UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051898 |
|---|---|
| Receipt number | R000059204 |
| Scientific Title | Exploratory study of long COVID risk in Japan using a claims database data from employee-based health insurance |
| Date of disclosure of the study information | 2023/08/14 |
| Last modified on | 2023/08/13 12:14:01 |
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Basic information
Public title
Exploratory study of long COVID risk in Japan using a claims database data from employee-based health insurance
Acronym
Exploratory study of long COVID risk in Japan using a claims database data from employee-based health insurance
Scientific Title
Exploratory study of long COVID risk in Japan using a claims database data from employee-based health insurance
Scientific Title:Acronym
Exploratory study of long COVID risk in Japan using a claims database data from employee-based health insurance
Region
| Japan |
Condition
Condition
SARS-CoV-2 infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By comparing COVID-19 patients and non-affected patients using the JMDC claims database, quantitative evaluation of known long COVID, and quantitative search and medical consideration of unreported long COVID, we will present the actual situation of long COVID under the actual clinical practice in Japan
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
-The known long COVID
Outcomes were defned by ICD10 codes related to diagnosis shown below.
(cardiovascular disorders, arrhythmia, heart failure, acutemyocardial infarction, hypertension, asthma, respiratory failure, other respiratory diseases/symptoms, renal failure, chronickidney disease, blood coagulation/bleeding, thromboembolism, leukopenia, anemia, pulmonary thromboembolism, type I diabetes, type II diabetes, obesity, gastrointestinal/esophageal disorders, liver disease, smell/taste disorders, neurological conditions, cerebrovascular disorders, sleep disorders, other mental conditions, substance use disorders, anxiety, mood disorders, malaise , skeletal muscle pain, muscle disorder, hair loss, skin disease, atopic dermatitis, urticaria, herpes virus vesicular dermatitis, heart murmur, weight loss, ejaculation failure)
For known long COVID, the outcome is not only each diagnosis, but also the entire known long COVID and the diagnosis grouped by each body system (cardiovascular system, respiratory system, kidney, coagulation/blood, endocrine system, digestive system, nervous system, mental system, muscular system, skin system, others).
-The unknown long COVID
ICD10 codes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Definition of COVID-19 patients and date of onset]
-Patients with a diagnosis of COVID-19 [ICD-10 code (disease.icd10_sai_code): U071, U072 (no suspicionflag)] are considered as patients with COVID-19.
-The smallest month of COVID-19 diagnosis (disease.shinryo_ym) from July 2019 to September 2022 is considered the first diagnosis month (IM: Index month).
[Inclusion criteria of COVID-19 patients]
-Observable from July 2019 to 6 months post-IM
-IM is included from January 2020 to March 2022.
[Definition of non-affected patients]
-Patients without a diagnosis of COVID-19 [ICD-10 code (disease.icd10_sai_code): U071, U072, B342].
[Inclusion criteria of non-affected pathients]
-Observable from July 2019 September 2022
[Creation of affected-unaffected pairs]
-COVID-19-affected individuals who met the inclusion criteria are matched 1:1 with COVID-19-unaffected individuals who matched sex, date of birth, and risk factors for exacerbation.
Key exclusion criteria
In the population shown in the previous section, out of matched affected-unaffected pairs, if either pair had a diagnosis to be assessed during the 6 months prior to IM, that pair will be excluded.
Target sample size
263456
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kutsuna |
Organization
Department of Infection, Control, Graduate School of Medicine
Division name
Osaka University
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-5070
kutsuna@hp-infect.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryotaro |
| Middle name | |
| Last name | Tajima |
Organization
Shionogi & Co., Ltd.
Division name
Data Science Department
Zip code
541-0047
Address
4F, Midosuji MTR Building, 6-3, Awajimachi, 3-chome, Chuo-ku, Osaka-shi, Osaka, 541-0047, Japan
TEL
06-6202-2161
Homepage URL
ryotaro.tajima@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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 | 08 | Month | 14 | 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
| 2023 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 08 | Month | 13 | Day |
Last modified on
| 2023 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059204
