| Trial registration number
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NCT04490200 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04490200
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First author
Last imported at : July 4, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Rodrigo L Carregaro, PhD
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Contact
Last imported at : July 4, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-07-29
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Recruitment status
Last imported at : July 4, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- 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.
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Exclusion criteria
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov
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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.
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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University of Brasilia
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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20
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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59
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Countries
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Brazil
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Health workers
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : July 4, 2023, 8 p.m.
Source : ClinicalTrials.gov
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300
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primary outcome
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov
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Incidence of laboratory-confirmed COVID-19
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 848, "treatment_name": "N95 respirator", "treatment_type": "Protective device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1357, "treatment_name": "Vesta respirator", "treatment_type": "Protective device", "pharmacological_treatment": "Non pharmacological treatment"}]
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