UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046188 |
|---|---|
| Receipt number | R000052714 |
| Scientific Title | A survey for the prevalence of chronic cough after recovery from COVID-19 |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2023/11/28 20:45:37 |
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Basic information
Public title
A survey for the prevalence of
chronic cough after recovery from COVID-19
Acronym
A survey for the prevalence of
chronic cough after recovery from COVID-19
Scientific Title
A survey for the prevalence of
chronic cough after recovery from COVID-19
Scientific Title:Acronym
A survey for the prevalence of
chronic cough after recovery from 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
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
kaney32@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Aichi Hospital
Institute
Department
Personal name
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
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
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
170
Results
Cough was prevalent (n = 41, 24%) and often accompanied by other symptoms, including gastrointestinal symptoms. Cough-specific QoL after recovery was correlated with reflux-related symptoms and abnormal laryngeal sensations. Multivariate analyses revealed that gastrointestinal symptoms, sputum, and chronic cough before contracting COVID-19 are significant predictors of cough-related outcomes in the post-COVID-19 condition.
Results date posted
| 2023 | Year | 11 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median length of the duration after recovery was 158 days. Chronic cough (once a week) was the third most frequent symptom after recovery, following dyssomnia and fatigue. A total of 65 individuals presented with respiratory symptoms such as cough, sputum, dyspnea, and wheezing. Cough was present in 115 individuals (68%) at admission. Pneumonia was also present in 149 individuals (88%), and oxygen therapy was required in 95 individuals (56%) during hospitalization. The prevalence rates of asthma, gastroesophageal reflux disease, and sinonasal disorders such as allergic rhinitis and chronic rhinosinusitis, which are representative causes of chronic cough, were low.
Participant flow
We conducted a cross-sectional survey about the sequelae of COVID-19 in patients who were admitted to Aichi Hospital, a specialized hospital for COVID-19 treatment, from October 2020 to October 2021. A total of 743 individuals were eligible for this study. However, 193 individuals were excluded due to the following reasons: (1) could not complete the questionnaires by themselves due to dementia or being bedridden (n = 112), (2) died in the hospital (n = 33), or (3) could not read or understand Japanese language (n = 48). A research information letter, a consent form, and some questionnaires were sent to 550 individuals between December 2021 and January 2022. These were sent at least 3 months after discharging from the hospital due to COVID-19. Of these individuals, only 170 agreed to participate in the study. The study was approved by the ethics committee of Aichi Hospital (approval date: 19th November 2021, approval number: 2021-3) and registered on the UMIN clinical trial registry (UMIN000046188).
Adverse events
None
Outcome measures
Using self-developed questionnaires and visual analog scales, 19 symptoms, including cough, were assessed. Cough-specific quality of life (QoL), reflux-related symptoms, and abnormal laryngeal sensations were also evaluated. The patient clinical characteristics such as blood tests and the presence of pneumonia, and indices, including cough-specific QoL, at admission were extracted from their medical records. Multivariate regression analyses were conducted to determine the factors associated with cough-related outcomes, such as prevalence, QoL, and severity, in the post-COVID-19 condition.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052714
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