UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047779 |
|---|---|
| Receipt number | R000054469 |
| Scientific Title | Long-term symptoms, complications and social outcomes after COVID-19: a retrospective cohort study using a self-administered questionnaire |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2025/04/07 12:17:08 |
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Basic information
Public title
COVID-19 Recovery Study II
Acronym
CORES II
Scientific Title
Long-term symptoms, complications and social outcomes after COVID-19: a retrospective cohort study using a self-administered questionnaire
Scientific Title:Acronym
CORES II
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Psychosomatic Internal Medicine | Infectious disease | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate long-term symptoms and complications of patients hospitalized and discharged alive after a diagnosis of COVID-19
Basic objectives2
Others
Basic objectives -Others
Presence of long-term symptoms and complications
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of long-term symptoms and complications at one year and two years after diagnosis
Key secondary outcomes
Physical and mental health status, socioeconomic status, and quality of life at one year and two years after diagnosis
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
1) Persons diagnosed with COVID-19 at a medical institution, etc.
(2) Persons 20 years of age or older who were hospitalized and discharged alive from a cooperative research institute in Japan between April and September 2021 for the treatment of 1 above.
Key exclusion criteria
(1) Persons deemed unfit by the physician
(e.g., patients who have difficulty communicating in Japanese or cooperating in surveys)
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Iso |
Organization
Japan Institute for Health Security
Division name
Institute for Global health Policy Research, Bureau of Global Health Cooperation
Zip code
162-8655
Address
1-21-1, Toyama Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
iso.h@jihs.go.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Hosozawa |
Organization
Japan Institute for Health Security
Division name
Institute for Global health Policy Research, Bureau of Global Health Cooperation
Zip code
162-8655
Address
1-21-1, Toyama Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
hosozawa.m@jihs.go.jp
Sponsor or person
Institute
Japan Institute for Health Security
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare (Japan)
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
IRB, Japan Institute for Health Security
Address
1-21-1, Toyama Shinjuku-ku, Tokyo, Japan
Tel
03-3202-7181
rinrijm@jihs.go.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
日立総合病院（茨城県）、信州大学医学部附属病院（長野県）、千葉大学医学部附属病院（千葉県）、那覇市立病院（沖縄県）、琉球大学病院（沖縄県）、広島大学病院高度救命救急センター（広島県）、大阪医科薬科大学（大阪府）、横浜市立大学付属市民総合医療センター（神奈川県）、関西医科大学総合医療センター（大阪府）、大阪急性期・総合医療センター（大阪府）、国立病院機構北海道医療センター（北海道）、独立行政法人地域医療推進機構北海道病院（北海道）、聖マリアンナ医科大学（神奈川県）、聖マリアンナ医科大学横浜市西部病院（神奈川県）、横浜市立大学附属病院（神奈川県）、公立豊岡病院組合立豊岡病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | 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
| 2022 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective cohort study of patients hospitalized and discharged alive from collaborative research institutes with COVID-19 between April and September 2021. A self-administered questionnaire will be used to examine long-term symptoms and complications associated with COVID-19, physical and mental health status, and socioeconomic status.
Management information
Registered date
| 2022 | Year | 05 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054469
