UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041168 |
|---|---|
| Receipt number | R000046991 |
| Scientific Title | A study of the COVID-19 sequlae |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2022/04/03 21:19:56 |
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Basic information
Public title
A study of the COVID-19 sequlae
Acronym
A study of the COVID-19 sequlae
Scientific Title
A study of the COVID-19 sequlae
Scientific Title:Acronym
A study of the COVID-19 sequlae
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
COVID-19 have spread worldwide since the end of 2019. In Japan as of July 1, 18,800 people have been infected and 975 have died. The infection is still spreading.
It has been reported that pulmonary function tests at the time of discharge after recovery from COVID-19 have decreased lung diffusion capacity (DLCO) and total lung capacity (TLC). There are also reports that symptoms such as fever and olfactory abnormality remain. Moreover, the course of chest CT after discharge is unknown.
Therefore, we decided to conduct a survey on the subsequent course (clinical symptoms, pulmonary function tests, chest CT) of patients who have recovered from COVID-19 and to examine the sequlae of COVID-19 and their predictive factors.
Basic objectives2
Others
Basic objectives -Others
survey on the COVID-19 sequlae
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Actual condition of sequelae such as deterioration of lung function after COVID-19
1.Changes in pulmonary function tests (FVC, DLCO, TLC, etc.).
2.Lung volume pred Total lung capacity ratio in Chest CT scan
3. Subjective symptoms (shortness of breath: mMRC, olfaction, dysgeusia, malaise, headache, fever, chronic fatigue syndrome diagnostic criteria, Pittsburgh sleep questionnaire, etc.)
4. Changes in chest CT (HRCT) findings
Key secondary outcomes
1. Search for factors (including biomarkers) that predict lung dysfunction and other sequelae
2.The actual condition survey of rehabilitation for sequlae of COVID-19
Reality
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were hospitalized for COVID-19 and were discharged by December 31, 2021
Patients of moderate or higher
Patients who have consent
Key exclusion criteria
Patients under the age of 20
Cases judged by the attending physician to be ineligible
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Akihito |
| Middle name | |
| Last name | Yokoyama |
Organization
Kochi Medical school, Kochi University
Division name
Department of Respiratory and Allergy Medicine,
Zip code
783-8505
Address
Oko-cho, Kohasu, Nankoku, Kochi
TEL
088-880-2345
ayokoyama@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazufumi |
| Middle name | |
| Last name | Takamatsu |
Organization
Kochi Medical school, Kochi University
Division name
Department of Respiratory and Allergy Medicine,
Zip code
783-8505
Address
Oko-cho, Kohasu, Nankoku, Kochi
TEL
088-880-2345
Homepage URL
ktakamatsu@kochi-u.ac.jp
Sponsor or person
Institute
The Japanese Respiratory Society
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi University ethic comittee
Address
Oko-cho, Kohasu, Nankoku, Kochi
Tel
088-866-5811
rinri21@kochi-u.ac.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
| 2020 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 08 | 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
After IRB approval of the research core facility, a survey is planned to start at cooperating facilities in nationwide.
Management information
Registered date
| 2020 | Year | 07 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046991
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
