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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046188
Receipt No. R000052714
Scientific Title An exploratory research of the prevalence and risk factors of chronic cough associated with post-infectious COVID-19
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/26

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Basic information
Public title An exploratory research of the prevalence and risk factors of chronic cough associated with post-infectious COVID-19
Acronym An exploratory research of the prevalence and risk factors of chronic cough associated with post-infectious COVID-19
Scientific Title An exploratory research of the prevalence and risk factors of chronic cough associated with post-infectious COVID-19
Scientific Title:Acronym An exploratory research of the prevalence and risk factors of chronic cough associated with post-infectious COVID-19
Region
Japan

Condition
Condition COVID-19
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the prevalence and risk factors of chronic cough associated with post-infectious COVID-19.
Basic objectives2 Others
Basic objectives -Others To identify other presenting symptoms related to cough in patients with post-infectious COVID-19.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate associations of clinical factors with the prevalence of chronic cough and the impact of cough-specific QoL
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
16 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients who admitted to Aichi hospital due to the treatment for COVID-19 from 15th October 2020 to 31th October 2021.
Key exclusion criteria Patients with dementia
Patients with bedridden
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Kanemitsu
Organization Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Division name Department of Respiratory Medicine, Allergy and Clinical Immunology,
Zip code 467-8601
Address 1 kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL 0528538216
Email kaney32@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Yoshihiro
Middle name
Last name Kanemitsu
Organization Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Division name Department of Respiratory Medicine, Allergy and Clinical Immunology,
Zip code 4678601
Address 1 kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL 0528538216
Homepage URL
Email kaney32@med.nagoya-cu.ac.jp

Sponsor
Institute Aichi Hospital
Institute
Department

Funding Source
Organization Aichi Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Aichi Hospital
Address 18 Kuriyado, Kakemachi, Okazaki
Tel 0564-21-6251
Email toshio_kawabata@pref.aichi.lg.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
2021 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 15 Day
Date of IRB
2021 Year 11 Month 19 Day
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To observe prolonged symptoms after the recovery from COVID-19

Management information
Registered date
2021 Year 11 Month 26 Day
Last modified on
2021 Year 11 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052714

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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