Covid19NCT04490200
Effectiveness of a Novel Respirator With Chitosan Nanoparticles
A study testing VESTA respirator and Conventional N95 respirator in people with Covid19 and SARS-CoV Infection, run by University of Brasilia at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV Infection, Worker-Patient Transmission, Healthcare
- What is being tested?
- VESTA respirator and Conventional N95 respirator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2021to 28 Jun 2023
- Phase
- Interventional
- 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 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Novel Respirator With Chitosan Nanoparticles to Reduce the Incidence of SARS-CoV-2 Infection in Healthcare Professionals: Randomized Controlled Trial (VESTA Trial)
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).
Read 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 the clinical trial register. After analyzing the data from the pilot trial we included some updates within the clinical trial register. Summary of changes after the pilot trial: 1) We performed a new sample size calculation, which resulted in a sample size of 700 participants (n=350 in each group). This information was updated within the trial register; 2) We removed the secondary outcome "Ability of the filtering element to inactivate the SARS-Cov-2". The team decided that this outcome would be more appropriately assessed in a controlled laboratory study, and not associated with the clinical trial. Thus, this outcome will be investigated in a secondary study; 3) We decided to include the clinical assessments (Job stress, Quality of life, Musculoskeletal discomfort, Burnout, and Work ability) exclusively as baseline measurements.
- Being tested
- VESTA respirator, Conventional N95 respirator
- Keywords
- Protective personal equipment, SARS-Cov-2, Chitosan, Occupational health, Prevention
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VESTA respiratorDevice
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.
Conventional N95 respiratorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Conventional N95 respirator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of laboratory-confirmed COVID-19
Number of professionals infected, confirmed by reverse-transcription polymerase chain reaction (RT-PCR)
Measured: 21 days (Assessments at T1 - day 10, and T2 - day 21)
Secondary outcomes (3)
Usability and comfort of the respirator
11-point Likert scale ranging from -5 ("extremely unsatisfied"), 0 ("neutral"), to 5 ("completely satisfied")
Measured: Assessments at T1 (day 10) and T2 (day 21)
Adherence to the use of the Respirator
quantified based on the activities and procedures performed by the participants. Adherence will be measured by a self-report recorded in a diary, estimating the percentage of use referring to the total workhours.
Measured: Assessments at T1 (day 10) and T2 (day 21)
Incidence of acute respiratory illness
Self-reported signs and symptoms of respiratory illness, defined as the presence of at least 1 sign or 2 symptoms (presented to the participants as a list of possible signs and symptoms), and also confirmed by reverse-transcription polymerase chain reaction (RT-PCR).
Measured: Change from Pre-Intervention (T0), compared to T1 (day 10), and T2 (day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Mar 2021
- Primary completion30 Apr 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil, Centro de Pesquisa em Biotecnologia Ltda, Hospital Regional da Asa Norte (HRAN)
- Responsible party
- Principal investigator, Prof. Rodrigo Luiz Carregaro, University of Brasilia
- Investigators
- Rodrigo L Carregaro, PhD, Principal investigator, Universidade de Brasília (FCE/UnB)Suelia S Fleury Rosa, PhD, Study director, Universidade de Brasília (FGA/UnB)Marcella L Brettas Carneiro, PhD, Study chair, Universidade de Brasília (FUP/UnB)Henry M Peixoto, PhD, Study chair, Universidade de Brasília (FM/UnB)Graziella A Joanitti, PhD, Study chair, Universidade de Brasília (FCE/UnB)Glécia V Silva Luz, PhD, Study chair, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490200
- Sponsor's protocol ID
- VESTA Trial
- Other IDs
- 32862320.0.0000.0030
- Status last verified
- Jun 2023
- First submitted
- 19 Jul 2020
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39333902
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Novel Respirator With Chitosan Nanoparticles to Reduce the Incidence of SARS-CoV-2 Infection in Healthcare Professionals: Randomized Controlled Trial (VESTA Trial)
- ClinicalTrials.gov ID
- NCT04490200
- Acronym / sponsor ID
- VESTA Trial
- Keywords
- Protective personal equipment, SARS-Cov-2, Chitosan, Occupational health, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil, Centro de Pesquisa em Biotecnologia Ltda, Hospital Regional da Asa Norte (HRAN)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 the clinical trial register. After analyzing the data from the pilot trial we included some updates within the clinical trial register. Summary of changes after the pilot trial: 1) We performed a new sample size calculation, which resulted in a sample size of 700 participants (n=350 in each group). This information was updated within the trial register; 2) We removed the secondary outcome "Ability of the filtering element to inactivate the SARS-Cov-2". The team decided that this outcome would be more appropriately assessed in a controlled laboratory study, and not associated with the clinical trial. Thus, this outcome will be investigated in a secondary study; 3) We decided to include the clinical assessments (Job stress, Quality of life, Musculoskeletal discomfort, Burnout, and Work ability) exclusively as baseline measurements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Novel chitosan semi facial respirator (VESTA) | Experimental | Device: VESTA respiratorVESTA 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. |
| Conventional N95 semi facial respirator | Active comparator | Device: Conventional N95 respiratorThe 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. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VESTA respiratorThe 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. | Device | Novel chitosan semi facial respirator (VESTA) |
| Conventional N95 respiratorThe 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. | Device | Conventional N95 semi facial respirator |
Primary outcome
Incidence of laboratory-confirmed COVID-19
Time frame: 21 days (Assessments at T1 - day 10, and T2 - day 21)
Number of professionals infected, confirmed by reverse-transcription polymerase chain reaction (RT-PCR)
3 secondary outcomes
Usability and comfort of the respirator
Time frame: Assessments at T1 (day 10) and T2 (day 21)
Adherence to the use of the Respirator
Time frame: Assessments at T1 (day 10) and T2 (day 21)
Incidence of acute respiratory illness
Time frame: Change from Pre-Intervention (T0), compared to T1 (day 10), and T2 (day 21)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 39333902Kubota 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo L Carregaro, PhD principal investigator
Universidade de Brasília (FCE/UnB)
Suelia S Fleury Rosa, PhD study director
Universidade de Brasília (FGA/UnB)
Marcella L Brettas Carneiro, PhD study chair
Universidade de Brasília (FUP/UnB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VESTA respirator and Conventional N95 respirator in people with Covid19 and SARS-CoV Infection, run by University of Brasilia at 1 site in Brazil.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of laboratory-confirmed COVID-19 (time frame: 21 days (Assessments at T1 - day 10, and T2 - day 21)). 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 NCT04490200, which also lists 1 linked publication.
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 3 Jul 2023.