UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042299 |
|---|---|
| Receipt number | R000048241 |
| Scientific Title | Infrastructure research for understanding the actual situation and pathophysiology of long-term complications of Coronavirus disease 2019 (COVID-19) |
| Date of disclosure of the study information | 2020/11/02 |
| Last modified on | 2021/02/22 09:25:13 |
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Basic information
Public title
Infrastructure research for understanding the actual situation and pathophysiology of long-term complications of Coronavirus disease 2019 (COVID-19)
Acronym
Infrastructure research for understanding the actual situation and pathophysiology of long-term complications of Coronavirus disease 2019 (COVID-19)
Scientific Title
Infrastructure research for understanding the actual situation and pathophysiology of long-term complications of Coronavirus disease 2019 (COVID-19)
Scientific Title:Acronym
Infrastructure research for understanding the actual situation and pathophysiology of long-term complications of Coronavirus disease 2019 (COVID-19)
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the the real-world conditions of complications and sequelae of COVID-19 in Japan
Basic objectives2
Others
Basic objectives -Others
Survey of the sequelae of COVID-19 patients, including those with mild cases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of long-term complications of COVID-19
Key secondary outcomes
Risk factors for progression to sequelae of COVID-19 infection
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted to a cooperating hospital with a diagnosis of COVID-19 by PCR or antigen testing and discharged
Key exclusion criteria
Patients under the age of 18
Cases judged by the attending physician to be ineligible
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Fukunaga |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3793
kfukunaga@keio.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ishii |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3793
Homepage URL
ishii@keio.jp
Sponsor or person
Institute
Division of Pulmonary Medicine, Department of Medicine, Keio University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour 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
Keio University Faculty of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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 | 11 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective and retrospective observational study.
Patient information (age, gender, past medical history, treatment for COVID-19, imaging studies, etc) will be extracted from the subject's medical records for patients aged 18 years or older who were diagnosed with COVID-19, admitted to a cooperating institution, and discharged. In addition, subjects will be asked to complete questionnaires related to complications and sequelae of COVID-19 at 3, 6 and 12 months after diagnosis.
Management information
Registered date
| 2020 | Year | 10 | Month | 30 | Day |
Last modified on
| 2021 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048241
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
