UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045578 |
|---|---|
| Receipt number | R000051988 |
| Scientific Title | Long-term functional prognostic study of Coronavirus disease - 2019 (COVID-19) infection |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/04/03 14:47:20 |
* 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
Long-term functional prognostic study of Coronavirus disease - 2019 (COVID-19) infection
Acronym
Long-term functional prognostic study of Coronavirus disease - 2019 (COVID-19) infection
Scientific Title
Long-term functional prognostic study of Coronavirus disease - 2019 (COVID-19) infection
Scientific Title:Acronym
Long-term functional prognostic study of Coronavirus disease - 2019 (COVID-19) infection
Region
| Japan |
Condition
Condition
Coronavirus disease - 2019(COVID-19) infection
Classification by specialty
| Pneumology | Infectious disease | Intensive care medicine |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the dysfunction (respiration, mental and physical function) caused by COVID-19 infection for one year, and to clarify the relationship between the duration and severity of the disorder.
Basic objectives2
Others
Basic objectives -Others
Patients with COVID-19 infection
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise tolerance at hospital discharge, and 1 month, 3 months, 6 months, and 1 year after discharge
Key secondary outcomes
Social regression, health-related QOL, cognitive function, mental status, muscle strength, MRS score, O2 inhalation, gait speed
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized patients
Key exclusion criteria
Inability to walk before admission, patients diagnosed with the cognitive disorder before admission, patients diagnosed with the psychological disease before admission.
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Tomotaka |
| Middle name | |
| Last name | Koike |
Organization
Kitasato university hospital
Division name
Intensive care center
Zip code
2520329
Address
Kitasato 1-15-1, Minami-ku, Sagamihara city, Kanagawa, Japan
TEL
0427788111
tkoike@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomotaka |
| Middle name | |
| Last name | Koike |
Organization
Kitasato university hospital
Division name
Intensive care center
Zip code
2520329
Address
Kitasato 1-15-1, Minami-ku, Sagamihara city, Kanagawa, Japan
TEL
0427788111
Homepage URL
tkoike@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato university
Institute
Department
Personal name
Funding Source
Organization
Kitasato university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Medical Ethics Organization(KMEO)
Address
Kitasato 1-15-1, Minami-ku, Sagamihara city, Kanagawa, Japan
Tel
0427788111
rinrib@med.kitasato-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
| 2021 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35443966/
Publication of results
Partially published
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
| 2021 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2021 | Year | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051988
