UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051673 |
|---|---|
| Receipt number | R000058708 |
| Scientific Title | Does saline nasal irrigation prevent COVID-19? |
| Date of disclosure of the study information | 2023/07/21 |
| Last modified on | 2023/07/21 07:54:40 |
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Basic information
Public title
Does saline nasal irrigation prevent COVID-19?
Acronym
Does saline nasal irrigation prevent COVID-19?
Scientific Title
Does saline nasal irrigation prevent COVID-19?
Scientific Title:Acronym
Does saline nasal irrigation prevent COVID-19?
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether nasal irrigation with saline water can prevent SARS-CoV2 infection in persons who come in contact with a SARS-CoV2-positive person without a mask.
Basic objectives2
Others
Basic objectives -Others
To determine whether nasal irrigation with saline reduces COVID-19 symptoms.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Results of SARS-CoV2 PCR after nasal lavage twice a day for a total of 10 times (5 days after the start of nasal lavage).
Key secondary outcomes
Types of symptoms and their duration.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
nasal irrigation with saline water
Interventions/Control_2
No nasal irrigation
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Full-time employees of Rakwakai Otowa Hospital and Rakwakai Otowa Rehabilitation Hospital who had contact with SARS-CoV2-positive persons without masks.
Key exclusion criteria
Gargled nose within the past 14 days of contact with an infected person
Has had surgery on the nasal cavity
Has had COVID19 within the past 3 months
Already have respiratory tract symptoms (cough, nasal discharge, sore throat) or fever (>37.5 degrees)
Unable to accept the assignment of gargling or not gargling
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Koshida |
Organization
Rakuwakai Otowa Rehabilitation Hospital
Division name
Internal Medicine
Zip code
6078113
Address
Kitamizo-cho 32-1, Koyama, Yamashina district, Kyoto city, Kyoto prefecture
TEL
0755816221
koshidamasahiko@hotmail.com
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Koshida |
Organization
Rakuwakai Otowa Rehabilitation Hospital
Division name
Internal Medicine
Zip code
6078113
Address
Kitamizo-cho 32-1, Koyama, Yamashina district, Kyoto city, Kyoto prefecture
TEL
0755816221
Homepage URL
koshidamasahiko@hotmail.com
Sponsor or person
Institute
Rakwakai Healthcare System
Institute
Department
Personal name
Masahiko Koshida
Funding Source
Organization
Rakuwakai Healthcare System
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rakuwakai Healthcare System
Address
Chinji-cho 2, Otowa, Yamashina district, Kyoto city, Kyoto prefecture
Tel
0755934111
matsuoka-aya@rakuwa.or.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
洛和会音羽リハビリテーション病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058708
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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