UMIN-CTR Clinical Trial

Basic information
Public title	Venous Thromboembolism in Patients with COVID-19 in Japan Study
Acronym	VTE and COVID-19 in Japan Study
Scientific Title	Venous Thromboembolism in Patients with COVID-19 in Japan Study
Scientific Title:Acronym	VTE and COVID-19 in Japan Study
Region	Japan

Condition
Condition	Coronavirus disease 2019: COVID-19, severe acute respiratory syndrome coronavirus 2: SARS-CoV-2
Classification by specialty	Medicine in general Cardiology Hematology and clinical oncology Infectious disease Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The coronavirus disease 2019 (COVID-19) has become a huge threat all over the world as a pandemic, which also could cause venous thromboembolism (VTE), including pulmonary embolism (PE). Based on the concept of a high risk for VTE occurrence in patients with COVID-19, some studies reported potential benefit of anticoagulation for the primary prevention of VTE. However, the optimal strategies for the prevention of VTE in COVID-19 still remain unknown. Additionally, ethnic differences may have notable implications in the presentation of VTE. Unfortunately, there is a scarcity of data on current status of VTE in patients with COVID-19 in Japan. Thus, we are going to conduct the observational study to reveal the current status of VTE in patients with COVID-19 in Japan.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Occurrence of VTE during the hospitalization
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	1 years-old <=
Age-upper limit	999 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who were admitted to the hospital during the study period and were evaluated by contrast-enhanced CT examinations for chest.
Key exclusion criteria	None
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Norikazu Middle name Last name Yamada
Organization	Kuwana City Medical Center
Division name	Department of Cardiology
Zip code	511-0061
Address	Kuwana City Kotobukicho 3-11
TEL	0594-22-1211
Email	noriyamada7@gmail.com

Public contact
Name of contact person	1st name Yugo Middle name Last name Yamashita
Organization	Kyoto University
Division name	Department of Cardiovascular Medicine
Zip code	606-8507
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-4255
Homepage URL
Email	yyamashi@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Cardiology, Kuwana City Medical Center
Institute
Department

Funding Source
Organization	None
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	Ethics committee of Kuwana City Medical Center
Address	Kuwana City Kotobukicho 3-11
Tel	0594-22-1211
Email	noriyamada7@gmail.com

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	2020 Year 10 Month 26 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/34011824/
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	45
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 05 Month 20 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2020 Year 10 Month 14 Day
Date of IRB	2020 Year 10 Month 20 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2021 Year 02 Month 01 Day
Date of closure to data entry	2021 Year 02 Month 13 Day
Date trial data considered complete	2021 Year 02 Month 14 Day
Date analysis concluded	2021 Year 02 Month 15 Day

Other

Other related information

Yamashita Y, Maruyama Y, Satokawa H, Nishimoto Y, Tsujino I, Sakashita H, Nakata H, Okuno Y, Ogihara Y, Yachi S, Toya N, Shingaki M, Ikeda S, Yamamoto N, Aikawa S, Ikeda N, Hayashi H, Ishiguro S, Iwata E, Umetsu M, Kondo A, Iwai T, Kobayashi T, Mo M, Yamada N; Taskforce of VTE and COVID-19 in Japan Study. Incidence and Clinical Features of Venous Thromboembolism in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19) in Japan. Circ J. 2021 May 20. doi: 10.1253/circj.CJ-21-0169. Epub ahead of print. PMID: 34011824.

Management information
Registered date	2020 Year 10 Month 26 Day
Last modified on	2021 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048031