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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042299
Receipt No. 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

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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
Email 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
Email ishii@keio.jp

Sponsor
Institute Division of Pulmonary Medicine, Department of Medicine, Keio University, School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.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


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