that they already follow instructions for the use of protective personal equipment (PPE) and the proposed intervention will follow all local regulations and guidelines for the use and conservation of PPE and semi facial respirators.

Novel chitosan semi facial respirator (VESTA)

Conventional N95 respirator DEVICE

The protocol will be composed by the use of the N95 respirator for 21 days (approximately 8 consecutive shifts lasting 6 to 12 hours, followed by approximately 36 hours of rest). Each participant will receive a total of approximately 8 respirators, with instructions for a maximum usage time of 6 hours. Therefore, participants will receive 1 respirator to be used in each shift of 6 hours, and 2 respirators in shifts of 12 hours. All participants will receive a booklet with guidelines and training in the use and proper handling of the respirator. All respirators will be sterilized and packaged in the laboratory, to ensure that they are not contaminated before use by the participants. The intervention will not change the participants' routine, considering that they already follow instructions for the use of protective personal equipment (PPE) and the proposed intervention will follow all local regulations and guidelines for the use and conservation of PPE and semi facial respirators.

Conventional N95 semi facial respirator

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brasilia: lead
• University of Campinas, Brazil: collaborator
• Centro de Pesquisa em Biotecnologia Ltda: collaborator
• Hospital Regional da Asa Norte (HRAN): collaborator

Study Sites (1)

HRAN (Hospital Regional da Asa Norte)

Brasília, Brazil

Location

Related Publications (1)

• 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 SSRF, Peixoto HM, Luiz Carregaro R. 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 Infect Dis. 2024 Sep 27;24(1):1061. doi: 10.1186/s12879-024-09966-x.

  PMID: 39333902 DERIVED

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rodrigo L Carregaro, PhD

  Universidade de Brasília (FCE/UnB)

  PRINCIPAL INVESTIGATOR

• Suelia S Fleury Rosa, PhD

  Universidade de Brasília (FGA/UnB)

  STUDY DIRECTOR

• Marcella L Brettas Carneiro, PhD

  Universidade de Brasília (FUP/UnB)

  STUDY CHAIR

• Henry M Peixoto, PhD

  Universidade de Brasília (FM/UnB)

  STUDY CHAIR

• Graziella A Joanitti, PhD

  Universidade de Brasília (FCE/UnB)

  STUDY CHAIR

• Glécia V Silva Luz, PhD

  University of Brasilia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The outcome assessor won't have any knowledge about the study purposes and will be unaware of the group allocation. Participants will be blinded as they will not distinguish the novel respirator (VESTA) from the conventional N95 respirator (both will have the same shape, color and size). The statistical analysis will also be performed blinded for group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized controlled clinical trial, characterized by the application of semi facial respirators, in which participants will be randomly and concealed allocated into two groups: VESTA respirator (GExp) and Conventional N95 respirator (CG). The participants will be healthcare professionals working in hospital environments contaminated by SARS-Cov-2. The study will be reported following the recommendations of the CONSORT Statement.

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 29, 2020
• Study Start: March 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: June 28, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

BR (1)