UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055914 |
|---|---|
| Receipt number | R000063887 |
| Scientific Title | Effectiveness of N95 Mask Fit Testing for the Prevention of Severe Acute Respiratory Syndrome Coronavirus 2 |
| Date of disclosure of the study information | 2024/10/22 |
| Last modified on | 2025/04/22 16:51:44 |
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Basic information
Public title
Effectiveness of N95 Mask Fit Testing for the Prevention of Severe Acute Respiratory Syndrome Coronavirus 2
Acronym
Effectiveness of N95 Mask Fit Testing for the Prevention of Severe Acute Respiratory Syndrome Coronavirus 2
Scientific Title
Effectiveness of N95 Mask Fit Testing for the Prevention of Severe Acute Respiratory Syndrome Coronavirus 2
Scientific Title:Acronym
Effectiveness of N95 Mask Fit Testing for the Prevention of Severe Acute Respiratory Syndrome Coronavirus 2
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluated the ability of N95 mask fit testing to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and explored the risk factors associated with SARS-CoV-2.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cumulative infection rate of COVID-19
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study targeted 299 employees who were required to wear N95 masks as part of infection control measures between December 12, 2022 and January 29, 2024.
Key exclusion criteria
Employees who joined the company after the study period
Target sample size
299
Research contact person
Name of lead principal investigator
| 1st name | GOSHI |
| Middle name | |
| Last name | FUJIMOTO |
Organization
Koga Community Hospital
Division name
Gas
Zip code
425-0088
Address
2-30-1 Daikakuji, Yaizu, Shizuoka 425-0088, Japan
TEL
09021690887
g_chimera_7@yahoo.co.jp
Public contact
Name of contact person
| 1st name | GOSHI |
| Middle name | |
| Last name | FUJIMOTO |
Organization
Koga Community Hospital
Division name
Gastroenterological surgery
Zip code
425-0088
Address
2-30-1 Daikakuji, Yaizu, Shizuoka 425-0088, Japan
TEL
09021690887
Homepage URL
g_chimera_7@yahoo.co.jp
Sponsor or person
Institute
Koga Community Hospital
Institute
Department
Personal name
Goshi Fujimoto
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Koga Community Hospital
Address
2-30-1 Daikakuji, Yaizu, Shizuoka 425-0088, Japan
Tel
0546285500
g_chimera_7@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC11806276/
Number of participants that the trial has enrolled
299
Results
Of the 265 employees who were included in the initial fit test, 154 (58.1%) passed. During the first cluster, the cumulative infection rate was 19.2% (51/265 employees). A significantly higher infection rate was observed among those who failed the initial fit test (p = 0.0264), and those with household COVID-19 cases (p = 0.00615). During the second cluster, a household COVID-19 case was the only significant risk factor (p = 0.0147) for infection.
Results date posted
| 2025 | Year | 04 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective case-control study
Management information
Registered date
| 2024 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063887
