UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050453 |
|---|---|
| Receipt number | R000057353 |
| Scientific Title | A survey for the effect of COVID-19 infection on the incidence of chronic cough |
| Date of disclosure of the study information | 2023/03/03 |
| Last modified on | 2026/09/02 14:13:14 |
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Basic information
Public title
A survey for the effect of COVID-19 infection on the incidence of chronic cough
Acronym
A survey for the effect of COVID-19 infection on the incidence of chronic cough
Scientific Title
A survey for the effect of COVID-19 infection on the incidence of chronic cough
Scientific Title:Acronym
A survey for the effect of COVID-19 infection on the incidence of chronic cough
Region
| Japan |
Condition
Condition
COVID-19, chronic cough
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively investigate the impact of SARS-CoV-2 infection on the rate of symptoms such as chronic cough by measuring the SARS-CoV-2 anti-N antibodies of medical staff and conducting a questionnaire on subjective symptoms such as chronic cough.
Basic objectives2
Others
Basic objectives -Others
To compare markers that have been reported to be associated with the severity of COVID-19 and chronic cough in anti-N antibody persistently positive, persistently negative, positive conversion, and negative conversion cases.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To examine the difference in symptomatic rates of chronic cough between SARS-CoV-2 anti-N antibody positive and negative cases.
Key secondary outcomes
To examine the significant differences in biomarkers between SARS-CoV-2 anti-N antibodiy positive and negative cases, to examine the change in the symptomatic rate of chronic cough after 1 year in the two groups,to compare the prevalence of symptoms of chronic cough and changes in biomarkers between anti-N antibody seroconverted and negative converted cases,to clarify the score distribution of NLHQ, HARQ, and LCQ in the general adult population, and to clarify the prevalence of complaints such as broadly defined pharyngolaryngeal paresthesia.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Workers at our hospital
Key exclusion criteria
Workers with abnormal shadows in the lungs on plain chest X-ray examination
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Oguri |
Organization
Gamagori City Hospital
Division name
Respiratory Medicine
Zip code
443-8501
Address
1-1,mukaida,hirata-cho,gamagori-shi
TEL
0533662200
t-oguri@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Amakusa |
Organization
Gamagori City Hospital
Division name
Respiratory Medicine
Zip code
4438501
Address
1-1,mukaida,hirata-cho,gamagori-shi
TEL
0533662200
Homepage URL
ama111uki@yahoo.co.jp
Sponsor or person
Institute
Gamagori City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gamagori City Hospital Institutional Review Board
Address
1-1,mukaida,hirata-cho,gamagori-shi
Tel
0533662200
hospital@city.gamagori.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
| 2023 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
https://dx.doi.org/10.1007/s00408-025-00860-0
Publication of results
Partially published
Result
URL related to results and publications
https://dx.doi.org/10.1007/s00408-025-00860-0
Number of participants that the trial has enrolled
556
Results
LAS was identified in 53/556 participants (9.5%). The LAS(+) group had significantly higher cough prevalence across all durations, poorer cough QoL, and higher reflux burden. Anti-SARS-CoV-2 seropositivity did not differ. Asthma, GERD, and mood swings were independent risk factors for LAS.
Results date posted
| 2026 | Year | 09 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age (mean +/- standard deviation): 39.6 +/- 13.7 years (range: 20-72 years)
Sex (female): 430 (77.3%)
BMI (mean +/- standard deviation): 22.3 +/- 3.85
Current smokers: 51 (9.7%)
Medical history/comorbidities: Bronchial asthma 24 (4.3%), chronic sinusitis 6 (1.1%), gastroesophageal reflux disease (GERD) 12 (2.2%), allergic rhinitis 83 (14.6%)
Presence of cough symptoms: Cough present 72 (13.0%) [acute cough 33 (5.9%), subacute cough 13 (3.3%), chronic cough 26 (4.7%)]
Seropositivity for anti-SARS-CoV-2 antibodies: N-antibody positive 125 (22.5%), S-antibody positive 414 (74.5%)
Participant flow
A total of 791 hospital employees undergoing routine health checkups at Gamagori City Hospital in January 2023 (n = 557) and January 2024 (n = 234) provided written informed consent. No participants were excluded by the predefined exclusion criteria (under 18 or over 85 years old, or abnormal chest X-ray findings). A total of 235 individuals (January 2023: n = 141; January 2024: n = 94) were excluded due to missing significant questionnaire responses or questionnaire omissions caused by printing errors. Consequently, 556 participants (January 2023: n = 416; January 2024: n = 140) were enrolled and included in the final analysis.
Adverse events
none
Outcome measures
Primary Outcome Measure: Prevalence of laryngeal abnormal sensation (LAS), defined as a Newcastle Laryngeal Hypersensitivity Questionnaire (NLHQ) score < 17.1. Secondary Outcome Measures:Cough-specific quality of life measured by the Leicester Cough Questionnaire (LCQ) Airway reflux symptoms assessed by the Hull Airway Reflux Questionnaire (HARQ) Cough severity assessed by a 0-100 mm Visual Analog Scale (VAS) Frequency of clinical symptoms (sputum, shortness of breath, malaise, gastrointestinal symptoms, mood swings, etc.) Association between anti-SARS-CoV-2 seropositivity and LAS Independent risk factors associated with LAS using binary logistic regression analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
At the time of the health checkup, we will obtain a medical questionnaire, check the subject's background (BMI, smoking history, current illness history, past history, current treatment details), and perform a blood test. A similar survey will be conducted at the health check-up one year later. Anti-N antibodies are measured using residual sera from physical examinations. We will also measure serum biomarkers that have been reported to be associated with the severity of COVID-19 and serum biomarkers associated with chronic cough.
Management information
Registered date
| 2023 | Year | 02 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057353
