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

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 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

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

Value
https://center6.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