UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044212 |
|---|---|
| Receipt number | R000050487 |
| Scientific Title | Biomarker study for exacerbation predictive markers in patients with COVID-19 |
| Date of disclosure of the study information | 2021/05/14 |
| Last modified on | 2021/05/14 22:54:40 |
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Basic information
Public title
Biomarker study for exacerbation predictive markers in patients with COVID-19
Acronym
Biomarker study in patients with COVID-19
Scientific Title
Biomarker study for exacerbation predictive markers in patients with COVID-19
Scientific Title:Acronym
Biomarker study in patients with COVID-19
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Identifying predictors of exacerbations in blood from patients with COVID-19 and exploring new therapeutic targets for COVID-19
Basic objectives2
Others
Basic objectives -Others
Clarify the clinical significance of coagulation-related factors in blood at the time of diagnosis, and longitudinal changes in clinical course
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identifying predictors of exacerbations in blood from patients with COVID-19
Key secondary outcomes
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
Patients with COVID-19
Key exclusion criteria
1) Patients judged by investigators to have an active inflammatory disease other than COVID-19
2) Patients using anticoagulants at the time of diagnosis of COVID-19
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Morishita |
Organization
Division of Health Sciences, Graduate School of Medical Science, Kanazawa University
Division name
Department of Clinical Laboratory Science
Zip code
920-0942
Address
5-11-80, Kodatsuno, Kanazawa, Ishikawa
TEL
076-265-2500
eriko86@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideharu |
| Middle name | |
| Last name | Kimura |
Organization
Kanazawa University Hospital
Division name
Respiratory Medicine
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2000
Homepage URL
hkimura3625@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Reserch and Development
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
Human Genome/Gene Analysis Research Ethics Committee of Kanazawa University
Address
13-1 Takara-machi, Kanazawa city, Ishikawa
Tel
076-265-2110
rinri@adm.kanazawa-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 | 05 | Month | 14 | 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
| 2021 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 02 | 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
Measurements for searching for biomarker candidates
1)Coagulation-related factors, 2)Inflammatory cytokines, 3)Angiogenesis-related factors, 4)Coagulation abnormality-related gene polymorphisms
Management information
Registered date
| 2021 | Year | 05 | Month | 14 | Day |
Last modified on
| 2021 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050487
