UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046991