UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041168
Receipt No. R000046991
Scientific Title A study of the COVID-19 sequlae
Date of disclosure of the study information 2020/08/01
Last modified on 2020/09/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 July 31, 2020

Patients of moderate II or higher requiring oxygen administration

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
Email 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
Email ktakamatsu@kochi-u.ac.jp

Sponsor
Institute The Japanese Respiratory Society
Institute
Department

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
Email 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 Open public 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
2021 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
2020 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046991

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.