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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044212
Receipt No. 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

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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
Email 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
Email hkimura3625@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050487

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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